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
Import & Export
Consent for Specimens
Kenya
QUICK FACTS
Clinical trial application languageUnspecified
Parallel regulatory and ethical review permittedNo
Clinical trial registration requiredYes
In-country sponsor presence/representation requiredNo
Age of minorsUnder 18
Specimens export allowedUnspecified
Regulatory Authority > Regulatory Authority
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SUMMARY

Overview
As per the G-KenyaCT and Additional Resources (A), (B), and (C), Kenya’s Pharmacy and Poisons Board (PPB) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. In 2012, the PPB appointed an Expert Committee on Clinical Trials (ECCT) to evaluate all matters relating to clinical trials and to grant permission for clinical trials to be conducted in Kenya.

As indicated in the PPA, the PPB was established as the national drug regulatory authority within the Ministry of Health (MOH) in 1957. According to Additional Resources (B) and (D), the MOH was divided into the Ministry of Medical Services (MOMS) and the Ministry of Public Health and Sanitation (MOPHS) in 2008. At this time, the PPB began to function as a department under the MOMS, which is authorized to oversee pharmaceutical policy development. As per Additional Resource (E), the PPB’s mandate is to implement the appropriate regulatory measures to achieve the highest standards of safety, efficacy, and quality for all drugs, chemical substances, and medical devices, and to ensure consumer protection. In addition, as stated in the G-KenyaCT, the PPB is authorized to ensure that clinical trials involving new investigational drugs, older drugs for new conditions or diseases, or medical devices, comply with national regulations and guidelines.

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

For General Inquiries:
Phone: +254 (020) 3562107, +254 (720) 608811, or +254 (733) 884411
Fax: +254 (020) 2716906, +254 (020) 2713538, or +254 (020) 2721937
General Email: enquiries@pharmacyboardkenya.org

Registrar's Office:
Phone and Fax: +254 (020) 2721937

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 NACOSTI prior to initiating a study. Established in 2013 by the STI Act, the NACOSTI is the successor of the National Council for Science and Technology (NCST). The 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, the 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.)

Contact Information
National Commission for Science, Technology and Innovation
8th - 9th Floor
Utalii House off Uhuru Highway
P. O. Box 30623
Nairobi Kenya

Phone: Tel (+254) 020 310571/(+254) 020 2241349
Fax: (+254) 020 2213215
Email: customercare@nacosti.go.ke

ADDITIONAL RESOURCES

(A) (Website) Online Clinical Trials (Current as of November 15, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(B) (Document) Sessional Paper on National Pharmaceutical Policy (June 2010)
Ministry of Medical Services & Ministry of Public Health and Sanitation, Republic of Kenya

Relevant Sections: 3.2.1.1, 3.7.1.1, and Annex 2

(C) (Document) Checklist for Submitting Documents to the Expert Committee on Clinical Trials (January 19, 2012)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(D) (Document) Kenya Pharmaceutical Country Profile (November 2010)
Ministry of Medical Services, Republic of Kenya

Relevant Section: 4.1

(E) (Website) Pharmacy and Poisons Board – Mission & Vision (Current as of November 15, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(F) (Website) Pharmacy and Poisons Board - Contact Us (Current as of November 15, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(G) (Website) NACOSTI - Research License (Current as of November 15, 2015)
National Commission for Science, Technology and Innovation, Republic of Kenya

(H) (Website) NACOSTI – Contact Us (Current as of November 15, 2015)
National Commission for Science, Technology and Innovation, Republic of Kenya

REQUIREMENTS

(1) (Legislation) Pharmacy and Poisons Act, Chapter 244 (PPA) (December 31, 2012) (Revised Edition)
Parliament, Republic of Kenya

Relevant Section: Part I (3)

(2) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Foreword and Introduction

(3) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (January 14, 2013)
Parliament, Republic of Kenya

Relevant Section: Part IV


Regulatory Authority > Scope of Assessment
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SUMMARY

Overview
In accordance with the G-KenyaCT and Additional Resources (A), (B), and (C), Kenya’s Pharmacy and Poisons Board (PPB) 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
As set forth in the G-KenyaCT, the Expert Committee on Clinical Trials (ECCT) within the PPB coordinates the clinical trial application process. Upon receipt of a clinical trial application, the PPB’s Clinical Trials Unit within the Division of Medicines Information and Pharmacovigilance screens the application package for completeness. 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 (no timeframe is available on this process). 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 PPB’s Clinical Trials Unit according to its standard operating procedures. The PPB’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. 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.)

ADDITIONAL RESOURCES

(A) (Website) Online Clinical Trials (Current as of November 16, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(B) (Document) Sessional Paper on National Pharmaceutical Policy (June 2010)
Ministry of Medical Services & Ministry of Public Health and Sanitation, Republic of Kenya

Relevant Sections: 3.2.1.1, 3.7.1.1, and Annex 2

(C) (Document) Checklist for Submitting Documents to the Expert Committee on Clinical Trials (January 19, 2012)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Foreword, Abbreviations and Definition of Terms, Introduction, Section One (1, 2, 5, and 10), and Annexes 1 and 2

Regulatory Authority > Regulatory Fees
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SUMMARY

Overview
As per the G-KenyaCT and Additional Resource (A), 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) at the prevailing bank rates.

In addition, according to Additional Resource (B), the investigator(s) or the head of a research institution is responsible for paying a fee to the National Commission for Science, Technology and Innovation (NACOSTI) to obtain the research permit.

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 (B), the NACOSTI charges a non-refundable 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.)

See Additional Resource (B) for detailed information on NACOSTI research permit fees.

ADDITIONAL RESOURCES

(A) (Document) Checklist for Submitting Documents to the Expert Committee on Clinical Trials (January 19, 2012)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(B) (Document) The Science, Technology and Innovation Act, 2013 (Part IV) – Licensing of Research: Checklist – When Submitting the Application (Date Unavailable)
National Commission for Science, Technology and Innovation, Republic of Kenya

(C) (Website) NACOSTI – Research License (Current as of November 17, 2015)
National Commission for Science, Technology and Innovation, Republic of Kenya


REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Section One (1), and Annexes 1 and 2

Ethics Committee > Ethics Committee
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SUMMARY

Overview
As per the G-KenyaCT, the G-ECBiomedRes, and Additional Resource (A), Kenya has a multi-layered ethics review process, requiring investigator(s) to obtain local, institutional and/or national level ethics committee (EC) approval for each clinical trial. For the initial review, the investigator is typically required to obtain ethics approval from his/her department within the local institution. An additional review of the clinical protocol must be conducted by the National Commission for Science, Technology and Innovation (NACOSTI)’s National Bioethics Committee (NBC) or an NBC-accredited institutional EC.

In cases where the investigator is not affiliated with a specific institution, or is affiliated with an institution lacking an EC, the investigator should submit the protocol directly to the NACOSTI’s NBC for review and approval.

Although most investigators will generally seek final approval from the NACOSTI’s NBC, they may also choose to obtain final approval from an NBC-accredited EC, as delineated in the STI Act, the G-ECAccred, and Additional Resources (A), (B), and (C). See the G-ECAccred and Additional Resource (E) for detailed instructions and 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 detailed submission requirements.

