What assurance must institutions have to engage in NIH-funded human subject research?

To engage in NIH-funded human subject research, institutions must have a current Federalwide Assurance (FWA). The FWA is a formal agreement between an institution and the federal government, specifically the Office for Human Research Protections (OHRP), in which the institution agrees to comply with federal regulations concerning the protection of human subjects involved in research.

Having a FWA demonstrates that the institution has established protocols and procedures to protect the rights and welfare of human subjects, which is a fundamental principle of ethical research. It ensures that the institution adheres to ethical standards in conducting research, including obtaining informed consent, ensuring the confidentiality of participants, and minimizing risks. This assurance is crucial for maintaining public trust in research practices and protecting the integrity of the research process.

The necessity of a current FWA is a key requirement that must be met before receiving funding for human subject research from the NIH, emphasizing the importance of ethical considerations in the conduct of research involving human participants.