Ethical Review Process by Ethics Committees

RECs evaluate research projects initially as part of the decision process. They then re-evaluate ongoing research at regular intervals. With consideration of the researcher’s suggestions, it is left to the discretion of the REC to determine the frequency of follow-up - or continuing review - of ongoing research. This would be based on the level of risk the project poses to human participants.

As part of the continuing review process, examples of events or instances that trigger the need for follow-up by the REC:

1. Any protocol amendment which is substantial and likely to have a significant impact on the safety or physical or mental integrity of the clinical trial participants or the scientific value of the trial.
   
2. Serious and unexpected adverse events related to the conduct of the study or study product, and the response taken by investigators, sponsors, and regulatory agencies.
   
3. Any event or new information that may affect the benefit-risk ratio of the study.

The purpose of continuing ethics review is to find out if the research (including recruitment and informed consent process) is being conducted in compliance with the approved protocol. The review will also confirm that the potential benefits and burdens to research participants remain acceptable. If the burdens and/or potential benefits have changed, the participants should be informed of the change. They should then be asked to re-consent to the study, confirming their continued choice to participate in the research. They may also refuse to continue participation.

If anything observed during follow-up is found to be unacceptable, the REC might: