On August 25, 2011 the Department of Health and Human Services (HHS) published a final rule amending its long-standing regulations on financial conflicts of interest in Public Health Service (PHS) funded research. 76 Fed. Reg. 53,256 (August 25, 2011).1 The new rule, titled "Promoting Objectivity in Research," adopts the majority of changes proposed in the HHS Notice of Proposed Rulemaking (NPRM), issued on May 21, 2010. 75 Fed. Reg. 28,688 (May 21, 2010). For the majority of institutions that conduct PHS-funded research, including research under National Institutes of Health (NIH) grants and contracts, the new rule will require revision of institutional policy and disclosure forms. Institutions will likely face increased administrative burden associated with the rule's enhanced reporting obligations, public accessibility requirements, new training components, and enhanced subrecipient-monitoring responsibilities. To help institutions take needed steps to comply with the revised regulations, HHS is developing guidance materials, that will be accessible on NIH's Financial Conflicts of Interest website.
The new rule becomes effective 30 days after publication, but institutions generally have until August 24, 2012 to be in full compliance.2 76 Fed. Reg. 53,256. In the interim, institutions are to comply with the prior regulations. The new rule applies to each PHS-funded grant or cooperative agreement with a Notice of Award issue date after the August 24, 2012 compliance deadline and all research solicitations issued and contracts awarded after August 24, 2012. 76 Fed. Reg. 53,258. Institutions may, however, for administrative convenience, opt to apply the new rule to all active PHS awards. Id.
Investigator disclosure of significant financial interests
Interests related to institutional responsibilities. Under the new rule, Investigators on PHS-funded research are required to disclose to the institution all significant financial interests (SFIs) related to their "institutional responsibilities." 76 Fed. Reg. 53,284 (42 C.F.R. § 50.603). This revision shifts from the investigator to the institution the responsibility to determine whether the investigator's SFI "could be affected by the PHS-funded research; or is in an entity whose financial interest could be affected by the research." 76 Fed. Reg. 53,285 (42 C.F.R. § 50.604(f)). "Institutional responsibilities" are "an investigator's professional responsibilities on behalf of the Institution," as defined in the institution's financial conflict of interest (FCOI) policy. 76 Fed. Reg. 53,284 (42 C.F.R. § 50.603). Although HHS has left it to the institution to determine the scope of an investigator's professional responsibilities, HHS does provide examples, including "research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards and Data and Safety Monitoring Boards." Id. (42 C.F.R. § 50.603).
Dollar thresholds. The final rule adopts HHS's proposal in the NPRM to revise the definition of "significant financial interest." The final rule reduces from US$10,000 to US$5,000 the threshold for disclosure of equity interests, salary, royalties, and other forms of remuneration in public companies, and for remuneration from private companies. There is no threshold for disclosure of equity interests in private companies. Id. (42 C.F.R. § 50.603). For all financial interests disclosed, investigators are required to disclose payments received during the twelve months preceding the disclosure. Id. (42 C.F.R. § 50.603). The final rule also dispenses with a minimum threshold for disclosing intellectual property rights, including royalties. Id. (42 C.F.R. § 50.603).
Travel reimbursement. HHS has added a new requirement that investigators disclose reimbursed or sponsored travel related to their institutional responsibilities. Exception is made for travel reimbursed or sponsored by federal, state, or local government agencies, institutions of higher education, academic teaching hospitals, medical centers, and research institutes affiliated with an institution of higher education. Id. (42 C.F.R. § 50.603).
Financial interests exempt from disclosure. The NPRM narrowed the list of interests exempt from disclosure and, if adopted, would have required disclosure of income received from non-profits, other than higher education institutions, for seminars, lectures, teaching, and advisory committee and review panel service. Under the final rule as adopted, income from seminars, lectures, teaching engagements, and service on advisory committees or review panels from federal, state, or local government agencies, institutions of higher education, academic teaching hospitals, medical centers, and research institutes affiliated with an institution of higher education are exempt from disclosure. Id. (42 C.F.R. § 50.603). Also exempt from disclosure are salary, royalties, and other remuneration paid by the institution to the investigator. Id. (42 C.F.R. § 50.603). However, the revised regulations specify that the investigator must be currently employed by the institution or otherwise appointed by the institution for this exemption to apply. Id. (42 C.F.R. § 50.603).
Enhanced institutional reporting to PHS
The final rule substantially revises and expands institutional reporting obligations to PHS. Prior to the expenditure of any funds under a PHS-supported research project, institutions are required to submit to the PHS Awarding Component a FCOI report regarding any SFI found by the institution to be conflicting. If a SFI is found after the institution provides its initial FCOI report, the institution must provide an updated report to the PHS Awarding Component within 60 days of identifying the conflicting SFI. 76 Fed. Reg. 53,287 (42 C.F.R. § 50.605(b)(1)-(2)). If institutional policy includes standards more stringent than the regulations, the institution is required to report to the PHS Awarding Component the FCOIs identified under its policy, even if the financial interest would not have been considered conflicting under the PHS regulations. 76 Fed. Reg. 53,285 (42 C.F.R. § 50.604(a)).
