Share thisHHS Updates Conflict of Interest Regulations for PHS-Funded Research
On August 22, 2011, the U.S. Department of Health and Human Services (HHS) announced its final rule to amend the Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94).1 This final rule, published on August 25, 2011,2 updates the previous regulations promulgated in 1995. It was needed, “because the biomedical and behavioral research, and the resulting interactions among government, research institutions, and the private sector have become increasingly complex.” In updating these rules of conflict of interest, the NIH is seeking to “preserve the public’s trust in the research supported by PHS without bias, and with the highest scientific and ethical standards.” Institutions applying for or receiving PHS funding from a grant, cooperative agreement, or contract that is covered by the final rule must be in full compliance with all of the revised regulatory requirements:3
- No later than 365 calendar days after the date of publication in the Federal Register, i.e. August 24, 2011; and
- Immediately upon making its institutional Financial Conflict of Interest (FCOI) policy publicly accessible as described in the final rule.”
Until then, institutions should comply with the 1995 regulations. and report Investigator FCOIs to the Public Health Service (PHS) Awarding Component as required in the 1995 regulations.4 The final rule includes the following major changes to the 1995 regulations as listed in the table shown here.
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