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:
These changes are outlined further in the attached table.
|Topic||1995 Regulations||2011 Final Rule|
|Significant Financial Interests (SFI) threshold||De minimis threshold of $10,000 for disclosure generally applies to payments or equity interests||De minimis threshold of $5,000 for disclosure generally applies to payments for services and equity interests. Includes any equity interest in non-publicly traded entities.|
|Which SFIs need to be disclosed (once the threshold is met)||Only those SFI the Investigator deems related to the PHS-funded research.||All SFI related to the Investigator's institutional responsibilities.|
|Excluded from disclosure requirement||Income from seminars, lectures, or teaching, and service on advisory committees or review panels, for public or nonprofit entities||Income from seminars, lectures, or teaching engagements sponsored by and service on advisory or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.|
|Types of SFI excluded||Income from seminars, lectures, or teaching, and service on advisory committees or review panels, for public or nonprofit entities||Income from seminars, lectures, or teaching engagements sponsored by and service on advisory or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.|
|Travel reimbursements and sponsored travel||Travel reimbursement is not mentioned explicitly in the regulations but is not excluded from the SFI definition.||Disclose the occurrence of any reimbursed travel or sponsored travel related to Institutional responsibilities (including purpose of trip, sponsor/organizer, destination, and duration). NOT required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution will determine if any travel requires further investigation, including determination or disclosure of the monetary value.|
|Information on an identified Financial Conflict of Interest (FCOI) reported by the Institution to the PHS Awarding Component||
Requirements in 1995 reg, plus:
|Subrecipient Institutions/Investigators and Reporting of identified FCOIs||Institutions must take reasonable steps to ensure that Investigators working for subs comply with the regs by requiring those Investigators to comply with the Institution's policy or by requiring the entities to provide assurances to the Institution that will enable the Institution to comply with the regs||
|Public Accessibility||No requirement||Make certain information available concerning identified FCOIs held by senior/key personnel via a publicly accessible Web site or by a written response to any requestor within five business days of a request, and update such information as specified in the rule.|
|FCOI training||No requirement||FCOI training No requirement Each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the designated circumstances:
|Retrospective Review ("Mitigation plan," discussed in NPRM)||Not mentioned||Institution is required to conduct a retrospective review in those cases of non-compliance with the regulation but is not required to report the review to the PHS Awarding Component. The Institution will be required to notify the PHS Awarding Component promptly and submit a report to the PHS Awarding Component only in cases where bias is found. The report will address the impact of the bias on the research project and the actions the Institution has taken, or will take, to eliminate or mitigate the effect of the bias.|