Policy on Research Involving Human Participants
1.0 Purpose
This policy provides principles and guidelines for all research involving human participants funded directly or indirectly by the Science for Africa Foundation (SFA Foundation).
SFA Foundation recognises that improving human health through research requires the involvement of humans as research participants. Research involving human participants is central in understanding factors that underpin health and disease. It is also important in evaluating the safety and effectiveness of biomedical and social interventions. Accordingly, SFA Foundation supports such research as a key part of its broad mission. In conducting research that involves human participants, the priority for researchers should always be the protection of the rights, interests and safety of research participants.
SFA Foundation further expects that research involving human participants should be undertaken in accordance with the appropriate standards and principles. Research involving human participants is governed by principles outlined in the Declaration of Helsinki, The Nuremberg Code (1947), The Belmont Report, Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS) and International Council for Harmonization QESM (Quality, Efficacy, Safety, Multidisciplinary) guidelines; all of which set out requirements about the rights and safety of research participants and standards for research design and conduct.
SFA Foundation recognises the importance of maintaining rigorous standards of clinical trial management, including pre-trial, during the trial and post-trial requirements. Grantees must conform to local research ethics and regulatory requirements, processes and standards where the research is being conducted as well as the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and the WHO Guidance for best practices for clinical trials.
SFA Foundation funded researchers are therefore required to be aware of, and comply with relevant legislation, and follow best practice guidance surrounding research involving human participants.
2.0 Scope
This policy applies to all SFA Foundation grantees undertaking research that involves human participants or related components such as patient personal information, biological samples and associated data.
3.0 Definitions
Human Participants
Any behavioural, social science, biomedical, or epidemiological activity that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human beings i) are exposed to manipulation, intervention, observation, or other interaction with investigators either directly or through alteration of their environment, or ii) become individually identifiable through investigator's collection, preparation, or use of biological material or medical or other records.
Clinical Trials
A subset of research involving human participants that specifically evaluates the safety and effectiveness of health interventions. The SFA Foundation uses the World Health Organization (WHO) definition of a clinical trial which is defined as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
Research Ethics Committee (REC)
Also referred to as institutional review board (IRB), or, independent ethics committee (IEC), or ethics review board (ERB), or research ethics board (REB); is a committee that reviews proposed studies with human participants to ensure that they conform to internationally and locally accepted ethical guidelines in order to promote and safeguard the rights of the research participants.
4.0 Policy Statement
4.1 Healthcare Benefits of Research
SFA Foundation requires that SFA Foundation funded research involving human participants should meet at least one of the following criteria:
- Local and regional relevance: Address healthcare priorities or needs within the research setting, demonstrating relevance to the short- or long-term needs of the region(s) or population(s) where the research is conducted;
- Potential for sustainable health benefits: Aim to generate outcomes that have the potential to lead to sustainable health benefits and demonstrate local applicability;
- Discovery and exploratory potential: Contribute to the fundamental scientific understanding or generate exploratory data that could inform future research or interventions; or
- Global knowledge contribution: Generate knowledge that can contribute to a broader understanding of human health.
SFA Foundation will conduct due diligence processes. A checklist for the evaluation of clinical trial research is availed here.
Research ethics guidelines and oversight mechanisms are intended to ensure that research involving human participants is conducted in a manner that demonstrates, protects and preserves respect for persons, concern for the welfare of individuals, families and communities, and justice.
Research in Low- and Middle-Income Countries (LMICs) must be a collaborative partnership between researchers, sponsors, policymakers, and participating/affected communities, regardless of where the researchers or sponsors are based.
SFA Foundation requires that for SFA Foundation-funded research involving human participants, researchers must seek and obtain the relevant regulatory and ethical approvals, and appropriate governance mechanisms before the research begins. However, applicants may apply for funding before seeking and obtaining the above requirements. In the event of an award being made, commencement of any research involving human participants will be subject to these approvals and governance mechanisms being in place - including, in the case of ethical review, from an appropriately constituted ethics review committee.
SFA Foundation does not require copy of approval documents when they are obtained but reserves the right to see relevant approval documents at any point during the lifetime of the grant.
Where research is anticipated to run over a number of years, for example in cohort studies, researchers must ensure measures are in place to maintain continuing appropriate ethical oversight and to monitor and, where necessary, obtain advice on ethical, legal and social issues on an ongoing basis. An example of this would be use of an oversight committee with members who are independent of the research in question. These measures would be additional to ethics review and would provide an additional layer of ethical oversight throughout the lifetime of the research.
SFA Foundation may bear the actual direct costs of the ethics review process in resource-poor settings, as part of a grant application. However, this must be done in a way that does not compromise the independence of the ethical review process. Such decisions will be made by SFA Foundation CEO or designate on a case-by-case basis, where an applicant may request a one-off fee for ethical review based on actual cost. SFA Foundation will not consider calculating such payments in terms of a percentage of the total cost of the grant.
