Clinical Trial Consent Form (Kenya)

A Clinical Trial Consent Form in Kenya records a party's informed permission for a specified act, authorising it to proceed.

The National Commission for Science, Technology and Innovation (NACOSTI), established under the Science, Technology and Innovation Act No. 28 of 2013, is the primary regulatory body for research ethics in Kenya. NACOSTI administers a system of ethical review committees — including institutional research ethics committees (IRECs) at hospitals and universities — that must approve the consent form and study protocol before any clinical trial may commence in Kenya. All clinical trials conducted in Kenya, whether funded by Kenyan institutions, international pharmaceutical companies, or bilateral development partners, require NACOSTI research authorisation and ethics approval.

The Kenya Pharmacy and Poisons Board (PPB), operating under the Pharmacy and Poisons Act (Cap. 244), has regulatory authority over clinical trials involving pharmaceutical products, medical devices, and biological products. The PPB reviews the trial protocol, the investigator's brochure, and the consent form, and issues a Clinical Trial Authorisation (CTA) before any pharmaceutical trial may begin. Without a valid CTA from the PPB, conducting a clinical drug or device trial in Kenya is a criminal offence under the Pharmacy and Poisons Act.

Informed consent requirements in Kenya are consistent with the World Medical Association Declaration of Helsinki (as revised in 2013) and the ICH-GCP E6(R2) guidelines, which require that consent be: voluntary (free from coercion or undue influence); informed (participant has received all material information); comprehended (participant has understood the information); and ongoing (participant may withdraw at any time without penalty). For participants who cannot read, consent may be obtained orally in the presence of a literate, impartial witness who signs the consent form.

The Data Protection Act No. 24 of 2019 administered by the Office of the Data Protection Commissioner (ODPC) applies to all personal health data collected during clinical trials in Kenya. The consent form must include a specific section on data processing, the identity of the data controller, and the participant's rights under the Data Protection Act including the right to access, rectify, and object to processing of their personal data. Under Kenya law, Section 3 of the Companies Act 2015 (No. 17 of 2015) and Section 25 of the Data Protection Act 2019 (No. 24 of 2019) govern the core requirements for this type of document.

A Kenya Clinical Trial Consent Form is required before any human participant is enrolled in a clinical research study, and in several specific regulatory and operational contexts.

A Clinical Trial Consent Form is required for all pharmaceutical trials conducted in Kenya — including trials of new drugs, biological products, medical devices, and diagnostics — before the Kenya Pharmacy and Poisons Board (PPB) will issue a Clinical Trial Authorisation (CTA) under the Pharmacy and Poisons Act (Cap. 244). No subject may be enrolled in a pharmaceutical trial without a signed consent form reviewed and approved by the relevant institutional research ethics committee (IREC).

A Clinical Trial Consent Form is needed for non-pharmaceutical research involving human subjects — including social science research, public health surveys, and epidemiological studies — that require NACOSTI research authorisation under the Science, Technology and Innovation Act No. 28 of 2013. NACOSTI's research permit application requires a copy of the approved consent form.

A Clinical Trial Consent Form is required when international pharmaceutical companies — including those conducting multi-country trials funded by the US National Institutes of Health (NIH), the Wellcome Trust, or the Bill & Melinda Gates Foundation — enrol Kenyan participants at trial sites including Kenyatta National Hospital (KNH), Kenya Medical Research Institute (KEMRI), the Aga Khan University Hospital Nairobi, or Moi Teaching and Referral Hospital in Eldoret.

A Clinical Trial Consent Form is needed when researchers at Kenyan universities — including the University of Nairobi School of Medicine, Kenyatta University, Moi University, and Strathmore University — conduct student research projects involving human participants. The university's IREC will review the consent form as part of the ethical clearance process.

A Clinical Trial Consent Form is required when a study involves vulnerable populations — including children (requiring parental or guardian consent under the Children Act No. 29 of 2022), pregnant women, prisoners, or persons with cognitive impairment — for whom additional ethical safeguards and simplified consent procedures are mandated by NACOSTI and ICH-GCP E6(R2).

A Clinical Trial Consent Form is required under the Data Protection Act No. 24 of 2019 administered by the Office of the Data Protection Commissioner (ODPC) when health data is collected, processed, or shared with third parties — including overseas sponsors or data repositories — as part of a research study.

A Kenya Clinical Trial Consent Form must include the following essential elements to satisfy the requirements of NACOSTI, the Kenya Pharmacy and Poisons Board (PPB), the applicable institutional research ethics committee (IREC), and the ICH-GCP E6(R2) standard.

Study Information: The official title of the clinical trial, the study sponsor's name and address, the principal investigator's name and institutional affiliation, the NACOSTI research permit number (if already issued), and the PPB Clinical Trial Authorisation number (for pharmaceutical trials). This information confirms the study's regulatory standing for participants.

Purpose of the Study: A clear, plain-language explanation of why the research is being conducted, what question it aims to answer, and what the study involves — including the number of visits, the duration of participation, and the interventions (blood draws, questionnaires, drugs administered, procedures performed).

Risks and Discomforts: A complete and honest description of all foreseeable risks, side effects, and discomforts — both physical and psychological — that participants may experience. NACOSTI and ICH-GCP E6(R2) require that no known risk be omitted, even if the study team considers it unlikely.

Benefits: A balanced statement of the potential benefits to the participant and to society. Compensation or payment to participants must not be characterised as a benefit and should not be of a magnitude that constitutes undue inducement under NACOSTI guidelines.

Alternatives to Participation: A statement of what other treatment or care options are available to the participant outside the study — particularly important for therapeutic trials where participants have treatment choices.

Confidentiality and Data Protection: A statement of how participant data will be collected, stored, and protected under the Data Protection Act No. 24 of 2019; who will have access to identifiable data; whether data will be shared with overseas sponsors or deposited in a data repository; and the participant's rights under the Data Protection Act including the right of access (Section 26) and the right to erasure (Section 35).

Voluntary Participation and Right to Withdraw: A clear statement that participation is entirely voluntary, that refusing to participate will not affect the participant's access to other healthcare or services, and that the participant may withdraw at any time without penalty and without affecting their normal care. This reflects the Helsinki Declaration principle of voluntary consent.

Contact Information: Names, telephone numbers, and email addresses of the principal investigator, the study coordinator, and the relevant institutional research ethics committee (IREC) chairperson — so participants can ask questions before and during the study. The forms-legal.com Clinical Trial Consent Form template reflects NACOSTI, PPB, and ICH-GCP requirements. Signatures of the participant and a witness are required; for illiterate participants, a thumbprint and an impartial literate witness signature are acceptable under Kenyan research ethics practice. Under Kenya law, Section 135 of the Companies Act 2015 (No. 17 of 2015) and Section 25 of the Data Protection Act 2019 (No. 24 of 2019) govern the core requirements for this type of document. Under Kenya law, Section 15 of the Employment Act 2007 (No. 11 of 2007) and Section 10 of the Law of Contract Act (Cap 23) govern the core requirements for this type of document.