Guinea
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
QUICK FACTS
Clinical trial application language French
Regulatory authority & ethics committee review may be conducted at the same time Yes
Clinical trial registration required No
In-country sponsor presence/representation required No
Age of minors Unspecified
Specimens export allowed Unspecified
Regulatory Authority > Regulatory Authority
Last content review/update: July 09, 2019
Requirements
(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French) (October 29, 1998)
National Assembly
Relevant Sections: Chapters I and II
Summary

Overview

According to DecreeNo D/218 and Additional Resources (C), (D), and (E), the Ministry of Health (MOH) is the regulatory authority responsible for clinical trial approvals and drug import licensing in the Republic of Guinea. The two (2) branches within the MOH directly involved with the clinical trial approval process are as follows:

According to a subject matter expert, in April 2016, the MOH divided the DNPL into two (2) directorates, one (1) related to laboratory oversight and the DNPM, which is related to drug oversight. Many documents referenced in this profile refer to the DNPL, so DNPL/DNPM will be used to refer to the directorate.

According to Additional Resource (F), for all Ebola-related research, the applicant must first obtain protocol approval from the Ebola Research Commission in Guinea (ERCG) prior to obtaining CNERS’ approval. For detailed information on CNERS’ responsibilities, composition, and procedures, please refer to the Ethics Committee topic.

Contact Information

CNERS

Pr Oumou Younoussa SOW
Head of Pneumophysiology
CNERS President

Phone: (+224) 664-96-24-34, (+224) 622-03-48-51
Email:
oumou45@yahoo.fr

DNPL/DNPM

Dr. Kabiné Souare
National Director
Ministry of Health (Ministère de la Santé)
BP: 1490 Conakry, Guinea

Phone: (+224) 628-73-38-04
Email:
drsouare_kabine@yahoo.fr

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: I
National Ethics Committee for Research in Health (CNERS)
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
Relevant Sections: Appendix 2
Ministry of Health and the World Health Organization
Relevant Sections: 5.0 – Pharmaceutical Regulation
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea
Network for Medicine and Development (ReMeD), Paris, France
(H) (Website) Ministry of Health - Our Missions (Current as of July 9, 2019)
Ministry of Health
National Ethics Committee of Research in Health
Regulatory Authority > Scope of Assessment
Last content review/update: July 09, 2019
Requirements
(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French) (October 29, 1998)
National Assembly
Relevant Sections: Chapters I and II
Summary

Overview

In accordance with DecreeNo D/218 and Additional Resources (C), (D), and (E), the Ministry of Health (MOH) is responsible for reviewing, evaluating, and approving clinical trial applications and drug import licenses in the Republic of Guinea. The MOH’s two (2) branches include the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS)), which is in charge of the clinical trial application review and approval process for studies conducted in humans, and the National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire (DNPL))—now known as the Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))—which handles the licensing of drug products for import. According to Additional Resource (C), the CNERS and DNPL/DNPM reviews may be conducted at the same time.

Clinical Trial Review Process

The MOH’s CNERS and DNPL/DNPM application dossiers each have different requirements.

CNERS

Please refer to the Ethics Committee topic, Scope of Review subtopic for detailed information on the CNERS as well as the Ebola Research Commission in Guinea (ERCG) clinical trial application review and approval process.

DNPM/DNPM

According to an in-country subject matter expert, the sponsor or his/her designated representative (typically the principal investigator (PI)) is responsible for hand delivering the drug import license application to the DNPL/DNPM's Pharmacovigilance, Drugs and Quality Control section for review and approval. The DNPL/DNPM may request drug samples for testing and evaluation unless the PI or the sponsor can provide detailed proof of testing and licensing from regulatory authorities based abroad. Once the DNPL/DNPM has approved the application, it will provide the authorization for imported drugs on behalf of the MOH.

(See the Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed submission requirements.)

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: I
National Ethics Committee for Research in Health (CNERS)
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
Relevant Sections: Appendix 2
Ministry of Health and the World Health Organization
Relevant Sections: 5.0 – Pharmaceutical Regulation
Regulatory Authority > Regulatory Fees
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé) (CNERS) Fees

As per Additional Resource (A), the principal investigator (PI) is responsible for paying a fee to the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) to submit a clinical trial application for authorization. The CNERS currently requires a non-refundable fee of 3,000,000 Guinean Francs to submit the application including the protocol for ethics committee (EC) review and approval. For protocol amendments or extension of approval validation, the fee is 1,500,000 Guinean Francs.

Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) Fees

No information is currently available regarding taxes and fees associated with submitting a drug import license application to the DNPM, formerly known as the National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire (DNPL)).

Additional Resources
National Ethics Committee for Research in Health (CNERS)
Ethics Committee > Ethics Committee
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter IV
(2) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French) (October 29, 1998)
National Assembly
Relevant Sections: Chapters I and II
Summary

Overview

According to the Guinea-PHC and Additional Resource (B), Guinea requires the principal investigator (PI) or his/her representative to obtain ethics committee (EC) approval from the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS)) for each clinical trial. As per DecreeNo D/218 and Additional Resource (D), the CNERS was established in 1998 and operates under the Ministry of Health (MOH). According to the Guinea-PHC and Additional Resources (A) and (D), the CNERS is responsible for reviewing and approving clinical research protocols for studies conducted in humans. Additionally, according to Additional Resource (G), CNERS is responsible for ensuring research is conducted in accordance with the provisions of the Code of Ethics for Health Research, proposing amendments to the Code of Ethics, and examining ethical issues related to health research submitted by institutions or individuals. Per Additional Resource (C) and in-country subject matter experts, institutional EC approval is not required prior to obtaining the CNERS approval.

In addition, according to Additional Resource (E), for all Ebola-related research, the PI must first obtain protocol approval from the Ebola Research Commission in Guinea (ERCG) prior to obtaining the CNERS approval.

CNERS Composition

As specified in DecreeNo D/218 and Additional Resource (D), the CNERS consists of 17 members appointed by the MOH Minister, including an executive office responsible for coordinating committee activities, ensuring its proper functioning, and holding regular meetings. The executive office is comprised of a president, a vice president and two (2) secretaries. However, Additional Resource (G) states that the executive office is comprised of five (5) members elected within CNERS: a president, a vice-president, a secretary general (held by the Section Head in charge of Research at the MOH), a secretary in charge of following up on protocol implementation, and a treasurer. Committee members are selected for their interest in research ethics, and for their qualifications and experience in reviewing and evaluating the scientific, medical, and ethical aspects of proposed clinical trials.

As delineated in DecreeNo D/218 and Additional Resources (C) and (D), the CNERS composition specifically includes:

  • Two (2) members representing Guinea’s main religions (Islam and Christianity)
  • Eight (8) members with professional health research qualifications including doctors, clinicians, epidemiologists, biologists, chemists, statisticians, methodology and research ethics experts
  • Seven (7) members representing organizations including health professional associations, relevant ministerial departments, research institutions, non-governmental organizations and human rights organizations

CNERS Terms of Reference, Review Procedures and Meeting Schedule

According to DecreeNo D/218, the CNERS committee is required to follow standard operating procedures (SOPs) specifying the conditions for organizing and convening committee meetings and delineating member rights and responsibilities. See Additional Resource (A) for the SOPs.

As specified in DecreeNo D/218, the president (also known as the chairman) shall convene CNERS committee sessions, appoint rapporteurs to present the files/protocols submitted to the committee, and determine the matters to be discussed in the session. DecreeNo D/218 specifies that the CNERS committee meets in regular sessions two (2) times a year; additional sessions are convened by the president. Additional Resources (B), (C), and (H) however, indicate that the committee meets in regular sessions on the last Thursday of each month; additional sessions are convened by the president. Moreover, Additional Resources (A) and (C) state that the minimum and maximum time limits for the review of a research project following its submission are two (2) weeks and one (1) month respectively. Additional Resource (B) indicates that an application must be filed during the first week of the month or 10 days before the last Thursday of the month for consideration at the monthly review session. It also indicates that a minimum of two (2) weeks is required between the filing and its review by CNERS. The CNERS Administrative Assistant will provide the applicant an acknowledgement of receipt and keep all files in the CNERS archives.

DecreeNo D/218 states that the appointment of CNERS committee members is valid for three (3) years and is renewable. Members must have no conflict of interest with the protocols under review. Additional Resource (A) indicates that the quorum required for voting is nine (9) members. For detailed CNERS procedures and information on other administrative processes, see DecreeNo D/218 and Additional Resource (A).

Ebola Research Commission in Guinea (ERCG)

According to Additional Resource (E), as part of Guinea’s national coordination to fight the Ebola virus, the MOH has formed the Ebola Research Commission in Guinea (ERCG). The ERCG requires the PI to obtain approval for all research protocols studying the Ebola Virus Disease in Guinea.

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: III , V, VI, VII, and VIII
National Ethics Committee for Research in Health (CNERS)
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: Creation, Mission/Powers, and Organization/Functions
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea
(F) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2017)
National Ethics Committee of Research in Health
(H) (Website) National Ethics Committee for Research in Health (CNERS) - FAQ (Current as of July 9, 2019)
National Ethics Committee of Research in Health
Relevant Sections: What is the frequency of CNERS meetings?, Who should apply for protocol reviews?
Ethics Committee > Scope of Review
Last content review/update: July 09, 2019
Requirements
(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French) (October 29, 1998)
National Assembly
Relevant Sections: Chapter I
(2) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapters I, III, and IV
Summary

Overview

According to DecreeNo D/218, the Guinea-PHC, and Additional Resource (A), the mission of the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) is to ensure the scientific quality and ethical conduct of health research in the Republic of Guinea. As per the Guinea-PHC and Additional Resource (A), the primary scope of information assessed by the CNERS relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. Additional Resource (C) requires the principal investigator to respect the fundamental ethical principles of research involving human beings.

As per the Guinea-PHC and Additional Resource (A), the CNERS must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable.

DecreeNo D/218, the Guinea-PHC, and Additional Resource (A) also state that the CNERS is responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants, and they must verify the adequacy of confidentiality and privacy safeguards. See the Guinea-PHC and Additional Resource (A) for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

According to the Guinea-PHC and Additional Resource (A), the CNERS must approve a clinical trial application and the protocol, and the National Directorate of Pharmacy and Laboratory (Direction National de la Pharmacie et du Laboratoire (DNPL))—now known as the Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))—must issue a drug import license prior to the sponsor or his/her representative initiating the clinical trial.

As per the Guinea-PHC and Additional Resources (B) and (C), the principal investigator (PI) or his/her representative is responsible for submitting an application to the CNERS for review and approval.

CNERS

Although the Guinea-PHC indicates that the PI is required to submit a research proposal to the CNERS at least 90 days prior to the date set for the study’s commencement, Additional Resource (E) indicates that this is not required by CNERS. Additional Resource (B) indicates that an application must be filed during the first week of the month or 10 days before the last Thursday of the month for consideration at the monthly review session. It also indicates that a minimum of two (2) weeks is required between the filing and its review by CNERS. Additional Resources (B) and (F) indicate that the CNERS Administrative Assistant will provide the applicant an acknowledgement of receipt and keep all files in the CNERS archives. Additional Resource (F) states that committee members should have a copy of the protocol for review at least six (6) working days before the committee session.

Per the Guinea-PHC, the CNERS must give its opinion on any research proposal submitted within a period not exceeding 60 days from the project’s filing date. However, Additional Resource (C) indicates that if the application is complete, an approval letter can be expected in one (1) to two (2) weeks. Additional Resource (A) states that the minimum and maximum deadlines for review of the research project after submission are two (2) weeks and one (1) month respectively. Additional Resource (F) indicates that the sponsor or PI who submitted the protocol will be notified of the opinion of CNERS within 10 days of the committee meeting via email and that CNERS protocol approval is valid for one (1) year and is renewable upon request by the PI/sponsor.

Guinea-PHC states that when research is on an epidemic or calamity, the proposal must be submitted within 30 days from the project’s filing date. Additional Resource (A) further states that in emergencies (e.g., epidemics or disasters), an accelerated procedure is adopted without prejudice to the requirements of submitting the protocol and including the following:

  • Reduction of the minimum and maximum periods of review and decision to 48 hours and one (1) week respectively
  • Reduction of the required quorum of the members of CNERS to five (5)
  • Possibility of calling on other national and international experts
  • Acceptances of online submission and evaluation
  • Sending the response letter within 48 hours after evaluation

Ebola Research Commission in Guinea (ERCG)

ERCG approval is required for all Ebola Virus Disease studies before the protocol will be reviewed by the CNERS. As delineated in Additional Resource (D), the following documentation must be submitted to the ERCG:

  • Protocol (in electronic format; hard copies are acceptable)
  • Cover letter (one (1) copy) including contact information for PI(s) or person responsible for the study
  • Protocol synopsis (summary in French)
  • Complete Protocol (in French or English)
  • Investigator’s Brochure
  • Informed Consent Form (in French and to be translated to the local languages for administrative purposes)
  • Investigators list (attached abstracts/summaries of CVs)
  • Data collection tools
  • Study budget

See Additional Resource (D) for detailed format requirements.

