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Who must comply with federal research regulations?

Any institution conducting human subject research that is supported by federal funds must comply with federal regulations and must provide written Assurance that they will comply with the Rule. Some institutions, upon written assurance to the Office of Human Research Protections (OHRP), elect to comply with the Rule regardless if the funding is provided by private or collaborative sources. Therefore, this leaves some privately funded human research, conducted at institutions that do not elect to follow the Rule regardless of the funding source, exempt from federal regulations.

Privately funded research at an institution receiving no federal funds for human subject research is exempt from federal regulation, though this may be changing. In Ethical and Policy Issues in Research Involving Human Participants (2001) NBAC recommended that federal oversight should protect the rights and welfare of human subjects in both publicly and privately funded research. In addition, NBAC and the Working Group of the HHS recommended that journals should consider adopting a policy that would include a statement about whether the (public or privately funded) research conducted was compliant with federal regulations for protection of human subjects.