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The AIDS Research Alliance Institutional Review Board (IRB) was established as an independent body in 1995, operating in compliance with federal regulations.
1) What is an IRB?
2) What is the required composition of an IRB?
3) What type of documentation must an IRB Maintain?
1) 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 community standards where the research is to be conducted, our IRB ensures the following:
1. Safeguards are provided to protect the rights and welfare of study subjects.
2. Risks to the study subjects do not outweigh benefits or knowledge gained through the study.
3. Selection of study subjects is fair and equitable.
4. Each study subject gives informed consent prior to participation, according to FDA requirements.
5. Adequate evaluation of the data ensures the ongoing safety of study subjects.
6. Provisions are made to protect the privacy of study subjects, and the confidentiality of data collected.
2) What is the required composition of an IRB?
FDA regulations require that an IRB be comprised of at least 5 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), when applicable.
• At least one member not affiliated with the company or institution, when applicable.
3) 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 3 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 and unexpected events).
• Written records of all activities, including accurate minutes of all IRB meetings.
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