Clinical Research Regulation For Kenya
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
QUICK FACTS
Clinical trial application language Unspecified
Regulatory authority & ethics committee review may be conducted at the same time No
Clinical trial registration required Yes
In-country sponsor presence/representation required No (but must have affiliation with a local institution)
Age of minors Under 18
Specimens export allowed Unspecified
Regulatory Authority > Regulatory Authority
Last content review/update: July 23, 2020
Requirements
(1) (Legislation) Health Laws (Amendment) Act, 2019 (PPA-Amndts) (Effective May 17, 2019)
Parliament
Relevant Sections: 3A, 3B, and 25A
(2) (Legislation) Pharmacy and Poisons Act, Chapter 244 (PPA) (Amended through May 21, 2018)
Parliament
Relevant Sections: Part I (3)
(3) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms, Preface, and Introduction
(4) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (Effective January 25, 2013)
Parliament
Relevant Sections: Part IV
Summary

Overview

As per the PPA-Amndts (which amends the PPA), the G-KenyaCT, and Additional Resources (A), (B), (C), and (D), Kenya’s Pharmacy and Poisons Board (PPB) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. As described in Additional Resource (B), the PPB and its Expert Committee on Clinical Trials (ECCT) evaluate all matters relating to clinical trials and grant permission for clinical trials to be conducted in Kenya.

Per the PPA-Amndts, the PPB is authorized to undertake various mandated duties regarding regulation of medicines including:

  • Advise the government in all matters relating to the safety, packaging, and distribution of medicines
  • Ensure that all medicinal products manufactured in, imported into, or exported from the country conform to prescribed standards of quality, safety, and efficacy
  • Ensure that the personnel, premises, and practices employed in the manufacture, storage, marketing, distribution, and sale of medicinal substances comply with the defined codes of practice and other prescribed requirements
  • Enforce the prescribed standards of quality, safety, and efficacy of all medicinal substances manufactured, imported into, or exported out of the country
  • Grant or revoke licenses for the manufacture, importation, exportation, distribution, and sale of medicinal substances
  • Maintain a register of all authorized medicinal substances
  • Publish, at least once every three (3) months, lists of authorized or registered medicinal substances and lists of products with marketing authorizations
  • Regulate narcotic, psychotropic substances, and precursor chemical substances
  • Consider applications for approval and alterations of dossiers intended for use in marketing authorization of medicinal substances
  • Inspect and license all manufacturing premises, importing and exporting agents, wholesalers, distributors, pharmacies (including those in hospitals and clinics), and other retail outlets
  • Prescribe a system for sampling, analysis, and other testing procedures of finished medicinal products released into the market to ensure compliance with the labeled specifications
  • Conduct post-marketing surveillance of safety and quality of medical products
  • Monitor the market for the presence of illegal or counterfeit medicinal substances
  • Regulate the promotion, advertising, and marketing of medicinal substances in accordance with approved product information
  • Approve the use of any unregistered medicinal substance for purposes of clinical trials and compassionate use
  • Approve and regulate clinical trials on medicinal substances
  • Disseminate information on medical products to health professionals and to the public to promote their rational use
  • Collaborate with other national, regional, and international institutions on medicinal substances regulation
  • Advise the Cabinet Secretary on matters relating to control, authorization, and registration of medicinal substances
  • Implement any other function relating to the regulation of medicinal substances

Please note: Kenya is party to the Nagoya Protocol on Access and Benefit-sharing (Additional Resource (E)), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see Additional Resource (F).

Contact Information

Pharmacy and Poisons Board
P.O. Box 27663 – 00506
Nairobi
Lenana Road Opp. DOD
Kenya

For General Inquiries:

Phone: (+254) 709 770 100
General Email: enquiries@pharmacyboardkenya.org

Clinical Trials Inquiries

Email: cta@pharmacyboardkenya.org

For Medicine Problems:

Email: pv@pharmacyboardkenya.org

National Commission for Science, Technology, and Innovation (NACOSTI)

As delineated in the STI Act, in addition to obtaining the PPB’s permission to conduct research in Kenya, the principal investigator or the head of a research institution must register their research proposal and obtain a research permit from the National Commission for Science, Technology, and Innovation (NACOSTI) prior to initiating a study. Established in 2013 by the STI Act, NACOSTI is the successor of the National Council for Science and Technology (NCST). NACOSTI’s role is to regulate and ensure quality in the science, technology, and innovation sector, and to advise the Kenyan government on related matters. According to Part II of the STI Act, NACOSTI has specific research coordination and oversight functions, and it liaises with the National Innovation Agency and the National Research Fund to ensure funding and implementation of prioritized research programs. Additional Resource (G) provides detailed instructions on how to apply for a research permit as well as links to the forms and an online application system. (See the Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements.)

NACOSTI Contact Information:

National Commission for Science, Technology and Innovation
off Waiyaki, Upper Kabete
P. O. Box 30623-00100
Nairobi, Kenya

Phone (landline): (+254) 020 4007000/(+254) 020 2241349/(+254) 020 3310571/(+254) 020 8001077
Phone (wireless): (+254) 020 2673550
Phone (mobile): 0713 788 787/0735 404 245
WhatsApp: 0792 746282

Email: customercare@nacosti.go.ke or info@nacosti.go.ke

Additional Resources
(A) (Website) Pharmacy and Poisons Board – About Us (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(B) (Website) Pharmacy and Poisons Board – Clinical Trials (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(C) (Website) Pharmacy and Poisons Board - Online Clinical Trials Registry System (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(D) (Website) Pharmacy and Poisons Board - Contact Us (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
Convention on Biological Diversity, United Nations
(F) (Website) Country Profile: Kenya (Current as of July 17, 2020)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
(G) (Website) RIMS, NACOSTI Research Information Management System (Current as of June 25, 2020)
National Commission for Science, Technology, and Innovation
(H) (Website) NACOSTI – Contact Us (Current as of June 25, 2020)
National Commission for Science, Technology and Innovation
Regulatory Authority > Scope of Assessment
Last content review/update: June 26, 2020
Requirements
(1) (Legislation) Health Laws (Amendment) Act, 2019 (PPA-Amndts) (Effective May 17, 2019)
Parliament
Relevant Sections: 3A, 3B, and 25A
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definition of Terms, Preface, Introduction, Section One (1, 2, 6, 11, 23, 24, and 34), and Annexes 1-3, 7, and 8
(3) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (Effective January 25, 2013)
Parliament
Relevant Sections: Part IV
Summary

Overview

In accordance with the PPA-Amndts, the G-KenyaCT, and Additional Resources (A) and (B), Kenya’s Pharmacy and Poisons Board (PPB), together with its Expert Committee on Clinical Trials (ECCT), is responsible for reviewing, evaluating, and approving applications for clinical trials using registered or unregistered investigational products (IPs). The G-KenyaCT specifies that the scope of the PPB’s assessment includes all clinical trials (Phases I-IV). As delineated in the G-KenyaCT, the PPB review and approval process may not be conducted in parallel with the ethics committee (EC) review. Rather, EC approval must be obtained prior to applying for PPB approval.

Clinical Trial Review Process

Per the PPA-Amndts, any person who intends to commence a clinical trial on an IP must apply to the PPB in the prescribed form with the study protocol and fee. Annex 2 of the G-KenyaCT delineates the application requirements in the Checklist for Submission of Request for Approval of New Application. As set forth in the G-KenyaCT, PPB appoints an ECCT who, together with PPB staff, is responsible for reviewing the submitted clinical trial applications. However, first, all applications to conduct a clinical trial will be received at PPB’s Clinical Trial Department of Directorate of Medicines Information and Pharmacovigilance. The application will be screened for completeness prior to acceptance. Upon acceptance, an acknowledgement of receipt (via email or through the online system (Additional Resource (B)) will be issued to the applicant with a reference number for each application. The applicant must reference the PPB/ECCT reference number in all future application-related correspondence.

The application is then evaluated by the ECCT and PPB staff according to their respective standard operating procedures. The PPB/ECCT’s decision to approve, request additional information, or reject the application is communicated to the sponsor or his/her representative in writing within 30 working days of receiving a valid application. In certain cases, the PPB may refer the application to external experts for their recommendation. (See the Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed submission requirements.)

In addition, per the G-KenyaCT, the sponsor or his/her representative is required to request approval annually from the PPB at least six (6) weeks prior to the expiration of the previous approval. Refer to Annex 3 of the G-KenyaCT for a checklist of annual approval documentation requirements.

Furthermore, as delineated in the STI Act, the principal investigator or the head of a research institution must register their research proposal and obtain a research permit from the National Commission for Science, Technology, and Innovation (NACOSTI) prior to initiating a study. Registration with NACOSTI does not need to be done prior to PPB approval.

The G-KenyaCT outlines PPB’s scope of assessment of a clinical trial application during a public health emergency. PPB will conduct an expedited review and liaise with relevant stakeholders (including relevant ECs and other oversight bodies) to facilitate a holistic review of an application in a fast-track manner. The following prioritization criteria must be applied in the selection of applications for expedited review:

  • Epidemiology of the emergency
  • Morbidity and mortality associated with the emergency and/or condition under study
  • Supporting scientific data/information available for the IP at the time of submission
  • Feasibility of the implementation of the trial design within the context of the emergency
  • Benefit impact of the intervention and/or trial design

In addition, PPB’s assessment will consider the following:

  • The research does not compromise the response to an outbreak or appropriate care
  • Studies are designed so as to yield scientifically valid results under the challenging and often rapidly evolving conditions of disasters and disease outbreak
  • The research is responsive to the health needs or priorities of the disaster victims and affected communities and cannot be conducted outside a disaster situation
  • The participants are selected fairly and adequate justification is given when particular populations are targeted or excluded, for example, health workers
  • The potential burdens and benefits of research participation and the possible benefits of the research are equitably distributed
  • The risks and potential individual benefits of experimental interventions are assessed realistically, especially when they are in the early phases of development
  • Communities are actively engaged in study planning to ensure cultural sensitivity, while recognizing and addressing the associated practical challenges
  • The individual informed consent of participants is obtained from individuals capable of giving informed consent
  • Research results are disseminated, data are shared, and any effective interventions developed or knowledge generated are made available to the affected communities
Additional Resources
(A) (Website) Pharmacy and Poisons Board – Clinical Trials (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(B) (Website) Pharmacy and Poisons Board - Online Clinical Trials Registry System (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(C) (Website) NACOSTI – Mandate & Functions (Current as of June 25, 2020)
National Commission for Science, Technology and Innovation
Regulatory Authority > Regulatory Fees
Last content review/update: June 26, 2020
Requirements
(1) (Legislation) Health Laws (Amendment) Act, 2019 (PPA-Amndts) (Effective May 17, 2019)
Parliament
Relevant Sections: 3A, 3B, and 25A
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Legal Framework, Section One (1), and Annexes 1-3
Summary

Overview

Per the PPA-Amndts and the G-KenyaCT, the sponsor or his/her representative is responsible for paying a fee to the Pharmacy and Poisons Board (PPB) to submit a clinical trial application for authorization. The PPB currently requires a non-refundable application fee of $1,000 USD, or the equivalent in Kenya Shillings (KES or Kshs) at the prevailing bank rates.

In addition, per Additional Resource (A), to obtain a research permit from the National Commission for Science, Technology, and Innovation (NACOSTI), the applicant must submit evidence of fee payment on the last page of the online clinical trial application.

Instructions for Payment of Clinical Trial Application Fee

As stated in the G-KenyaCT, payment is to be made by a bank check payable to the “Pharmacy and Poisons Board” and presented to the PPB’s accounts office upon submitting the application.

Payment can also be made by electronic fund transfer (EFT), if required. The sponsor or his/her representative is responsible for all bank charges associated with the EFT. Details of the EFT payment should be obtained from the PPB prior to initiating such a transaction.

NACOSTI Registration Fee

As delineated in Additional Resource (A), NACOSTI charges a fee that varies depending on the applicant’s status as Kenyan or non-Kenyan, and his/her standing as a researcher (i.e., student, public/private institution, private company). Details on additional requirements are provided in the Clinical Trial Lifecycle topic, Submission Content subtopic.

  • Undergraduate/Diploma: East African Community (EAC) Citizens – 100 Kshs; Rest of Africa – 200 Kshs; Non Africans - $150 USD
  • Masters: EAC Citizens – 1,000 Kshs; Rest of Africa – 2,000 Kshs; Non Africans - $350 USD
  • PhD: EAC Citizens – 2,000 Kshs; Rest of Africa – 4,000 Kshs; Non Africans - $400 USD
  • Individual/Post Doc: EAC Citizens – 5,000 Kshs; Rest of Africa – 10,000 Kshs; Non Africans - $500 USD
  • Public Institutions: EAC Citizens – 10,000 Kshs; Rest of Africa – 20,000 Kshs; Non Africans - $1,000 USD
  • Private Institutions/Companies/NGOs: EAC Citizens – 20,000 Kshs; Rest of Africa – 40,000 Kshs; Non Africans - $10,000 USD

Additional Resource (B) indicates that the applicant must submit the clinical trial application through the online application system (Login is in top right corner of page in Additional Resource (B)), but payment should be deposited in the NACOSTI Bank Account as listed in Additional Resources (A) and (B):

Kenya Shillings Account:
Kenya Commercial Bank
Branch: Kipande House
Account Name: National Commission for Science, Technology and Innovation
Account Number: 1104162547
Swift Code: KCBLKENX
Transaction Description: Research License Fee

U.S. Dollar Account:
NCBA Bank
Branch: City Centre
Account Name: National Commission for Science, Technology and Innovation
Account Number: 1001467375
Swift Code: CBAFKENX
Transaction Description: Research License Fee

Additional Resources
(A) (Flyer) NACOSTI Research Licensing in Kenya (November 2018)
National Commission for Science, Technology and Innovation
(B) (Website) Guidelines for Online Applications of Research License (Current as of July 10, 2020)
National Commission for Science, Technology and Innovation
Ethics Committee > Ethics Committee
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (11 and 23), and Annex 2
(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical; Guidelines; Externally Sponsored Research; and Constituting an Ethical Committee
(3) (Guidance) Guidelines for Accreditation of Institutional Ethics Review Committees in Kenya (G-ECAccred) (October 2017)
National Commission for Science, Technology and Innovation
Relevant Sections: Definition of Terms, 1.0, 2.0., 3.0, 4.0, and Annexes I-III
(4) (Regulation) The Science, Technology and Innovation (Registration and Accreditation of Research Institutions) Regulations, 2014 (STI Regs) (August 1, 2014)
National Council for Science, Technology, and Innovation
Relevant Sections: Legal Notice No. 107 (Part II) and Third Schedule
Summary

Overview

As per the G-KenyaCT, the G-ECBiomedRes, and Additional Resource (A), Kenya requires an independent review of research through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC) in one (1) of the local institutions charged with the responsibility of conducting research in human participants. The G-ECBiomedRes indicates that private institutions, individuals, and groups of individuals who wish to engage in biomedical research involving humans, should affiliate themselves with public institutions mandated to do medical research in Kenya, or they can send their research proposals to the NACOSTI for evaluation and advice as to which institution they should affiliate.

