The Institutional Review Board is an administrative body whose main purpose is to ensure the protection of the rights and wellbeing of human research subjects that are recruited to serve as subjects (participants) of research activities by an institution or organization.
The IRB’s responsibility is the review of all research that involves human subjects, irrespective of whether the research is funded or not. This the IRB does prior to the initiation of the research. Towards this end, the IRB empowered to approve or disapprove any research. It also has the authority to monitor the research, and ask the sponsor of the clinical research to carry out modifications, as and when necessary, in all research areas that come under its purview. Its scope and jurisdiction are set out by institutional policy and federal regulations. Ask more
Differences between 45 CFR 46 and 21 CFR 56
The definition of human subjects and research are set out by the Department of Health and Human Services (HHS) regulations (45 CFR 46). However, FDA 21 CFR 56 has a different set of criteria for application of regulations for IRB review and has a different definition.
Although both these regulations have the same criteria for IRB approval; they differ from each other when it comes to certain activities like evaluations, quality assurance/improvement, public health, etc., there is lack of clarity on not only the meaning of these definitions, but also on whether such activities require IRB approval. Once an IRB determines whether a study requires IRB approval or not, the sponsor must consider many regulatory requirements prior to approval of a study.
Removing concerns concerning IRB audits
Understand the steps needed for IRB compliance. Most sponsors that carry out human subjects research are concerned about the next FDA or OHRP audit of their IRB. They are often unclear about issues like what criteria should be applied to the review of studies, when their evaluations or quality assurance efforts require IRB approval, how an IRB can appropriately protect vulnerable subjects in research, and to what degree risks should be minimized in research studies.
- Applicability of HHS and FDA regulations for the protection of human subjects
- Important definitions every IRB administrator/member must know
- How to identify and minimize potential risks in a research study
- IRB’s role to determine that risks are reasonable in relation to anticipated benefits
- IRB’s review of protocols to ensure equitable selection of subjects
- Focused review of the criterion for obtaining legally-effective consent
- When and how to require documentation of informed consent for different types of studies
- IRB review of safety monitoring plans
- How to protect confidentiality of research data and minimize potential breaches of confidentiality
- Consideration of additional safeguard for the protection of vulnerable subjects.