The ERCG will give their opinion within a minimum of two (2) weeks, not to exceed one (1) month. In exceptional circumstances, the review period may be reduced to one (1) week. Once the opinion of the ERCG is obtained, the protocol is transferred to CNERS for approval.

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: I, III, IV, V, VI, and 7.2
National Ethics Committee for Research in Health (CNERS)
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea
(E) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (June 2017)
(F) (Website) National Ethics Committee for Research in Health (CNERS) - FAQ (Current as of July 9, 2019)
National Ethics Committee of Research in Health
Relevant Sections: What is the validity period of a protocol approval by the CNERS?, Who should apply for protocol reviews?
Ethics Committee > Ethics Committee Fees
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

According to Additional Resource (A), the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) requires the principal investigator (PI) to pay a non-refundable fee of 3,000,000 Guinean Francs to submit a protocol for ethics committee (EC) review and approval. For protocol amendment or extension of approval validation, the fee is 1,500,000 Guinean Francs.

Additional Resources
National Ethics Committee for Research in Health (CNERS)
Ethics Committee > Authorizing Body
Last content review/update: July 09, 2019
Requirements
(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French) (October 29, 1998)
National Assembly
Relevant Sections: Chapter I
Summary

Overview

As stated in the Ethics Committee subtopic, per DecreeNo D/218, the Ministry of Health (MOH) is the authorizing body of the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)). The CNERS is responsible for reviewing and approving clinical research protocols for studies conducted in humans at the national level.

Registration, Auditing and Accreditation

According to Additional Resource (A), the CNERS is accredited by the MOH.

Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
Clinical Trial Lifecycle > Submission Process
Last content review/update: July 09, 2019
Requirements
(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French) (October 29, 1998)
National Assembly
Relevant Sections: Chapters I and II
Summary

Overview

According to DecreeNo D/218, Additional Resources (A), (B), (C), (D), (E), and (F), and in-country subject matter experts, Guinea requires the principal investigator (PI) or his/her designated representative to obtain clinical trial authorization from the Ministry of Health (MOH). In addition, the sponsor or his/her designated representative (typically the PI) is responsible for obtaining the MOH’s approval to import study drugs. As per Additional Resources (A), (B), (C), (D), and (E), the MOH’s two (2) branches include the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS)), which is in charge of the clinical trial application review and approval process for studies conducted in humans, and the National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire (DNPL))—now known as the Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))—which handles the licensing of drug products for import. According to Additional Resource (C) and an in-country subject matter expert, the CNERS and the DNPL/DNPM may conduct their reviews at the same time. However, per Additional Resources (C) and (F), and in-country subject matter experts, the clinical trial authorization will only be finalized once both the CNERS approval and the drug import license are obtained. (See Submission Content subtopic for detailed submission requirements). Additionally, according to Additional Resource (J), any amendments to protocols currently being implemented must also be submitted to CNERS.

In addition, as per Additional Resource (G), for all Ebola-related research, the PI or his/her representative must first obtain protocol approval on the sponsor’s behalf from the Ebola Research Commission in Guinea (ERCG) before obtaining the CNERS approval. Please refer to the Ethics Committee topic for more information regarding the CNERS and the ERCG requirements.

Delivery Address for Clinical Trial Applications

According to Additional Resource (B) and in-country subject matter experts, the contact information for the CNERS and the DNPL/DNPM is as follows:

CNERS

Pr Oumou Younoussa SOW
National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé)
BP 634
Conakry, Guinea

Phone: (224) 664 57 19 33
Email: oumou45@yahoo.fr

*ERCG applications are also submitted to the CNERS address.

DNPL/DNPM

Dr. Kabiné Souare
National Director
Ministry of Health (Ministère de la Santé)
BP: 1490 Conakry, Guinea

Phone: (+224) 628-73-38-04
Email:
drsouare_kabine@yahoo.fr

Assembly and Number of Copies

According to Additional Resource (B), 12 hard copies and an electronic copy of the clinical trial application should be submitted to the CNERS. See Additional Resource (B) for the application form.

According to Additional Resource (C), one (1) hard copy of the drug import license application should be submitted to the DNPL/DNPM. The DNPL/DNPM application forms are only available in paper form from the DNPL/DNPM's Pharmacovigilance, Drugs and Quality Control section.

Clinical Trial Application Language Requirements

According to Additional Resources (B) and (C), the clinical trial application and accompanying materials including the DNPL/DNPM drug import license application must be provided in French. Per Additional Resource (G), the clinical protocol portion of the application may be submitted in French or in English. Although, this is not indicated by Additional Resource (B).

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: I and VIII (8.2)
National Ethics Committee for Research in Health (CNERS)
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: Creation, Mission/Powers, and Organization/Functions
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
Relevant Sections: Appendix 2
Ministry of Health and the World Health Organization
Relevant Sections: 5.0 – Pharmaceutical Regulation
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea
Network for Medicine and Development (ReMeD), Paris, France
(I) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2017)
(J) (Website) National Ethics Committee for Research in Health (CNERS) - FAQ (Current as of July 9, 2019)
National Ethics Committee of Research in Health
Relevant Sections: Who can submit protocols to the CNERS?
(K) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
Clinical Trial Lifecycle > Submission Content
Last content review/update: July 09, 2019
Requirements
(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French) (October 29, 1998)
National Assembly
Relevant Sections: Chapters I and II
(2) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter IV
Summary

Overview

In accordance with DecreeNo D/218, the Guinea-PHC, Additional Resources (B), (C), (D), (E), and (F), and in-country subject matter experts, Guinea requires the principal investigator (PI) to obtain clinical trial authorization from the Ministry of Health’s (MOH) National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS)). In addition, the sponsor or his/her representative (typically the PI) is responsible for obtaining the MOH’s approval to import study drugs from the National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire (DNPL))—now known as the Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))—prior to initiating a study.

