Session Duration: 1.5 hours
Format: Case analysis, checklist development workshop
Before any research involving human participants, animals, or sensitive data can begin, it must undergo a formal ethical review to ensure that it meets established ethical standards and safeguards the rights and well-being of all involved. This review process is carried out by Research Ethics Committees (RECs). RECs are independent bodies composed of experts and community representatives who assess the ethical acceptability of research protocols. In this unit, participants will explore the ethics review process, including the various types of reviews available and the decision pathways a research application may follow. Understanding the structure and function of RECs is crucial for research councils and institutions to ensure compliance, build public trust, and promote responsible science.
The Ethics Approval Process
All research involving human subjects, animals, or potentially hazardous materials must undergo ethical review before commencement. Ethical approval is not a bureaucratic burden; it is a safeguard. Ethical approval is a formal process by which research proposals are assessed for compliance with ethical standards before any data collection or participant engagement begins. The process is essential for ensuring that research is conducted with respect for human dignity, transparency, and professional responsibility.
a) Obtain ethical approval: Ensure that planned research meets ethical standards and obtain necessary approvals. Before initiating any study involving human participants, personal data, animals, or the environment, researchers must submit their research protocol to a recognized Research Ethics Committee (REC). This committee evaluates whether the study meets ethical and legal standards. The protocol typically includes details about the study design, recruitment methods, informed consent procedures, data handling, and risk mitigation. Without this approval, the study is not permitted to proceed. For councils, enforcing this step ensures that publicly funded or institutionally affiliated research does not compromise participants’ rights or institutional reputation.
b) Adhere to ethical guidelines: Staff and students must follow the terms of any given ethical approval: Once ethical approval is granted, researchers are obligated to conduct the study exactly as described in their approved protocol. This includes following the agreed consent procedures, using the stated methodology, and recruiting only eligible participants. Any deviation from the approved plan must be reported to the REC and, if necessary, a request for protocol amendment must be submitted. Adherence to these guidelines ensures that participants are not exposed to unforeseen risks and that the study remains credible. Non-compliance can lead to withdrawal of approval or institutional penalties.
c) Protect participants: Obtain informed consent, safeguard data, and address participant safety concerns: This is the core of ethical research. Researchers must prioritize the rights, dignity, and welfare of all participants. Informed consent must be voluntarily given after the participant fully understands the study’s purpose, risks, benefits, and their right to withdraw without penalty. Additionally, data collected from participants must be protected through secure storage, encryption, and anonymization where appropriate. Researchers must also monitor for any adverse effects, physical, psychological, or social, and respond appropriately. Funding councils and institutions should ensure that mechanisms are in place to support participant protection, especially in high-risk studies.
d) Prevent legal issues: Failure to comply with ethical guidelines can lead to harm to participants and potential litigation: Conducting research without ethical approval or failing to adhere to approved guidelines, can have serious legal and reputational consequences. Participants may suffer harm, and institutions may face lawsuits, funding withdrawal, or public backlash. Ethical lapses can also result in retraction of published studies, loss of academic credibility, or blacklisting by international collaborators. Councils have a responsibility to educate researchers about these risks and to implement strong compliance mechanisms that discourage unethical behavior and ensure accountability.
e) Retrospective approval of research protocols should not be given: Retrospective approval refers to approving a study after data collection has already begun or been completed. This practice is universally discouraged and considered unethical because it bypasses the entire purpose of the review process,to evaluate and mitigate risks before they occur. Data collected without prior ethical approval is considered compromised and cannot ethically be used for analysis, publication, or policy development. Councils and RECs must be firm on this rule and ensure that researchers understand that any research involving human subjects, personal data, or ethical concerns must receive approval in advance, not after the fact.
These ethical approval requirements form the backbone of responsible research governance. By following each step, researchers demonstrate respect for participants, uphold institutional standards, and contribute to a trustworthy research environment. For West African Research and Innovation Funding Councils, implementing and enforcing this process helps to elevate national and regional research credibility, fosters international collaboration, and safeguards the public interest.
Types of Reviews:
• Regular Review: Standard REC meeting evaluation.
• Fast Track Review: Used in urgent or time-sensitive cases.
• Expedited Review: Applied for low-risk studies.
Possible REC Decisions:
a) Approved as submitted
b) Approved with conditions
c) Request for amendments
d) Returned for resubmission
e) Rejected
Facilitator Notes
a) Walk through REC structures (chair, secretariat, reviewers).
b) Facilitate a mock ethics review of a proposal.
c) Stress consistency and transparency in decision-making.
Suggestions for Further Reading
a) CIOMS (2016). International Ethical Guidelines for Health-related Research Involving Humans.
b) WHO (2011). Standards and Operational Guidance for Ethics Review of Health-related Research.