Financial Conflicts of Interest
Public Disclosure of Financial Conflicts of Interest in Research
In compliance with regulatory and institutional requirements for public accessibility, information is posted regarding financial conflicts of interest in research held by Investigators involved in the design, conduct and/or reporting of research at the institutions and under their auspices. These conflicts of interest in research are responsibly managed and reported, in order to ensure the integrity of the research process and to maintain the public trust.
Conflict of Interest in Research
The U.S. Department of Health and Human Services is committed to preserving the public trust in the objectivity of biomedical and behavioral research. We at the National Institutes of Health strongly believe that it is vital that all research be conducted with the highest scientific and ethical standards. In 1995, HHS promulgated the current Public Health Service (PHS) regulations, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought” and “Responsible Prospective Contractors.” These are also known as the financial conflict of interest, or FCOI, regulations (42 CFR Part 50 Subpart F and 45 CFR Part 94).
In the intervening years, biomedical and behavioral research and the resulting interactions among government, research institutions, and the private sector has become increasing complex. This complexity, as well as increased public scrutiny and a need to strengthen transparency and accountability have led HHS to propose a more rigorous approach to Investigator disclosure, management of financial conflicts, and federal oversight. To that end, after reviewing public comments from HHS’ advance notice of proposed rulemaking (ANPRM) published on May 8, 2009, HHS published a notice of proposed rulemaking (NPRM) on May 21, 2010. The proposed rule was published to amend the 1995 regulations by expanding and adding transparency to investigators’ disclosure of significant financial interests, enhancing regulatory compliance and effective institutional oversight and management of investigators’ financial conflicts of interests, as well as HHS’ compliance oversight.
After careful consideration of the comments to the NPRM, HHS is publishing a final rule that amends the 1995 regulations. Major changes to the 1995 regulations include:
- Lower financial disclosure thresholds
- New conflict of interest training
- New public accessibility requirements
- Increased transparency for travel reimbursement
These changes are outlined further in this table.
How do I comply with the Conflict of Interest in Research policy?
- Complete the required training. You must take this training every four years and provide certificate of completion to IRB administrators (listed below).
- Complete Disclosure of Significant Financial Interests Form annually, and update within thirty days when there is a change.
- If you are a Principal Investigator on a project, complete the PI Certification Form for any new or renewing application to the IRB.
Please contact the IRB administrators listed below with any questions and for further information:
Saskia Shuman: sshuman @institute.org or (212) 633-0800 x1391