Research Participant Consent Form (Ghana)

A Research Participant Consent Form in Ghana authorises a defined activity and evidences that the necessary permission was given.

Ghana has a developed institutional framework for research ethics. The Ghana Health Service / Teaching Hospitals' Health Research Ethics Committee (GHS-THAHREC) reviews and approves health and biomedical research involving human participants conducted within Ghana. The Committee on Human Research, Publications and Ethics (CHRPE) at Kwame Nkrumah University of Science and Technology (KNUST) in Kumasi reviews social science, biological, and medical research by KNUST staff and students. The University of Ghana Institutional Review Board (UG-IRB) at Legon, Accra oversees research by University of Ghana affiliates. All health research conducted in Ghana must receive ethics clearance from a recognised Institutional Review Board (IRB) or Ethics Committee before recruitment of participants begins.

The Data Protection Act 2012 (Act 843) is the principal statute governing the lawful processing of personal data in Ghana. The Data Protection Commission (DPC), established under Act 843, registers data controllers and enforces compliance. Every researcher or research institution that collects, stores, or processes personal data from Ghanaian participants must register with the Data Protection Commission as a data controller. Section 17 of Act 843 requires consent to be freely given, specific, and informed. A Research Participant Consent Form documents the giving of consent in writing, satisfying the consent requirement of Act 843.

For clinical trials and research involving medicines, medical devices, or health interventions, the Food and Drugs Authority (FDA Ghana), established under the Food and Drugs Authority Act 1992 (PNDC Law 305B) as amended, provides a separate regulatory layer. The FDA Ghana requires that all clinical trials be registered in an approved trial registry and that participants provide written informed consent documented on an FDA-approved consent form template where applicable.

The Mental Health Act 2012 (Act 846) governs research involving persons with mental illness or intellectual disability in Ghana. Research involving vulnerable populations — including children, prisoners, pregnant women, and persons with diminished capacity — requires additional protections. For children under 18, consent must be obtained from the parent or legal guardian under the Children's Act 1998 (Act 560), which governs the welfare of children in Ghana. Where a child is capable of understanding, the child's assent should also be obtained in addition to parental consent.

The Electronic Transactions Act 2008 (Act 772) recognises electronic signatures and electronic records as legally valid in Ghana. A Research Participant Consent Form signed electronically through a secure platform is admissible as evidence of consent under Section 8 of Act 772. Remote and online research using electronic consent forms is permissible under Act 772 provided the consent process genuinely allows the participant to read, understand, ask questions, and voluntarily agree to participate.

The Personal Data Protection Regulations that implement Act 843 require data controllers to retain consent records for the duration of the processing activity and for a reasonable period thereafter. Research institutions should retain signed consent forms for at least ten years or for the duration required by the relevant ethics committee, whichever is longer, consistent with international good clinical practice (GCP) standards adopted by Ghana.

A Research Participant Consent Form in Ghana is required before any researcher collects personal information, biological samples, health data, or any other data from an identifiable human participant.

A Research Participant Consent Form is required under Section 17 of the Data Protection Act 2012 (Act 843) before a researcher collects any personal data — including names, contact information, demographic details, health records, or biometric measurements — from individuals in Ghana as part of a study.

A Research Participant Consent Form is required before recruitment of participants in health and biomedical research approved by the Ghana Health Service / Teaching Hospitals' Health Research Ethics Committee (GHS-THAHREC) or the Committee on Human Research, Publications and Ethics (CHRPE) at KNUST.

A Research Participant Consent Form is needed for social science and humanities research — including surveys, interviews, focus groups, and observational studies — conducted by researchers affiliated with the University of Ghana (Legon), Kwame Nkrumah University of Science and Technology (KNUST), University of Cape Coast (UCC), or any other Ghanaian university or research institution.

A Research Participant Consent Form is required for market research and consumer surveys conducted by organisations registered under the Companies Act 2019 (Act 992) that collect identifiable personal data from Ghanaian consumers, as the Data Protection Act 2012 (Act 843) applies to all data controllers regardless of whether their activities are academic or commercial.

A Research Participant Consent Form is needed for international research collaborations involving Ghanaian participants — for example, multi-country studies funded by the Bill and Melinda Gates Foundation, Wellcome Trust, or the US National Institutes of Health (NIH) — where Ghanaian ethical standards under GHS-THAHREC must be met in addition to the ethics requirements of the foreign funding institution.

A Research Participant Consent Form is required before collecting data from employees as part of workplace health studies or organisational behaviour research, given that the employer–employee power imbalance can affect the voluntariness of consent under the Labour Act 2003 (Act 651).

Parties in Ghana should prepare a Research Participant Consent Form (Ghana) proactively rather than waiting for a dispute to arise. Courts interpret agreements based on the written terms rather than oral representations. Under Ghanaian law, the Data Protection Act 2012 (Act 843) and the Data Protection Commission govern personal data processing. The Marriages Act 1884-1985 (Cap. 127) and Marriages Ordinance (Cap. 127) govern civil marriages. The Intestate Succession Law 1985 (PNDC Law 111) overrides customary succession for specified relatives. The Courts Act 1993 (Act 459) governs court procedures. The Children's Act 1998 (Act 560) governs child welfare. Where the transaction involves regulated activities, prior approval from the relevant authority may be required before execution.

A Research Participant Consent Form in Ghana compliant with the Data Protection Act 2012 (Act 843) and Ghana Health Service ethical guidelines must contain the following essential elements.

Study Title and Principal Investigator: The full title of the research study, the name and institutional affiliation of the principal investigator, and the ethics approval reference number issued by the relevant Institutional Review Board — GHS-THAHREC, CHRPE at KNUST, UG-IRB, or another recognised committee.

Purpose of the Research: A clear, plain-language explanation of the purpose of the study, why the participant has been invited to take part, and how many participants are expected to be recruited.

Nature and Duration of Participation: A description of what participation involves — including interviews, questionnaires, blood draws, physical measurements, or other procedures — the expected duration of each session and the total time commitment.

Risks and Benefits: An honest and balanced description of any foreseeable risks or discomforts associated with participation — physical, psychological, social, or legal — and any anticipated benefits to the participant or to society. Overstating benefits or understating risks invalidates consent under GHS-THAHREC guidelines.

Confidentiality and Data Protection: An explanation of how the participant's data will be collected, stored, used, and protected in accordance with the Data Protection Act 2012 (Act 843). The participant should be informed whether their data will be anonymised, pseudonymised, or retained in identifiable form; who will have access to the data; and whether the data will be shared with international collaborators.

Voluntary Participation and Right to Withdraw: A clear statement that participation is entirely voluntary, that refusal to participate will not affect any service or benefit to which the participant is entitled, and that the participant may withdraw from the study at any time without penalty and without giving a reason, consistent with Section 17 of the Data Protection Act 2012 (Act 843).

Contact Information: The names, institutional addresses, telephone numbers, and email addresses of the principal investigator and the relevant ethics committee or Institutional Review Board, so that the participant may ask questions or raise concerns at any time.

Consent Declaration: A signed declaration by the participant confirming that they have read and understood the information, have had the opportunity to ask questions, and voluntarily agree to participate. For participants who cannot read, the form should be read aloud in the participant's language (including Twi, Ga, Ewe, Dagbani, or Hausa as appropriate) in the presence of a literate witness.

Parent / Guardian Consent (where applicable): For participants under 18 years, a separate section for parental or guardian consent under the Children's Act 1998 (Act 560), together with the child's assent where the child is capable of understanding.

Forms-legal.com provides this Research Participant Consent Form template as a starting point for researchers conducting studies in Ghana. Researchers must adapt this template to meet the specific requirements of the relevant Institutional Review Board and the Data Protection Commission (DPC). Clinical trial consent forms must also comply with FDA Ghana requirements and international Good Clinical Practice (GCP) guidelines adopted by Ghana.

Additional compliance elements for a Research Participant Consent Form (Ghana) used in Ghana include: Under Ghanaian law, the Data Protection Act 2012 (Act 843) and the Data Protection Commission govern personal data processing. The Marriages Act 1884-1985 (Cap. 127) and Marriages Ordinance (Cap. 127) govern civil marriages. The Intestate Succession Law 1985 (PNDC Law 111) overrides customary succession for specified relatives. The Courts Act 1993 (Act 459) governs court procedures. The Children's Act 1998 (Act 560) governs child welfare. Forms-legal.com provides this template as a starting point for Ghana-compliant documentation.