If an IRB has a question regarding the Common Rule for a study funded by the U.S. Department of Energy, who should they contact?

In situations where an Institutional Review Board (IRB) has questions concerning the application of the Common Rule to a study specifically funded by the U.S. Department of Energy (DOE), the appropriate action is to reach out to the DOE itself. The DOE has its own regulations and policies that may extend or modify the Common Rule's provisions for studies it funds, given its unique mission and the types of research it supports.

By contacting the DOE, the IRB can receive accurate guidance tailored to the specifics of the funded project, ensuring that their oversight and compliance measures align with both federal regulations and the nuances of the DOE's requirements. Engaging directly with the funding agency helps clarify any ambiguity regarding oversight responsibilities, informed consent, and other ethical considerations pertinent to the research context.

In contrast, while the Office for Human Research Protections (OHRP) is generally a key resource for issues related to the Common Rule, it does not hold the same specificity regarding Department of Energy-funded studies. The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) also address human research protections but do so within their own specific scopes and contexts, further limiting their applicability to this particular inquiry regarding DOE-funded research.