Obtaining Ethical Approval for Research Projects in Zambia

Conducting research involving human participants is a critical endeavour that requires adherence to ethical standards to protect the rights, dignity, and welfare of those involved. In Zambia, the ethical approval process is overseen by various Institutional Review Boards (IRBs) and the National Health Research Authority (NHRA). This article outlines the process of obtaining ethical approval for research projects in Zambia, highlighting key requirements, documentation, procedures, and how M31 Research can support you through this process.

Understanding the Role of Institutional Review Boards (IRBs)

Institutional Review Boards (IRBs) are responsible for reviewing and approving research proposals involving human subjects in Zambia. Their mandate includes ensuring that research is conducted with integrity, respects participants' rights, and mitigates potential risks. Researchers are required to submit their proposals to an IRB to obtain ethical clearance before commencing their studies.

Submission Requirements

To apply for ethical approval, researchers must submit a comprehensive proposal that includes several critical documents. The submission package typically includes:

1. Proposal Review Application Form - This form is the primary document submitted to request a review by the IRB. It should include the title of the study, details of the principal investigator (PI) and co-investigators, and a summary of the study methodology.
2. Informed Consent and Assent Forms - Informed consent is a fundamental requirement for any research involving human participants. Researchers must provide clear and concise information to participants, ensuring they understand the purpose of the study, the procedures involved, and their rights. In cases where minors are involved, assent forms must also be provided.
3. Participant Information Sheet - This document should be written in simple, non-technical language and include details such as the study's purpose, procedures, risks, benefits, and the participant's rights to confidentiality and voluntary participation.
4. Curriculum Vitae (CV) - The CVs of the principal investigator, co-investigators, and, for student projects, the supervisors, must be submitted along with the proposal.
5. Other Supporting Documents - Depending on the nature of the study, additional documents such as questionnaires, authorization letters from study sites, clearance letters from regulatory authorities, and data safety monitoring plans may be required.

The Role of the National Health Research Authority (NHRA)

In addition to the IRBs, researchers must engage with the National Health Research Authority (NHRA), which is responsible for the registration and accreditation of health research ethics committees, research institutions, and researchers in Zambia. The NHRA ensures that all research conducted within the country complies with national regulations and international standards. The NHRA's responsibilities include:

• Registration and Accreditation - All health research ethics committees, research institutions, and researchers must be registered and accredited by the NHRA. This includes the submission of relevant documents and payment of prescribed fees.
• Monitoring and Compliance -The NHRA monitors research activities to ensure compliance with ethical standards and can suspend or revoke registrations and accreditations if necessary.
• Issuance of Certificates - Upon successful registration and accreditation, the NHRA issues certificates that are required for conducting research in Zambia.

Ethical Review Process

Once the submission is complete, the IRB and the NHRA review the proposal to ensure it meets ethical and regulatory standards. The review process includes an assessment of:

• Scientific Validity: The IRB and NHRA evaluate whether the research question is scientifically sound and whether the proposed methodology is appropriate to answer the question.
• Risk-Benefit Analysis: They assess the potential risks to participants against the potential benefits of the research. Studies with high risks may require additional safeguards, such as insurance for study-related injuries.
• Informed Consent: The process for obtaining informed consent is scrutinised to ensure that participants are fully informed and that their consent is voluntary. For studies involving minors, the assent process is also evaluated.
• Confidentiality Measures: The IRB and NHRA examine how the confidentiality of participants will be maintained, including how data will be stored, who will have access, and how it will be used.

In general, the time required to obtain ethical approval in Zambia can range from 7 days to one month, depending on the type of application and the completeness of the submission. Researchers should plan for this timeline when designing their study to avoid delays.

Progress Reporting and Continuing Review

Ethical approval is not a one-time process. Researchers are required to submit progress reports every six months and at the end of the study. These reports should include updates on participant enrolment, any adverse events, and any changes to the study protocol. The IRB and NHRA will review these reports to ensure continued compliance with ethical standards.

If a study extends beyond the initially approved period, researchers must apply for a renewal of ethical approval. The renewal application should outline the activities planned for the coming year and provide a summary of the study's progress to date.

How M31 Research Can Assist

• Proposal Preparation - We assist in drafting and reviewing your research proposal to ensure it addresses all ethical considerations required by the IRBs and NHRA.
• Document Preparation - M31 Research can help prepare all necessary documentation, including informed consent forms, participant information sheets, and CVs, ensuring they meet both IRB and NHRA standards.
• Submission Support - We handle the submission process on your behalf, ensuring that all documents are complete and correctly submitted to the IRB and NHRA.
• Ongoing Compliance - M31 Research monitors the progress of your ethical approval and ensures timely submission of progress reports and renewal applications, helping you maintain compliance throughout your study.
• Local Expertise - With our deep understanding of the local context and regulations, M31 Research provides invaluable insights and guidance, making the ethical approval process smoother and more efficient.