Ethics Review Board is an independent body constituted of medical/scientific professionals and non-medical/nonscientific members, whose responsibility is to ensure the protection of rights, safety and well being of human subjects involved in a trial. ERB ensures a competent review of all ethical aspects of the project proposals received and executes the same free from any bias and influence that could affect their objectivity. It might have different names at different institutions but the prime responsibility remains the same. ERB is also known as:
- Independent Ethics Committee (IEC)
- Institutional Review Board (IRB)
- Ethics Committee (EC)
The chief responsibilities of ERB are:
1. Approval/Permission for the conduct of clinical trials
2. Review of progress
3. Regulatory Compliance
1. Approval/Permission for the conduct of clinical trials
No clinical trial should be initiated at any investigator site without obtaining a written approval/permission by the respective ERB. In order to grant approval/permission for a trial proposal, ERB reviews the following document:
- Protocol (for scientific rationale)
- Informed Consent document (for the safety and welfare of research subjects)
- Informed Consent document's translation(s) in patient's native language (for protecting the rights of research subjects)
- Investigator Brochure for all relevant clinical and non-clinical data on the investigational product
- Grants & Payments (as per institutional policy)
- Study Advertisement (if applicable)
- Investigator's Qualification
- Trial permission by Drug Controller General of India (DCGI)
Only after review of all the applicable documents during the scheduled meetings ERB either approves (full or conditional) or disapproves any trial proposal. Any amendment(s) to the approved trial documents (protocol & informed consent document) requires a fresh approval by the ERB.
2. REVIEW OF PROGRESS
After granting the approval for the conduct of clinical trial(s) it is the responsibility of ERB to have an ongoing review of the trial progress. This includes but is not limited to:
- Review of safety reports (all the serious adverse events and adverse drug reactions happening at the trial sites)
- Review and approval of the amendment(s) in protocol or informed consent document.
- Review of significant deviations or violations (if any)
The frequency of these reviews may vary from institute to institute as specified in the respective ERB charters or standard operating procedures.
3. REGULATORY COMPLIANCE
In order to comply with all the applicable regulatory requirements and guide-lines each ERB is required to have the following records:
- Written standard operating procedures or charter
- Constitution and composition of the ERB
- The curriculum vitae of all ERB members
- Copies of all the trial(s) documents received for review
- All the correspondence between ERB and investigator
- Agenda & minutes of all ERB meetings
- Final report of the study
The ethical review should be done through formal meetings and should not resort to decisions through circulation of proposals.
Tips to the Investigator(s)/ Sponsor(s) for ERB Compliance
1. Ensure that:
ERB has a written charter or operating procedure
Constitution and com-position is as per the ICH-GCP and /or applicable regulatory requirements.
Records are retained for appropriate duration of time.
Initial review will help in ensuring compliance to the GCP/applicable regulations throughout the course of trial.
2. Find out
When the ERB meets
What documents should be submitted
How long the decision will take
Good planning and preparation will lead to timely submission and faster review.
3. Always look for
Version(s) of the documents mentioned in all the correspondence to ERB and vice versa; Version(s) of the documents approved/disapproved by ERB; Duration of approval
Incomplete and inappropriate approvals can lead to significant audit issues.
4. Make sure, ERB approval contains
Signature, date and seal of Chairperson; List of voting members; List of members who were absent
The ethical review should be done through formal meetings and should not resort to decisions through circulation of proposals. At least a "quorum" as specified in the written procedure should be present.
5. Promptly notify and submit
Adverse drug reaction(s)/ Serious adverse events experienced by any of the trial subject. Periodic and/or ongoing progress report. Trial closure report
Safety reporting is essential for protecting the rights, safety and well being of trial subjects.
-The authors are Editors of Clinical Quest, India's first publication for clinical research professionals