The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) recently released a proposal for new guidelines regarding public health service (PHS) funding disclosure policy’s concerning research. The Department Issued an Advanced Notice of Public Rule Making. The nature of this information, which was conveyed through a federal register, was to ask for comments on how these ‘new’ guidelines should be crafted.
Interestingly, NIH cites recent “public scrutiny” as a reason for addressing this issue, just as it has gained momentum in medical schools and professional associations.
They also suggest the need to revise these policies because researchers are now frequently working in multidisciplinary teams to develop new strategies and approaches for translating basic research into clinical application. But haven’t multidisciplinary teams of researchers been around for decades?
The main points include:
· Expanding the scope to include SBIR Phase I research
· Expanding the definition of significant financial interest
· Identification and Management of Conflicts by Institutions
· Assuring Institutional Compliance
· Reviewing Institutional Conflicts of Interest
As a result, HHS and NIH assert that in order to ensure the objectivity of research, a commitment to uphold the following principles are required:
· Research must be conducted with transparency and the highest scientific and ethical standards in a manner that promotes and respects the rights, safety, and welfare of all human research participants.
· Appropriate interactions and relationships between government, academia, and industry, which do not compromise objectivity in research, frequently have beneficial outcomes and should be encouraged.
· The integrity of the scientific record is critical to the conduct of science.
· Risk management is essential in evaluating and managing conflict of interest; risk management should be commensurate with the level of risk of the research.
· Complete and timely disclosure of financial interests and effective management of conflicts of interest are essential to ensuring objectivity in research.
Furthermore, they then outline what considerations the agencies are making to address these principles through changes in policies and disclosure.
I. Expanding the Scope of the Regulation & Disclosure of Interests
Present
Regulations apply to Institutions that apply for PHS funding for research and, through implementation of the regulations by each Institution, to each Investigator participating in such research. However, the regulations do not apply to Phase I SBIR/STTR applications. The regulations also require that Investigators disclose to the Institution only those Significant Financial Interests (SFI) (1) that would reasonably appear to be affected by the research for which funding is sought from the PHS; and (2) in entities whose financial interests would reasonably appear to be affected by the research.
Future
The NIH is now considering if regulations should be expanded so that they also apply to Phase I SBIR/ STTR research applications/proposals for PHS funding. The agency is also considering whether Investigators should be required to disclose to their Institutions all Significant Financial Interests that are related to their Institutional responsibilities, and whether these Significant Financial Interests constitute a Financial Conflict of Interest (FCOI)?
II. Definition of ‘‘Significant Financial Interest’’
Present
HHS and NIH presently define a ‘‘Significant Financial Interest’’ is as anything of monetary value, including but not limited to:
· Salary or other payments for services (e.g., consulting fees or honoraria);
· Equity interests (e.g., stocks, stock options or other ownership interests);
· Intellectual property rights (e.g., patents, copyrights and royalties from such rights).
The present definition does not include the following types of financial interests:
· Salary, royalties, or other remuneration from the Institution;
· Any ownership interests in the Institution, if the Institution is an applicant under the SBIR/STTR program;
· Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
· Income from service on advisory committees or review panels for public or nonprofit entities;
· An equity interest that, when aggregated for the Investigator and the Investigator’s spouse and dependent children, does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and does not represent more than a five percent ownership interest in any single entity;
· Salary, royalties or other payments that when aggregated for the Investigator and the Investigator’s spouse and dependent children over the next twelve months, are not expected to exceed $10,000. (42 CFR 50.603; 45 CFR 94.3).
Future
NIH and HHS are considering whether to keep current exemptions; whether the current de minimis thresholds ($10,000 and 5 percent ownership interest in any single entity) are reasonable, or if they should be changed; and whether Significant Financial Interests from certain sources or types of research should automatically be considered a FCOI.
III. Identification and Management of Conflicts by Institutions
Present
Current regulations require that an official(s) designated by the Institution review all financial disclosures; determine whether a financial conflict of interest exists; and, if so, determine what actions the Institution should take to manage, reduce, or eliminate the conflict of interest. The regulations provide that a conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the research funded by the PHS.
The regulations currently do not define the term ‘‘designated Institutional official(s)’’, or mandate specific actions that Institutions must take to manage, reduce or eliminate particular types of FCOIs.
Future
NIH and HHS are focusing on ways to manage, reduce, and eliminate particular types of FCOI. The proposed changes would consider if large institutions (defined as greater than 50 employees) should be required to establish an independent committee to review financial disclosures, and require that committee to report to an organizational level within the Institution that is not conflicted by the short-term financial interests of the Investigator or Institution. Other thresholds besides 50 employees will also be considered.
In addition, the agencies want to consider whether an Institution should be required to submit a standardized or particular conflict management plan to the PHS funding component, what that plan should consist of, and what types of research it should be required for.
Furthermore, NIH is acknowledging the need for Investigators who are involved in participant selection, the informed consent process, and clinical management of a trial, to be prohibited from having a Significant Financial Interest in any company whose interests could be affected by their research or clinical trial. They will also consider what circumstances to allow waving this requirement.
Lastly, they want to create specific requirements related to the identification, management, and reporting of FCOI for subrecipients (i.e., subgrantees, contractors, subcontractors, collaborators); and if amounts received by Investigators from certain kinds of organizations should be limited to certain maximum thresholds if an Investigator is supported with PHS research funds
IV. Assuring Institutional Compliance
Present
Under the current regulations, the PHS funding component may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in PHS funded research, including a requirement for submission, or review on site, of all records pertinent to compliance with the regulation. The PHS funding component may determine that suspension of funding/the issuance of a Stop Work order is necessary until the matter is resolved.
Future
NIH and HHS are considering whether to enhance existing enforcement options for noncompliance; whether Investigators should be required under the regulations to complete routine FCOI training; and finally if independent confirmation of an Institution’s compliance with the regulation should be required (e.g., accreditation by an outside body, an independent audit).
V. Requiring Institutions to Provide Additional Information to the PHS
Present
Today’s regulations require that prior to spending any funds under an award, the Institution must report to the PHS funding component the existence of any conflicting financial interest found by the Institution and assure that the interest has been managed, reduced, or eliminated in accordance with the regulation(s)
The regulations do not require the Institution to report to PHS officials the nature of the interest or other details.
Future
Both agencies are determined to require Institutions to submit to the PHS funding component additional information on any identified conflict.
VI. Institutional Conflict of Interest
Present
Finally, present guidelines address how Institutional conflict of interest policies are currently not addressed by the regulations, even though some Institutions have adopted such standards.
Future
NIH and HHS want to define Intuitional conflicts of interest, and specifically outline what an Institutional conflict of Interest policy should address in order to assure the PHS of objectivity in research.
No where in the call does NIH layout a case for the changes other than “public scrutiny” I do agree that institutions should be more diligent in collecting accurate information from their researchers, but am not convinced that more changes (last changes were in 2005) are needed other than greater diligence.
You are encouraged to send in your recommendations. Comments are Due July 7, 2009.
NIH Advanced Notice of Proposed Rule Making