CNERS Requirements

According to Additional Resources (A) and (B), the CNERS requires a 12 hard copies and an electronic copy of each of the documents listed below (Note: the two (2) resources provide overlapping and unique elements so each of the items listed below will not necessarily be in each source):

  • Letter of submission of the research protocol
  • Clinical trial application form (see Additional Resource (B))
  • Project summary
  • Protocol
  • Methodology
  • Investigator’s Brochure (IB)
  • Informed Consent Form (ICF)
  • Presentation of risks faced by individuals and communities
  • Data collection instruments and analysis tools
  • Methods for sharing results, data, and biological materials
  • Involvement of health authorities and communities
  • Methods for sharing research benefits with research populations
  • Timing of activities
  • Identities of research sponsors and investigators and their Curriculum Vitaes (CVs)
  • Detailed project budget
  • Bibliographic references
  • Previous related decisions from the CNERS and/or associated partners
  • Letters from associated partners
  • Other complementary documents

DNPL/DNPM Requirements

As per Additional Resource (C) and an in-country subject matter expert, an electronic copy of application form is available from the DNPL/DNPM upon request. However, detailed information on accompanying materials to be included with the DNPL/DNPM application are not available at this time.

Ebola Research Commission in Guinea (ERCG) Requirements

As per Additional Resource (G), for all Ebola-related research, the Ebola Research Commission in Guinea (ERCG) must review and approve the clinical trial application prior to obtaining the CNERS approval. Below is a list of required ERCG documentation:

  • Cover letter (one (1) copy) including contact information for PI(s) or person responsible for the study
  • Protocol synopsis (summary in French)
  • Complete protocol (in French or English)
  • IB
  • ICF (in French and to be translated to the local languages for administrative purposes)
  • Investigators list (attached abstracts/summaries of CVs)
  • Data collection tools
  • Study budget

See Additional Resource (H) for detailed submission requirements.

CNERS/ERCG Clinical Protocol

As indicated in the Guinea-PHC and Additional Resource (G), the CNERS/ERCG clinical protocol should contain the following elements:

  • Background
  • Identity of the sponsor and investigator
  • Study rationale
  • Objectives
  • Methodology
  • Study duration and progress
  • Data collection
  • Statistical analysis
  • Ethical aspects
  • Expected results
  • Detailed budget
  • References

See the Guinea-PHC for additional details regarding protocol elements.

In addition, per Additional Resource (H), Guinea is implementing the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum). Accordingly, the ICH-GCPs-Addendum requires the following protocol contents:

  • General information (protocol title, identifying number, and date; contact information for the sponsor, medical expert, investigator(s), trial site(s), qualified physician(s), and laboratory and/or institutions involved in the study)
  • Background information
  • Objectives and purpose
  • Trial design
  • Selection, withdrawal, and treatment of participants
  • Assessment of efficacy
  • Assessment of safety
  • A description of the statistical methods to be used in the trial
  • Direct access to source data and documents
  • Quality control and quality assurance
  • Ethical considerations
  • Data handling and recordkeeping
  • Publication policy
Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: II and IV
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: Section 3 - Documents to be attached to the application for ethics review
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: Creation, Mission/Powers, and Organization/Functions
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
Relevant Sections: Appendix 2
Ministry of Health and the World Health Organization
Relevant Sections: 5.0 – Pharmaceutical Regulation
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea
(H) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 6
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: July 09, 2019
Requirements
(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French) (October 29, 1998)
National Assembly
Relevant Sections: Chapters I and II
(2) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter IV
Summary

Overview

According to DecreeNo D/218, the Guinea-PHC, and Additional Resources (B), (C), and (D), the Ministry of Health (MOH)’s National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS)) must approve the clinical trial application. Furthermore, according to Additional Resources (C) and (E), the MOH’s National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire (DNPL))—now known as the Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))—must issue a drug import license prior to the sponsor or his/her representative initiating the clinical trial. According to Additional Resource (C), the CNERS and the DNPL/DNPM may conduct their reviews at the same time. However, per Additional Resources (C) and (F), and in-country subject matter experts, the clinical trial authorization will only be finalized once both the CNERS approval and the drug import license are obtained. (See Submission Content subtopic for detailed submission requirements).

Ebola Research Commission in Guinea (ERCG) Approval

No information is currently available on the timeline for approval of the ERCG.

MOH Approval

CNERS Clinical Trial Application

Per the Guinea-PHC, the CNERS must give its opinion on any research proposal submitted within a period not exceeding 60 days from the project’s filing date. Additional Resource (C), however, indicates that if the application is complete, an approval letter can be expected in one (1) to two (2) weeks.

Although the Guinea-PHC indicates that the PI is required to submit a research proposal to the CNERS at least 90 days prior to the date set for the study’s commencement, Additional Resource (G) indicates that this is not required by CNERS. Additional Resource (B) indicates that an application must be filed during the first week of the month or 10 days before the last Thursday of the month for consideration at the monthly review session. It also indicates that a minimum of two (2) weeks is required between the filing and its review by CNERS. Per Additional Resources (B) and (H), the CNERS Administrative Assistant will provide the applicant an acknowledgement of receipt and keep all files in the CNERS archives. Additional Resource (H) states that committee members should have a copy of the protocol for review at least six (6) working days before the committee session.

Per the Guinea-PHC, the CNERS must give its opinion on any research proposal submitted within a period not exceeding 60 days from the project’s filing date. Additional Resource (C), however, indicates that if the application is complete, an approval letter can be expected in one (1) to two (2) weeks. Additional Resource (A) states that the minimum and maximum deadlines for review of the research project after submission are two (2) weeks and one (1) month respectively. Additional Resource (H) indicates that the sponsor or PI who submitted the protocol will be notified of the opinion of CNERS within 10 days of the committee meeting via email and that CNERS protocol approval is valid for one (1) year and is renewable upon request by the PI/sponsor.

Guinea-PHC states that when research is on an epidemic or calamity, the proposal must be submitted within 30 days from the project’s filing date. Additional Resource (A) further states that in emergencies (e.g., epidemics or disasters), an accelerated procedure is adopted without prejudice to the requirements of submitting the protocol and including the following:

  • Reduction of the minimum and maximum periods of review and decision to 48 hours and one (1) week respectively
  • Reduction of the required quorum of the members of CNERS to five (5)
  • Possibility of calling on other national and international experts
  • Acceptances of online submission and evaluation
  • Sending the response letter within 48 hours after evaluation

DNPL/DNPM Import License Application

According to Additional Resource (C), the DNPL/DNPM’s approval of a drug import license application typically takes two (2) weeks, or, about one (1) month when the customs processing phase is included.