NBC Composition
As specified in Additional Resource (B), the NACOSTI’s NBC consists of 17 members whose mandate is to ensure the highest ethical research standards, and consider and review EC accreditation application. Further information on the NBC’s composition requirements is not currently available.

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

  • At least one (1) member with knowledge and understanding of Kenyan law
  • Gender composition should consist of at least a one-third to two-thirds ratio between genders
  • At least one (1) member who is unaffiliated with the institution
  • At least two (2) members should have research expertise and experience, one of whom should be in the health field
  • At least one (1) member should be a lay member
  • For ECs reviewing clinical research, at least two (2) members should be clinicians, one of whom is currently in active practice or clinical research


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 and the G-ECBiomedRes, institutional ECs must operate within written standard operating procedures (SOPs) which delineate the EC’s process for conducting reviews. The SOPs should include 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 and recordkeeping procedures, quorum requirements, communication procedures, and complaint process and dispute resolution procedures.

For detailed institutional EC requirements and information on other administrative processes, see the G-ECAccred and the G-ECBiomedRes. See Additional Resources (E) and (F) for examples of NBC-accredited EC guidelines.

ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Kenya (Last updated December 22, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) NACOSTI – Achievements (Current as of November 15, 2015)
National Council for Science and Technology, Republic of Kenya

Relevant Section: 1.a) Establishment of the National Bioethics Committee (NBC) 2009

(C) (Document) Accredited Institutional Ethics Review Committees (IERCs) (Date Unavailable)
National Council for Science and Technology, Republic of Kenya

(D) (Form) Application Form for Institutional Ethics Review Committee Accreditation/ Renewal of Accreditation (Form NCST/ AC-01) (Version 1) (2011)
National Council for Science and Technology, Republic of Kenya

(E) (Guidance)  Appendix D - Kenyatta National Hospital Ethics & Research Committee Guidelines for Protocol Development (Date Unavailable)
Kenyatta National Hospital and University of Nairobi Ethics and Research Review Committee, Republic of Kenya

(F) (Guidance) Research Guidelines – Development and Conduct of Research (February 2010)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Section: Annex 2

(2) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Council for Science and Technology, Republic of Kenya

Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee; Externally Sponsored Research

(3) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (January 25, 2013)
Parliament, Republic of Kenya

Relevant Sections: Parts II, IV, V, X, and Fourth Schedule

(4) (Guidance) Guidelines for Accreditation of Ethics Review Committees in Kenya (G-ECAccred) (February 2011)
National Bioethics Committee, National Council for Science and Technology, Republic of Kenya

Relevant Sections: 1.0, 2.0., 3.0, and Annex 1


Ethics Committee > Scope of Review
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SUMMARY

Overview
According to the G-ECAccred and the G-ECBiomedRes, the primary scope of information assessed by the National Commission for Science, Technology and Innovation’s (NACOSTI)’s National Bioethics Committee (NBC) and the local and host 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.

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-ECAccred and the G-ECBiomedRes also state that the NBC and 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; confirming the suitability of the investigator(s), facilities, and methods; 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, the G-ECBiomedRes, the STI Act, 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 the local, institutional, and national level ECs. Consequently, the PPB and EC reviews may not be conducted in parallel.

According to the G-KenyaCT and Additional Resource (A), the principal investigator (PI) is responsible for submitting an application to the local, institutional, and national level ECs for review and approval. See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission process requirements.)

No information is currently available on EC review and approval timelines.

ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Kenya (Last updated November 15, 2015)
Global Health Technologies Coalition, Washington, DC

REQUIREMENTS

(1) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004)
National Council for Science and Technology, Republic of Kenya

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 Ethics Review Committees in Kenya (G-ECAccred) (February 2011)
National Bioethics Committee, National Council for Science and Technology, Republic of Kenya

Relevant Sections: 1.0 and Annex 1

(3) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (January 25, 2013)
Parliament, Republic of Kenya

Relevant Sections: Parts II, IV, V, X, and Fourth Schedule

(4) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Section One (10) and Annex 2


Ethics Committee > Ethics Committee Fees
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Ethics Committee > Authorizing Body
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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. Established in 2013 by the STI Act, the NACOSTI is the successor of the National Council for Science and Technology (NCST). The 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, the NACOSTI’s National Bioethics Committee (NBC) was founded in 2009, initially as part of the NCST, and is dedicated to promoting and monitoring ethical issues in Kenya.

NBC Composition
As specified in Additional Resource (B), the NBC consists of 17 members whose mandate is to ensure the highest ethical research standards, consider and review ethics committee (EC) accreditation applications, advise the government on scientific and technological requirements to conserve Kenya’s natural and social environment, and maintain a relationship with corresponding scientific organizations internationally. Further information on the NBC’s composition requirements is not currently available.

Registration, Auditing, and Accreditation
As per the G-ECAccred and Additional Resource (B), the NBC is responsible for accrediting institutional ECs. For NBC-accredited ECs, the standard operating procedures must be provided to the NBC for the reaccreditation review process, which occurs every three (3) years. See the G-ECAccred for additional details on the NBC’s accreditation process. No information is currently available on the NBC’s audit responsibilities.

ADDITIONAL RESOURCES

(A) (Website) NACOSTI – Mandate & Functions (Current as of November 15, 2015)
National Council for Science and Technology, Republic of Kenya

(B) (Website) NACOSTI – Achievements (Current as of November 15, 2015)
National Council for Science and Technology, Republic of Kenya

Relevant Section: 1.a) Establishment of the National Bioethics Committee (NBC) 2009


REQUIREMENTS

(1) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (January 25, 2013)
Parliament, Republic of Kenya

Relevant Section: Part II

(2) Guidelines for Accreditation of Ethics Review Committees in Kenya (G-ECAccred) (February 2011)
National Bioethics Committee, National Council for Science and Technology

Relevant Sections: 1.0, 2.0, 3.0., and Annex

Clinical Trial Lifecycle > Submission Process
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SUMMARY

Overview
In accordance with the G-KenyaCT, the G-ECBiomedRes, the G-ECAccred, the STI Act, and Additional Resources (A), (B), and (C), Kenya requires the sponsor or his/her representative to obtain clinical trial authorization from the Pharmacy and Poisons Board (PPB) and to ensure the principal investigator (PI) obtains ethics committee (EC) approval from his/her local institution, the host institution, and national approval from either the National Commission for Science, Technology and Innovation (NACOSTI)’s National Bioethics Committee (NBC) or an NBC-accredited EC prior to initiating a study. In addition, the STI Act and Additional Resource (D) 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 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 Resources (E) and (F) for examples of the NACOSTI’s NBC-accredited EC guidelines.

