FUNCTIONING OF ETHICS COMMITTEE

MODULE 4

In any Ethics Committee, the ‘quorum’ requirements would be as fulfilled if at least 5 members are present during the meeting and that should represent five categories, from both genders which are mentioned below:

  1. Basic medical scientists (preferably one pharmacologist).
  2. Clinicians
  3. Legal expert
  4. Social scientist / representative of non-governmental voluntary agency /Philosopher / ethicist / theologian or a similar person
  5. Lay person from the community (Non-Scientific)

A. Function of Ethics Committee listed as:

  1. A list of members, their qualifications and affiliation will be maintained by the Ethics Committee.
  2. The IRB/IEC should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s).
  3. An IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in its written operating procedures, is present.
  4. Only members who participate in the IRB/IEC review and discussion should vote/provide their opinion and/or advice.
  5. The investigator may provide information on any aspect of the trial, but should not participate in the deliberations of the IRB/IEC or in the vote/opinion of the IRB/IEC.
  6. An IRB/IEC may invite nonmembers with expertise in special areas for assistance.
  7. Scheduling, notifying its members of, and conducting its meetings.
  8. Conducting initial and continuing review of trials.
  9. Determining the frequency of continuing review, as appropriate.
  10. Providing, according to the applicable regulatory requirements, expedited review and approval/favourable opinion of minor change(s) in ongoing trials that have the approval/favourable opinion of the IRB/IEC.
  11. Specifying that the investigator should promptly report to the IRB/IEC:
    Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects.
    Changes increasing the risk to subjects and/or affecting significantly the conduct of the trial.
    All adverse drug reactions (ADRs) that is both serious and unexpected.
    New information that may affect adversely the safety of the subjects or the conduct of the trial.
    Study Completion Report
  12. Ensuring that the IRB/IEC promptly notify in writing the investigator/institution concerning:
    Its trial-related decisions/opinions.
    The reasons for its decisions/opinions.
    Procedures for appeal of its decisions/opinions.

Decisions will be taken by consensus after discussions, and whenever needed voting will be done. The decision should be documented as minutes and Chairperson’s approval should be taken in writing. The Member Secretary will make sure to cover all contents in each particular category to include the following:

  • Name of person preparing the minutes
  • Location where the meeting was held (city, state)
  • Meeting date/duration of the meeting
  • Names of the attending board members and guests
  • Name of the individual serving as Chairperson of the meeting
  • Determination of a duly constituted quorum by the Chairperson to proceed with the meeting
  • Requirements for each study or activity requesting Approval:
  • Sponsor’s name;
  • Protocol number/date/version of protocol, when available;
  • Investigator’s name;
  • Discussion as deemed appropriate by the Chairperson
  • Reference to the investigator approval letter that lists all changes requested by the board;
  • Determination of the next requested continuing review.
  • Requirements for each study or activity requesting Expedited Review:

B. Records Keeping

The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 5 years after completion of the trial and make them available upon request from the regulatory authority (ies).