According to Additional Resource (C) and an in-country subject matter expert, the PI or his/her representative should hand deliver the drug import license application on the sponsor’s behalf to the DNPL/DNPM’s Division of Pharmaceutical Products.

Additional information on the DNPL/DNPM review and approval process is not available at this time.

Institutional EC Approval

According to Additional Resource (C) and in-country subject matter experts, institutional ethics committee approval is not required prior to obtaining the CNERS approval.

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: II and VIII (8.2)
National Ethics Committee for Research in Health (CNERS)
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: Creation, Mission/Powers, and Organization/Functions
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
Relevant Sections: Appendix 2
Ministry of Health and the World Health Organization
Relevant Sections: 5.0 – Pharmaceutical Regulation
(G) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (June 2017)
(H) (Website) National Ethics Committee for Research in Health (CNERS) - FAQ (Current as of July 9, 2019)
National Ethics Committee of Research in Health
Relevant Sections: What is the validity period of a protocol approval by the CNERS?, Who should apply for protocol reviews?
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: July 09, 2019
Requirements
(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French) (October 29, 1998)
National Assembly
Relevant Sections: Chapters I and II
(2) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter IV
Summary

Overview

In accordance with DecreeNo D/218, the Guinea-PHC, Additional Resources (B), (C), (D), (E), and (F), and in-country subject matter experts, a clinical trial can only commence after the applicant obtains approval from the Ministry of Health (MOH)’s National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS)) and the National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire (DNPL))—now known as the Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))—for both the clinical trial and drug import license applications respectively. As per Additional Resource(C), and an in-country subject matter expert, the principal investigator (PI) or his/her designated representative will submit the CNERS clinical trial application, and the sponsor or his/her representative (typically the PI) will submit the DNPL/DNPM drug import license application. Additional Resource (C) and an in-country subject matter expert also state that the CNERS and the DNPL/DNPM may conduct their reviews at the same time. However, per Additional Resources (C), and (F), and in-country subject matter experts, the clinical trial authorization will only be finalized once both the CNERS approval and the drug import license are obtained. No waiting period is required following the sponsor’s receipt of these approvals. The research should comply with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (ICH-GCPs-Addendum), which, per Additional Resource (I), Guinea is implementing.

Clinical Trial Agreement

No information is available at this time on clinical trial agreement requirements.

Ethics Committee (EC) Confirmation of Review and Approval

In accordance with DecreeNo D/218, the Guinea-PHC, and Additional Resources (A), (B), (C), (D), and (H), a clinical trial can only commence after the applicant obtains ethical approval from the MOH’s CNERS (in addition to drug import approval from MOH’s DNPL/DNPM). Additionally, per Additional Resource (H), any amendments to protocols currently being implemented must also be submitted to CNERS.

For all Ebola-related research, per Additional Resource (G), the Ebola Research Commission in Guinea (ERCG) must approve these protocols prior to obtaining CNERS approval. (See Ethics Committee topic, Ethics Committee and Scope of Review subtopics, and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process and for more information on ERCG requirements).

Clinical Trial Registry

According to Additional Resource (C), the MOH does not currently require the PI or the sponsor or his/her representative to register with either a domestic or international clinical trial registry.

Data and Safety Monitoring Board (DSMB)

As per Additional Resource (C), the MOH does not require the sponsor or his/her representative to establish a Data and Safety Monitoring Board (DSMB).

However, per Additional Resource (I), Guinea is implementing the ICH-GCPs-Addendum, which notes that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: II and VIII (8.2)
National Ethics Committee for Research in Health (CNERS)
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: Creation, Mission/Powers, and Organization/Functions
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
Relevant Sections: Appendix 2
Ministry of Health and the World Health Organization
Relevant Sections: 5.0 – Pharmaceutical Regulation
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea
(H) (Website) National Ethics Committee for Research in Health (CNERS) - FAQ (Current as of July 9, 2019)
National Ethics Committee of Research in Health
Relevant Sections: Who can submit protocols to the CNERS
(I) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 4, 5.5
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

According to Additional Resource (A), all serious and unexpected adverse events (AEs)/adverse drug reactions (ADRs) must be reported to the Ministry of Health (MOH)’s National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS) for review.

Additional Resource (B) indicates that Guinea has not yet developed any formal pharmacovigilance regulations or guidelines of its own. However, an unspecified official AE/ADR reporting form is being used in Guinea, and this reported information is stored in a national AE/ADR database. No further information is available regarding either the form or the database at this time.

In addition, based on Additional Resource (C) and an in-country subject matter expert, Guinea does comply with the World Health Organization's (WHO) pharmacovigilance guidelines. For detailed AE/ADR reporting requirements and form completion, see Additional Resources (D) and (E).

Data and Safety Monitoring Board

As per Additional Resource (C), the MOH does not require the sponsor or his/her representative to establish a Data and Safety Monitoring Board (DSMB).

However, per Additional Resource (F), Guinea is implementing the ICH-GCPs-Addendum, which notes that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: 7.2 and 8.2
Ministry of Health and the World Health Organization
Relevant Sections: 5.0 – Pharmaceutical Regulation
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
World Health Organization, Geneva, Switzerland
(E) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(F) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 5.5, and 5.16
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

According to Additional Resources (A) and (B), and an in-country subject matter expert, the principal investigator (PI) and the sponsor share responsibility for submitting an annual progress report on the status of a clinical trial and for submitting a final study report upon the trial’s completion.

As per the ICH-GCPs-Addendum, which according to Additional Resource (C) Guinea is implementing, the investigator should promptly provide written reports to the sponsor and the institutional ethics committee on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: 7.2, 8.2, and 8.3
(B) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.10 and 4.13
Sponsorship > Definition of Sponsor
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

Per Additional Resource (A), Guinea is implementing the ICH-GCPs-Addendum, which defines a sponsor as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. A sponsor-investigator is an individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a participant. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.

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

Additional Resources
(A) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.53, 1.54, 5.1 and 5.2
Sponsorship > Trial Authorization
Last content review/update: July 09, 2019
Requirements
(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French) (October 29, 1998)
National Assembly
Relevant Sections: Chapters I and II
(2) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter IV
Summary

Overview

In accordance with DecreeNo D/218, the Guinea-PHC, Additional Resources (A), (B), (C), (D), (E), and (F), and in-country subject matter experts, Guinea requires the principal investigator (PI) to submit a clinical trial application to the Ministry of Health (MOH)’s National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS)) to obtain approval to conduct a study. In addition, the sponsor or his/her designated representative (typically the PI) is responsible for submitting a drug import application to the MOH’s National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire (DNPL))—now known as the Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))—to obtain approval to import study drugs.