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

Delivery Address for Clinical Trial Application
The Registrar
Pharmacy and Poisons Board
P.O. Box 27663-00506
Nairobi, Kenya
Attention: The Expert Committee on Clinical Trials

Clinical Research Office Phone: (020) 3562107; 2716905/6; 0720608811; 0733884411
Fax: (020) 2713431/2713409
Clinical Research Office Email: pv@pharmacyboardkenya.org

Assembly and Number of Copies
Based on information provided in Additional Resource (H), the sponsor or his/her representative are encouraged to register and submit the clinical trial application electronically via the PPB’s Expert Committee On Clinical Trials (ECCT). However, as specified in the G-KenyaCT and Additional Resource (H), 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 and one (1) electronic copy in PDF format via re-writable CD/Flash Drive. See Annex 1 in the G-KenyaCT for a copy of the application form or download the form from the ECCT website (Additional Resource (H)).

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 requires the informed consent form (ICF) to be submitted to the PPB in English.

ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Kenya (Last updated December 22, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) NACOSTI – Achievements (Current as of November 16, 2015)
National Council for Science and Technology, Republic of Kenya

Relevant Section: 1.a) Establishment of the National Bioethics Committee (NBC) 2009

(C) (Document) Accredited Institutional Ethics Review Committees (IERCs) (Date Unavailable)
National Council for Science and Technology, Republic of Kenya

(D) (Website) NACOSTI - Research License (Current as of November 16, 2015)
National Commission for Science, Technology and Innovation, Republic of Kenya

(E) (Guidance) Appendix D - Kenyatta National Hospital Ethics & Research Committee Guidelines for Protocol Development (Date Unavailable)
Kenyatta National Hospital and University of Nairobi Ethics and Research Review Committee, Republic of Kenya

(F) (Guidance) Research Guidelines – Development and Conduct of Research (February 2010)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

(G) (Document) Checklist for Submitting Documents to the Expert Committee on Clinical Trials (January 19, 2012)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(H) (Website) Online Clinical Trials (Current as of November 16, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Foreword, Introduction, Section One (1, 5, and 10), and Annexes 1 and 2

(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2004) National Council for Science and Technology, Republic of Kenya

Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee

(3) (Guidance) Guidelines for Accreditation of Ethics Review Committees in Kenya (G-ECAccred) (February 2011)
National Bioethics Committee, National Council for Science and Technology, Republic of Kenya

Relevant Sections: 1.0, 2.0., 3.0, and Annex 1

(4) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (January 25, 2013)
Parliament, Republic of Kenya

Relevant Sections: Parts II, IV, V, X, and Fourth Schedule

Clinical Trial Lifecycle > Submission Content
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SUMMARY

Overview
As set forth in the G-KenyaCT, the G-ECBiomedRes, the G-ECAccred, the STI Act, and Additional Resources (A), (B), and (C), Kenya requires the sponsor or his/her representative to obtain clinical trial authorization from the Pharmacy and Poisons Board (PPB), and to ensure the principal investigator (PI) obtains ethics committee (EC) approval from his/her local institution, the host institution, and national approval from either the National Commission for Science, Technology and Innovation (NACOSTI)’s National Bioethics Committee (NBC) or an NBC-accredited EC prior to initiating a study. In addition, the STI Act and Additional Resource (D) specifies that all applicants must register their research proposal with the NACOSTI and obtain a research permit prior to initiating a study.

PPB Requirements
As per the G-KenyaCT and Additional Resource (I), the following documentation must be submitted to the PPB:

  • Clinical trial application form
  • Cover letter
  • Protocol (see below for detailed protocol requirements)
  • Patient Information Leaflet (PIL) and Informed Consent Form (ICF) (See Informed Consent topic, Required Elements subtopic for additional information)
  • Investigator’s Brochure (IB)/Package Inserts or Investigational Medicinal Product Dossier (IMPD)
  • Good Manufacturing Practice (GMP) certificate for the investigational product (IP)
  • Signed investigator(s) curriculum vitaes (CVs)
  • Financial declaration by sponsor and/or principal investigator (PI)
  • Signed declaration by sponsor or PI
  • Indemnity cover and insurance certificate for the participants
  • Copy of local and host EC approval letters
  • Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
  • A signed statement by the sponsor indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading
  • Where the trial is part of an international study, provide sufficient information regarding the other participating countries and the scope of the study in these countries
  • For multicenter/multi-site studies, an addendum for each of the site should be provided with the initial application
  • Registration with the Pan African Clinical Trials Registry (PACTR) (see Clinical Trial Lifecycle topic, Trial Initiation subtopic for additional details)
  • Payment of application fee


NACOSTI Requirements
The PI or the head of a research institution must complete the NACOSTI’s Application Form for Kenyan Citizens or the Application Form for Non-Kenyans (see Additional Resource (D) for form links) to a obtain a research permit. 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 its own country.

As per Additional Resources (D) and (J), the following documentation is required for non-Kenyans:

  • One (1) copy of application form
  • One (1) copy of passport
  • Three (3) copies of current passport size photo
  • Reference letter from university/institution
  • Affiliation letter from local university/institution and completed Affiliation Form (see Additional Resource (D))
  • Referees details and signatures in application form
  • Letter from sponsor (if not self-sponsored)
  • One (1) copy of host university/institution endorsed research proposal
  • One (1) copy of applicant’s CV
  • One (1) copy of research assistant’s CV, where applicable
  • Prior informed consent, where applicable
  • Materials Transfer Agreement (MTA), where applicable
  • Genetic Materials Access Permit, where applicable
  • Accredited EC approval letter, where applicable
  • Application fee payment receipt
  • Company/institution registration and profile


See Additional Resources (D) and (I) for detailed application requirements, and for link to Kenyan citizen application form.

National Bioethics Committee (NBC) and Institutional EC Requirements
Although the National Bioethics Committee’s (NBC) application requirements are not currently available electronically, an example of NBC-accredited EC requirements are delineated in the Ethics and Research Application Form used by the Kenyatta National Hospital/University of Nairobi (KNH/UoN) and Kenya Medical Research Institute (KEMRI) (Additional Resource (J)). As specified in Additional Resource (J), the following documentation is required to obtain ethics approval:

  • Three (3) copies of application form (including at least one 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 NBC protocol submission requirements are not currently available electronically. As set forth in Additional Resource (E), the NBC-accredited EC, KNH/UoN, requires the following elements to be included in its protocol submission:

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

For detailed information on these elements, refer to Additional Resource (E).

ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Kenya (Last updated December 22, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) NACOSTI –Achievements (Current as of November 16, 2015)
National Council for Science and Technology, Republic of Kenya

Relevant Section: 1.a) Establishment of the National Bioethics Committee (NBC) 2009

(C) (Document) Accredited Institutional Ethics Review Committees (IERCs) (Date Unavailable)
National Council for Science and Technology, Republic of Kenya

(D) (Website) NACOSTI – Research License (Current as of November 16, 2015)
National Commission for Science, Technology and Innovation, Republic of Kenya

(E) (Guidance) Appendix D - Kenyatta National Hospital Ethics & Research Committee Guidelines for Protocol Development (Date Unavailable)
Kenyatta National Hospital and University of Nairobi Ethics and Research Review Committee, Republic of Kenya

(F) (Guidance) Research Guidelines – Development and Conduct of Research (February 2010)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

(G) (Document) Checklist for Submitting Documents to the Expert Committee on Clinical Trials (January 19, 2012)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(H) (Form) Clinical Trial Application Form (Date Unavailable)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(I) (Document) The Science, Technology and Innovation Act, 2013 (Part IV) – Licensing of Research: Checklist – When Submitting the Application (Date Unavailable)
National Commission for Science, Technology and Innovation, Republic of Kenya

