If you are preparing your first IRB application submission for review by the RFUMS IRB, it is strongly recommended that you reach out to an experienced investigator or a member of the IRB for mentorship as you prepare the application. Such mentorship may help you avoid common pitfalls that lead to delays in approval of submissions. If you need assistance in identifying such a person, please reach out to the IRB at: IRB@rosalindfranklin.edu
IRB applications should be written for professionals who are not in your field of expertise. Applications should be complete with all appendices and supporting documents and agreements. It should be consistent in its content throughout. The need for clarification or additional information may significantly delay IRB approval and your ability to start your research.
The Institutional Review Board, or IRB, is a committee that is required by federal law to protect the rights and welfare of human subjects participating in research activities. The committee meets this mandate by reviewing proposed and ongoing research activities, ensuring they meet specific criteria for approval.
Federal law governs the IRB’s function, make-up, and authority, but meeting the regulations is done on an institution-specific level. The IRB ensures that valid studies meet the ethical mandates of the Belmont Report, and the legal mandates of federal law.
The federal law, commonly referred to as 45 CFR 46, formally, the Code of Federal Regulations at Title 45-Public Welfare, Department of Health and Human Services, Part 46-Protection of Human Subjects, is specific to research conducted or supported by a federal department or agency. However, many institutions, including RFUMS, voluntarily apply some or all subparts of 45 CFR 46 (also referred to as the “Common Rule”) to all research conducted by their investigators, regardless of status or source of funding.