What is necessary for an institution to secure HHS funding for human subjects research?

To secure funding from the Department of Health and Human Services (HHS) for human subjects research, it is essential for an institution to have an active Federalwide Assurance (FWA) with the Office for Human Research Protections (OHRP). The FWA serves as a formal agreement in which the institution commits to adhere to federal regulations regarding the protection of human subjects involved in research. This assurance demonstrates the institution's dedication to ethical standards and regulations required for conducting research with human participants. Having an active FWA is a prerequisite for receiving HHS funding, as it ensures that the institution has the necessary systems in place to protect human subjects and comply with ethical guidelines.

In contrast, approval from a single researcher or compiling a dedicated research team, while important in their own right, do not fulfill the institutional requirement for federal funding. Similarly, creating a summary of research prior to submission may enhance the application process but does not address the fundamental need for an active FWA.