All SFA Foundation funded researchers must understand the ethics of research involving human participants. SFA Foundation requires that all SFA Foundation funded researchers involved in such research undergo training in research ethics and when required, build capacity in this area.
4.7 Procedure in Case of Special Ethical Concerns
Where an application for funding raises ethical concerns for the SFA Foundation reviewers, decision committee members, referees or staff, the SFA Foundation reserves the right to send the research protocol to experts in research ethics or appropriate field of training for advice before a funding decision is made.
The SFA Foundation expects all research involving human participants to be designed and implemented in a manner that demonstrates a clear and proportionate duty of care. Responsibility for fulfilling this duty rests with researchers, institutions, and sponsors involved in the design and conduct of the study. These provisions must ensure that the dignity, rights, safety, and well-being of participants are upheld throughout the research.
Duty of care provisions must prioritise ensuring timely access to appropriate care in the event of research-related harm, providing participants with clear and accessible information about their rights and available support, and maintaining systems to identify and respond to concerns affecting participant welfare. These areas should be addressed as a minimum, with additional measures considered as appropriate to the context, risks, and needs of the research.
Duty of care should be embedded in research protocols, oversight procedures, and engagement strategies, and must align with applicable ethical standards, legal requirements, and good research practices.
4.9.1 Individual Valid Consent
SFA Foundation requires that all funded research involving human participants, consent must be provided by the participant directly, or, in cases where they are legally unable to do so (e.g., minors or adults lacking capacity), by their legal guardian or authorised representative, in accordance with the principles outlined in the Declaration of Helsinki, the CIOMS Ethical Guidelines, and applicable local and national regulations (including data protection laws and regulations), ICH GCP for clinical trials, and The UNESCO Universal Declaration on the Human Genome and Human Rights for genome research. This includes ensuring that consent processes are culturally appropriate and information is provided in a language and format understandable to participants.
4.9.2 Research Involving Vulnerable Individuals and Children
The SFA Foundation prioritises inclusive research that appropriately represents all population groups. SFA Foundation encourages the default inclusion of children, pregnant women, and other historically underserved groups unless there is compelling scientific, ethical or safety justification for exclusion. Recognising that regulatory frameworks vary across African jurisdictions, with some having more restrictive approaches to including these populations, researchers must navigate both our inclusion principles and local regulatory requirements. Where participation involves individuals with limited or no capacity to consent, researchers must: (1) demonstrate that their inclusion is essential to answering the research question, (2) implement robust safeguards to protect participants’ interests, (3) engage appropriately with parents, legal guardians, or relevant authorities per local requirements, and (4) comply with both local laws and international best practices. Applications should detail specific strategies for the ethical recruitment and retention of underserved groups, clearly justify any exclusion criteria, and outline approaches for navigating any tensions between inclusive research principles and local regulatory constraints.
SFA Foundation will consider funding emergency research (e.g., accident and emergency research) where the ability of an individual to give consent is compromised or impracticable, provided that the research protocol receives REC approval and complies with all relevant national legislation and any best practice guidance. Where appropriate, measures to inform the general public that these studies are planned or are in progress should be implemented.
4.9.4 Use Of Biological Samples and Data
Where research will involve the collection of human biological samples and/or data, researchers must outline as part of their application how the samples or data will be collected, stored and accessed by any third parties and ensure that appropriate ethical approvals are sought. The confidentiality of research participants must be safeguarded, unless appropriate consent has been obtained to disclose information to a third party.
The consent process must, wherever practicable, include seeking consent for approved secondary use of the samples or data in subsequent research studies. SFA Foundation recognises, however, that in some situations, this may not be possible. In such cases, SFA Foundation considers that it is acceptable to use samples and/or medical data for secondary purposes without returning to the participant for specific consent, if the proposed research:
- Has clear healthcare benefits in accordance with this policy and complies with relevant national laws;
- Complies with any binding codes of practice or ethical guidance (such as professional guidelines or licensing regulations);
- Is not inconsistent with the consent as approved by an ethics committee for the original study;
- Uses samples or data that have been anonymised (fully or pseudo-anonymised);
- Meets policy requirements regarding secondary use as required by the principal investigator's employing institution;
- Includes appropriate mechanisms to monitor consent for the original study and any cases where it is withdrawn, where practicable.
4.9.5 Feedback to Participants
SFA Foundation requires researchers to consider the circumstances and mechanisms by which aggregated research findings might be made available to research participants, where this is deemed appropriate, and the manner in which such information is presented.
It is the responsibility of the research institution that receives SFA Foundation funding to conduct research involving human participants to take all reasonable measures to safeguard the safety of participants and to ensure that appropriate compensation arrangements (including insurance or indemnity cover as applicable) are in place to cover research participants and/or their dependants against injuries or damage caused as a result of their participation in research, in accordance with local law and best practice. SFA Foundation will not fund the costs of such insurance or indemnity cover and would not be liable for any such compensation.