Additional Resource (B) provides a list of the accredited institutional ECs. As delineated in the G-ECAccred, NACOSTI will issue a certificate of accreditation to accredited institutional ECs, which is effective for three (3) years from the date of NACOSTI notification. All accredited ECs must submit annual reports to NACOSTI by July 31st for review and monitoring. Applications for renewal of accreditation should be made six (6) months before expiry of the accreditation period. Failure to renew accreditation or failure to maintain the appropriate standards for continuity of accreditation will mean that the accredited status of the EC will lapse at the end of the current accreditation period. Accreditation must be terminated if the accredited committee fails to maintain the required standards. See the G-ECAccred for detailed instructions and Additional Resource (C) for the application form required for institutional EC accreditation.

Externally Sponsored Research

As set forth in the G-ECBiomedRes, an external sponsoring agency must first submit its research protocol for ethics and scientific review according to its own country’s standards. The standards applied should be comparable to those used to evaluate studies in its own country.

Once the ethics and scientific review is completed in the sponsor’s own country, Kenya’s host institutional EC must also approve the research protocol according to its own standards. Externally sponsored research must also address health problems central to Kenya. See the G-ECBiomedRes for more details.

Institutional EC Composition

As delineated in the G-ECAccred, institutional ECs should consist of at least seven (7) members, or an odd number above seven (7). The G-ECBiomedRes states that these members should be multidisciplinary and multisectoral in composition, collectively encompass relevant scientific expertise, balanced age and gender distribution, and include laypersons representing community interests and concerns. Per the G-ECAccred, the composition should meet the following requirements:

  • At least one (1) member with knowledge and understanding of Kenyan law
  • At least one-third of the members of the committee must be female and one-third must be male
  • At least one (1) member who is unaffiliated with the institution
  • At least two (2) members must have research expertise and experience, one of whom must be in the health field
  • At least one (1) member must be a lay member
  • For ECs reviewing clinical research, at least two (2) members must be clinicians, one (1) of whom is currently in active practice or clinical research
  • Reflect the regional and ethnic diversity of the people of Kenya

The chairperson must also have some basic training and/or experience in bioethics and leadership. All EC appointments are the responsibility of the institution’s administrative head. See the G-ECAccred and the G-ECBiomedRes for detailed institutional EC requirements.

Terms of Reference, Review Procedures, and Meeting Schedule for Institutional ECs

As delineated in the G-ECAccred, the G-ECBiomedRes, and the STI Regs, institutional ECs must operate within written standard operating procedures (SOPs) which delineate the EC’s process for conducting reviews. Per the G-ECAccred, SOPs should include but are not limited to information on EC scope, responsibility, and objectives, institutions served, committee functions, terms and conditions of member appointment, business procedures including meeting schedules and types of reviews, documentation, recordkeeping, and archiving procedures, quorum requirements, communication procedures, and complaint process and dispute resolution procedures. Per the G-ECAccred and the STI Regs, these documents must be provided to NACOSTI.

Per the G-ECAccred, the quorum for NACOSTI-accredited EC meetings must be:

  • At least 50 percent of the membership must form the quorum;
  • A lay person must be present in all meetings; and
  • For ECs reviewing clinical research, at least two (2) members must be clinicians, one (1) of whom is currently in active practice or clinical research.

The G-ECBiomedRes also defines quorum requirements:

  • The minimum number of members required to compose a quorum (e.g., more than half the members)
  • The professional qualifications requirements (e.g., physician, lawyer, statistician, paramedical, or layperson) and the distribution of those requirements over the quorum; no quorum should consist entirely of members of one (1) profession or one (1) gender; a quorum should include at least one (1) member whose primary area of expertise is in a non-scientific area, and at least one (1) member who is independent of the institution/research site

For detailed institutional EC requirements and information on other administrative processes, see the G-ECAccred and the G-ECBiomedRes. See Additional Resources (D) and (E) for examples of accredited EC submission and review guidelines. With regard to the Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI) (see Additional Resource (E), detailed SOPs may be obtained by contacting SERU at seru@kemri.org.

Additional Resources
(A) (Website) NACOSTI – Frequently Asked Questions (Current as of June 25, 2020)
National Council for Science, Technology, and Innovation
(B) (Website) Accredited Institutional Ethics Review Committees (IERCs) (Current as of June 25, 2020)
National Commission for Science, Technology and Innovation
National Commission for Science, Technology and Innovation
(D) (Website) KNH-UoN Ethics and Research Committee – E-Resources (Current as of June 25, 2020)
Kenyatta National Hospital and University of Nairobi Ethics and Research Review Committee
(E) (Website) The Scientific and Ethics Review Unit (Current as of June 25, 2020)
Kenya Medical Research Institute
Ethics Committee > Scope of Review
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical; General Ethical Principles; and Constituting an Ethical Committee
(2) (Guidance) Guidelines for Accreditation of Institutional Ethics Review Committees in Kenya (G-ECAccred) (October 2017)
National Commission for Science, Technology and Innovation
Relevant Sections: 1.0-1.2
(3) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviation and Definition of Terms, Section One (11 and 23), and Annex 2
Summary

Overview

According to G-ECBiomedRes the primary scope of information assessed by the institutional ethics committees (ECs) relate to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. The G-ECAccred further states that the National Commission for Science, Technology and Innovation (NACOSTI) accredits ECs in order to uphold the standard of ethics review in the country; develop public confidence and trust in the national research system; facilitate equitable access to research and human health records in health facilities; and facilitate coordination and collaboration among ECs.

As per the G-ECBiomedRes, the ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; and Mentally Impaired for additional information about these populations).

The G-ECBiomedRes also state that the institutional ECs are responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; and verifying the adequacy of confidentiality and privacy safeguards. See the G-ECAccred and the G-ECBiomedRes for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

As per the G-KenyaCT and Additional Resource (A), the Pharmacy and Poisons Board (PPB)’s review and approval of a clinical trial application is dependent upon obtaining approval by an accredited institutional EC. Consequently, the PPB and EC reviews may not be conducted in parallel.

See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission process requirements.)

Additional Resources
(A) (Website) Pharmacy and Poisons Board – Clinical Trials (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
Ethics Committee > Ethics Committee Fees
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms and Annex 2
(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical; Guidelines; Externally Sponsored Research; and Constituting an Ethical Committee
Summary

Overview

As per the G-KenyaCT, G-ECBiomedRes, and Additional Resource (A), Kenya requires an independent review of research through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC) in the local institution charged with the responsibility of conducting research in human participants. The EC fee to review a clinical trial application will vary depending on the institution. For example, per Additional Resource (B), the Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI) charges non-KEMRI investigators 100,000 Kshs (Kenya shillings) for an initial protocol review and 200,000 Kshs for an expedited review. SERU notes that this is a one-off fee for each study. Detailed standard operating procedures may be obtained by contacting SERU at seru@kemri.org (Additional Resource (C)). Per Additional Resource (D), the Kenyatta National Hospital and the University of Nairobi Ethics and Research Review Committee (KNH-UoN) charges a processing fee as indicated in the protocol submission checklist; the specific amount is not identified.

For a list of NACOSTI-accredited ECs, see Additional Resource (E).

Additional Resources
(A) (Website) NACOSTI – Frequently Asked Questions (Current as of June 25, 2020)
National Council for Science, Technology, and Innovation
Relevant Sections: Where do I get a letter of ethical approval before applying for a research license?
(B) (Website) FAQs (Current as of June 25, 2020)
Kenya Medical Research Institute
(C) (Website) The Scientific and Ethics Review Unit (Current as of June 25, 2020)
Kenya Medical Research Institute
(D) (Website) KNH-UoN Ethics and Research Committee – E-Resources (Current as of June 25, 2020)
Kenyatta National Hospital and University of Nairobi Ethics and Research Review Committee
Relevant Sections: Protocol Submission Checklist
(E) (Website) Accredited Institutional Ethics Review Committees (IERCs) (Current as of June 25, 2020)
National Commission for Science, Technology and Innovation
Ethics Committee > Authorizing Body
Last content review/update: June 26, 2020
Requirements
(1) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (Effective January 25, 2013)
Parliament
Relevant Sections: Part II
(2) (Guidance) Guidelines for Accreditation of Institutional Ethics Review Committees in Kenya (G-ECAccred) (October 2017)
National Commission for Science, Technology and Innovation
Relevant Sections: 1.0, 2.0, 4.0, and Annex III
(3) (Regulation) The Science, Technology and Innovation (Registration and Accreditation of Research Institutions) Regulations, 2014 (STI Regs) (August 1, 2014)
National Council for Science, Technology, and Innovation
Relevant Sections: Legal Notice No. 107 (Part II)
Summary

Overview

As set forth in the STI Act and Additional Resource (A), the National Commission for Science, Technology and Innovation (NACOSTI) is the central body responsible for the oversight, promotion, and coordination of research. NACOSTI’s role is to regulate and ensure quality in the science, technology, and innovation sector, and to advise the Kenyan government on related matters. As per the G-ECAccred, NACOSTI has delegated the task of reviewing research proposals for ethical clearance to accredited institutional ethics committees (ECs) to ensure that research conducted in the country observes high research ethics standards.

Registration, Auditing, and Accreditation

As per the G-ECAccred and the STI Regs, NACOSTI is responsible for accrediting institutional ECs. Per the G-ECAccred, the application requirements for accreditation are:

  • A completed application form (Additional Resource (B) or Annex III of the G-ECAccred)
  • Copy of the standard operating procedures (SOPs)
  • Copies of abridged curriculum vitaes (CVs) (no more than four (4) pages) for each member of the proposed EC (including the training attended)
  • Profile of the organization/institution detailing the areas of competence (no more than four (4) pages)

NACOSTI issues a certificate of accreditation to accredited institutional ECs, which is effective for three (3) years from the date of NACOSTI’s notification. All accredited ECs must submit annual reports to NACOSTI by July 31st for review and monitoring. Applications for renewal of accreditation should be made six (6) months before expiry of the accreditation period. Failure to renew accreditation or failure to maintain the appropriate standards for continuity of accreditation will mean that the accredited status of the EC will lapse at the end of the current accreditation period. Accreditation shall be terminated if the accredited committee fails to maintain the required standards. For re-accreditation review purposes, ECs must provide the SOPs under which they will operate. The SOPs are not required as part of the annual reporting process, unless they have been amended, but are required to be stated/included for the reaccreditation review process (every three (3) years). See the G-ECAccred for additional details on the accreditation process.

Additional Resources
(A) (Website) NACOSTI – Mandate & Functions (Current as of June 25, 2020)
National Commission for Science, Technology and Innovation
National Commission for Science, Technology and Innovation
Clinical Trial Lifecycle > Submission Process
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms, Preface, Introduction, Section One (1, 9, 11, and 23), and Annexes 1-3, 7, and 8
(2) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (Effective January 25, 2013)
Parliament
Relevant Sections: Parts II, IV, V, and X and Fourth Schedule
Summary

Overview

In accordance with the G-KenyaCT and Additional Resources (A) and (B), Kenya requires the sponsor or his/her representative to obtain clinical trial authorization from the Pharmacy and Poisons Board (PPB)’s Expert Committee on Clinical Trials (ECCT) and an independent ethics review through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committees (EC) in a local institution. In addition, the STI Act and Additional Resource (C) specify that applicants must register their research proposal with the NACOSTI and obtain a research permit prior to initiating a study. The G-KenyaCT also states that the PPB review and approval process may not be conducted in parallel with the EC review. EC approval must be obtained prior to applying for PPB approval.

As delineated in the G-KenyaCT, in the event of a multicenter clinical trial, the sponsor should only file one (1) application to the PPB.

Each institutional EC has its own required submission procedures, which can differ significantly regarding the application format and number of copies. See Additional Resource (D) for an example of a NACOSTI accredited EC’s guidelines.

Per the G-KenyaCT, sponsors (applicants) can request pre-submission meetings with PPB to discuss pertinent issues prior to formal submissions. The request must be made in an official letter and include the following information:

  • Background information on the disease to be treated
  • Background information on the product·Quality development
  • Non-clinical development
  • Clinical development
  • Regulatory status
  • Rationale for seeking advice
  • Proposed questions and applicant’s positions

In addition, the letter must be addressed to the Chief Executive Officer of PPB and sent to admin@pharmacyboardkenya.org, copied to cta@pharmacyboardkenya.org. The request for a meeting should propose two (2) different dates for the meeting with the proposed dates being at least three (3) weeks away.

(See Submission Content subtopic for details of what must be submitted.)

Delivery Address for Clinical Trial Application

Pharmacy and Poisons Board
P.O. Box 27663-00506
Lenana Road Opp. DOD
Nairobi, Kenya
Attention: The Expert Committee on Clinical Trials
General Enquiries Phone: (+254) 709 770 100

General Enquiries Email: enquiries@pharmacyboardkenya.org
Clinical Trials Email: cta@pharmacyboardkenya.org

Assembly and Number of Copies

Based on information provided in Additional Resource (B), the sponsor or his/her representative are encouraged to register and submit the clinical trial application electronically via the PPB ECCT’s online system. However, as specified in the G-KenyaCT, the ECCT will also accept applications submitted by mail. When submitting an application by mail, the sponsor or his/her representative should provide four (4) bound hard copies. A copy of the application form may be accessed directly from Additional Resource (F).