(J) (Form) Ethics and Research Application Form – Kenyatta National Hospital/University of Nairobi KEMRI Centers (Date Unavailable)
Kenyatta National Hospital/University of Nairobi, Kenya Medical Research Institute

(K) (Document) Clinical Trials in Kenya (May 2006)
Patel, Vaishalee, SOMO

Relevant Section: 3.2.2

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Foreword, Introduction, Section One (1 and 5), and Annexes 1 and 2

(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005) National Council for Science and Technology, Republic of Kenya

Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee; Externally Sponsored Research

(3) (Guidance) Guidelines for Accreditation of Ethics Review Committees in Kenya (G-ECAccred) (February 2011)
National Bioethics Committee, National Council for Science and Technology, Republic of Kenya

Relevant Sections: 1.0, 2.0, 3.0, and Annex 1

(4) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (January 25, 2013)
Parliament, Republic of Kenya

Relevant Sections: Parts II, IV, V, X, and Fourth Schedule

Clinical Trial Lifecycle > Timeline of Review
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SUMMARY

Overview
Based on the G-KenyaCT, the G-ECBiomedRes, the G-ECAccred, the STI Act, and Additional Resources (A), (B), and (C), the Pharmacy and Poisons Board (PPB)’s review and approval of a clinical trial application is dependent upon the principal investigator (PI) obtaining ethics committee (EC) approval from his/her local institution, the host institution, and national approval from either the National Commission for Science, Technology and Innovation (NACOSTI)’s National Bioethics Committee (NBC) or an NBC-accredited EC prior to initiating a study. Consequently, the PPB and EC reviews may not be conducted in parallel.

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

PPB Approval
Clinical Trial Application Submission
As per the G-KenyaCT and Additional Resource (G), the PPB’s Expert Committee on Clinical Trials (ECCT) review and approval process for a clinical trial application takes 30 days.

Upon receipt of a clinical trial application, the PPB’s Clinical Trials Unit within the Division of Medicines Information and Pharmacovigilance screens the application package for completeness. 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 (no timeline available). 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 PPB’s Clinical Trials Unit according to its standard operating procedures. The PPB’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. In certain cases, the PPB may refer the application to external experts for their recommendation.

In addition, Additional Resource (G) states that all clinical trial submissions should be received at least 21 working days prior to an upcoming scheduled ECCT meeting. Submissions received less than 21 working days, will be tabled at the next scheduled meeting. See Additional Resource (G) for more detailed information.

NACOSTI NBC Ethics Approval
No relevant provisions regarding the NACOSTI NBC’s review and approval timeline are currently available.

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

NACOSTI Research Permit Approval
No information currently available on timeline for processing research permits.

ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Kenya (Last updated December 22, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) NACOSTI – Achievements (Current as of November 16, 2015)
National Council for Science and Technology, Republic of Kenya

Relevant Section: 1.a) Establishment of the National Bioethics Committee (NBC) 2009

(C) (Document) Accredited Institutional Ethics Review Committees (IERCs) (Date Unavailable)
National Council for Science and Technology, Republic of Kenya

(D) (Website) NACOSTI – Research License (Current as of November 16, 2015)
National Commission for Science, Technology and Innovation, Republic of Kenya

(E) (Website) Global Health Technologies Coalition – Kenya: Drugs (Last updated September 29, 2014)
Global Health Technologies Coalition, Washington, DC

(F) (Website) Online Clinical Trials (Current as of November 16, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(G) (Document) Checklist for Submitting Documents to the Expert Committee on Clinical Trials (January 19, 2012)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Foreword, Introduction, Section One (2, 5, and 10), and Annex 2

(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical

(3) (Guidance) Guidelines for Accreditation of Ethics Review Committees in Kenya (G-ECAccred) (February 2011)
National Bioethics Committee, National Council for Science and Technology, Republic of Kenya

Relevant Sections: 1.0, 2.0., 3.0, and Annex 1

(4) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (January 25, 2013)
Parliament, Republic of Kenya

Relevant Sections: Parts II, IV, V, X, and Fourth Schedule

Clinical Trial Lifecycle > Trial Initiation
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SUMMARY

Overview
In accordance with the G-KenyaCT, the G-ECBiomedRes, the G-ECAccred, the STI Act, and Additional Resources (A), (B), (C), and (D), 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 approval from the principal investigator’s (PI) local institution, host institution, and national approval from either the National Commission for Science, Technology and Innovation (NACOSTI)’s National Bioethics Committee (NBC) or an NBC-accredited EC prior to initiating a study. The G-KenyaCT specifies that the PPB review and approval process may not be conducted in parallel with the ethics committee (EC) review. In addition, the STI Act and Additional Resource (E) states 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, the PPA, and Additional Resources (F) and (G), 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 from the PPB’s Trade Affairs Department. (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

As stated in the G-KenyaCT, the 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 GCPs course was attended within the past three (3) years. The trials should be conducted in compliance with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs).

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.

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 and Additional Resource (G), all clinical trials taking place in Kenya must be registered in Kenya's Clinical Trials Registry. The principal investigator (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.

Data and Safety Monitoring Board
The G-KenyaCT recommends establishing a Data and Safety Monitoring Board (DSMB), and provides documentation submission requirements to be submitted to the PPB. The documentation should include:

  • DSMB composition
  • Copy of DSMB charter
  • DSMB reports to be submitted to the PPB within two (2) weeks of its deliberations
ADDITIONAL RESOURCES

(A) (Website) Global Health Technologies Coalition – Kenya (Last updated December 22, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) NACOSTI – Achievements (Current as of November 16, 2015)
National Council for Science and Technology, Republic of Kenya

Relevant Section: 1.a) Establishment of the National Bioethics Committee (NBC) 2009

(C) (Document) Accredited Institutional Ethics Review Committees (IERCs) (Date Unavailable)
National Council for Science and Technology, Republic of Kenya

(D) (Website) NACOSTI – Research License (Current as of November 16, 2015)
National Commission for Science, Technology and Innovation, Republic of Kenya

(E) (Website) Trade Affairs (Current as of November 16, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(F) (Website) Global Health Technologies Coalition – Kenya: Drugs (Last updated September 29, 2014)
Global Health Technologies Coalition, Washington, DC

(G) (Document) Checklist for Submitting Documents to the Expert Committee on Clinical Trials (January 19, 2012)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(H) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation, Geneva, Switzerland

Relevant Sections: 5.12, 5.13, 5.14, 5.15, 5.5, and 7

(I) (Website) Online Clinical Trials (Current as of November 16, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Foreword, Abbreviations and Definition of Terms, Introduction, Section One (1, 2, 3, 5, 16, and 24), and Annexes 1 and 2

(2) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee

(3) (Guidance) Guidelines for Accreditation of Ethics Review Committees in Kenya (G-ECAccred) (February 2011)
National Bioethics Committee, National Council for Science and Technology, Republic of Kenya

Relevant Sections: 1.0, 2.0, 3.0, and Annex 1

(4) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (January 25, 2013)
Parliament, Republic of Kenya

Relevant Sections: Parts II, IV, V, X, and Fourth Schedule

(5) (Legislation) Pharmacy and Poisons Act, Chapter 244 (PPA) (2012) (Revised Edition)
Parliament, Republic of Kenya

Relevant Section: Part IV (44)


Clinical Trial Lifecycle > Safety Reporting
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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 an investigational medicinal product 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 and/or investigator should report serious and fatal SAEs/SADRs within seven (7) days, and report non-serious SAEs/SADRs within 15 days. As delineated in the G-KenyaCT, the sponsor or his/her representative is responsible for initially reporting SUSARs to the Pharmacy and Poisons Board (PPB) as soon as possible, but within seven (7) calendar days from the occurrence of the incident. The submitted SUSAR information must be updated with any additional relevant information within eight (8) calendar days.

