Ethical Review Process by Ethics Committees

1. Authority, Role and Mandate of Research Ethics Committees (RECs)

1.7. Follow-up Of Ongoing Research

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 goal of continuing ethics review

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.

REC decisions during continuing review

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

  • Suspend or withdraw favourable ethical opinion of the research (until further information is provided and reviewed).

  • Request that new information, changes to the research, or changes to the balance of burdens and benefits be communicated to research participants to enable an informed choice or refusal to continue in the research.

  • Request modifications to the project or to the Informed Consent Form, which will require re-approval by the REC and a new informed choice or refusal from participants.