Clinical Trial Application Language Requirements

While there is no specified language requirement for documents submitted to the PPB, English appears to be the preferred language. The G-KenyaCT states that the informed consent to participants must be administered in either English or Kiswahili and spoken language of the local area, where applicable. The same information will be given to participants in a written format. Copies of the informed consent forms must be submitted to the PPB.

Additional Resources
(A) (Website) Pharmacy and Poisons Board – Clinical Trials (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(B) (Website) Pharmacy and Poisons Board - Online Clinical Trials Registry System (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(C) (Website) RIMS, NACOSTI Research Information Management System (Current as of June 25, 2020)
National Commission for Science, Technology, and Innovation
(D) (Website) KNH-UoN Ethics and Research Committee – E-Resources (Current as of June 25, 2020)
Kenyatta National Hospital and University of Nairobi Ethics and Research Review Committee
(E) (Website) Pharmacy and Poisons Board - Contact Us (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(F) (Form) Kenya: Clinical Trial Application Form (Date Unavailable)
Pharmacy and Poisons Board, Ministry of Health
Clinical Trial Lifecycle > Submission Content
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Preface, Introduction, Section One (1 and 11), and Annexes 1-5, 7, and 8
(2) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (Effective January 25, 2013)
Parliament
Relevant Sections: Parts II, IV, V, and X and Fourth Schedule
(3) (Regulation) The Science, Technology and Innovation (Registration and Accreditation of Research Institutions) Regulations, 2014 (STI Regs) (August 1, 2014)
National Council for Science, Technology, and Innovation
Relevant Sections: Legal Notice No. 108 (Part II)
(4) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical; Constituting an Ethical Committee; and Externally Sponsored Research
Summary

Overview

As set forth in the G-KenyaCT, and Additional Resources (A) and (B), Kenya requires the sponsor or his/her representative to obtain clinical trial authorization from the Pharmacy and Poisons Board (PPB)’s Expert Committee on Clinical Trials (ECCT) and an independent ethics review through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committees (EC) in a local institution. In addition, the STI Act and Additional Resource (C) specify that applicants must register their research proposal with the NACOSTI and obtain a research permit prior to initiating a study.

PPB Requirements

Based on information provided in Additional Resource (B), the sponsor or his/her representative are encouraged to register and submit the clinical trial application electronically via the PPB online system. The clinical trial application form is available in the online system (Additional Resource B)) and directly at Additional Resource (D). As per Annex 2 of the G-KenyaCT, the following documentation must be submitted (signed, dated, and version referenced) to the PPB:

  • Cover letter
  • Study protocol
  • Patient information leaflet and informed consent form (ICF) (English, Swahili, and local languages to be used)
  • Investigators brochure (IB) and package inserts
  • Investigational Medicinal Product Dossier (IMPD) including stability data of the study product
  • Adequate data and information on previous studies and phases
  • Good manufacturing practice (GMP) certificate of the investigational product (IP) from the site of manufacture and certificate of analysis
  • Pictorial sample of the IPs, including the labeling text
  • Signed investigator(s) curriculum vitae(s) (CV(s)) including that of the study pharmacist
  • Evidence of recent good clinical practice (GCP) training of the core study staff
  • Data and Safety Monitoring Board (DSMB) charter/draft charter, including the composition and meeting schedule
  • Statistical analysis plan submitted with initial application or commitment to submit it before end of enrollment
  • Detailed study budget
  • Copy of favorable EC opinion letter
  • Indemnity cover for principal investigators (PIs) and investigators
  • Insurance Certificate for the study participants
  • Copy of current licenses for the investigators and study pharmacist
  • Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
  • For multicenter/multi-site studies, a site-specific addendum for each of the proposed sites including, among other things, the sites’ capacity to carry out the study (e.g., personnel, equipment, laboratory)
  • Registration at PPB’s Online Clinical Trials Registry System (Additional Resource (B))
  • Registration of the study at Pan African Clinical Trials Registry (Additional Resource (E))
  • Signed Declarations (Annexes 4-5 of G-KenyaCT and Additional Resources (F) and (G))
  • Payment of fees
  • Four (4) bound hard copies of all the above listed documents
  • Signed checklist (Annex 2 of G-KenyaCT)

Annex 3 of G-KenyaCT describes the submission content for requesting annual approval from PPB.

NACOSTI Requirements

Per Additional Resources (C) and (H), applicants must apply online through NACOSTI’s Research Information Management System website and upload the following:

  • Passport size photo
  • Scanned ID/passport
  • Affiliation letter from relevant local institution for foreigners
  • Research proposal
  • Introductory letter for students
  • Certificate of ethical clearance of the research (list of accredited ECs in Additional Resource (I))
  • Evidence of payment as the last page of the uploaded proposal

The following conditions apply to the research permit:

  • The research permit is valid for the proposed research, site, and specified period
  • Both the research permit and any rights thereunder are non-transferable
  • NACOSTI may monitor and evaluate the research
  • The licensee must report to relevant government offices in the area of research before commencement
  • Excavation, filming, and collection of specimens are subject to further permissions from relevant government agencies
  • The research permit does not give authority to transfer research materials
  • The licensee shall submit one (1) hard copy and upload a soft copy of their final report within one (1) year of completion of the research
  • NACOSTI reserves the right to modify the conditions of the research permit including its cancellation without prior notice

Per the STI Regs, non-Kenyan applicants must be affiliated with a Kenyan institution.

As set forth in the G-ECBiomedRes, a foreign sponsoring agency must submit its research protocol for ethics and scientific review according to its own country’s standards. The standards applied should be comparable to those used to evaluate studies in the agency’s own country.

Institutional EC Requirements

EC requirements vary depending on the specific EC. Examples of NACOSTI-accredited EC requirements are delineated in the Ethics and Research Application Form used by the Kenyatta National Hospital/University of Nairobi (KHN/UoN) Ethics and Research Committee and the Kenya Medical Research Institute (KEMRI) (Additional Resource (J)). As specified in Additional Resource (J), the following documentation is required to obtain ethics approval from these two (2) ECs:

  • Three (3) copies of application form (including at least one (1) copy with original linked signatures)
  • Three (3) copies of relevant documentation (ICFs, questionnaires, data instruments, drug information summary, data collection forms, debriefing statements, advertisements, etc.)
  • Three (3) copies of protocol and grant/contract
  • One (1) copy of protocol and IB for trials
  • Three (3) copies of thesis/dissertation proposal, where applicable to students
  • PI name and contact information
  • Project title
  • Research personnel
  • Funding information
  • Project description
  • Methodology and procedures
  • Participants description (e.g., selection/withdrawal criteria and treatment)
  • Risk benefits and adverse events (See Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional information)
  • Research data confidentiality
  • Consent/assent forms and waiver

Clinical Protocol

NACOSTI’s protocol submission requirements are not currently available electronically. An example of accredited EC KNH/UoN’s requirements for the protocol submission is provided in Additional Resource (L) and includes the following:

  • Title
  • Investigator(s) and supervisor(s) name and contact information
  • Collaborating institutions name and contact information
  • Summary
  • Rationale
  • Hypothesis/Hypotheses
  • Methodology
  • References
  • Budget

In addition, per the G-KenyaCT, research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum). Accordingly, the ICH-GCPs-Addendum requires the following protocol contents:

  • General information (protocol title, identifying number, and date; contact information for the sponsor, medical expert, investigator(s), trial site(s), qualified physician(s), and laboratory and/or institutions involved in the study)
  • Background information
  • Objectives and purpose
  • Trial design
  • Selection, withdrawal, and treatment of participants
  • Assessment of efficacy
  • Assessment of safety
  • A description of the statistical methods to be used in the trial
  • Direct access to source data and documents
  • Quality control and quality assurance
  • Ethical considerations
  • Data handling and recordkeeping
  • Publication policy
Additional Resources
(A) (Website) Pharmacy and Poisons Board – Clinical Trials (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(B) (Website) Pharmacy and Poisons Board - Online Clinical Trials Registry System (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(C) (Website) RIMS, NACOSTI Research Information Management System (Current as of June 25, 2020)
National Commission for Science, Technology, and Innovation
(D) (Form) Kenya: Clinical Trial Application Form (Date Unavailable)
Pharmacy and Poisons Board, Ministry of Health
(E) (Website) Pan African Clinical Trials Registry (Current as of June 25, 2020)
Pan African Clinical Trials Registry
Pharmacy and Poisons Board, Ministry of Health
(G) (Document) Declaration by Applicant (Date Unavailable)
Pharmacy and Poisons Board, Ministry of Health
(H) (Flyer) NACOSTI Research Licensing in Kenya (November 2018)
National Commission for Science, Technology and Innovation
(I) (Website) Accredited Institutional Ethics Review Committees (IERCs) (Current as of June 25, 2020)
National Commission for Science, Technology and Innovation
Kenyatta National Hospital/University of Nairobi, Kenya Medical Research Institute
Kenyatta National Hospital and University of Nairobi Ethics and Research Committee
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 6
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Preface, Introduction, Section One (2, 9, 11, 23, and 24), and Annexes 2, 3, and 7-8
(2) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (Effective January 25, 2013)
Parliament
Relevant Sections: Parts II, IV, V, and X and Fourth Schedule
Summary

Overview

In accordance with the G-KenyaCT, and Additional Resources (A) and (B), Kenya requires the sponsor or his/her representative to obtain clinical trial authorization from the Pharmacy and Poisons Board (PPB) and its Expert Committee on Clinical Trials (ECCT) and an independent ethics review through a National Commission for Science, Technology, and Innovation (NACOSTI)-accredited ethics committee (EC) in a local institution. The G-KenyaCT also states that the PPB review and approval process may not be conducted in parallel with the EC review. EC approval must be obtained prior to applying for PPB approval.

In addition, the STI Act and Additional Resource (C) specify that all applicants must register their research proposal with NACOSTI and obtain a research permit prior to initiating a study.

PPB Approval

Clinical Trial Application Submission

Per the G-KenyaCT, sponsors (or applicants) can request pre-submission meetings to discuss pertinent issues prior to formal submissions. The request must be made in an official letter addressed to the Chief Executive Officer of PPB and sent to admin@pharmacyboardkenya.org, copied to cta@pharmacyboardkenya.org. The request for a meeting should propose two (2) different dates for the meeting with the proposed dates being at least three (3) weeks away. (See Submission Process subtopic for details on the content of request.)

As per the G-KenyaCT, the PPB’s ECCT review and approval process for a clinical trial application takes 30 working days.

Upon receipt of a clinical trial application, the PPB’s Clinical Trial Department of the Directorate of Medicines Information and Pharmacovigilance screens the application package for completeness, which will take five (5) days. If accepted, the sponsor or his/her representative is issued an acknowledgement of receipt, and a PPB/ECCT reference number is assigned to the application. If additional information is needed, the sponsor will have 10 days to respond. The PPB aims to respond to applications within 30 working days. The sponsor or his/her representative must reference the PPB/ECCT number in all future application-related correspondence.

The application is then evaluated by the ECCT and PPB staff according to their respective standard operating procedures. The PPB/ECCT’s decision to approve, request additional information, or reject the application is communicated to the sponsor or his/her representative in writing within 30 days of receiving a valid application. If additional information is requested, the sponsor has 90 days to respond and PPB has 15 days from that to issue a final decision. In certain cases, the PPB may refer the application to external experts for their recommendation.

Per the G-KenyaCT, the sponsor or his/her representative is also required to request approval annually from the PPB at least six (6) weeks prior to the expiration of the previous approval. Refer to Annex 3 of the G-KenyaCT for a checklist of annual approval documentation requirements.

The G-KenyaCT outlines PPB’s review of a clinical trial during a public health emergency. PPB will conduct an expedited review of the application and will liaise with relevant stakeholders (including relevant ECs and other oversight bodies) to facilitate a holistic review of an application in a fast-track manner. The following prioritization criteria must be applied in the selection of applications for expedited review:

  • Epidemiology of the emergency
  • Morbidity and mortality associated with the emergency and/or condition under study
  • Supporting scientific data/information available of the investigational product at the time of submission
  • Feasibility of the implementation of the trial design within the context of the emergency
  • Benefit impact of the intervention and/or trial design

Institutional EC Approval

The EC review and approval process timeline will vary by institution.

NACOSTI Research Permit Approval

Per Additional Resources (E), (F), and (G), the timeline for NACOSTI’s permit application process is 30 days. Additional Resources (E) and (G) indicate that the duration of the research permit is one (1) year.

Additional Resources
(A) (Website) Pharmacy and Poisons Board – Clinical Trials (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(B) (Website) Pharmacy and Poisons Board - Online Clinical Trials Registry System (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(C) (Website) RIMS, NACOSTI Research Information Management System (Current as of June 25, 2020)
National Commission for Science, Technology, and Innovation
(D) (Website) Accredited Institutional Ethics Review Committees (IERCs) (Current as of June 25, 2020)
National Commission for Science, Technology and Innovation
(E) (Flyer) NACOSTI Research Licensing in Kenya (November 2018)
National Commission for Science, Technology and Innovation
(F) (Document) NACOSTI Service Charter (2018)
National Commission for Science, Technology and Innovation
(G) (Website) Guidelines for Online Applications of Research License (Current as of July 10, 2020)
National Commission for Science, Technology and Innovation
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: June 26, 2020
Requirements
(1) (Legislation) Health Laws (Amendment) Act, 2019 (PPA-Amndts) (Effective May 17, 2019)
Parliament
Relevant Sections: 25A
(2) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definition of Terms, Preface, Introduction, Section One (1-3, 5, 11, 17-18, 23, and 31), and Annexes 1-3 and 7
(3) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee
(4) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (Effective January 25, 2013)
Parliament
Relevant Sections: Parts II, IV, V, and X and Fourth Schedule
(5) (Guidance) Guidelines for Accreditation of Institutional Ethics Review Committees in Kenya (G-ECAccred) (October 2017)
National Commission for Science, Technology and Innovation
Relevant Sections: Introduction
(6) (Legislation) Pharmacy and Poisons Act, Chapter 244 (PPA) (Amended through May 21, 2018)
Parliament
Relevant Sections: Part IV (44)
Summary

Overview

In accordance with the PPA-Amndts, the G-KenyaCT, the G-ECBiomedRes, the STI Act, and Additional Resource (A), a clinical trial can only commence after the sponsor or his/her representative receives authorization from Kenya’s Pharmacy and Poisons Board (PPB), and ethics committee (EC) approval from an institutional EC that has been accredited by the National Commission for Science, Technology and Innovation (NACOSTI) prior to initiating a study. ECs are accredited pursuant to the requirements delineated in the G-ECAccred. (See Additional Resource (C) for a list of accredited ECs.) The G-KenyaCT specifies that the PPB review and approval process may not be conducted in parallel with the EC review. In addition, the STI Act and Additional Resource (D) state that all applicants must register their research proposal with the NACOSTI and obtain a research permit prior to initiating a study. No waiting period is required following the applicant’s receipt of these approvals.