As per the G-KenyaCT, the sponsor and/or investigator must also submit a summary of SAEs/SADRs and SUSARs every six (6) months from the day of approval of the study. The SAE/SADR Log should include the following:

  • Patient Identification
  • Age
  • Type of SAE/SADR
  • SAE/SADR start and end dates
  • Reason for reporting the event as an SAE/SADR
  • Relation to investigational product (IP)
  • SAE/SADR outcome

Other important timelines include the following:

  • Any IP related SAE/SADR must receive immediate medical attention and be reported to the PPB
  • SAE/SADR 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 PI is required to submit follow-up information as soon as it becomes available

Please refer to Section 15 of the G-KenyaCT for additional safety reporting requirements.

The G-KenyaCT also indicates that periodic safety update reports (PSURs) for all medicinal products should be submitted using the following timelines:

  • At least six (6) months following product authorization and until placed on the market
  • At least six (6) months for the first two (2) years after being placed on the market
  • Annually for the subsequent two (2) years
  • At three (3) year intervals following the two (2) years on the market
  • Immediately upon request


As per the G-KenyaCT, the SUSAR reports can be submitted to the PBB through the online Pharmacovigilance Electronic Reporting System at http://www.pv.pharmacyboardkenya.org. See Section 15 of the G-KenyaCT for detailed safety reporting requirements.

Form Completion & Delivery Requirements
As per the G-KenyaPV, and Additional Resources (A), (B), and (C), all SAEs/SADRs and SUSARs must be reported on the PPB’s Suspected Adverse Drug Reaction Reporting Form (Additional Resource (B)), and be emailed to pv@pharmacyboardkenya.org, or mailed to the following address:

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

Tel: +254 020 2716905/6 Ext. 114
Fax: +254 020 2713431/2713409

Data and Safety Monitoring Board
The G-KenyaCT recommends establishing a Data and Safety Monitoring Board (DSMB), and provides documentation submission requirements to be submitted to the PPB. The documentation should include:

  • DSMB composition
  • Copy of DSMB charter
  • DSMB reports to be submitted to the PPB within two (2) weeks of its deliberations
ADDITIONAL RESOURCES

(A) (Document) Medicine Safety Pharmacovigilance Fact Sheet (Date Unavailable)
Pharmacy and Poisons Board, Ministry of Medical Services and Ministry of Public Health and Sanitation, Republic of Kenya

(B) (Form) Suspected Adverse Drug Reaction Reporting Form (PV1) (Date Unavailable)
Pharmacy and Poisons Board, Ministry of Health, Republic of Kenya

(C) (Website) Reporting a Suspected Adverse Drug Reaction (Current as of November 16, 2015)
Pharmacy and Poisons Board,  Ministry of Medical Services, Republic of Kenya


REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Abbreviations and Definitions of Terms and Section One (4.5, 5, 15, and 16)

(2) (Guidance) Guidelines for the National Pharmacovigilance System in Kenya (G-KenyaPV) (2nd Edition) (February 2009)
Pharmacy and Poisons Board, Ministry of Medical Services and Ministry of Public Health and Sanitation, Republic of Kenya

Relevant Sections: Basic Principles of Efficient Reporting and Annexes 1 and 8


Clinical Trial Lifecycle > Progress Reporting
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SUMMARY

Overview
In accordance with the G-KenyaCT, the principal investigator (PI) and the sponsor share responsibility for submitting progress reports on the status of a clinical trial and for submitting a final study report upon the trial’s completion.

Interim/Progress Reports
As stated in the G-KenyaCT, the sponsor and/or the PI is required to send progress reports to the Pharmacy and Poisons Board (PPB) on an annual basis from the date of the trial’s initiation. on an annual basis every six (6) months 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 violations
  • Updated investigational product Investigator’s Brochure
  • Number of trial participants enrolled
  • Copy of the latest Data Safety Management Board report
  • Copy of favourable opinion from the ethics committee on record
  • 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.

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 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.

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 90 days.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Section One (5 and 18)

Sponsorship > Definition of Sponsor
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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.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Abbreviations and Definitions of Terms, Section One (1), and Annex 1

Sponsorship > Trial Authorization
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SUMMARY

Overview
In accordance with the G-KenyaCT, the sponsor is responsible for submitting a clinical trial application to the Pharmacy and Poisons Board (PPB) to obtain authorization to conduct a clinical trial.

In accordance with the G-KenyaCT, the G-ECBiomedRes, the G-ECAccred, the STI Act, and Additional Resources (A), (B), and (C), the sponsor must also ensure that the principal investigator (PI) obtains ethics committee (EC) approval from the PI’s local institution, host institution, and national approval from either the National Commission for Science, Technology and Innovation (NACOSTI)’s National Bioethics Committee (NBC) or an NBC-accredited EC prior to initiating a study, and as a pre-requisite to the clinical trial application. The G-KenyaCT specifies that the PPB review and approval process may not be conducted in parallel with the ethics committee (EC) review.

To complete the clinical trial application package, the sponsor must use the PPB’s clinical trial application form available (Additional Resource (D)), which is also available in Annex 1 of the G-KenyaCT. In addition to submitting the completed application, as per the G-KenyaCT and Additional Resource (E), 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) Global Health Technologies Coalition – Kenya (Last updated December 22, 2014)
Global Health Technologies Coalition, Washington, DC

(B) (Website) NACOSTI –Achievements (Current as of November 16, 2015)
National Council for Science and Technology, Republic of Kenya

Relevant Section: 1.a) Establishment of the National Bioethics Committee (NBC) 2009

(C) (Document) Accredited Institutional Ethics Review Committees (IERCs) (Date Unavailable)
National Council for Science and Technology, Republic of Kenya

(D) (Form) Clinical Trial Application Form (Date Unavailable)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(E) (Document) Checklist for Submitting Documents to the Expert Committee on Clinical Trials (January 19, 2012)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Foreword, Abbreviations and Definitions of Terms, Introduction, Section One (1, 2, 3, 5, 10, and 16), and Annexes 1 and 2

(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee

(3) (Guidance) Guidelines for Accreditation of Ethics Review Committees in Kenya (G-ECAccred) (February 2011)
National Bioethics Committee, National Council for Science and Technology, Republic of Kenya

Relevant Sections: 1.0, 2.0, 3.0, and Annex 1

(4) (Legislation) Science, Technology and Innovation Act, 2013 (No. 28 of 2013) (STI Act) (January 25, 2013)
Parliament, Republic of Kenya

Relevant Sections: Parts II, IV, V, X, and Fourth Schedule

Sponsorship > Insurance
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SUMMARY

Overview
As set forth in the G-KenyaCT, the sponsor is responsible for providing an insurance certificate and indemnity coverage for any unforeseen injury to research participants (submitted as part of the clinical trial application). All participants must be adequately insured against possible injuries that might arise during the study, and the sponsor(s) and principal investigator(s) must submit a certificate of insurance coverage as evidence to the Pharmacy and Poisons Board (PPB). An insurance 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. Finally, for all sponsor-initiated trials, a valid insurance certificate for the study’s duration must be provided prior to the study’s initiation.

