FEDERAL COI-RELATED REGULATIONS
Public Health Service (PHS)
42 CFR Part 50 Subpart F (Grants): Promoting Objectivity in Research
45 CFR Part 94 (Contracts): Responsible Prospective Contractors
National Institutes of Health Guidance on Financial Conflicts of Interest
National Science Foundation Policy (NSF)
In 1995, the National Science Foundation (NSF) added Section 510, Conflict of Interest Policies, to its Grant Policy Manual.
Food and Drug Administration (FDA)
In 1998, the Food and Drug Administration added a section, Part 54, Financial Disclosure by Clinical Investigators, to its general regulations found in Chapter 1 of 21 CFR.
Under this FDA regulation, all investigators in any sponsored clinical research that will be used in part to support a marketing application for a human drug, biological product, or device must submit conflict of interest disclosures on a specified FDA form, including any financial interest of the investigator in the product and a statement of any compensation for the investigator that could be higher for a favorable outcome of the clinical study than for an unfavorable outcome.
In distinction to the regulations governing research grants and contracts, the disclosures required by the FDA policy, although similar to those for grants, are to be forwarded through the sponsor of the investigation, which may be a company processing or manufacturing biologicals, drugs, or devices.
For investigator-sponsored research that is regulated by the FDA, the sponsor must collect disclosures from each investigator and study team member involved in the treatment and/or evaluation of study subjects. These disclosures must be maintained in the sponsor’s regulatory files.
ORGANIZATIONAL CONFLICTS OF INTEREST (OCIs)