As per the G-KenyaCT and the PPA, the sponsor or his/her representative is required to obtain an import license for the shipment of an investigational product to be used in the trial. (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

As stated in the G-KenyaCT, the principal investigator (PI) must possess appropriate qualifications, training, and experience, and must also be a resident of Kenya. For multisite studies in Kenya, the coordinating investigator should be a Kenyan resident, and should assume full responsibility for the trial. All investigators involved in the trial must have had formal training in good clinical practices (GCPs), and submit proof that a GCP course was attended within the past two (2) years. The trials should be conducted in compliance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum).

The G-KenyaCT also states that before the trial begins, the protocol should be dated and signed by the investigator, the institution(s) involved, and the sponsor.

Clinical Trial Agreement

Prior to initiating the trial, the G-KenyaCT requires the sponsor to sign and date an agreement with the investigator(s)/institution(s) as part of the protocol submitted for the PPB’s approval or in a separate agreement. The sponsor must obtain their agreement on the following:

  • The conduct of the trial in compliance with the ICH-GCPs-Addendum and also with the approved protocol
  • Compliance with procedures for data recording/reporting and to permit monitoring, auditing, and inspection according to the protocol

EC Confirmation of Review and Approval

The G-KenyaCT requires the sponsor to obtain a copy of the favorable opinion letter from the local and national ECs, and submit this documentation to the PPB in the clinical trial application package prior to the trial’s commencement. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).

Kenya Clinical Trials Registry

As per the G-KenyaCT, all clinical trials taking place in Kenya must be registered in the PPB’s Online Clinical Trials Registry System. The PI is required to log in and set up an account to register a study. The sponsor or his/her representative must include proof of this registration in the application package submitted to the PPB.

In addition, all clinical trials taking place in Kenya must be registered in the Pan African Clinical Trials Registry (Additional Resource (F)).

Data and Safety Monitoring Board

The G-KenyaCT indicates that the PPB recommends establishing a Data and Safety Monitoring Board (DSMB) to monitor trials in the following types of studies:

  • Where the endpoint is such that a highly favorable or unfavorable result, or even a finding of futility at an interim analysis, might ethically require the trial to be terminated early
  • When there are safety concerns due to the use of a particularly invasive treatment
  • Where there is prior information suggesting the possibility of serious toxicity with the study treatment
  • Where the participants involved represent a vulnerable population (e.g., children, pregnant women, elderly, terminally ill, or mentally incapacitated)
  • When the participants represent a population at higher risk of death or other serious outcomes
  • When the study is large, of long duration, and multi-center

Per the G-KenyaCT, the DSMB must provide the following documentation to the PPB:

  • DSMB composition
  • Copy of DSMB charter (Annex 2 of the G-KenyaCT requires submission of the charter with the clinical trial application)
  • DSMB reports to be submitted to the PPB within two (2) weeks of its deliberations and in the request for annual approval

For detailed requirements on establishing a DSMB, see Section 17 of the G-KenyaCT.

In addition, the ICH-GCPs-Addendum recommends establishing a DSMB to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
(A) (Website) Pharmacy and Poisons Board – Clinical Trials (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(B) (Website) Pharmacy and Poisons Board - Online Clinical Trials Registry System (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(C) (Website) Accredited Institutional Ethics Review Committees (IERCs) (Current as of June 25, 2020)
National Commission for Science, Technology and Innovation
(D) (Flyer) NACOSTI Research Licensing in Kenya (November 2018)
National Commission for Science, Technology and Innovation
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 4, 5.5
(F) (Website) Pan African Clinical Trials Registry (Current as of June 25, 2020)
Pan African Clinical Trials Registry
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms, Section One (4-5, 16, 17, and 21), and Annex 2
(2) (Guidance) Guidelines for the National Pharmacovigilance System in Kenya (G-KenyaPV) (2nd Edition) (February 2009)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Basic Principles of Efficient Reporting and Annexes 1 and 8
Summary

Overview

According to the G-KenyaCT and the G-KenyaPV, the following definitions provide a basis for a common understanding of Kenya’s safety reporting requirements:

  • Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product
  • Adverse Drug Reaction (ADR) – Any noxious and unintended response in a participant to a medicinal investigational product (IP) which is related to any dose administered to that participant
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
  • Suspected Unexpected Serious Adverse Reaction (SUSAR) – A serious adverse reaction where the nature and severity of the event is inconsistent with the medicinal product

Reporting Requirements for AEs/ADRs

As indicated in the G-KenyaCT, the sponsor must report to Kenya’s Pharmacy and Poisons Board (PPB) all SUSARs occurring in clinical trials being conducted in Kenya or occurring in the same clinical trial in a third country. All SUSARs related to the same active substance (regardless of pharmaceutical form and strength or indication investigated) in a clinical trial performed exclusively in a third country must be reported by the sponsor to the PPB. Initial fatal or life-threatening SUSARs should be reported by the sponsor as soon as possible, and in any case, no later than seven (7) days after being made aware of the case. If the initial report is incomplete, the sponsor must submit a completed report based on the initial information within an additional eight (8) days. SUSARs that are neither fatal nor life-threatening must be reported within 15 days. The SUSARs to be reported include those that occur within or outside the concerned trial. The SUSAR and SAE reports must also be submitted to the PPB through the online system (Additional Resource (A)).

Further, the G-KenyaCT requires the sponsor to report all SUSARs and SAEs to all relevant institutions, including ethics committees (ECs), occurring during the course of the trial. The sponsor should expedite such reporting and, with the investigator, immediately undertake appropriate and necessary measures and treatment to protect the trial participants.

The G-KenyaCT states that the sponsor and/or investigator must also submit a safety report to the PPB once a year throughout the clinical trial, or, upon request. The purpose of the annual safety report is to briefly describe all new safety information relevant to one or more clinical trial(s), and to assess the safety conditions of the participants enrolled in these trial(s). The safety report must include a log of SAE and SUSAR events. The SAE and SUSAR log should include the following:

  • Patient Identification
  • Age
  • Date of recruitment into the study
  • Type of SAE or SUSAR
  • SAE or SUSAR start and end dates
  • Reason for reporting the event as an SAE or SUSAR
  • Relation to IP
  • SAE or SUSAR outcome

Other important timelines include the following:

  • The sponsor must notify all the investigators involved in ongoing clinical trials of the IP of all SUSARs within 15 calendar days
  • Any IP-related SAE must receive immediate medical attention and be reported to the PPB
  • SAE report form must be completed (including lab results) and submitted to enable causality assessment
  • All fatal cases must be accompanied by a formal autopsy report, and a verbal autopsy report should be submitted in those exceptional cases where a formal autopsy is not possible
  • Any frequent IP related AE/ADR must receive immediate medical attention and be reported to the PPB within seven (7) days
  • The principal investigator (PI) is required to submit follow-up information as soon as it becomes available
  • All additional information should be clearly marked as updated and must include the Protocol Number and Participant Number
  • Foreign regulatory decisions that affect the safety or use of the product under study must be reported to the PPB within seven (7) days through a detailed report
  • Literature reports that affect the safety of the IP must be submitted within 15 days with a detailed report and a copy of the publication

Please refer to Section 16 of the G-KenyaCT for additional safety reporting requirements.

Form Completion & Delivery Requirements

As per the G-KenyaPV, all SAEs and SUSARs must be reported to the PPB via the Online Clinical Trials Registry System (Additional Resource (A)). Once you log into the system, select the SAE tab. A form will prompt you through the required information.

Data and Safety Monitoring Board

The G-KenyaCT indicates that the PPB recommends establishing a Data and Safety Monitoring Board (DSMB) to monitor trials in the following types of studies:

  • Controlled human infection studies
  • Where the endpoint is such that a highly favorable or unfavorable result, or even a finding of futility at an interim analysis, might ethically require the trial to be terminated early
  • When there are safety concerns due the use of a particularly invasive treatment
  • Where there is prior information suggesting the possibility of serious toxicity with the study treatment
  • Where the participants involved represent a vulnerable population (e.g., children, pregnant women, elderly, terminally ill, or mentally incapacitated)
  • When the participants represent a population at higher risk of death or other serious outcomes
  • When the study is large, of long duration, and multi-center

Per the G-KenyaCT, the DSMB must provide the following documentation to the PPB:

  • DSMB composition
  • Copy of DSMB charter (Annex 2 of the G-KenyaCT requires submission of the charter with the clinical trial application)
  • DSMB reports to be submitted to the PPB within two (2) weeks of its deliberations and in the request for annual approval

For detailed requirements on establishing a DSMB, see Section 17 of the G-KenyaCT.

In addition, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) recommends establishing a DSMB to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
(A) (Website) Pharmacy and Poisons Board - Online Clinical Trials Registry System (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 5.5, and 5.16
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (24, 27, and 29)
Summary

Overview

In accordance with the G-KenyaCT and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), the principal investigator (PI) and the sponsor share responsibility for submitting progress reports on an annual basis regarding the status of a clinical trial and for submitting a final study report upon the trial’s completion. The annual report is submitted as part of the requirement to obtain annual approval for the study.

Interim/Progress Reports

As stated in the G-KenyaCT, the sponsor and/or the PI is required to send progress reports tor the Pharmacy and Poisons Board (PPB) on an annual basis from the date of the trial’s initiation. The progress report should contain the following:

  • Current status of the study
  • Summary of the participants screened (e.g., failed screenings, participants enrolled, withdrawn, or lost to follow-up, and other challenges)
  • Summary of protocol deviations and violations
  • Updated investigational product Investigator’s Brochure
  • Number of trial participants enrolled
  • Drug Safety Update Report
  • Copy of the latest Data Safety Management Board report
  • Copy of favorable opinion from the ethics committee (EC) on record
  • Copy of annual practice license for the investigators and pharmacists
  • Suspected, Unexpected, Serious Adverse Event (SUSAR) and Serious Adverse Event (SAE) Log

For multisite trials, per the G-KenyaCT, the sponsor or his/her representative must submit a summarized report for all of the sites and include the information listed above.

As per the ICH-GCPs-Addendum, the investigator should promptly provide written reports to the sponsor and the institutional EC on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

Annual Report

According to the G-KenyaCT, for annual renewal of the study, the sponsor or his/her representative must submit a copy of the progress report including the documents listed above. The request must also be accompanied by copies of annual practice licenses for the investigators and pharmacists, and a copy of valid insurance coverage for the participants. All of the documents must be submitted using the PPB’s Online Clinical Trials Registry System (Additional Resource (A)). The sponsor or his/her representative must receive an acknowledgement of this submission before proceeding with the study. These documents must be submitted to the PPB at least six (6) weeks prior to the expiration of the previous approval.

Pursuant to the ICH-GCPs-Addendum, the investigator should submit written summaries of the trial status to the institutional EC annually, or more frequently, if requested.

Final Report

As per the G-KenyaCT, when a trial is completed, the sponsor or his/her representative should submit a preliminary report to the PPB within 30 days and a final report within 180 days of the trial’s end. The report must be in compliance with the International Council for Harmonisation's ICH E3 format (Additional Resource (C)). The report must include a short but comprehensive summary of the trial’s essential findings and methodology, and should also contain a layman’s summary. Additionally, the sponsor must inform the PPB of any results that will be publically released at least 14 days before release. In addition, upon completion of the trial, as delineated in the ICH-GCPs-Addendum, the investigator is required to submit a final report to the institutional EC summarizing the trial’s outcome.

Additional Resources
(A) (Website) Pharmacy and Poisons Board - Online Clinical Trials Registry System (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.10 and 4.13
(C) (ICH Guidance) Structure and Content of Clinical Study Reports E3 (Step 4 Version) (November 30, 1995)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Sponsorship > Definition of Sponsor
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms and Section One (1)
(2) (Legislation) Data Protection Act, 2019 (DPA) (Effective November 25, 2019)
Parliament
Relevant Sections: Part I (2) and Part III (18)
Summary

Overview

As per the G-KenyaCT, a sponsor is defined as an individual, a company, an institution, or an organization who takes legal responsibility for the initiation, management, and financing of a trial. According to the G-KenyaCT, a sponsor can also authorize his/her representative to carry out certain work and obligations regarding the clinical trial. A sponsor may be domestic or foreign.

In accordance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), Kenya permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control.

For the purposes of data protection requirements, DPA delineates that the sponsor acts as the “controller” in relation to research data. This is because the sponsor determines the purpose and means of processing personal data. The "data processor" processes personal data on behalf of the data controller. Data controllers and processors must be registered with the Kenya Data Commissioner. See DPA for detailed registration requirements.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.1 and 5.2
Sponsorship > Trial Authorization
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Foreword, Abbreviations and Definitions of Terms, Introduction, Section One (1, 2, 3, 11, 18, and 23), and Annexes 1-3 and 7-8
(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee
(3) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (Effective January 25, 2013)
Parliament
Relevant Sections: Parts II, IV, V, and X and Fourth Schedule
Summary

Overview

In accordance with the G-KenyaCT, the G-ECBiomedRes, the STI Act, and Additional Resources (A) and (B), Kenya requires the sponsor or his/her representative to obtain clinical trial authorization from the Pharmacy and Poisons Board (PPB)’s Expert Committee on Clinical Trials (ECCT) and an independent review through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committees (EC) in a local institution. (List of accredited ECs in Additional Resource (C).) In addition, the STI Act and Additional Resources (D) and (E) specify that applicants must register their research proposal with the NACOSTI and obtain a research permit prior to initiating a study. The G-KenyaCT also states that the PPB review and approval process may not be conducted in parallel with the EC review. EC approval must be obtained prior to applying for PPB approval.

