Conflict of Interest
Related Federal Regulations
PUBLIC HEALTH SERVICE (PHS)

42 CFR Part 50 Subpart F (Grants): Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought

45 CFR Part 94 (Contracts): Responsible Prospective Contractors

Conflict of Interest Information Resources available on the Web
http://grants1.nih.gov/grants/policy/coi/

FAQs to FCOI 2011 Revised Regulations (effective Aug 24, 2012)
http://grants1.nih.gov/grants/policy/coi/coi_faqs.htm

National Science Foundation Policy (NSF)
In 1995, the National Science Foundation (NSF) added Section 510, Conflict of Interest Policies, to its Grant Policy Manual. It may be accessed at: http://www.nsf.gov/pubs/2002/nsf02151/gpm5.jsp#510

DEPARTMENT OF EDUCATION
http://cfr.vlex.com/vid/75-conflict-interest-participation-19756404

US FOOD AND DRUG ADMINISTRATION (FDA)
In 1998, the Food and Drug Administration added a section, 21 CFR Part 54, Financial Disclosure by Clinical Investigators, to its general regulations found in Chapter 1 of 21 CFR. It can be accessed at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=54

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 institution-sponsored or investigator-sponsored research, the Principal Investigator (PI) must submit such disclosures for all investigators directly to the FDA.