Saturday, December 25, 2010
Make sure that the local ethics committee fulfils the ICH GCP requirements. ICH GCP Composition and Operations of IEC/IRB
Make sure that the local ethics committee fulfils the ICH GCP requirements.
ICH GCP Composition and Operations of IEC/IRB
The IRB/IEC should determine the authority under which it is established and the composition (names and qualifications)of its members, which should consist of:
Ø A reasonable number of members who collectively have the qualifications and experience to review and evaluate the science, medical aspects and ethics of the proposed trial.
Ø At least five members.
Ø At least one member whose primary interest is in a non-scientific area.
Ø At least one member who is independent of the trial site.
An IEC/IRB may invite nonmembers with expertise in special areas to give assistance.
The Investigator may provide information on any aspect of the trial, but may not participate in the IEC/IRB deliberations, vote, or provide opinion.
Only members who participate in review and discussion of the protocol, and who are independent of the investigator and the sponsor, can vote or provide opinion.
The IEC/IRB should perform initial and continual reviews of the trials according to the written operating procedures, and maintain records of activities and minutes of meetings.
The IEC/IRB should notify promptly, and in writing, all trial-related decisions and opinions, specifying the reasons for each.
See ICH Guidelines 3.2