To complete the clinical trial application package, the sponsor must use PPB’s clinical trial application form, which is available via the PPB’s Online Clinical Trials Registry System. A copy of the application form may be accessed directly from Additional Resource (F).

In addition to submitting the completed application, as per the G-KenyaCT, the sponsor or his/her representative must also provide the clinical protocol, the patient information leaflet and informed consent form, a signed declaration by the sponsor or principal investigator, a certificate of good manufacturing practice for the manufacture of the trial medicine, and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

Additional Resources
(A) (Website) Pharmacy and Poisons Board – Clinical Trials (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(B) (Website) Pharmacy and Poisons Board - Online Clinical Trials Registry System (Current as of June 25, 2020)
Pharmacy and Poisons Board, Ministry of Health
(C) (Website) Accredited Institutional Ethics Review Committees (IERCs) (Current as of June 25, 2020)
National Commission for Science, Technology and Innovation
(D) (Website) RIMS, NACOSTI Research Information Management System (Current as of June 25, 2020)
National Commission for Science, Technology, and Innovation
(E) (Flyer) NACOSTI Research Licensing in Kenya (November 2018)
National Commission for Science, Technology and Innovation
(F) (Form) Kenya: Clinical Trial Application Form (Date Unavailable)
Pharmacy and Poisons Board, Ministry of Health
Sponsorship > Insurance
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (5, 8, and 21) and Annex 2
Summary

Overview

As set forth in the G-KenyaCT, the sponsor must provide insurance cover for the study participants and ensure that the clinical trial institution, contract research organization (CRO), and researchers have sufficient insurance cover for the clinical trial. The sponsor’s policies and procedures should address the costs of treatment of trial participants in the event of trial-related injuries, and the sponsor should submit this information as part of the clinical trial application (see Annex 2). In addition, a no-fault insurance cover must be obtained for all controlled human infection studies. The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) guides sponsors on providing insurance.

For all sponsor-initiated studies, insurance coverage must be provided by an insurer registered by Kenya’s Insurance Regulatory Authority (IRA), and a valid insurance certificate must be issued by the IRA prior to the trial’s initiation and cover the duration of the study. The insurance certificate must be submitted as evidence to the Pharmacy and Poisons Board (PPB). The certificate must be properly executed by an insurance company under a valid insurance policy which makes explicit reference to the proposed study. In addition, the policy must grant coverage for any participant injury that is causally linked to trial activities. The policy must also cover the investigator(s)’ and the sponsor(s)’ liability in the trial, without excluding any damage which may be attributed to negligence. Moreover, self-insurance of the participants by other entities, such as the National Hospital Insurance Fund, will not be sufficient.

Further, per the G-KenyaCT, the sponsor must ensure that the investigators and CROs have professional indemnity insurance coverage for the period of the trial. The host institution must also have in place sufficient insurance to meet the potential liability of its investigators, those acting on behalf of the investigators, and its research members.

See the Sponsorship topic, Compensation subtopic and Informed Consent topic, Compensation Disclosure subtopic for specific details related to sponsorship compensation obligations.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.8
Sponsorship > Compensation
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (6 and 8)
(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: Guidelines
Summary

Overview

As specified in the G-KenyaCT and the G-ECBiomedRes, the sponsor is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death.

The G-ECBiomedRes states that participants are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of death, their dependents are entitled to material compensation. The right to compensation may not be waived. The sponsor must also inform the participants of any available medical treatment in the event of trial-related injuries.

As part of a post-trial access program, per the G-KenyaCT, the sponsor must put in place measures to ensure that the study participants have access to successful investigational products for their disease condition before the products have received a marketing authorization in Kenya, especially for Phase III clinical trials.

In addition, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8 and 5.8
Sponsorship > Quality, Data & Records Management
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms and Section One (1, 3, 5, 6, 17, 21-22, 24, 29, and 30)
(2) (Regulation) The Science, Technology and Innovation (Registration and Accreditation of Research Institutions) Regulations, 2014 (STI Regs) (August 1, 2014)
National Council for Science, Technology, and Innovation
Relevant Sections: Legal Notice No. 106 (Part III-IV) and Legal Notice No. 107 (Parts I- III)
(3) (Legislation) Data Protection Act, 2019 (DPA) (Effective November 25, 2019)
Parliament
Relevant Sections: Parts IV - VII
Summary

Overview

As stated in the G-KenyaCT, the sponsor is responsible for maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), the STI Regs, and other applicable regulatory requirements. The sponsor is required to obtain agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. In addition, per the STI Regs, all persons and research institutions (i.e., sponsors) undertaking research in Kenya must ensure the highest standards and quality of research for the realization of institutional mandates and national priorities.

In addition to complying with the ICH-GCPs-Addendum, the G-KenyaCT requires the following quality assurance processes:

  • Regular and continuous monitoring of the study and the implementation of monitoring reports’ recommendations
  • The study monitoring plan must be submitted to the PPB during the initial submission of the application
  • The clinical trials research site must have valid registrations and approvals
  • Ensure patient safety and confidentiality are not compromised
  • Analysis or evaluation of samples is performed in accordance with the protocol and, where applicable, the contract/agreement, the work instruction, and associated methods
  • Adherence to the laboratories’ policies and SOPs
  • Trial data is recorded and reported accurately, legibly, completely and in a timely manner
  • Trial data is archived
  • Prepare a work instruction detailing the procedures, which will be used to conduct the analysis or evaluation prior to the initiation of sample analysis or evaluation, as necessary 
  • Be purpose-built or adapted for the purpose
  • Have automated equipment for routine hematology, biochemistry, and serology tests
  • Have procedures for analyzer calibration and quality control
  • Regularly maintain all the equipment, including point-of-care equipment
  • Have a procedure for transporting samples safely and quickly from clinical areas to the laboratory
  • Have written procedures for all assays, and validate the assays
  • Have a stock control procedure to make sure that reagents and consumables are used within their expiry dates
  • Keep records, including source documents and final reports
  • Have a procedure for authorizing and releasing results
  • Have a procedure for ‘flagging’ and notifying medical staff of abnormal results
  • Have a laboratory information management system, and validate and backup the system
  • Provide protective clothing and safety equipment for staff
  • Have a central alarm system for all fridges and freezers
  • Have an internal audit program

Per the ICH-GCPs-Addendum, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

  • During protocol development, identify processes and data that are critical to ensure participant protection and the reliability of trial results
  • Identify risks to critical trial processes and data
  • Evaluate the identified risks against existing risk controls
  • Decide which risks to reduce and/or which risks to accept
  • Document quality management activities and communicate to those involved in or affected by these activities
  • Periodically review risk control measures to ascertain whether the implemented quality management activities are effective and relevant
  • In the clinical study report, describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken

Per the G-KenyaCT, the sponsor must also obtain the investigator(s) and the institution(s) agreement in writing to:

  • conduct the trial in compliance with the ICH-GCPs-Addendum and the approved protocol
  • comply with data recording and reporting procedures, and
  • permit monitoring, auditing, and inspection

The revised G-KenyaCT establishes new requirements for protocol violations by research centers, researchers, sponsors, and clinical research organizations (CROs). Everyone involved in the clinical trial must comply with good clinical practice (GCP), and the legal and regulatory requirements associated with the conduct of clinical trials. Protocol violations and protocol deviations must be reported to Kenya’s Pharmacy and Poisons Board (PPB) within seven (7) days of the principal investigator (PI) becoming aware of them. The details to be reported must include:

  • Date of the deviation/violation
  • Study participant(s) affected
  • Name of the treating physician
  • Detailed description of the deviation/violation
  • Indication whether the study participants were adversely affected by the deviation/violation
  • Explanation of why the deviation/violation occurred
  • Measures taken to address the deviation/violation
  • Measures taken to preclude future recurrence of the deviation/violation

Data Protection

Per the DPA, the sponsor (known as the “controller” in data protection legislation) must ensure that personal data is:

  • Processed in accordance with the right to privacy of the data subject
  • Processed lawfully, fairly, and in a transparent manner in relation to any data subject
  • Collected for explicit, specified, and legitimate purposes and not further processed in a manner incompatible with those purposes
  • Adequate, relevant, and limited to what is necessary in relation to the purposes for which it is processed
  • Collected only where a valid explanation is provided whenever information relating to family or private affairs is required
  • Accurate and, where necessary, kept up to date, with every reasonable step being taken to ensure that any inaccurate personal data is erased or rectified without delay
  • Kept in a form that identifies the data subjects for no longer than is necessary for the purposes for which it was collected
  • Not transferred outside Kenya, unless there is proof of adequate data protection safeguards or consent from the data subject

See the DPA Parts IV-VII for detailed requirements on data processing, sensitive personal data, exemptions, and transfer of personal data outside of Kenya.

Controlled Human Infection Studies (CHIS)

The G-KenyaCT also provides detailed information on CHIS requirements to ensure investigator/study personnel compliance with GCP and other quality assurance and control requirements, including the following:

  • The well characterized strain of an infectious agent should be administered at a controlled dose and by a specific route to carefully selected adult volunteers
  • The studies require safe and accurate microbiology, good clinical facilities, careful recruitment, and monitoring
  • Participants must be monitored for evidence of carriage or infection under medical supervision to anticipate or manage symptoms of disease and adverse events
  • The value of the information to be gained should clearly justify the risks and the study must have a risk mitigation plan
  • The investigators should be adequately qualified, trained, and experienced in the conduct of CHIS as well as treating patients with the infectious disease being investigated

For the complete list of requirements, see the G-KenyaCT.

Electronic Data Processing System

As per ICH-GCPs-Addendum, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. Per the ICH-GCPs-Addendum, the sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain SOPs for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to the ICH-GCPs-Addendum for additional information.

Records Management

According to the G-KenyaCT, it is the responsibility of the investigator and the sponsor to archive safely all trial-related documentation. All Kenyan trial site- related documentation must be archived within the country and not exported. Additionally, the sponsor/applicant must inform the PPB’s Expert Committee on Clinical Trials (ECCT) in writing prior to destroying any trial documents. The notification must include the protocol number, date started and ended, and the license number.

The G-KenyaCT states that study documents must be archived for a minimum of 10 years from the end of the study. Also, records must be made available to the PPB within three (3) days if there is a concern regarding the use of a clinical trial drug and/or a risk to the health of the clinical trial participant. In any other case, records must be provided within seven (7) days of request.

Per the STI Regs, sponsors should store research findings and information regarding research systems in a designated section of the research records institution with clear labels of the subject area. Research findings must be documented in bound books or documents with the title of the research, author, year, and other relevant information clearly printed on the cover page. A report of research work by staff and the research institution must be submitted to the National Commission for Science, Technology, and Innovation (NACOSTI) within two (2) months after publication or compilation of the research report.

In addition, the ICH-GCPs-Addendum states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

Audit Requirements

As part of its QA system, the G-KenyaCT requires the sponsor to develop an internal audit program. The G-KenyaCT defines an audit as a systematic examination, carried out independently of those directly involved in the trial, to determine whether the conduct of a trial complies with the agreed study protocol and whether data reported are consistent with those on record at the site.

Per the ICH-GCPs-Addendum, the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose onsite monitoring, a combination of onsite and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

Premature Study Termination/Suspension

The G-KenyaCT states that if a trial is terminated by the PI or the sponsor, the PI or the sponsor must inform the PPB not later than 15 days following the termination date. The co-investigators must also be informed as soon as possible, and should be advised in writing of potential risks to the research participants, and they must ensure that patients continue to receive medical care The PPB must be provided with reason(s) for the termination and its impact on the proposed or ongoing trials with respect to the investigational product (IP), including issues relating to IP accountability and disposal as well as record(s) maintenance.

According to the ICH-GCPs-Addendum, if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. Further, the EC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor.

Multicenter Studies

As delineated in the G-KenyaCT, in the event of a multicenter clinical trial, the sponsor should only file one application to the PPB. Also, the sponsor must appoint a coordinating PI to be responsible for all of the sites. The PI should assume full responsibility for the trial and must be a resident of Kenya.

As delineated in the ICH-GCPs-Addendum, in the event of a multicenter clinical trial, the sponsor must ensure that:

  • All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and, if required, by PPB, and given EC approval
  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
  • Investigator responsibilities are documented prior to the start of the trial
  • All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
  • Communication among investigators is facilitated
Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.65, 5.0, 5.1, 5.2, 5.5, 5.18, 5.19, 5.21, 5.23, 6.10, and 8
Sponsorship > Site/Investigator Selection
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms, Section One (1.3, 3-5, and 17), and Annex 6
(2) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (Effective January 25, 2013)
Parliament
Relevant Sections: Part V
(3) (Regulation) The Science, Technology and Innovation (Registration and Accreditation of Research Institutions) Regulations, 2014 (STI Regs) (August 1, 2014)
National Council for Science, Technology, and Innovation
Relevant Sections: Legal Notice No. 106 (Part II, First Schedule, and Second Schedule)
(4) (Guidance) Manual for Registration of Research Institutions in Kenya (G-InstitutionRegistration) (November 2016)
National Commission for Science, Technology, and Innovation
Summary

Overview

The G-KenyaCT, which requires sponsors to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), states that the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial and for ensuring that the investigator(s) are qualified by training and experience. Investigators must also meet the following requirements:

  • Provide evidence of his/her qualifications and experience through an up-to-date curriculum vitae (CV)
  • Have a current practice license from the Kenya Medical Practitioners and Dentist Board
  • Be familiar with the characteristics and appropriate use of the investigational product as described in the protocol, current investigator’s brochure, in the product information, and in other information sources
  • Have a clear understanding and willingness to obey the ethical, good clinical practice (GCP) and legal requirements in the conduct of the trial
  • Permit monitoring and auditing of the trial and inspection by the Pharmacy and Poisons Board (PPB) or appointed representatives
  • Keep a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties
  • The principal investigator (PI) must be an appropriately qualified and competent person having practical experience within the relevant professional area, who is a resident in Kenya and who is responsible for the conduct of the clinical trial at a clinical site
  • A PI must have had previous experience as a coinvestigator in at least two (2) trials in the relevant professional area
  • Have adequate time and resources to carry out the study (See Annex 6 of the G-KenyaCT for PPB’s recommended format to document investigator’s workload)

The G-KenyaCT states that sponsors must ensure that investigators have had formal training in GCPs within the last two (2) years. If training has not been completed, it is the responsibility of the sponsor to organize this training prior to initiating the study. The investigators will need to provide evidence of having obtained this training. As delineated in the ICH-GCPs-Addendum, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure. Furthermore, the sponsor must sign an agreement or contract with the participating institution(s).

Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. As delineated in the ICH-GCPs-Addendum, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure. (See the Clinical Trial Lifecycle topic, Submission Content subtopic for additional information on clinical trial application requirements.)

As delineated in the G-KenyaCT, in the event of a multicenter clinical trial, the sponsor must appoint a coordinating PI to be responsible for all of the sites. The PI should assume full responsibility for the trial and must be a resident of Kenya.

Foreign Sponsor Responsibilities

No information is currently available specifying requirements for foreign sponsors.

Data and Safety Monitoring Board

The G-KenyaCT indicates that the PPB recommends establishing a Data and Safety Monitoring Board (DSMB) to monitor trials in the following types of studies:

  • Where the endpoint is such that a highly favorable or unfavorable result, or even a finding of futility at an interim analysis, might ethically require the trial to be terminated early
  • When there are safety concerns due the use of a particularly invasive treatment
  • Where there is prior information suggesting the possibility of serious toxicity with the study treatment
  • Where the participants involved represent a vulnerable population (e.g., children, pregnant women, elderly, terminally ill, or mentally incapacitated)
  • When the participants represent a population at higher risk of death or other serious outcomes
  • When the study is large, of long duration, and multi-center

The ICH-GCPs-Addendum states that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Per the G-KenyaCT, the DSMB must provide the following documentation to the PPB:

  • DSMB composition
  • Copy of DSMB charter
  • DSMB reports to be submitted to the PPB within two (2) weeks of its deliberations and in the request for annual approval

For detailed requirements on establishing a DSMB, see Section 17 of the G-KenyaCT.

Institutional Registration

The STI Act and the STI Regs require research institutions to register with the National Commission for Science, Technology, and Innovation (NACOSTI) and obtain a Certificate of Registration. For detailed guidance on the vetting and approval process, see the STI Regs and the G-InstitutionRegistration. The application for registration of research institutions is provided in Additional Resource (B).

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 5.5, and 5.6
National Commission for Science, Technology, and Innovation
Informed Consent > Documentation Requirements
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (11)
(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee
(3) (Legislation) Data Protection Act, 2019 (DPA) (Effective November 25, 2019)
Parliament
Relevant Sections: Part I (2)
Summary

Overview

In all Kenyan clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum). The informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by a National Commission for Science, Technology and Innovation (NACOSTI)-accredited institutional ethics committee (EC). The ICF must be provided to the Pharmacy and Poisons Board (PPB) with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

The G-KenyaCT and the G-ECBiomedRes state that the investigator, or his/her designated representative, must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The G-KenyaCT and the G-ECBiomedRes also specify that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. The participant, and his/her legal representative(s) or guardian(s), should also be given adequate time to consider whether to participate.

Kenya’s Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI) provides a sample format and template for the ICF form (Additional Resource (C)). The template instructions state that the level of language and syntax used should be appropriate to the age, comprehension, and reading level of the study population. The use of legalistic phrases or scientific and medical terminologies should be avoided. Volumes, weights, and scientific measurements should be expressed in meaningful scales (e.g., blood draws in numbers of teaspoons, tablespoons, or proportion of a National Blood Services donation). All consent documents must have a version number, date, and be signed and stamped by the SERU Committee Chairperson or SERU EC coordinator. Detailed standard operating procedures may be obtained by contacting SERU at seru@kemri.org.

Per the DPA, for the purposes of processing personal data, consent means any manifestation of express, unequivocal, free, specific, and informed indication of the data subject's wishes by a statement or by a clear affirmative action, signifying agreement to the processing of personal data relating to the data subject.

Re-Consent

According to the G-KenyaCT and the ICH-GCPs-Addendum, any change in the ICF due to a protocol modification should be approved by the EC before such changes are implemented. The participant and/or his/her legal representative(s) or guardian(s) will also be required to re-sign the revised ICF and receive a copy of any amended documentation.

Language Requirements

As stated in the G-KenyaCT, the ICF content should be presented in either English or Kiswahili, and the local spoken language of the area, where applicable. Copies of the English ICF should be submitted to the PPB and to the EC.

Documentation Copies

The G-KenyaCT states that the participant and/or the participant’s legal representative(s) or guardian(s), and the person who conducted the informed consent discussion should sign and personally date the ICF. Where the participant is illiterate, and/or his/her legal representative(s) or guardian(s) is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness.

Before participating in the study, the participant should receive a copy of the signed and dated ICF, and any other written information provided during the informed consent process. The participant and/or his legal representative(s) or guardian(s) should also receive a copy of any updates to the signed and dated ICF.

According to the ICH-GCPs-Addendum, where the participant is illiterate and/or his/her legal representative(s) and/or guardian(s) is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

  • The written ICF and any other written information to be provided to the participant is read and explained to the participant and his/her legal representative(s) and/or guardian(s)
  • The participant and his/her legal representative(s) and/or guardian(s), have orally consented to the participant’s involvement in the trial, and has signed and dated the ICF, if capable of doing so

Before participating in the study, the participant or his/her legal representative(s) and/or guardian(s) should receive a copy of the signed and dated ICF.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2, 4.4, 4.8, 8.2, and 8.3
(B) (Website) The Scientific and Ethics Review Unit (Current as of June 25, 2020)
Kenya Medical Research Institute
(C) (Document) KEMRI SERU ICF Template (Version 5.0) (Effective July 1, 2019)
Kenya Medical Research Institute
Informed Consent > Required Elements
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (11)
(2) (Legislation) Data Protection Act, 2019 (DPA) (Effective November 25, 2019)
Parliament
Relevant Sections: Part I (2), Part III (25), and Part IV - Part V
(3) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee
Summary

Overview

As delineated in the G-KenyaCT and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), prior to beginning a clinical trial, the investigator is required to obtain ethics committee (EC) approval from a National Commission for Science, Technology and Innovation (NACOSTI)-accredited EC for the written informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s).

The ICH-GCPs-Addendum states that information about the research study should be presented in easily understandable language in a format that facilitates understanding. For example, written documentation may be supplemented with audio and/or visual aids. The participant and his/her legal representative(s) or guardian(s) should also be given adequate time to consider whether to participate.

Data Protection

As per the DPA, a data controller or data processor must bear the burden of proof for establishing a data subject's consent to the processing of their personal data for a specified purpose. Unless otherwise provided under the DPA, a data subject has the right to withdraw consent at any time. The withdrawal of consent must not affect the lawfulness of processing based on prior consent before its withdrawal. See the DPA Parts IV-VII for detailed requirements on consent to data processing, sensitive personal data, exemptions, and transfer of personal data outside of Kenya.

No Coercion

As per the G-KenyaCT, the G-ECBiomedRes, and the ICH-GCPs-Addendum, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) and/or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

ICF Required Elements

Based on the G-KenyaCT, the G-ECBiomedRes, and the ICH-GCPs-Addendum, the ICF should include the following statements or descriptions, as applicable:

  • That the study involves research and an explanation of its nature and purpose
  • The expected duration of the participant's participation
  • The participant’s responsibilities in participating in the trial
  • Experimental aspects of the study
  • Approximate number of participants involved in the trial
  • Trial treatment schedule and the probability for random assignment to each treatment
  • The person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury
  • Any foreseeable risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
  • Any expected benefits or prorated payment to the participant; if no benefit is expected, the participant should also be made aware of this
  • Alternative procedures or treatment that may be available to the participant
  • Compensation and/or medical treatment available to the participant or his/her family or dependents in the event of a trial-related injury
  • Any additional costs to the participant that may result from participation in the research
  • The extent to which confidentiality records identifying the participant will be maintained, and if the results of the trial are published, the participant’s identity will remain confidential
  • That the Pharmacy and Poisons Board (PPB) will be granted direct access to the participant’s original medical records to verify clinical trial procedures and/or data without violating the participant’s confidentiality
  • The extent of the investigator’s responsibility, if any, to provide medical services to the participant
  • That therapy will be provided free of charge for specified types of research-related injury
  • That participation is voluntary, the participant may withdraw at any time, and refusal to participate will not involve any penalty or loss of benefits, or reduction in the level of care to which the participant is otherwise entitled
  • That the participant will be informed about any publication of his/her medical information, including photographs and pedigree charts
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • That the participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue

Kenya’s Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI) provides a sample format and template for the ICF form (Additional Resource (B)). Detailed KEMRI standard operating procedures may be obtained by contacting SERU at seru@kemri.org. See Additional Resource (C), for more information about KEMRI’s SERU.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.4 and 4.8
(B) (Document) KEMRI SERU ICF Template (Version 5.0) (Effective July 1, 2019)
Kenya Medical Research Institute
(C) (Website) The Scientific and Ethics Review Unit (Current as of June 25, 2020)
Kenya Medical Research Institute
Informed Consent > Compensation Disclosure
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (11)
(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: Guidelines
Summary

Overview

In accordance with the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), the informed consent form (ICF) should contain a statement describing the compensation and medical treatment a participant can receive for participating in a clinical trial.

The G-ECBiomedRes states that participants are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of death, their dependents are entitled to material compensation. The right to compensation may not be waived.

Compensation for Participation in Research

Kenya’s Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI) provides a sample format and template for the ICF form (Additional Resource (B)). The template indicates that a participant or his/her legal representative(s) or guardian(s) can be reimbursed for loss of wages, transportation expenses, and for his/her time. Under no circumstances should payment be offered for harm or discomfort. The ICF should also clearly state that if the participant withdraws from the study, there will be appropriate pro-rated reimbursement, where applicable. A token of appreciation may be presented after the study’s completion, but this should not be mentioned in the ICF. However, details regarding a token of appreciation must be indicated in the study protocol. Detailed KEMRI standard operating procedures may be obtained by contacting SERU at seru@kemri.org.

Per the ICH-GCPs-Addendum, the ICF should contain a statement with a description of the anticipated prorated payment to the participant(s) that is reasonably expected for participation in the trial. Any compensation or incentive to participants must not be so excessive that it may unfairly influence participants, or cause them to overlook important facts and risks.

Compensation for Injury

Per the G-KenyaCT and the ICH-GCPs-Addendum, the ICF must state that compensation and/or treatment is available to the participant in the event of trial-related injury. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 3.1 and 4.8
(B) (Document) KEMRI SERU ICF Template (Version 5.0) (Effective July 1, 2019)
Kenya Medical Research Institute
Relevant Sections: 8
(C) (Website) The Scientific and Ethics Review Unit (Current as of June 25, 2020)
Kenya Medical Research Institute
Informed Consent > Participant Rights
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (11)
(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical; General Ethical Principles; Guidelines; and Constituting an Ethical Committee
Summary

Overview

In accordance with the Declaration of Helsinki principles upheld in the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), Kenya’s ethical standards promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.

Kenya’s Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI) provides a sample template for the ICF form which includes participant rights (Additional Resource (C)). Detailed KEMRI standard operating procedures may be obtained by contacting SERU at seru@kemri.org. For more information about SERU, see Additional Resource (D).

The Right to Participate, Abstain, or Withdraw

As set forth in the G-KenyaCT, the G-ECBiomedRes, and the ICH-GCPs-Addendum, a participant and/or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

As delineated in the G-KenyaCT, the G-ECBiomedRes, and the ICH-GCPs-Addendum, a potential research participant and/or his/her legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study. (See the Informed Consent topic, Required Elements subtopic for a more detailed list.)

The Right to Privacy and Confidentiality

As per the G-KenyaCT, the G-ECBiomedRes, and the ICH-GCPs-Addendum, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal

The G-KenyaCT, and the ICH-GCPs-Addendum, state that the research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries.

The Right to Safety and Welfare

The G-ECBiomedRes and the ICH-GCPs-Addendum state that a research participant’s right to safety and the protection of his/her health and welfare must take precedence over the interests of science and society. The ICH-GCPs-Addendum upholds the Declaration of Helsinki. (See the Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.)

Additional Resources
(A) (WMA Guidance) Declaration of Helsinki (October 19, 2013)
World Medical Association
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 3.1 and 4.8
(C) (Document) KEMRI SERU ICF Template (Version 5.0) (Effective July 1, 2019)
Kenya Medical Research Institute
(D) (Website) The Scientific and Ethics Review Unit (Current as of June 25, 2020)
Kenya Medical Research Institute
Informed Consent > Special Circumstances/Emergencies
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (11 and 34)
(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical; Constituting an Ethical Committee; and Guidelines (6)
Summary

Overview

The G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances. Special circumstances include medical emergencies and when a participant is mentally incapacitated.

Medical Emergencies

As delineated in the G-KenyaCT and the G-ECBiomedRes, in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of his/her legal representative(s) or guardian(s) should be obtained. If the prior consent of the participant or his/her legal representative(s) or guardian(s) cannot be obtained, the participant’s enrollment should follow measures specified in the protocol, and/or elsewhere, to ensure compliance with ethics committee (EC) and the Pharmacy and Poisons Board (PPB) requirements.

During a public health emergency, the G-KenyaCT stipulates that the informed consent of participants must be obtained in individuals capable of giving informed consent.

Per the ICH-GCPs-Addendum, in an emergency, if the signed ICF has not been obtained from the research participant and/or his/her legal representative(s) or guardian(s), or, if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the EC must approve the protocol in advance. The participant and/or his/her legal representative(s) or guardian(s) should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

Mentally Incapacitated Persons

The G-ECBiomedRes states that participants who are unable to make their own decisions about participating in a study (e.g., in cases of diminished mental capacity or being rendered unconscious due to head trauma or stroke) have interests and values that must be respected. This typically involves empowering a proxy decision maker to determine whether to enroll the participant. In making this decision, the proxy should use the substituted judgment standard, i.e., what research decision would the participant make if he/she was in a position to do so.

Waiver of Consent

Per the G-KenyaCT, none of the oral and written information concerning the trial, including the written informed consent form, should contain any language that causes the participant or the participant's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence. The G-ECBiomedRes states that if the research design involves no more than minimal risk—the risk not greater than that attached to routine medical or psychological examination—and it is not practicable to obtain informed consent (e.g., where the research involves extracting data from the patient’s records), the ethical review of the relevant institution may waive some or all of the elements of the informed consent. Due to sociocultural arrangements in most rural communities in Kenya, women, particularly married ones, may not give their consent to participate in research without the express permission of their husbands. In such circumstances, while the husband may give his “consent,” the woman should still be allowed to give her individual consent. If after the husband has given his consent but she decides not to participate in the research, her decision not to do so must be respected.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Vulnerable Populations
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms
(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: General Ethical Principles
Summary

Overview

As per the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), in all Kenyan clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Vulnerable populations include those participants with diminished autonomy whose decision to participate in a clinical trial may be unduly influenced by the expectation of benefits associated with participation or by coercion. This may include, but is not limited to, children/minors, pregnant women, neonates, fetuses, medical students, members of the uniformed forces, prisoners, orphans, homeless youths, unemployed, internally displaced persons, economically or educationally disadvantaged persons, marginalized social groups, individuals with terminal illnesses, and the mentally challenged. The ICH-GCPs-Addendum also includes members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include persons in nursing homes, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Persons in Underdeveloped Communities

The G-ECBiomedRes provides specific requirements related to conducting research on participants in underdeveloped communities, which are outlined below.

Clinical trials involving participants in underdeveloped communities must meet the following requirements:

  • Participants must be ordinarily involved in research that could be carried out reasonably well in developed communities
  • The research should be responsive to the health needs and priorities of the community in which it is to be implemented
  • Undue inducement to participate in the research must be avoided at all costs

For an example of an accredited ethics committee’s (EC) review on research in underdeveloped communities, the Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI) has detailed standard operating procedures that may be obtained by contacting SERU at seru@kemri.org.

See the Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired for additional information about these vulnerable populations.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61, 3.1, and 4.8
(B) (Website) The Scientific and Ethics Review Unit (Current as of June 25, 2020)
Kenya Medical Research Institute
Informed Consent > Children/Minors
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms, Section One (7), and Annex 1
(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical; Constituting an Ethical Committee; and Guidelines
(3) (Legislation) Data Protection Act, 2019 (DPA) (Effective November 25, 2019)
Parliament
Relevant Sections: Part III (33)
Summary

Overview

According to the G-KenyaCT, a minor is someone under 18 years of age. As set forth in the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), when the research participant is a minor, informed consent should be obtained from his/her legal representative(s) or guardian(s). The informed consent forms, assent forms, and the patient information sheets should be in a language that the parent or legal representative clearly understand. All pediatric participants should be fully informed about the trial and its risks and benefits in a language and terms that they are easily able to understand.

Per the G-KenyaCT, a minor should take part in the informed consent procedure in a way tailored to his/her age and mental maturity. If capable, the participant should sign and personally date the written informed consent. In addition, consent given by pediatric participants should not be considered valid without prior approval by the ethics committee (EC).

Per an in-country expert, the adolescent age will be greater than 10 years but less than 18 years. Those parents less than 18 years can consent to participate in clinical trials as emancipated minors, but only for minimal risk studies.

The G-ECBiomedRes and the G-KenyaCT state that a study may only be conducted on minors if several conditions are fulfilled including (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

  • Pediatric participants will not be involved in research that might be equally carried out in adults
  • The purpose of the research is to generate knowledge relevant to the health needs of children
  • The legal representative(s) or guardian(s) must provide proxy consent and ensure assent of the child has been obtained to the extent of his/her capabilities. However, if the minor refuses to participate after proxy consent is given, the minor’s refusal must be respected unless there is no other medical alternative from which the minor could benefit
  • The risk presented by interventions not intended to benefit the minor is low and commensurate with the importance of the knowledge to be gained
  • Interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the individual child as any available alternative
  • No incentives or financial inducements are given to the participant or his/her legal representative(s) or guardian(s) except to provide compensation for expenses and loss of earnings directly related to the participation in the trial

Additionally, per the G-KenyaCT, the trial should also address the following considerations:

  • Provide useful answers to the study population
  • The medicine satisfies a need for the population being studied
  • Children are adequately monitored and protected
  • If there is no direct benefit to the child, or there is no more than minimal risk to the participant(s)
  • Trial results will be published
  • End-of-trial treatment provisions will be made

With regard to data processing, the DPA requires that every data controller or data processor must not process personal data relating to a child unless consent is given by the child's parent or guardian and the processing is in a manner that protects and advances the rights and best interests of the child. A data controller or data processor must incorporate appropriate mechanisms for age verification and consent to process personal data of a child, including available technology, volume of personal data processed, proportion of such personal data likely to be that of a child, possibility of harm to a child arising out of processing of personal data, and other factors as may be specified by the Kenya Data Commissioner. A data controller or data processor that exclusively provides counselling or child protection services to a child may not be required to obtain parental consent.

Assent Requirements

As delineated in the G-KenyaCT, before undertaking research involving children, the investigator must ensure that the agreement (assent) of each child has been obtained to the extent of the child`s capabilities, and a child’s refusal to participate or continue in the research must be respected. Assent is defined as a child’s affirmative agreement to participate in research, where the child is below the age of the majority but old enough to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as participants.

For an example of an accredited EC’s assent requirements, see the Kenyatta National Hospital and University of Nairobi Ethics and Research Review Committee’s sample minor assent form (Additional Resource (B)). In addition, assent standard operating procedures from the Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI) may be obtained by contacting SERU at seru@kemri.org.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
(B) (Website) KNH-UoN Ethics and Research Committee – E-Resources (Current as of June 25, 2020)
Kenyatta National Hospital and University of Nairobi Ethics and Research Review Committee
Relevant Sections: Parental Consent for Children, and Sample Minor Assent Form
(C) (Website) The Scientific and Ethics Review Unit (Current as of June 25, 2020)
Kenya Medical Research Institute
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: Guidelines
Summary

Overview

As per the G-ECBiomedRes, any research studies involving women who are pregnant or nursing require additional safeguards to ensure the research conforms to appropriate ethical standards and upholds societal values. The following conditions are required for research to be conducted with this population:

  • The research carries no more than minimal risk to the fetuses and nursing infants, and the objective of the research is to obtain new knowledge about pregnancy or lactation
  • Pregnant or nursing women should generally not be clinical trial participants except where such trials are designed to protect or advance the health of the pregnant/nursing women or fetuses/nursing infants, and for which women who are not pregnant or nursing would not be suitable participants

In accordance with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), informed consent requirements for conducting clinical trials with pregnant or nursing women or fetuses follow the general requirements listed in the Informed Consent topic, Required Elements subtopic. Specifically, the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Prisoners
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: Guidelines
Summary

Overview

Per the G-ECBiomedRes and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that these prospective participants are informed and are given the opportunity to make their own decisions without any interference from a higher authority. The ethics committee must also ensure that the study will be independently monitored to assure the dignity and rights of the prisoners involved in the research.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61
Informed Consent > Mentally Impaired
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Commission for Science, Technology and Innovation
Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Guidelines
Summary

Overview

As per the G-ECBiomedRes and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), an ethics committee (EC) within the relevant institution must approve the participation of adult research participants who are incapable by reason of physical and mental capacity to give consent.

In addition, as delineated in the G-ECBiomedRes, a research study may involve participants with mental incapacities or behavioral disorders under the following conditions:

  • The participant has received information according to his/her capacity of understanding regarding the trial, its risks, and its benefits
  • Such research could not be carried out equally well with individuals who are in possession of their full mental faculties
  • The knowledge gained would be relevant to the particular health needs of persons with mental or behavioral disorders
  • The participant’s consent has been obtained to the extent of his/her capabilities, and a prospective participant’s refusal to participate is always respected
  • Informed consent is obtained from a legal representative(s) and/or guardian(s)
  • The degree of risk attached to the intervention not intended to benefit the individual participant is low and commensurate with the importance of knowledge to be gained
  • Interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the individual participant as any alternative
Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61 and 3.1
Investigational Products > Definition of Investigational Product
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms
Summary

Overview

As delineated in the G-KenyaCT, an investigational product is also referred to as an investigational new drug (IND). The G-KenyaCT and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) define it as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.33
Investigational Products > Manufacturing & Import
Last content review/update: July 23, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (1, 2, 13, 18, and 31) and Annex 2
(2) (Guidance) Registration of Drugs – Guidelines to Submission of Applications (G-RegDrug) (2010)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Verification of compliance to current Good Manufacturing Practices (cGMP) and Module 1 (Section 1, 1.15 GMP status of the Manufacturer and GCP/GLP status of the Clinical Research Organisation/Laboratory)
(3) (Legislation) Pharmacy and Poisons Act, Chapter 244 (PPA) (Amended through May 21, 2018)
Parliament
Relevant Sections: Part IIIA (35A and 35B) and Part IV (44)
(4) (Legislation) Health Laws (Amendment) Act, 2019 (PPA-Amndts) (Effective May 17, 2019)
Parliament
Relevant Sections: 3B
Summary

Overview

According to the G-KenyaCT, the G-RegDrug, the PPA, and the PPA-Amndts, the Pharmacy and Poisons Board (PPB) is responsible for authorizing the manufacture of all drug products, including investigational products (IPs) in Kenya. The sponsor may choose not to register an IP with the PPB prior to submitting a clinical trial application. The G-KenyaCT states that the sponsor must submit the IP directly to PPB or may submit it through the principal investigator. The IP dossier must be prepared as per the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) and manufactured in accordance with current Good Manufacturing Practices (GMP). The manufacture of IPs may be subject to GMP inspection by the PPB in the same way as the case of marketed drug products. See the G-KenyaCT for detailed chemistry and manufacturing information to be provided to the PPB if the sponsor chooses not to register the IP prior to submitting the clinical trial application. For details on registering an IP with the PPB, see Additional Resource (A).

The International Council for Harmonisation's ICH-GCPs-Addendum also requires IPs to be manufactured, handled, and stored in accordance with applicable GMPs and used in accordance with the approved protocol.

Per the PPA-Amndts, the PPB is authorized to regulate the manufacturing of medicine, including:

  • Ensure that all medicinal products manufactured in, imported into, or exported from the country conform to prescribed standards of quality, safety, and efficacy
  • Ensure that the personnel, premises, and practices employed in the manufacture, storage, marketing, distribution, and sale of medicinal substances comply with the defined codes of practice and other prescribed requirements
  • Grant or revoke licenses for the manufacture, importation, exportation, distribution, and sale of medicinal substances
  • Inspect and license all manufacturing premises, importing and exporting agents, wholesalers, distributors, pharmacies (including those in hospitals and clinics), and other retail outlets

As per the G-KenyaCT and the G-RegDrug, if the manufacturer registers the IP prior to the sponsor’s submission of the clinical trial application, the PPB will issue a Certificate of Registration for a Pharmaceutical Product. The manufacturer must complete the form listed in Additional Resource (A) to obtain a Certificate of Registration for a Pharmaceutical Product from the PPB.

The G-KenyaCT and the PPA specify that, in cases where the PPB does require an IP to be registered (e.g., when an IP is being investigated for a new condition), manufacturers must open a file with the agency and provide the following information:

  • If foreign, a manufacturer must appoint a local agent with blanket power of attorney documented in writing
  • Provide proof of current GMPs compliance
  • Provide a free sale certificate from the country of origin or a Certificate of a Pharmaceutical Product
  • Proof of payment of the approved fees
  • Certificate of Registration of a Pharmaceutical Product issued by the PPB valid for a period of five (5) years

As per the G-KenyaCT , to obtain an import license for a clinical trial, the sponsor or investigator must submit an application online to the Kenya Trade Network Agency (Additional Resource (D)). The following documents must be submitted:

  • The proforma invoice or invoice
  • The ethics committee favorable opinion letter
  • The Expert Committee on Clinical Trials approval letter from the PPB

The sponsor must submit to the PPB a copy of the endorsed clinical trial import license and/or evidence of delivery to the approved investigator(s)/trial center(s) on importation and supply of each consignment of the product. The product must only be supplied to the investigator(s) at the trial site(s) named in the clinical trial import license application for the purpose and use as stated in the said application. Prior PPB notification and approval is required for changes in investigator, trial site, or protocol. (See the Product Management subtopic for more details on IP management under an import license.)

Please note: Kenya is party to the Nagoya Protocol on Access and Benefit-sharing (Additional Resource (E)), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see Additional Resource (F).

Additional Resources
(A) (Website) Pharmacy and Poisons Board - GMP (Good Manufacturing Practice) (Current as of June 25, 2020)
Pharmacy and Poisons Board
Pharmacy and Poisons Board, Ministry of Health
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2.12 and 5.13
(D) (Website) KenTrade (Current as of June 25, 2020)
Kenya Trade Network Agency
Convention on Biological Diversity, United Nations
(F) (Website) Country Profile: Kenya (Current as of July 17, 2020)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
Investigational Products > IMP/IND Quality Requirements
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms, Section One (2, 12-13, 17, and 31), and Annex 2
(2) (Legislation) Health Laws (Amendment) Act, 2019 (PPA-Amndts) (Effective May 17, 2019)
Parliament
Relevant Sections: 3B
(3) (Guidance) Registration of Drugs – Guidelines to Submission of Applications (G-RegDrug) (2010)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Verification of compliance to current Good Manufacturing Practices (cGMP) and Module 1 (Section 1, 1.15 GMP status of the Manufacturer and GCP/GLP status of the Clinical Research Organisation/ Laboratory)
(4) (Legislation) Pharmacy and Poisons Act, Chapter 244 (PPA) (Amended through May 21, 2018)
Parliament
Relevant Sections: Part III A (35A and 35B)
Summary

Overview

In accordance with the G-KenyaCT, the sponsor is responsible for complying with the principles of good clinical practice (GCP) as specified in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) and for providing investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

Per the PPA-Amndts, the PPB is authorized to undertake various quality management duties regarding regulation of medicines, including:

  • Advise the government in all matters relating to the safety, packaging, and distribution of medicines
  • Ensure that all medicinal products manufactured in, imported into, or exported from the country conform to prescribed standards of quality, safety, and efficacy
  • Ensure that the personnel, premises, and practices employed in the manufacture, storage, marketing, distribution and sale of medicinal substances comply with the defined codes of practice and other prescribed requirements
  • Grant or revoke licenses for the manufacture, importation, exportation, distribution, and sale of medicinal substances
  • Maintain a register of all authorized medicinal substances
  • Inspect and license all manufacturing premises, importing and exporting agents, wholesalers, distributors, pharmacies (including those in hospitals and clinics), and other retail outlets
  • Approve the use of any unregistered medicinal substance for the purposes of clinical trials and compassionate use
  • Approve and regulate clinical trials on medicinal substances

IB Content Requirements

As specified in the G-KenyaCT and the ICH-GCPs-Addendum, the IB must provide coverage of the following areas (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
  • Summary of data and guidance for the investigator(s)
  • Toxicological effects in any animal species tested under a single dose study, a repeated dose study, or a special study

See the G-KenyaCT and the ICH-GCPs-Addendum for detailed content guidelines.

As defined in the G-KenyaCT, the sponsor must also supply the investigator(s)/institution(s) with the IP(s), including the comparator(s) and placebo, if applicable. The sponsor must submit to the Pharmacy and Poisons Board (PPB) a copy of the endorsed Clinical Trial Import License and/or evidence of delivery to the approved investigator(s)/institution(s) upon importing and supplying each product consignment. In addition, the IP must only be supplied to the investigator(s)/institution(s) named in the application for the Clinical Trial Import License/Clinical Trial Exemption for the purpose and use specified.

Drug Manufacturing Certificate Requirements

In accordance with the G-KenyaCT, the G-RegDrug, and the PPA, the manufacture of IPs for their use in a clinical trial must be approved by the PPB. As stated in the Investigational Products topic, Manufacturing & Import subtopic, the sponsor may choose not to register an IP with the PPB prior to submitting a clinical trial application. However, he/she is still required to manufacture the IP in accordance with Good Manufacturing Practices (GMPs) and to submit a GMP certificate for the IP to the PPB with the clinical trial application. See Section One (12) of the G-KenyaCT for detailed chemistry and manufacturing information to be provided to the PPB if the sponsor chooses not to register the IP prior to submitting the clinical trial application.

Per the ICH-GCPs-Addendum, the sponsor must maintain a Certificate of Analysis to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

(See Investigational Products topic, Product Management subtopic for additional information on sponsor requirements).

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 7
Pharmacy and Poisons Board, Ministry of Health
Investigational Products > Labeling & Packaging
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (15) and Annex 2
Summary

Overview

Investigational product (IP) labeling in Kenya must comply with the requirements set forth in the G-KenyaCT and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum). While there is no specified language requirement for IP labeling, English appears to be the preferred language.

In addition, a final copy/version of the labeling must be submitted to the Pharmacy and Poisons Board (PPB) for approval, and the following information must be included as a minimum on the product label:

  • Statement indicating that the product is for “clinical trial purpose only”
  • Name, address, and telephone number of the sponsor, contract research organization or investigator (the main contact for information on the product, clinical trial, and emergency unblinding)
  • Recommended storage conditions
  • Protocol code or identification
  • Pharmaceutical dosage form, route of administration, quantity of dosage units, and in the case of open trials, the name/identifier and strength/potency
  • The batch and/or code number to identify the contents and packaging operation
  • A trial reference code allowing identification of the trial, site, investigator, and sponsor, if not given elsewhere
  • The trial participant identification number/treatment number and, where relevant, the visit number
  • The name of the investigator (if not included above)
  • Directions for use (reference may be made to a leaflet or other explanatory document intended for the trial participant or person administering the product)
  • Period of use (use-by date, expiry date, or re-test date as applicable), in month/year format and in a manner that avoids any ambiguity
  • The complete physical address of the manufacturing site

The G-KenyaCT also specifies that any re-labeling of the remaining IPs from previously manufactured batches must be performed in accordance with Good Manufacturing Practices (GMPs) and is limited to an extension of the expiration date where sufficient evidence is available to support such an extension. In addition, any request for re-labeling should be accompanied by a Certificate of Analysis for the IP from a PPB recognized laboratory or World Health Organization-prequalified laboratories (Additional Resource (B)), and it requires prior approval from the PPB. For additional detailed re-labeling requirements, please refer to Section 15 of the G-KenyaCT.

The ICH-GCPs-Addendum states that the IP must be coded and labeled in a manner that protects the blinding, if applicable. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13
(B) (Website) Medicines Quality Control Laboratories (Current as of June 25, 2020)
World Health Organization
Investigational Products > Product Management
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms, Section One (2, 12, 15, 19, 22, 25, and 31), and Annex 2
(2) (Legislation) Health Laws (Amendment) Act, 2019 (PPA-Amndts) (Effective May 17, 2019)
Parliament
Relevant Sections: 3B
Summary

Overview

In accordance with the G-KenyaCT, the sponsor is responsible for complying with the principles of good clinical practice (GCP) as specified in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum) and for providing investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

Per the PPA-Amndts, the Pharmacy and Poisons Board (PPB) is responsible for the regulation of IPs, including all matters relating to the safety, packaging, and distribution of medicines. The PPB must ensure that all medicinal products manufactured in, imported into, or exported from the country conform to prescribed standards of quality, safety, and efficacy. Further, the PPB must ensure that the personnel, premises, and practices employed in the manufacture and storage of IPs complies with prescribed requirements.

Investigational Product Supply, Storage, and Handling Requirements

As defined in the G-KenyaCT and the ICH-GCPs-Addendum, the sponsor must also supply the investigator(s)/institution(s) with the IPs, including the comparator(s) and placebo, if applicable. The sponsor or his/her representative should not supply either party with the IP(s) until he/she obtains approval from the PPB and a favorable opinion letter from the local and national ethics committees (ECs). In addition, the G-KenyaCT requires the following supply, storage, and handling processes:

  • Analysis or evaluation of samples is performed in accordance with the protocol and, where applicable, the contract/agreement, the work instruction, and associated methods
  • Adherence to the laboratories, policies, and standard operating procedures (SOPs)
  • Prior to the initiation of sample analysis or evaluation, it is often necessary to prepare a work instruction detailing the procedures, which will be used to conduct the analysis or evaluation
  • Have automated equipment for routine hematology, biochemistry, and serology tests
  • Have procedures for analyzer calibration and quality control
  • Regularly maintain all the equipment, including point-of-care equipment
  • Have a procedure for transporting samples safely and quickly from clinical areas to the laboratory
  • Have written procedures for all assays, and validate the assays
  • Have a stock control procedure to make sure that reagents and consumables are used within their expiry dates
  • Keep records, including source documents and final reports
  • Have a laboratory information management system, and validate and backup the system
  • Provide protective clothing and safety equipment for staff
  • Have a central alarm system for all fridges and freezers
  • Have an internal audit program

The G-KenyaCT also states that the sponsor must submit to the PPB a copy of the endorsed Clinical Trial Import License and/or evidence of delivery to the approved investigator(s)/institution(s) upon importing and supplying each product consignment. In addition, the IP must only be supplied to the investigator(s)/institution(s) named in the application for the Clinical Trial Import License/Clinical Trial Exemption for the purpose and use specified. The sponsor must inform the PPB in the event of the any information changes including:

  • Information the sponsor receives that casts doubt on the continued validity of the submitted data, or,
  • Information associated with the Clinical Trial Import License

See section 31 of the G-KenyaCT for additional information on principal investigator requirements relating to the Clinical Trial Import License.

In addition, the G-KenyaCT and the ICH-GCPs-Addendum specify that the sponsor must ensure the following (Note: the regulations provide overlapping and unique elements so each of the items listed below will not necessarily be in each source.):

  • Timely delivery of the IP(s)
  • Records maintained for IP document shipment, receipt, disposition, return, and destruction
  • Written procedures including instructions for handling and storage of the IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
  • IP product quality and stability over the period of use
  • Maintain sufficient quantities of the IP(s) to reconfirm specifications, should this become necessary
  • IP manufactured according to any application of the Good Manufacturing Practices (GMPs)
  • Proper coding, packaging, and labeling of the IP(s)
  • Acceptable IP handling and storage conditions and shelf-life

Record Requirements

As per the G-KenyaCT, the sponsor is required to maintain records that document IP(s) shipment, receipt, disposition, return, and destruction. He/she must also maintain a system for retrieving IPs and documenting this retrieval, and maintain a system for the disposition of unused IPs.

According to the G-KenyaCT, IP manufacturers or importers must also retain samples for each batch of bulk product, and the packaging components used for each finished batch, for at least two (2) years following the trial.

Finally, the sponsor should maintain sufficient samples from each batch and keep a record of their analyses and characteristics for reference so that, if necessary, an independent laboratory could reconfirm the same data.

Additional Resources
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.5, 5.12, 5.13, 5.14, and 7
Specimens > Definition of Specimen
Last content review/update: June 26, 2020
Requirements
No applicable regulatory requirements
Summary

Per Additional Resource (A), the Kenya Medical Research Institute (KEMRI) identifies biological samples and specimens as including, but not limited to, blood samples, saliva, breast milk samples, mosquito parts samples, biological cultures, tissue and tissue samples, hair samples, human stool, and environmental samples used in human health research.

Additional Resources
(A) (Website) The Scientific and Ethics Review Unit (Current as of June 25, 2020)
Kenya Medical Research Institute
Relevant Sections: Submission Forms
Specimens > Specimen Import & Export
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Abbreviations and Definitions of Terms and Section One (7.42)
Summary

Overview

Information is currently unavailable regarding Kenya’s Pharmacy and Poisons Board (PPB)’s role in approving the import and export of biological specimens. However, the G-KenyaCT states that in the case of transfer of materials during research involving children, the sponsor or his/her representative or the principal investigator should provide to the ethics committee (EC) a Material Transfer Agreement (MTA) including, but not limited to, the following information:

  • Identification of the provider and recipient
  • Definition of the trial and how the material will and will not be used
  • Maintenance of confidentiality of background of supporting data or information, if any
  • Indemnification and insurance

In addition, Additional Resource (A) provides an example of the Kenya Medical Research Institute’s (KEMRI) procedures for handling requests to ship biological samples or specimens, and for handling requests for the secondary use of biological samples or specimens. Additional Resource (B) is an MTA form from the Kenyatta National Hospital and University of Nairobi (KNH-UoN) Ethics and Research Committee.

Additional Resources
(A) (Website) The Scientific and Ethics Review Unit (Current as of June 25, 2020)
Kenya Medical Research Institute
Relevant Sections: Submission Forms
(B) (Website) KNH-UoN Ethics and Research Committee – E-Resources (Current as of June 25, 2020)
Kenyatta National Hospital and University of Nairobi Ethics and Research Review Committee
Relevant Sections: KNH-UoN ERC Material Transfer Request Form
Specimens > Consent for Specimen
Last content review/update: June 26, 2020
Requirements
(1) (Guidance) Guidelines for the Conduct of Clinical Trials in Kenya (G-KenyaCT) (Rev. No. 2) (January 2020)
Pharmacy and Poisons Board, Ministry of Health
Relevant Sections: Section One (7.42)
Summary

Overview

Detailed information is currently unavailable regarding Kenya’s Pharmacy and Poisons Board (PPB)’s requirements for obtaining informed consent from participants prior to collecting, storing, or using his/her biological sample(s). However, the G-KenyaCT, states that for research involving children, the sponsor or his/her representative or the principal investigator should provide examples of patient information leaflets and informed consent forms (ICF) to the ethics committee (EC) for any proposed archiving of biological specimens for later research, or for genetics research.

See Additional Resource (A) for Kenya Medical Research Institute’s (KEMRI) sample ICF that includes guidance on specimens. Additional Resource (B) is the Kenyatta National Hospital and University of Nairobi (KNH-UoN) Ethics and Research Committee’s form and guidance on genetic research and biobanking.

See the Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent.

Additional Resources
(A) (Document) KEMRI SERU ICF Template (Version 5.0) (Effective July 1, 2019)
Kenya Medical Research Institute
(B) (Website) KNH-UoN Ethics and Research Committee – E-Resources (Current as of June 25, 2020)
Kenyatta National Hospital and University of Nairobi Ethics and Research Review Committee
Relevant Sections: KNH-UoN ERC Guidelines For Genetic Research and Biobanking
Sections Country Announcement
Country Announcement
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COVID-19 Guidance

African regulatory agencies, ethics committees to expedite COVID-19 clinical trial reviews (April 20, 2020)

Kenya’s Pharmacy and Poisons Board (PPB) has issued Guidance to Sponsors and Investigators for Conduct of Clinical Trials during the COVID-19 Pandemic in Kenya, which takes effect April 20, 2020. The guidance addresses the following topics:

  • Management of and amendments to existing trials
  • Restarting a trial that has been halted
  • Providing the investigational medicinal product (IMP) to trial participants
  • Reporting of serious adverse events (SAEs), and submission of annual safety reports (DSURs) and end of trial notifications
  • Protocol deviations, serious breaches, and waivers
  • Risks/benefits of conducting trials that may impact a participant’s immune system
  • Signatures and alternate methods of demonstrating approval

The guidance also discusses expedited review of new studies relating to COVID-19, including parallel ethics and regulatory review, which usually is not allowed.

This message was reviewed on August 14, 2020
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