All institutions engaged in human subjects research that is supported by federal funds must have in place a Federalwide Assurance, a written assurance to the DHHS Office for Human Research Protections that the institution will comply with federal regulations and policies for the protection of human subjects. This assurance requires that the institution establish an Institutional Review Board (IRB).
The primary mission of the IRB is to ensure the protection of the rights and welfare of all human participants in research conducted by university faculty, staff and students. The IRB review process is guided by federal and state regulations, university policy, and the Belmont Report. IRB members include faculty, staff and community members, scientists and non-scientists, who, in the aggregate, possess a broad range of interests and expertise that correspond with the areas of research reviewed.
The IRB Process training includes, how to write protocols for different levels of review, how to complete consent forms, and IRB staff will provide guidance on policies. IRB staff will discuss what types of research requires review, in addition to the following topics:
- levels of review, obtaining informed consent,
- collaborative Institutional Training Initiative (CITI) training requirements,
- data use agreements, and
- considerations when vulnerable populations are enrolled.