According to Additional Resource (C) and an in-country subject matter expert, the CNERS and the DNPL/DNPM may conduct their reviews at the same time. However, per Additional Resources (C) and (F), and in-country subject matter experts, the clinical trial authorization will only be finalized once both the CNERS and DNPL/DNPM approvals are obtained.

In addition to the completed application, the sponsor must also provide the clinical protocol, the informed consent form, the Investigator’s Brochure, and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

Ebola Research Commission in Guinea (ERCG)

As per Additional Resource (G), for all Ebola-related research, the PI or his/her designated representative must first obtain protocol approval on the sponsor’s behalf from the Ebola Research Commission in Guinea (ERCG) before obtaining the CNERS approval to conduct a clinical trial. Please refer to the Ethics Committee topic and Clinical Trial Lifecycle topic, Submission Content subtopic, for more information regarding ERCG and additional documentation requirements.

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: II and VIII (8.2)
National Ethics Committee for Research in Health (CNERS)
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: Creation, Mission/Powers, and Organization/Functions
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
Relevant Sections: Appendix 2
Ministry of Health and the World Health Organization
Relevant Sections: 5.0 – Pharmaceutical Regulation
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea
Sponsorship > Insurance
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Guinea does not have any specific requirements regarding insurance.

Additional Resources
No additional resources
Sponsorship > Compensation
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapters I and III
Summary

Overview

According to the Guinea-PHC, in the event of any temporary or permanent trial-related injury or disability, the participant should be compensated. In the case of the participant’s death, his/her legal heirs are entitled to financial compensation.

In addition, per Additional Resource (A), Guinea is implementing the ICH-GCPs-Addendum, which provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Additional Resources
(A) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8 and 5.8
Sponsorship > Quality, Data & Records Management
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

Per Additional Resource (A), Guinea is implementing the ICH-GCPs-Addendum, which provides guidance to sponsors on quality, data, and records management.

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

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

Electronic Data Processing System

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

Records Management

According to Additional Resources (A) and (C), recordkeeping should be conducted in compliance with the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) and ICH guidelines.

As set forth in the ICH-GCPs-Addendum, sponsor-specific essential documents should be retained until at least two (2) years after the last approval of a marketing application, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of the investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

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

Audit Requirements

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

Premature Study Termination/Suspension

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

Multicenter Studies

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

  • All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and given EC approval
  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
  • Investigator responsibilities are documented prior to the start of the trial
  • All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
  • Communication among investigators is facilitated
Additional Resources
(A) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.65, 5.0, 5.1, 5.2, 5.5, 5.18, 5.19, 5.21, 5.23, 6.10, and 8
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(D) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
Sponsorship > Site/Investigator Selection
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

Per Additional Resource (A), Guinea is implementing the ICH-GCPs-Addendum, which provides guidance to sponsors on investigator and site selection. According to the ICH-GCPs-Addendum:

  • The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by training and experience and should have adequate resources to properly conduct the trial for which the investigator is selected. If organization of a coordinating committee and/or selection of coordinating investigator(s) are to be utilized in multicentre trials, their organization and/or selection are the sponsor's responsibility.
  • Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator's Brochure, and should provide sufficient time for the investigator/institution to review the protocol and the information provided.

Furthermore, the sponsor should obtain the investigator's/institution's agreement to:

  • Conduct the trial in compliance with Good Clinical Practices (GCPs), with the applicable regulatory requirement(s), and with the approved protocol
  • Comply with procedures for data recording/reporting
  • Permit monitoring, auditing, and inspection
  • Retain the trial related essential documents until the sponsor informs the investigator/institution these documents are no longer needed

The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

Foreign Sponsor Responsibilities

No information is currently available regarding foreign sponsor regulatory requirements.

Data and Safety Monitoring Board

As per Additional Resource (C), the Ministry of Health (MOH) does not require the sponsor or his/her representative to establish a Data and Safety Monitoring Board (DSMB). However, the ICH-GCPs-Addendum, notes that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Additional Resources
(A) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.25, 5.5, and 5.6
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
Informed Consent > Documentation Requirements
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapters I and IV
Summary

Overview

In all Guinean clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the Guinea-PHC. According to Additional Resource (A), (B), and (C), the informed consent form (ICF) must be reviewed and approved by the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS) with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

Per the Guinea-PHC, investigator(s) must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). The ICF content should be presented in a manner that is easy to understand and without coercion or unduly influencing a potential participant to enroll in the clinical trial.

Language Requirements

According to Additional Resource (A), the ICF must be written in French and in the vernacular language of the research participant.

Documentation Copies

As indicated in the Guinea-PHC, the participant and/or the participant’s legal representative(s) or guardian(s) must sign and date the ICF before an independent witness. The Guinea-PHC does not indicate whether the investigator must also sign the ICF.

Per Additional Resource (D) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs).

Per Additional Resource (F), Guinea is implementing the ICH-GCPs-Addendum, which states that where the participant is illiterate and/or his/her legal representative(s) and/or guardian(s) is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

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

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

Additional Resources
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea
(B) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: IV, VI, and VIII (8.2)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: 3
(D) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(E) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(F) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2, 4.4, 4.8, 8.2, and 8.3
Informed Consent > Required Elements
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter I
Summary

Overview

According to Additional Resource (A), (B), and (C), prior to beginning a clinical trial, the principal investigator (PI) is required to obtain ethics committee (EC) approval from the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS) for the written informed consent form (ICF).

Per Additional Resource (D), clinical trials must comply with informed consent requirements in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs).

Per Additional Resource (F), Guinea is implementing the ICH-GCPs-Addendum, which provide guidance on the elements to include in the ICF.

No Coercion

As per the Guinea-PHC and the ICH-GCPs-Addendum, a participant should not be coerced or pressured in any way during the consent process. Per the ICH-GCPs-Addendum, none of the oral and written information concerning the trial, including the written informed consent form, should contain any language that causes the participant or the participant 's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.

