IRB FAQ

The AIDS Research Alliance Institutional Review Board (IRB) was established as an independent body in 1995, operating in compliance with federal regulations governing IRBs as set forth in 21 CFR Part 56, [Click Here] and other regulations governing informed consent set forth in 21 CFR part 50. [ Click here ]

1) What is an IRB?

2) What is the required composition of an IRB?

3) What type of documentation must an IRB Maintain?

What is an IRB?

 An Institutional Review Board (IRB) is a committee of individuals responsible for conducting the initial and ongoing review of clinical research involving human subjects pursuant to regulations adopted by the Food and Drug Administration (FDA). By assessing the acceptability of a proposed study in terms of applicable law, investigator commitment and standards of practice in the community where the research is to be conducted, our IRB ensures the following:

1. Safeguards are provided to protect the rights and welfare of subjects.
2. Risks to the subjects do not outweigh benefits or knowledge gained through the study.
3. Selection of subjects is fair and equitable.
4. Each subject gives informed consent prior to participation according to FDA requirements.
5. Adequate evaluation of the data ensures the ongoing safety of subjects.
6. Provisions to protect the privacy of subjects and the confidentiality of data collected.
   

What is the required composition of an IRB?

FDA regulations require that an IRB be comprised of at least five individuals and include the following:

• Men and women.
• Members with both scientific and nonscientific backgrounds.
• At least one member representing cultural or ethnic diversity.
• At least one member representing the welfare of special interest groups, in this case, a person living with HIV/AIDS.
• At least one member not affiliated with the company or institution.

What type of documentation must an IRB maintain?

The FDA requires that an IRB maintain the following documentation during a study, and for a period of three years after study completion:

• Written policies and procedures.
• Records of all initial, ongoing and expedited study reviews and approvals.
• Safety data collected during the study (reports on serious events and unexpected events).
• Written records of all activities, including accurate minutes of all IRB meetings.

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