Procedure for Ethics Review
Following is the proposed process for the procedure for ethics review carried out by the Clinical Research Ethical Committee (CREC) at Al Ain Fertility Center:
- Submission of Application: Researchers must submit a detailed proposal for their intended study to the CREC. This should include information such as the objective of the study, research methodology, potential risks and benefits, procedures for obtaining informed consent, measures for ensuring participant privacy and confidentiality, and plans for data analysis.
- Initial Review: The CREC conducts an initial review of the proposal to ensure that it includes all the required elements and aligns with general ethical guidelines. If necessary, the CREC may request further information from the researchers at this stage.
- Detailed Review: If the proposal passes the initial review, the CREC performs a detailed review. This includes assessing the scientific validity of the research, the balance of risks and benefits, the appropriateness of the methodology, and the process for obtaining informed consent.
- Meeting and Discussion: The CREC convenes a meeting where committee members can discuss the proposal in depth. During this meeting, any concerns or issues are addressed, and the committee decides whether the proposal is ethically acceptable.
- Decision: The CREC makes a decision to approve, reject, or request modifications to the research proposal. This decision is communicated to the researchers along with any recommendations or mandatory changes if the proposal is conditionally approved.
- Resubmission (if necessary): If the proposal is rejected or requires modifications, the researchers can revise and resubmit it for further review.
- Monitoring: If the proposal is approved, the CREC monitors the study’s progress to ensure ongoing ethical compliance. This might involve regular reports from the researchers, site visits, or audits.
- Post-Study Review: After the completion of the study, the CREC conducts a post-study review to confirm that the research was carried out as approved and to address any ethical issues that may have arisen during the study.
Note: This process provides a broad overview of the process. The exact procedure may vary depending on the specific requirements of the CREC at Al Ain Fertility Center. Individuals / Researchers are encouraged to consult with the AAFC Clinical Research Ethical Committee (CREC) contact for detailed guidance.