As of August 24, institutions that apply for or receive funds from the Public Health Service (PHS) for research must be in compliance with the final regulations promulgated by the U.S. Department of Health and Human Services (HHS) regarding conflicts of interest in research (Final Rule).1 Entitled "Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors," the Final Rule requires institutions to adopt and carry out policies and procedures to identify, disclose, and manage financial conflicts of interest (FCOI) prior to applying for or expending PHS research funds. The Final Rule effects major changes in the obligations of funded institutions, investigators, and subrecipients participating in PHS-funded research.
General Requirements
The Final Rule retains the basic framework of the prior regulations, but significantly expands the requirements for: (1) investigator disclosure of financial interests to their institutions; (2) institutional identification and management of FCOI; (3) reporting of FCOI to PHS and the public; (4) investigator training; (5) subrecipient compliance; and (6) investigation of potential research bias resulting from FCOI. As of August 24, institutions that have publicly accessible websites must have posted their policies and procedures to carry out the Final Rule.
Among other changes, the Final Rule expands the scope of financial interests that investigators must disclose to their institutions, lowering the monetary threshold from $10,000 to $5,000 for many interests, and requiring investigators to disclose financial interests that reasonably appear related to the investigator's "institutional responsibilities" (Significant Financial Interests). In another major shift from the prior regulations, institutions rather than investigators must determine whether Significant Financial Interests "relate" to PHS-funded research and, if so, whether the interest constitutes an FCOI. For interests identified as an FCOI, institutions must develop and implement management plans that contain key elements specified in the Final Rule. Institutions must also monitor investigator compliance, make FCOI reports to the appropriate PHS funding agency, and either disclose on a publicly accessible website certain information about FCOI held by senior and key personnel, or be prepared to provide that information to a requestor within five days of a request.
Steps to Comply
To comply with the Final Rule, institutions that receive PHS funding for research must have undertaken the following, among other steps:
- Develop and post a policy that specifies the process to identify, manage, and report FCOI, as well as key implementation terms and standards, such as the financial interests that investigators must disclose, including a definition of "institutional responsibility";
- Designate the official(s) responsible for determining whether investigators' Significant Financial Interests "relate" to their PHSfunded research, and if so, whether such interests constitute an FCOI;
- Adopt a policy for developing and monitoring management plans for FCOI;
- Create a process to report FCOI to PHS in advance of the expenditure of any PHS funds;
- Establish a policy and process to disclose required FCOI information on a public website or in response to requests;
- Train investigators about the Final Rule, institutional policies under the Final Rule, and investigators' responsibilities to disclose Significant Financial Interests; and
- Develop and implement procedures to oversee subrecipients, or for subrecipient institutions, adopt policies and procedures to comply with the Final Rule or prepare to comply with the policies of recipient institutions.
Online Resources
The National Institutes of Health has posted on its website helpful resources regarding Final Rule implementation, including the Final Rule, Frequently Asked Questions, a checklist for policy development, a summary chart on FCOI reporting requirements, and a user guide to the Electronic Research Administration Commons FCOI module. The website for the Conflicts of Interest and Transparency Affinity Group (COIT AG) also contains useful materials for Final Rule implementation.
Footnotes
1 42 CFR pt. 50; 45 CFR pt. 94 (2011).
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