ICF Required Elements

Per the ICH-GCPs-Addendum, both the informed consent discussion and the written ICF and any other written information to be provided to participants should include explanations of the following:

  • That the trial involves research
  • The purpose of the trial
  • The trial treatment(s) and the probability for random assignment to each treatment
  • The trial procedures to be followed, including all invasive procedures.
  • The participant’s responsibilities
  • Those aspects of the trial that are experimental
  • The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant
  • The reasonably expected benefits. When there is no intended clinical benefit to the participant, the participant should be made aware of this.
  • The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks
  • The compensation and/or treatment available to the participant in the event of a trial-related injury
  • The anticipated prorated payment, if any, to the participant for participating in the trial
  • The anticipated expenses, if any, to the participant for participating in the trial
  • That the participant's participation in the trial is voluntary and that the participant may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the participant is otherwise entitled
  • That the monitor(s), the auditor(s), the EC, and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written ICF, the participant or the participant's legally acceptable representative is authorizing such access
  • That records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, then the participant’s identity will remain confidential
  • That the participant or the participant's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant's willingness to continue participation in the trial
  • 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
  • The foreseeable circumstances and/or reasons under which the participant's participation in the trial may be terminated
  • The expected duration of the participant's participation in the trial
  • The approximate number of participants involved in the trial
Additional Resources
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea
(B) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: IV, VI, and VIII (8.2)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: 3
(D) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(E) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(F) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.4 and 4.8
Informed Consent > Compensation Disclosure
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

Per Additional Resource (A), clinical trials must comply with informed consent requirements in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs).

Per Additional Resource (C), Guinea is implementing the ICH-GCPs-Addendum, which states that 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. It should also describe the anticipated prorated payment, if any, to the participant for participating in the trial.

Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 3.1 and 4.8
Informed Consent > Participant Rights
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapters I, III, and IV
Summary

Overview

In accordance with the Guinea-PHC, Guinea’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The Guinea-PHC states that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. Additional Resource (A) requires the principal investigator to respect the fundamental ethical principles of research involving human beings.

Per Additional Resource (B), clinical trials must comply with informed consent requirements in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs). Per Additional Resource (D), Guinea is implementing the ICH-GCPs-Addendum.

The Right to Participate, Abstain, or Withdraw

As set forth in the Guinea-PHC and the ICH-GCPs-Addendum, a potential research participant or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she may refuse to participate or withdraw from the research study at any time.

The Right to Information

As delineated in the Guinea-PHC and the ICH-GCPs-Addendum, a potential research participant and/or his/her legal representative(s) or guardian(s) has/have the right to be informed about the nature and purpose of the research study, study procedures, obligations associated with his/her participation, any potential benefits or risks, and any compensation for participation or injury/treatment.

The Right to Privacy and Confidentiality

As per the Guinea-PHC and the ICH-GCPs-Addendum, all participants must be afforded the right to privacy and confidentiality.

The Right of Inquiry/Appeal

Information is currently unavailable on this topic.

The Right to Safety and Welfare

The Guinea-PHC and the ICH-GCPs-Addendum state that a research participant’s right to safety and the protection of his/her health and welfare must always take precedence over the interests of science and society.

Additional Resources
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: Engagement of the principal investigator
(B) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(D) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2, 3.1 and 4.8
Informed Consent > Special Circumstances/Emergencies
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter I
Summary

Overview

The Guinea-PHC makes 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.

Per Additional Resource (A), clinical trials must comply with informed consent requirements in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs). Per Additional Resource (C), Guinea is implementing the ICH-GCPs-Addendum.

Medical Emergencies

As delineated in the Guinea-PHC, in an emergency, when the participant is unable to give informed consent, the consent of a family member should be obtained.

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

Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Vulnerable Populations
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter I
Summary

Overview

As per the Guinea-PHC, in all Guinean 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 are persons because of his/her situation or mental state, cannot give a fully free and informed consent, and may include, but are not limited to, children/minors, prisoners, physically or mentally handicapped, persons whose condition requires emergency treatment or life support, and pregnant or lactating women.

Per Additional Resource (A), clinical trials must comply with informed consent requirements in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs). Per Additional Resource (C), Guinea is implementing the ICH-GCPs-Addendum, which includes the following as vulnerable populations: members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable populations include persons in nursing homes, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61 and 4.8
Informed Consent > Children/Minors
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter I
Summary

Overview

Guinea’s definition of child/minor is not currently available.

In accordance with the Guinea-PHC, when the research participant is a child, the informed consent form (ICF) must be signed by the child’s legal representative(s) or guardian(s). In the case of disagreement between the wishes of the child and his/her legal representative(s) or guardian(s), the child’s wishes should prevail. The child’s personal consent must be requested when his age allows him to understand the purpose of the research, the risk and disadvantages of this research, and what is expected of his/her participation. Research may only be conducted in children if it cannot be conducted in less vulnerable participants, such as for the purpose of researching childhood diseases or pathologies to which children are particularly susceptible. The age of consent for children and minors is not defined in the currently available regulatory resources.

Per Additional Resource (A), clinical trials must comply with informed consent requirements in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs). Per Additional Resource (C), Guinea is implementing the ICH-GCPs-Addendum, which states that when a clinical trial includes minors, the minor should be informed about the trial to the extent compatible with his or her understanding and, if capable, he or she should sign and personally date the written informed consent.

Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter I
Summary

Overview

As per the Guinea-PHC, any research studies involving women who are pregnant or nursing require additional safeguards to ensure the research conforms to appropriate ethical standards. The informed consent of the pregnant woman or nursing mother is required for all proposed research studies. Studies to be conducted with this population should meet one (1) or more of the following conditions:

  • The research should improve the health of the mother without harming the fetus or infant
  • The research should increase the viability of the fetus
  • The research should promote the proper development of the infant or the mother's ability to nurse the infant

Any research promoting abortion as provided for in section 269 of the Penal Code is prohibited.

Per Additional Resource (A), clinical trials must comply with informed consent requirements in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs). Per Additional Resource (C), Guinea is implementing the ICH-GCPs-Addendum, which states that the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 4.8
Informed Consent > Prisoners
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter I
Summary

Overview

According to the Guinea-PHC, prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. The Guinea-PHC states that prisoners may not participate in any research study while they are detained in prison and deprived of their freedom.

As indicated in the Guinea-PHC, if an ill person is placed under the responsibility of the judicial authority, the agreement of the latter is required in addition to the informed consent of the participant.

Additional Resources
No additional resources
Informed Consent > Mentally Impaired
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter I
Summary

Overview

As stated in the Guinea-PHC, participants with a mental impairment are at risk in research studies as they are unable to fully comprehend the nature of the research and the informed consent process. Per the Guinea-PHC, the mentally impaired participant should be fully informed about the study in which he/she has been asked to participate. Informed consent must be obtained from the legal representative(s) or guardian(s) who have been informed about the trial. The refusal of a mentally impaired participant should always be respected. Research may only be conducted in mentally impaired participants if it cannot be conducted in healthy participants.