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

ADDITIONAL RESOURCES

(A) (Document) Checklist for Submitting Documents to the Expert Committee on Clinical Trials (January 19, 2012)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya


REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Section One (7.17 and 8) and Annex 2

Sponsorship > Compensation
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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.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Section One (8 and 10) and Annex 2

(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Section: Guidelines (7 and 14)

Sponsorship > Quality, Data & Records Management
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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 Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs), 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.

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 and the approved protocol
  • comply with data recording and reporting procedures, and
  • permit monitoring, auditing, and inspection


Electronic Data Processing System
No relevant regulatory provisions are currently available regarding the sponsor’s role in implementing electronic data processing systems and record management schedules.

Audit Requirements
As part of its QA system, the G-KenyaCT notes that the sponsor, the institution, the ethics committee, or the Pharmacy and Poisons Board (PPB) may choose to perform a clinical trial audit. The G-KenyaCT defines an audit as the act of conducting an official review of documents, facilities, records, and any other resources deemed to be related to the clinical trial, and that may be located at the trial site, at the sponsor’s, and/or the contract research organization’s facilities. No specific timeframe is provided for the audit process.

Premature Study Termination/Suspension
The G-KenyaCT states that if a trial is terminated by the principal investigator (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.

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 principal investigator (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.

Data and Safety Monitoring Board
The G-KenyaCT recommends establishing a Data and Safety Monitoring Board (DSMB), and provides documentation submission requirements to be submitted to the PPB. The documentation should include:

  • DSMB composition
  • Copy of DSMB charter
  • DSMB reports to be submitted to the PPB within two (2) weeks of its deliberations
ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 1, 5.1, 5.2, 5.5, 5.19, 5.21, and 5.23

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Abbreviations and Definitions of Terms and Section One (1, 3.2, 5, 6.2, 21 and 24)

Sponsorship > Site/Investigator Selection
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SUMMARY

Overview
The G-KenyaCT, which implements the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs), 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. 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, 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 principal investigator (PI) to be responsible for all of the sites.

Foreign Sponsor Responsibilities
No information is currently available specifying requirements for foreign sponsors.

Data and Safety Monitoring Board
The G-KenyaCT recommends establishing a Data and Safety Monitoring Board (DSMB), and provides documentation submission requirements to be submitted to the Pharmacy and Poisons Board (PPB). The documentation should include:

  • DSMB composition
  • Copy of DSMB charter
  • DSMB reports to be submitted to the PPB within two (2) weeks of its deliberations
ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 5.6

(B) (Website) Global Health Technologies Coalition – Kenya (Last updated December 22, 2014)
Global Health Technologies Coalition, Washington, DC


REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Abbreviations and Definitions of Terms and Section One (1, 3, 4, 5, and 16)

(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee; Externally Sponsored Research

Informed Consent > Documentation Requirements
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SUMMARY

Overview
In clinical trials conducted in Kenya, 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 Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs). The informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by either the National Commission for Science, Technology and Innovation (NACOSTI)’s National Bioethics Committee (NBC) or an NBC-accredited 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, the G-ECBiomedRes, and Additional Resource (B) 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, the G-ECBiomedRes, and Additional Resource (B) 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.

Re-Consent
According to the G-KenyaCT and the ICH-GCPs, 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 and Additional Resource (B), the ICF content should be presented in either English or Kiswahili, and the local spoken language of the area, where applicable. The Kenya Medical Research Institute (KEMRI)'s Standard Operating Procedures (Additional Resource (B)) indicates that each translated consent document must be accompanied by a Certificate of Translation. The same information should be given to participants in a written format. Copies of the English ICF should be submitted to the PPB and to the EC.

Documentation Copies
The G-KenyaCT and Additional Resource (B) state 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. KEMRI's Standard Operating Procedures (Additional Resource (B)) indicate that the EC must also review and approve the written summary of what is presented orally. This summarized approved version of the ICF should be signed by the witness and the person actually obtaining the consent.

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.

ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 2, 4.4, and 4.8

(B) (Guidance) Kenya Medical Research Institute’s Ethical Review Committee Standard Operating Procedures (September 3, 2009) (Version 4.0)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

Relevant Sections: 7 and Appendix F

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Section: Section One (10)

(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Section: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee (6)

Informed Consent > Required Elements
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SUMMARY

Overview
As delineated in the G-KenyaCT and the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs), prior to beginning a clinical trial, the investigator is required to obtain ethics committee (EC) approval from either the National Commission for Science, Technology and Innovation (NACOSTI)’s National Bioethics Committee (NBC) or an NBC-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).

No Coercion
As per the G-KenyaCT the G-ECBiomedRes, 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 Additional Resource (B), 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
ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 4.4 and 4.8

(B) (Guidance) Kenya Medical Research Institute’s Ethical Review Committee Standard Operating Procedures (September 3, 2009) (Version 4.0)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

Relevant Sections: 7 and Appendix F

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Section: Section One (10)

(2) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Section: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee (6)

Informed Consent > Compensation Disclosure
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SUMMARY

Overview
In accordance with the G-KenyaCT, and the G-ECBiomedRes, and Additional Resource (A), 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
As stated in the G-KenyaCT and the G-ECBiomedRes, trial participants  will be entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In addition, Kenya Medical Research Institute The Kenya Medical Research Institute (KEMRI)’s (KEMRI)’s Standard Operating Procedures (Additional Resource (A)) 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.

Compensation for Injury
The ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)

ADDITIONAL RESOURCES

(A) (Guidance) Kenya Medical Research Institute’s Ethical Review Committee Standard Operating Procedures (September 3, 2009) (Version 4.0)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

Relevant Section: Appendix F

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Section: Section One (10)

(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Sections: Guidelines (7 and 14)

Informed Consent > Participant Rights
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SUMMARY

Overview
In accordance with the G-ECBiomedRes and Additional Resource (A), 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.