FCOI report contents. The FCOI report must include, at a minimum: (1) project number and principal Investigator; (2) name of the investigator with the FCOI; (3) name of the entity with which the investigator has the FCOI; (4) nature of the financial interest (e.g., equity, consulting fee, etc.); (5) approximate dollar value/range of the SFI or a statement that the value cannot be readily determined; (6) a description of the relationship between the financial interest and the PHS-funded research and the institution's basis for determining that the financial interest conflicts with the research; and (7) a description of key elements of the institution's FCOI management plan, which is now required for identified FCOIs. 76 Fed. Reg. 53,287-88 (42 C.F.R. § 50.605(b)(3)). Institutions must provide the PHS Awarding Component with annual updates on the status of previously disclosed FCOIs and any changes to the management plan. 76 Fed. Reg. 53,288 (42 C.F.R. § 50.605(b)(4)).
Retrospective review. Institutions that identify a FCOI after work on a grant is underway are required to undertake a retrospective review of the investigator's activities to determine if any PHS-funded research was biased. Such review must take place within 120 days of the institution's determination that there has been non-compliance with the regulations. 76 Fed. Reg. 53,286 (42 C.F.R. § 50.605(a)(3)(ii)(A)). The institution must document its review, which shall include the following details: (1) project number and title; (2) project director/principal investigator and the name of the investigator with the FCOI; (3) the name of the entity with which the FCOI exists; (4) the reasons for the retrospective review; (5) the methodology for the retrospective review; and (6) the findings and conclusion of the retrospective review. Id. (42 C.F.R. § 50.605(a)(3)(ii)(B)). If the institution finds there was bias, the institution must "promptly" notify the PHS Awarding Component as well as submit a mitigation report including, at a minimum, the elements from the retrospective review listed above, a description of the impact of the bias on the research project, and the institution's plans to eliminate or mitigate the bias. Id. (42 C.F.R. § 50.605(a)(3)(iii)). The institution must also implement an interim management plan to manage the FCOI. Id. (42 C.F.R. § 50.605(a)(3)(i)). If the retrospective review identifies information inconsistent with the institution's prior FCOI report to the PHS Awarding Component, the institution must update the previously reported information. Id. (42 C.F.R. § 50.605(a)(3)(iii)).
Public access to information
Information on conflicts of interest. PHS's expressed goal in revising the regulations is to increase transparency and public accessibility to information regarding FCOIs related to PHS-supported research. Consistent with that objective, if an institution finds a FCOI of "senior/key personnel," as defined in the regulations, related to a PHS-funded project, the institution must make publicly available certain information about the FCOI by either posting the information on a publicly accessible website or responding to written requests for such information within five business days of receipt of the request. 76 Fed. Reg. 53,287 (42 C.F.R. § 50.605(a)(5)(i)).
If the institution uses a publicly accessible website to satisfy this requirement, the institution must update the information at least annually and within 60 days of the institution's receipt or identification of information concerning any additional reportable SFIs of senior/key personnel that was not previously disclosed or upon the disclosure of a reportable SFI of senior/key personnel new to the PHS-funded project. 75 Fed. Reg. 53,287 (42 C.F.R. § 50.605(a)(5)(iii)). The website must note the information is current as of the date listed and is subject to updates. Id. (42 C.F.R. § 50.605(a)(5)(iii)).
The information posted must include, at a minimum: (1) the name, title and role of the investigator on the research project; (2) the name of the entity in which the SFI is held; and (3) the nature and approximate dollar value/range of the SFI or a statement that the value cannot be readily determined. Id. (42 C.F.R. § 50.605(a)(5)(ii)).
Conflict of interest policy. The final rule also adopts the requirement set forth in the NPRM that institutions post their conflict of interest policies applicable to PHS-funded research on a publicly accessible website. 76 Fed. Reg. 53,285 (42 C.F.R. § 50.604(a)). However, if an institution does not have a current presence on a publicly accessible website, the institution must make the policy available in writing within five business days of any request. Id. (42 C.F.R. § 50.604(a)). Institutions that acquire a presence on a publicly accessible website during the period of the PHS award must post their FCOI policy to the website within 30 calendar days of acquiring the presence. Id. (42 C.F.R. § 50.604(a)).
The final rule adopts the NPRM requirement that institutions require each investigator on PHS-supported research to complete training regarding the institution's FCOI policy and the investigator's responsibilities thereunder. 76 Fed. Reg. 53,285 (42 C.F.R. § 50.604(b)). The final rule reduces the frequency of training from every two years, as proposed in the NPRM, to every four years, and includes a requirement that training take place immediately after: (1) the institution revises its FCOI policies in a manner that affects investigator responsibilities; (2) an investigator joins the institution; or (3) the institution finds that an investigator has not complied with the regulations or the institution's FCOI policy or management plan. Id. (42 C.F.R. § 50.604(b)).
Application of regulations to subrecipients
Institutions carrying out PHS-funded research through a subrecipient must ensure that subrecipients comply with the new rule by setting forth in a written agreement whether the FCOI policy of the institution or of the subrecipient will apply to subrecipient investigators. Id. (42 C.F.R. § 50.604(c)(1)). The parties' agreement must specify time periods for the subrecipient to either report identified FCOI's to the institution, in the case where the subrecipient is following its own FCOI policy, or for the subrecipient to provide all investigator disclosures of SFIs to the institution, in the case where the institution's policy is being applied. Id. (42 C.F.R. § 50.604(c)(1)(ii)-(iii)). The institution is required to include FCOIs of subrecipients in its FCOI reports to the PHS Awarding Component. Id. (42 C.F.R. § 50.604(c)(2)).
Institutional conflicts of interest
Consistent with the NPRM, the final rule does not impose requirements related to institutional conflicts of interest. PHS is continuing to consider the appropriateness of issuing regulations addressing institutional conflicts of interest. 76 Fed. Reg. 53,278.