Relevant academic literature, applicable federal regulations for the protection of human subjects on emergency research involving artificial/substitute blood products (including PolyHeme)

Abstract

Federal oversight of research involving human subjects is found in two regulatory regimes within the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA). 21 CFR 50, 56 - the Office of Human Research Protections (OHRP), and 45 CFR 46. Generally, any research that is testing a drug, device, or other product that will be submitted for FDA approval must follow their regulations (21 CFR 50/56), while research that is supported by federal funds (e.g., an NIH grant) must also comply at a minimum with 45 CFR 46 Subpart A (the federal policy for the protection of human subjects, also known as the Common Rule), and with Subparts B,C,D as appropriate. While most of the FDA and OHRP regulations are similar (or substantially overlap), there are a number of areas in which they differ. Further, all institutions supported by federal funds must negotiate a Federalwide Assurance with OHRP that provides for all research within an institution to be subject to the Common Rule, regardless of whether the research is federally funded.