IRB/IEC

The Ethics Committees are entrusted not only with the initial review of the proposed research protocolsprior to initiation of the projects but also have a continuing responsibility of regular monitoring of the approved programmes to foresee the compliance of the ethics during the period of the project...... ICMR

Point is to b noted tht for all practical purposes IEC's approval carries same w8 as approval of IRB

even in US IRBs r of two types
1 ) Affiliated with institution ( institutional IRB)
2) Unaffiliated with institution ( independent , central or national IRB )

in US sponsors instead of taking approval from each site for multicentric trials , they take approval from these Unaffiliated institutions instead of taking approval form each site .

RB or EC ( Ethics Committee) is an independent body constituted of medical and science background people and non-medical/nonscientific people, whose prime responsibility is to ensure the protection of the rights, safety and well being of human subjects involved in a clinical study. ERB ensures a thorough review and scrutiny of all ethical aspects of the study.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 difference lies in affiliation. the IRB is formed with in the Institution/site/hospital as pnreddy told. This IRB is formed to approve the clincal trials that has to be conducted in that institution.

Whereas IEC is not related to any institution. The sites which do not have their own IRB will get the approval through this IEC. So IEC can give approval to any site but IRB can give approval to the site to which it belongs.