4.9.7 Community Consultation (Including Patient and Public Involvement)
Community consultation is a key benchmark of ethically conducted research. Researchers must consider how to maximise community involvement in their research.
This can include working with the community:
As co-creators in the design of research questions;
- To decide if it is appropriate to approach members of a community to take part in research;
- To design procedures for getting consent;
- To identify areas of concern to the community;
- To advise how and when aggregated research findings can be made available to research participants, and if this is appropriate.
Community consultation can be carried out using various ways. SFA Foundation encourages SFA Foundation funded researchers to be context specific and culturally sensitive when deciding which approaches to apply during community consultations and involvement.
5.0 Considerations for Clinical Trials
Applicants must submit an outputs management plan with their grant application. This should describe how and when trial data will be made more widely available, while maintaining the confidentiality and privacy of trial participants. The protocol and statistical analysis plan (SAP) should be made available publicly before completion of trial recruitment. These can be uploaded to Open Research Africa, along with other journals and platforms. This is to ensure that researchers and other interested parties can interpret the results of the trial.
5.2 Clinical Trials Sponsorship
All research involving clinical trials funded by the SFA Foundation must have a clearly designated trial sponsor. The sponsor, whether local or international, must take full responsibility for the initiation, management, and oversight of the trial in accordance with ICH-GCP guidelines and local regulations. At a minimum, sponsors must: (1) maintain appropriate insurance and indemnification, (2) demonstrate regulatory capacity in relevant jurisdictions, (3) implement robust safety monitoring and reporting systems, and (4) ensure ethical oversight throughout the trial.
5.3 Clinical Trial Governance and Monitoring
For clinical trials, the SFA Foundation recommends the set-up of a Trial Steering Committee (TSC) that will approve a clinical trial before it starts and monitor and supervise the trial’s progress. The SFA Foundation Program Manager/officer should be granted observer status and receive a copy of all reports issued by the TSC. If a TSC is not required, there should be an outline of how the trial will be monitored. The sponsor should complete a risk assessment to determine if a Data and Safety Monitoring Board (DSMB) is required and to constitute one with members who are independent of the study management and the TSC. The DSMB consists of an independent committee of experts who are responsible for monitoring the safety and efficacy of a clinical trial. The primary role of the DSMB shall be to ensure the safety of study participants by reviewing data on adverse events and monitoring the trial's progress to make recommendations to the sponsor on whether it should continue as planned or be modified or terminated.
The board is typically composed of independent experts in the relevant medical field, biostatisticians, and other qualified individuals who review the trial data in a blinded fashion to assess the ongoing safety of the study intervention. The DSMB can recommend modifications or early termination of the study if safety concerns arise. The DSMB shall be accountable to the Trial Sponsor.
The SFA Foundation expects that DSMBs should be established in line with the WHO Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards.
5.4 Clinical Trial Registration and Public Access to Findings
SFA Foundation requires all clinical trials of which it is a funder or part-funder to be registered on a publicly accessible platform. For trials in Africa, the primary registry is the Pan African Clinical Trials Registry (PACTR), if the trial includes sites outside of Africa, trials should be registered on PACTR and the applicable primary registry for the non-African sites e.g. ClinicalTrials.gov, or the International Standard Randomised Controlled Trial Number Register (ISRCTN), or on another register listed on the WHO International Clinical Trials Registry Platform (ICTRP). The entry on the register should cite the relevant grant number.
Grantees must publish the trial protocols and statistical analysis plans (SAPs) before trial recruitment is complete. They can use Open Research Africa, along with other journals and platforms.
Grantees are required to make the summary results from their clinical trials publicly available. These should be posted in the clinical trial registry where the trial was originally registered. The results must be posted to the results section of the clinical trial registry.
Research proposals should include all necessary post-research health monitoring related to a volunteer’s participation. This is the responsibility of the grantee. SFA Foundation may provide funds for post-research health monitoring where it is an integral part of the research proposal e.g., certain long-term drug or vaccine trials.
Grantees are responsible for complying with any requirements for monitoring of adverse events, at any stage of the research.
5.6 Publishing Results and Making Clinical Trial Database Accessible
Grantees must maximise the opportunities to make their research findings freely available, including null and negative results.
Any peer-reviewed publication(s) that arise from SFA Foundation funding must be made freely available in line with the SFA Foundation Open Access Publication Policy.
Data underlying your research publications must be made accessible to other researchers within twelve (12) months publication – either openly or via a managed access approach.
Clinical trial data must be managed and shared in accordance with the SFA Foundation Policy on Open Access Publication.
For any queries on this policy, please contact [email protected]