An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risks in relation to any benefits that might result from the research.
An IRB/IEC:
R eviews all study-related materials before and during the trial
Must operate in accordance with national and/or local regulations as well as with ICH good clinical practices (GCPs) guidelines
Local and Central IRBs/IECs
There are two types of IRBs/IECs: local and central. Local IRBs/IECs are functions of the academic institutions that conduct research and review only their trials, while central IRBs/IECs provide review services for multiple entities.
Some clinical trial investigators may not have access to a local IRB/IEC. There may also be compelling reasons for an institution not to use the local IRB/IEC and instead turn to a central IRB/IEC. If a trial site uses a central IRB/IEC and a local one exists, the site may be required to justify the decision or seek approval from the local IRB/IEC to the use of a central IRB/IEC.
IRB/IEC Membership
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
An IRB/IEC should have:
At least five members
Members with varying backgrounds: at least one member must represent a non-scientific area (a lay member)
At least one member who is not affiliated with the institution or the trial site (an independent member)
Competent members who are able to review and evaluate the science, medical aspect and ethics of the proposed trial In India Revised Schedule y (in 2008) stated that IEC must constitute maximum 15 members and minimum 8 members.
It must contain Advocate,Basic Medical Scientist Preferably Pharmacologist in Ph.D,Social Scientist,layperson.
IRB/IEC Responsibilities Before, During and After a Trial
Before a site is allowed to start enrolling patients in a clinical trial, the IRB/IEC must review all study-related materials in an initial review. The IRB/IEC also performs periodic reviews – called continuing reviews – throughout the trial’s duration. Continuing reviews may take place at least once a year and include the entire trial, not just changes.
The IRB/IEC may also ask for additional information regarding payments and compensation to study participants as well as the informed consent process.
Sponsor submit to site closeout to IEC through Investigator
The Investigator must submit Clinical Trail Report to IEC after trail close out.
Investigator Responsibilities for Ensuring Compliance
The principal investigator (PI) is responsible for ensuring compliance with any IRB/IEC procedures or requirements. He or she may deviate from the study protocol without prior IRB/IEC approval only to eliminate immediate safety hazard to a study participant. In addition, the PI must notify the IRB/IEC of any departures from the protocol as soon as possible.
please can you tell me if the setting up for an ethics committee is mandatory ?
ReplyDelete