Per Additional Resource (A), clinical trials must comply with informed consent requirements in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs). Per Additional Resource (C), Guinea is implementing the ICH-GCPs-Addendum, which states that when a clinical trial includes participants with mental impairment (e.g. those with severe dementia), the participant should be informed about the trial to the extent compatible with his or her understanding and, if capable, he or she should sign and personally date the written informed consent.

Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 8
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.61, 3.1, and 4.8
Investigational Products > Definition of Investigational Product
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

Per Additional Resource (A), clinical trials must comply investigational product requirements in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs). Per Additional Resource (C), Guinea is implementing the ICH-GCPs-Addendum, which defines an investigational product as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: Glossary and 5.6
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1.33
Investigational Products > Manufacturing & Import
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

According to Additional Resources (A) and (B), Ministry of Health (MOH)’s National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire (DNPL))—now known as the Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))—is responsible for authorizing the manufacture and import of drug products in Guinea. Specific information concerning the DNPL/DNPM’s role in reviewing and approving the manufacture of investigational products (IPs) is not currently available.

According to Additional Resource (A), once the sponsor or his/her representative obtains ethics committee approval from the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS)), he/she must submit a written request to the DNPL/DNPM director to obtain approval to import IPs. Additional Resource (A) also indicates that it typically takes two (2) to four (4) weeks for the DNPL/DNPM approval process to be completed. Information pertaining DNPL/DNPM documentation submission requirements is not currently available.

In addition, per Additional Resource (C), the sponsor or his/her representative must comply with manufacturing practices delineated in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs). Per Additional Resource (E), Guinea is implementing the ICH-GCPs-Addendum, which requires IPs to be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practices (GMPs) and used in accordance with the approved protocol.

Additional Resources
Ministry of Health and the World Health Organization
Relevant Sections: 5.0 – Pharmaceutical Regulation
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
Relevant Sections: Appendix 2
(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(D) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 5.6
(E) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2.12 and 5.13
Investigational Products > IMP/IND Quality Requirements
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire (DNPL))—now known as the Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))—documentation submission requirements are unavailable.

Per Additional Resource (A), the sponsor or his/her representative must comply with the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) in regards to in the production, supply, storage, and handling of investigational products (IPs). Per Additional Resource (C), Guinea is implementing the ICH-GCPs-Addendum.

Investigator’s Brochure (IB) Content Requirements

As specified in the ICH-GCPs-Addendum, the IB must include the following sections:

  • Table of Contents
  • Summary
  • Introduction
  • Physical, Chemical, and Pharmaceutical Properties and Formulation
  • Nonclinical Studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Effects in Humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
  • Summary of Data and Guidance for the Investigator(s)

The sponsor should also update the IB as significant new information becomes available. See the ICH-GCPs-Addendum for detailed content guidelines.

Drug Manufacturing Certificate Requirements

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

Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 5.6
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13, 5.14, 7, and 8.2
Investigational Products > Labeling & Packaging
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

Per Additional Resource (A), the sponsor or his/her representative must comply with manufacturing practices delineated in the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) in the labeling of investigational products (IPs). Per Additional Resource (C), Guinea is implementing the ICH-GCPs-Addendum, which states that the IP must be coded and labeled in a manner that protects the blinding, if applicable. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage.

Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 5.6
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 5.13
Investigational Products > Product Management
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

Per Additional Resource (A), the sponsor or his/her representative must comply with the International Council for Harmonisation’s guidelines and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) in regards to product management. Per Additional Resource (C), Guinea is implementing the ICH-GCPs-Addendum, which states that the Investigator’s Brochure (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

According to the ICH-GCPs-Addendum, the sponsor must also supply the investigator(s)/institution(s) with the IPs, including the comparator(s) and placebo, if applicable. The sponsor or his/her representative should not supply either party with the IP(s) until he/she obtains regulatory and ethics approval.

In addition, the ICH-GCPs-Addendum specifies that the sponsor must ensure the following:

  • Timely delivery of the IP(s)
  • Records maintained for IP document shipment, receipt, disposition, return, and destruction
  • Written procedures including instructions for handling and storage of the IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
  • IP product quality and stability over the period of use
  • Maintain sufficient quantities of the IP(s) to reconfirm specifications, should this become necessary
  • IP manufactured according to any application of the Good Manufacturing Practices (GMPs)
  • Proper coding, packaging, and labeling of the IP(s)
  • Acceptable IP handling and storage conditions and shelf-life
Additional Resources
(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)
(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995)
World Health Organization
Relevant Sections: 5.6
(C) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (not available online) (May 2019)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 2.12, 5.5, 5.12, 5.13, 5.14, and 7
Specimens > Definition of Specimen
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter I
Summary

Overview

The Guinea-PHC and Additional Resource (A) refer to specimens as biological materials.

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: IV and VI
Specimens > Specimen Import & Export
Last content review/update: July 09, 2019
Requirements
No applicable regulatory requirements
Summary

Overview

Additional Resource (A) states that the applicant must provide the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS)), the methods used to export biological materials from Guinea. CNERS must evaluate the proposed methods and determine whether or not they are well described and appropriate.

Additional Resources
(A) (Document) Standardized Operating Procedure (SOP) for Review of Health Research Protocol (French) (Version 4.0) (February 2019)
National Ethics Committee for Research in Health (CNERS)
Relevant Sections: IV and VI
Specimens > Consent for Specimen
Last content review/update: July 09, 2019
Requirements
(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French) (June 19, 1997)
National Assembly
Relevant Sections: Book Three, Chapter I
Summary

Overview

The Guinea-PHC states that the requirement for consent for research done on biological samples may be waived if it is impossible to locate the donor. However, approval must be granted by the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS)).

Additional Resources
No additional resources
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No symbol At least one of the keywords must be present
Search example: serious adverse event
Result: Will contain serious and/or adverse and/or event
+ Leading plus sign indicates that the word must be present
Search example: serious +adverse event
Result: Will contain adverse and may contain serious and/or event
- Leading minus sign indicates that the word must not be present
Search example: serious adverse -event
Result: Will contain serious and/or adverse but won’t contain event
“ ” Exact phrase must be present
Search example: “serious adverse event”
Result: Will contain the phrase serious adverse event
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