The Right to Participate, Abstain, or Withdraw
As set forth in the G-KenyaCT, the G-ECBiomedRes, and Additional Resource (A), 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 Additional Resource (A), 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 Additional Resource (A), 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 Additional Resource (A) 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 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. (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) (Guidance) Kenya Medical Research Institute’s Ethical Review Committee Standard Operating Procedures (September 3, 2009) (Version 4.0)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

Relevant Sections: 7 and Appendices F and O

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Section: Section One (10)

(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee (6 and 7), General Ethical Principles, Guidelines (4, 6, and 7), and Consulting an Ethical Committee

Informed Consent > Special Circumstances/Emergencies
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SUMMARY

Overview
The G-KenyaCT and the G-ECBiomedRes 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. According to an in-country subject matter expert, the PPB is responsible for ensuring that the EC has approved the ICF prior to approving the study’s commencement. The participant or the participant’s legal representative(s) or guardian(s) should be informed about the trial and provide consent as soon as possible.

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
According to the Kenya Medical Research Institute (KEMRI)’s Standard Operating Procedures (Additional Resource (A)), the EC shall waive all or part of the informed consent documentation requirements, but oral consent may be obtained, if the research being conducted meets one of the following conditions:

  • The justification for the waiver is valid; the signed consent is the only record linking the participant to the research and is the primary risk for a breach in confidentiality
  • The proposed plan to protect participant privacy is adequate
  • The waiver will not affect the rights and welfare of the participants
  • The participants will be given additional pertinent information after their participation
  • The research presents no more than minimal risk, and involves procedures for which consent would not normally be obtained outside the research context
ADDITIONAL RESOURCES

(A) (Guidance) Kenya Medical Research Institute’s Ethical Review Committee Standard Operating Procedures (September 3, 2009) (Version 4.0)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

Relevant Sections: 7 and Appendix F

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Section: Section One (10)

(2) (Guidelines) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Section: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee (6)

Informed Consent > Vulnerable Populations
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SUMMARY

Overview
As per the G-KenyaCT, the G-ECBiomedRes, and Additional Resource (A), 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, refugeesinternally displaced persons, economically or educationally disadvantaged persons, marginalized social groups, individuals with terminal illnesses, and the mentally challenged.

According to the Kenya Medical Research Institute (KEMRI)’s Standard Operating Procedures (Additional Resource (A)), in its assessment of proposed research studies involving vulnerable populations, the ethics committee (EC) requires that:

  • The study’s objective is to obtain knowledge relevant to the health needs of the population to be studied
  • The principal investigator demonstrates that the research question cannot be answered if the study is conducted on a less vulnerable group
  • The participants are explicitly informed that they are taking part in this study
  • The requirements for obtaining and documenting consent are tailored to the needs of the individual from the chosen vulnerable population (e.g., appropriate language should be used, etc.)

Persons in Underdeveloped Communities
The G-ECBiomedRes and Additional Resource (A) provide 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

In addition, KEMRI’s Standard Operating Procedures (Additional Resource (A)) states that during an evaluation of a research proposal, the EC must consider the following issues:

  • The potential research’s impact and relevance on the concerned communities from which the participants are selected
  • The steps taken to consult with concerned communities during the course of the study and in disseminating research findings
  • The measures taken to preclude the community from influencing the participant’s decision to consent
  • The proposed community engagement process
  • The extent to which the research contributes to capacity building in the community
  • The provision for making available any successful investigational product to the participating communities upon completing the study
  • The manner in which the research results will be made available to the participants and their communities
  • The consideration given to cultural sensitivities and concerns

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

(A) (Guidance) Kenya Medical Research Institute’s Ethical Review Committee Standard Operating Procedures (September 3, 2009) (Version 4.0)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

Relevant Section: 7

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Section: Abbreviations and Definitions of Terms

(2) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Section: General Ethical Principles

Informed Consent > Children/Minors
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SUMMARY

Overview
According to the G-KenyaCT and Additional Resource (A), a minor is someone under 18 years of age. As set forth in the G-KenyaCT, the G-ECBiomedRes, and Additional Resource (A), when the research participant is a minor, informed consent should be obtained from his/her legal representative(s) or guardian(s). 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. 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. In addition, according to the G-KenyaCT, the age of assent is greater than 12 years but less than 18 years of age.

The G-ECBiomedRes states that a study may only be conducted on minors if several conditions are fulfilled including:

  • 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; 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

Assent Requirements
As delineated in the G-KenyaCT and Additional Resource (A), a participant is considered to be a minor when the age of assent is greater than 12 years but less than 18 years of age. According to the Kenya Medical Research Institute (KEMRI)’s Standard Operating Procedures (Additional Resource (A)), if the minor is deemed capable of assenting to decisions about his/her participation in research, but is precluded from granting such consent solely on the grounds of his/her age, the principal investigator (PI) may obtain the minor’s written assent in addition to permission from his/her legal representative(s) or guardian(s).

In accordance with KEMRI’s Standard Operating Procedures (Additional Resource (A)), the ethics committee (EC) shall consider the following elements in its review of the assent process:

  • Procedures established for obtaining legal representative(s) or guardian(s) consent to have his/her child or children participate in the study.
  • For minors between 14 and up to 17 years of age, the language and syntax of the assent form should be written in a similar manner to the legal representative(s) or guardian(s) consent form
  • If the proposed research is determined to present a greater than minimal risk with no direct benefit to a pediatric participant, then permission from all legal representative(s) or guardian(s) shall be required whenever possible
  • The legal representative(s) or guardian(s) permission and pediatric assent should be completed in writing unless the EC grants a documentation waiver
  • If the child does not assent, he/she should not be forced to participate by his/her legal representative(s) or guardian(s)

See Additional Resource (A) for more details on assent requirements.

Mature Minors
KEMRI’s Standard Operating Procedures (Additional Resource (A)) further distinguishes between mature minors and minors in its definition of the legal age of consent for clinical research purposes. Mature minors are defined as individuals less than 18 years of age who are married, pregnant, mothers, or a household heads. A mature minor is permitted to give consent for him or herself and for his/her child/children, but is not allowed to consent on behalf of a sibling.

ADDITIONAL RESOURCES

(A) (Guidance) Kenya Medical Research Institute’s Ethical Review Committee Standard Operating Procedures (September 3, 2009) (Version 4.0)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

Relevant Section: 7

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Abbreviations and Definitions of Terms, Section One (10), and Annex 1

(2) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee (3 and 6) and Guidelines (6, 9, and 12)

Informed Consent > Pregnant Women, Fetuses & Neonates
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Last content review/update: November 16, 2015. Submit updates or comments.
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
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Section: Guidelines (13)

Informed Consent > Prisoners
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SUMMARY

Overview
According to the G-ECBiomedRes, prisoners are considered vulnerable because the conditions in Kenyan prisons are very harsh, and incarceration could affect their ability to make a voluntary decision regarding participation in research. An investigator who wishes to conduct a study on prisoners must ensure that the prisoners consent in conditions where there is no fear of reprisals from the wardens if they choose not to participate in the study. 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

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Section: Guidelines (11)

Informed Consent > Mentally Impaired
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SUMMARY

Overview
As per the G-ECBiomedRes, 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

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (NCST No. 45) (G-ECBiomedRes) (2005)
National Council for Science and Technology, Republic of Kenya

Relevant Sections: A Systematic and Coherent Framework for Determining Whether Clinical Research Is Ethical and Constituting an Ethical Committee (6) and Guidelines (6 and 10)

Investigational Products > Definition of Investigational Product
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SUMMARY

Overview
As delineated in the G-KenyaCT, an investigational product is also referred to as an investigational new drug (IND). It is defined 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

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Section: Abbreviations and Definitions of Terms

Investigational Products > Manufacturing & Import
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SUMMARY

Overview
According to the G-KenyaCT, the G-RegDrug, the PPA, and Additional Resources (A) and (B), 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. 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.

As per the G-KenyaCT, the G-RegDrug, the PPA, and Additional Resources (A) and (B), 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 (C) to obtain a Certificate of Registration for a Pharmaceutical Product from the PPB.

The G-KenyaCT, the PPA and Additional Resources (A) and (B) 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


The PPB’s Trade Affairs Department is responsible for authorizing the import of IPs. As per the G-KenyaCT, the PPA, and Additional Resources (D) and (E), the sponsor may submit a request to the PPB’s Trade Affairs Department to import an IP after the agency has approved the clinical trial application.

ADDITIONAL RESOURCES

(A) (Website) Evaluation and Reg. Human (Current as of November 16, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(B) (Website) Manufacturing Services (Current as of November 16, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(C) (Form) Application for Registration of a Drug (Form 1) (Revised 2010)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(D) (Website) Trade Affairs (Current as of November 16, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(E) (Website) Global Health Technologies Coalition – Kenya: Drugs (Last updated September 29, 2014)
Global Health Technologies Coalition, Washington, DC

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Section One (1, 2, and 12), and Annex 2

(2) (Guidance) Registration of Drugs – Guidelines to Submission of Applications (G-RegDrug) (2010)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

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) (December 31, 2012) (Revised Edition)
Parliament, Republic of Kenya

Relevant Sections: Part III A (35A and 35B),and Part IV (44)

(4) (Legislation) The Pharmacy and Poisons (Registration of Drugs) Rules (PPR) (December 31, 2012)
Parliament, Republic of Kenya

Relevant Sections: 3 and 9

Investigational Products > IMP/IND Quality Requirements
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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 Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) 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.

IB Content Requirements
As specified in the G-KenyaCT and the ICH-GCPs, the IB must provide coverage of the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Pharmaceutical aspects
  • Pharmacokinetics and metabolism
  • Toxicological effects in any animal species tested under a single dose study, a repeated dose study, or a special study
  • Results of clinical pharmacokinetic studies
  • Information regarding safety, pharmacodynamics, efficacy, and dose responses obtained from prior clinical trials in humans

See the G-KenyaCT and the ICH-GCPs 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, the PPA, and Additional Resources (B) and (C), the manufacture of IPs for their use in a clinical trial must be approved by the PPB. As stated in the 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 (1) 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.

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

ADDITIONAL RESOURCES

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 7

(B) (Website) Evaluation and Reg. Human (Current as of November 16, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(C) (Website) Manufacturing Services (Current as of November 16, 2015)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

(D) (Form) Application for Registration of a Drug (Form 1) (Revised 2010)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya


REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Abbreviations and Definitions of Terms, Section One (2, 11, 12, and 23), and Annex 2

(2) (Guidance) Registration of Drugs – Guidelines to Submission of Applications (G-RegDrug) (2010)
Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

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) (December 31, 2012) (Revised Edition)
Parliament, Republic of Kenya

Relevant Sections: Part III A (35A and 35B)

(4) (Legislation) The Pharmacy and Poisons (Registration of Drugs) Rules (PPR) (December 31, 2012)
Parliament, Republic of Kenya

Relevant Sections: 3 and 9

Investigational Products > Labeling & Packaging
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SUMMARY

Overview
Investigational product (IP) labeling in Kenya must comply with the requirements set forth in the G-KenyaCT. 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, number, or identifying mark
  • Recommended storage conditions
  • Sponsor name and address
  • Manufacture expiration date
  • “Keep Out of Reach of Children” included on the label


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, and it requires prior approval from the PPB. For additional detailed re-labeling requirements, please refer to Section 14.2 of the G-KenyaCT.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Section One (10 and 14)

Investigational Products > Product Management
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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 Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs), 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.

Investigational Product Supply, Storage, and Handling Requirements
As defined in the G-KenyaCT, 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 Pharmacy and Poisons Board (PPB) and a favorable opinion letter from the local and national ethics committees (ECs).

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

In addition, the G-KenyaCT specifies that the sponsor must ensure the following:

  • Timely delivery of the IP(s)
  • 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


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. 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

(A) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 5.12, 5.13, 5.14, 5.15, 5.5, and 7

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Sections: Abbreviations and Definitions of Terms, Section One (2, 11, 14.3, and 23), and Annex 2

Specimens > Definition of Specimen
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SUMMARY

No relevant provisions currently available.

Additional Resource (A) provides the Kenya Medical Research Institute’s (KEMRI) definition of genetic material: Any tissue sample that can serve as a source of DNA or RNA; including blood, saliva and any other tissues or body fluids containing nucleated cells from which DNA can be isolated.

ADDITIONAL RESOURCES

(A) (Guidance) Kenya Medical Research Institute’s Ethical Review Committee Standard Operating Procedures (September 3, 2009) (Version 4.0)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

Relevant Sections: Definition of Terms

REQUIREMENTS

No applicable regulatory requirements

Specimens > Import & Export
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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 does state that in the case of the transfer of materials, 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
  • Identification of the material and volume of material
  • 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 warranties (where applicable)


In addition, Additional Resource (A) provides an example of the Kenya Medical Research Institute’s (KEMRI) EC procedures for handling requests to ship biological samples or specimens and for handling requests for the secondary use of biological samples or specimens.

ADDITIONAL RESOURCES

(A) (Guidance) Kenya Medical Research Institute’s Ethical Review Committee Standard Operating Procedures (September 3, 2009) (Version 4.0)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

Relevant Sections: 6, 15, 25, and 26

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Section: Section One (7.17)


Specimens > Consent for Specimens
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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, does state that the sponsor or his/her representative or the principal investigator should provide examples of patient information leaflets and informed consent forms to the ethics committee (EC) for any proposed archiving of biological specimens for later research, or for genetics research.
Additional Resource (A) also provides an example of the Kenya Medical Research Institute’s (KEMRI) EC requirement for investigators to include plans for collection, storage, and protection of research data and/or biological samples/specimens. In addition, KEMRI’s standard operating procedures specify how investigators should submit proposals or applications to conduct genetic research studies.

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

ADDITIONAL RESOURCES

(A) (Guidance) Kenya Medical Research Institute’s Ethical Review Committee Standard Operating Procedures (September 3, 2009) (Version 4.0)
Kenya Medical Research Institute (KEMRI), Nairobi, Kenya

Relevant Sections: 6 and 11

REQUIREMENTS

(1) (Guidance) Guidelines for Applications to Conduct Clinical Trials in Kenya (G-KenyaCT) (Revised 2014)
Expert Committee on Clinical Trials, Pharmacy and Poisons Board, Ministry of Medical Services, Republic of Kenya

Relevant Section: Section One (7.17)

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OMB #: 0925-0668
Expiration Date: 2/28/2019