Institutional Review Board (IRB)/ Independent Ethics committee (IEC)

An Institutional Review Board (IRB), also known as an Independent Ethics Committee (IEC), is a committee responsible for reviewing and approving the ethical aspects of research involving human subjects. IRBs/IECs play a crucial role in protecting the rights, welfare, and safety of research participants. Here are some key points about IRBs/IECs

1. Institutional Review Board (IRB) / Independent Ethics Committee (IEC)

2. List of Contents Definition Roles and Responsibilities Composition, Functions and Operations Procedures Records

3. Institutional Review Board (IRB) / Independent Ethics Committee (IEC ) IRB/IEC Review E valuates A pproves D ecision B enefits & R isks R ight , safety, and well-being of the subject

4. ROLES AND RESPONSIBILITIES OF IRB/IEC Safeguard the rights, safety, and well-being of all trail subjects Reviews a proposed clinical trial within a reasonable time Conduct continuing review of each ongoing trial atleast once per year Provide advice to the researchers on all the aspects of welfare and safety of research participants

5. WHY IRB/IEC Balancing Two goals Advancement of science Protection of subject, welfare rights

6. Who decide, what is an ethical research? IRB/IEC When to apply to IRB/IEC? Before any research activity Allow at least 1 month for full board review

7. Why do I need an IRB/IEC to review my protocol ? Make research studies better!! Enhance study design Enhance protection of subject Enhance researcher preparation More likely to get published in good journals More likely to get funding/grants

8. Frequent Issues With IRB Application Incomplete or insufficient description of purpose, methods/procedures, subject selection . Incomplete or lack of contact information Inappropriate language on the informed consent document (too technical) Research related documents are not included in the application ISSUES

9. COMPOSITIONS, FUNCTIONS AND OPERATIONS The IRB/IEC should comprise of sufficient number of members. Who mutually have the qualifications and experience to review and assess the science, medical aspects and ethics of the proposed trial. It is proposed that the IRB/IEC should incorporate: The IRB/IEC should consist at least 5 members In that 5 members 1 of them should be from non scientific area

10. The IRB/IEC should perform its functions corresponding to written operating procedures. Should maintain written records of its venture and minutes of its meetings, and should abide by GCP and with the applicable regulatory specifications In the remaining 1 of them independent of the institution and trial site The members who are independent and the sponsor of the trial should vote their opinion on at trial related matter A list of IRB/IEC members and their qualifications should be maintained.

11. An IRB/IEC should take its decisions at announced meetings at which at least a quorum, As stipulated in its written operating procedure, is present. Only members who participate in the IRB/IEC review and discussion should vote their opinion and advises. The investigator may provide information on any aspects of the trial, but should not participate in he deliberations of the IRB/IEC (or) in the vote of the IRB/IEC. An IRB/IEC may invite non members with expertise in special areas for assistance.

12. PROCEDURES Establish , document in writing and follow its procedures: Determine composition and source of authority. Schedule , notify members and conduct meetings. Conduct initial and continuing review. Determine frequency of continuing review. Provide expedited review mechanism for minor changes . Specify that no subject may be enrolled and no deviation prior to approval. Specify that investigator promptly report protocol changes or deviations, increased risks to subjects, ADRs (serious and unexpected), new information related to subject safety. Promptly notify in writing the investigator/ institution about its decisions, reasons for its decisions, and procedures for appeal

13. RECORDS Maintain all relevant records at least 3 years after completion of the trial SOP’s Membership files Submitted documents of meetings Correspondence Make them available to regulatory authorities. Make available its SOP’s and membership lists to investigators , sponsors and regulatory authorities.

14. “If you can’t figure out your purpose, figure out your passion. For your passion will lead you right into your purpose” Thank you….