REVIEW AND APPROVAL PROCESS OF ETHICS COMMITTEE

MODULE 7

EC Members should discuss the various issues before arriving at a consensus decision. A member should withdraw from the meeting during the decision procedure concerning an application where a conflict of interest arises and this should be indicated to Chairperson. Decisions will be made only in meetings where quorum is complete. Decision may be to approve, reject or revise the proposals and reasons for rejection should be given. Procedures for appeal by researchers should be clearly defined. In cases of conditional decisions, clear suggestions for revision should be specified.

Decision will be communicated by the Member Secretary in writing. Suggestions for modifications, if any, should be sent by EC. Also the schedule/plan of ongoing review by the EC should be communicated to the PI.

Trial progress reports should be submitted at prescribed intervals for review. Final report should be submitted at the end of study. All SAEs and interventions undertaken should be intimated. Protocol deviation, if any, should be informed with adequate justifications. Any amendment to the protocol should be submitted for renewed approval. Any new information related to the study should be notified with reasons. Change of Investigators/Sites should be informed

Format for Approval of Ethics Committee: As per Schedule Y

To
Dr. XYZ
Address: ABC Hospital

Dear Dr. -XYZ

The Institutional Ethics Committee / Independent Ethics Committee (state name of the committee, as appropriate) reviewed and discussed your application to conduct the clinical trial entitled “…………………” on………………. (Date).

The following documents were reviewed:

  1. Trial Protocol (including protocol amendments), dated_____________ Version no. (s) ______________
  2. Patient Information Sheet and Informed Consent Form (including updates if any) in any) in English and/ or vernacular language.
  3. Investigator’s Brochure, dated _____________ Version No. ________
  4. Proposed methods for patient accrual including advertisement (s) etc. proposed to be used for the purpose.
  5. Principal Investigator’s current CV.
  6. Insurance Policy / Compensation for participation and for serious adverse events occurring during the study participation.
  7. Investigator’s Agreement with the Sponsor.
  8. Investigator’s undertaking

The following members of the ethics committee were present at the meeting held on (date, time, place)
______________________________ Chairman of the Ethics Committee
______________________________ Member secretary of the Ethics Committee
______________________________ Name of each member with designation

We approve the trial to be conducted in its presented form.

The ‘IEC’ expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information / informed consent and asks to be provided a copy of the final report.

Yours sincerely,

(Signature)
Member Secretary, Name ______________________
Name Ethics Committee.