What is an IRB?
IRB is an abbreviation for the Institutional Review Board. The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.
The official name of the IRB committees at CHOP is The Committees for the Protection of Human Subjects. For more information about the CHOP IRB, its membership and structure, go to CHOP Institutional Review Board.
How do I contact the IRB?
For IRB contact information, please go to Contact the IRB.
What is an FWA number and what is CHOP’s FWA number?
FWA stands for Federal Wide Assurance, which must be submitted to the Office of Human Research Protections (OHRP) in order for an IRB to review research that receives federal funding. An FWA is a document that assures an institution's commitment to comply with the federal research regulations, with national and international ethical principles, and with federal, state and local laws related to the protection of human research subjects. CHOP's FWA number is FWA00000459. For more information about FWAs, go to Federal Wide Assurance (FWA).
What is an Institutional Official and who is that at CHOP?
The Institutional Official (IO) is responsible for ensuring that the Human Research Protection Program (HRPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. The IO represents the institution named in the Federalwide Assurance (FWA). The IO is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance. At CHOP, the Institutional Official is Bryan Wolf MD, PhD.
What is the difference between laws, regulations and IRB policies/procedures?
There are a variety of federal regulations and state laws that apply to human subjects research. In addition, the Office of Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) have issued guidance documents and other materials that reflect their agency's current thinking.
The IRB's Standard Operating Procedures (SOPs) provide the institution's standard approach to the interpretation of the federal regulations, best practice standards and state and local law. The SOPs serve as a reference for the IRB membership, IRB Office staff, and the CHOP community of investigators. Regulations are necessarily grey and their interpretation can evolve over time. The IRB SOPs, therefore reflect our current understanding of the Office of Human Research Protections (OHRP) and the FDA's interpretation of the regulations. In addition, the IRB has identified a number of ways to implement additional flexibility in its SOPs for research that is neither federally funded nor federally regulated. For more information go to Regulations and IRB policies.