New Public Health Service/NIH regulation: Investigator responsibilities

February 20th, 2013 1:20 pm

  • Under new regulations, the definition of “investigator” is broadened.
  • The disclosure threshold for financial conflicts of interest has been lowered to $5,000.
  • Significant financial holdings are reportable if they are related to each investigator’s institutional responsibilities.
  • Sponsored travel costs related to the investigator’s institutional responsibilities are reportable.
  • The institution must train investigators on its policy and management plan to reduce or eliminate significant financial conflicts of interest.

The public’s trust in unbiased research funded by their money has taken a nose dive.  Banner headlines highlighting investigator financial conflicts of interest and the concomitant fear of “tainted” research results have led to the conclusion that the research may not be on the ‘up and up’.  That could be crippling to public support for Public Health Service/National Institutes of Health research projects.  Another factor is the increasingly complex web of research sponsors, which may be university-based but also include private sector and federal partners.  The increased pressure to produce marketable therapeutics, emphasis on translational medicine (from laboratory bench to patient bedside), and decreasing budgets especially at the state level) has made investigators’ work much trickier.  Furthermore, there has been increased demand for transparency, most especially demonstrated in the public reporting of funds awarded under the federal “Stimulus Act’.   Transparency and public reporting will only increase.

How will the changes affect me?

That will depend on your situation.  The underlying principle is anyone, regardless of title, who may have an effect on the design, conduct and reporting of Public Health Service (PHS), National Institutes of Health (NIH) funded research will be covered by the new regulation.  If you work for a domestic, foreign, public or private institution (except federal institutions) which receives PHS, NIH, funding, you may be covered by the new regulation.  If you are designated as ‘key personnel’ in the grant/cooperative agreement application, you are covered by the regulation.  If you are a consultant to or a collaborator on an NIH-funded project who has a role in the project’s design, conduct or reporting, you are covered by the new regulation.  If you work for a subcontractor/subrecipient on an NIH project, you may be covered by the new regulation.  If you, as an individual, receive NIH funding, you are covered.  If you are part of an SBIR/STTR Phase II (Phase I is exempt), you are covered.

The definition of investigator (key personnel) has been broadened to include those who, due to their institutional responsibilities as defined by the institution’s financial conflict of interest policies, could affect the design, conduct and reporting of NIH-funded research projects.  Some examples of institutional responsibilities might be research, research consultation, service on IRB committees or safety monitoring boards, teaching, professional practice and service on institutional committees.  Each institution is required to create a
written financial conflict of interest policy, so your institution can help you to decide if you are unsure if you’re covered by the new regulation.

What (and how much) do I have to report?

You have to disclose each financial holding which equals $5000 or more.  You have to disclose each financial holding held by your spouse and/or dependent children if the discrete financial holding equals $5000 or more.  If you (your spouse and/or dependent children) have an equity interest in and/or receive remuneration of $5000 and above in a publicly- traded entity over the twelve months before disclosing, that is a significant financial interest.  Remuneration includes salary and payments for services which are not salary-related such as honoraria, paid authorship, consulting fees.  Equity interest includes stock, stock options, or other ownership interest as valued through public prices or other reasonable measures to determine fair market value.

For non-publicly-traded entities, a significant financial interest is defined as any remuneration, when aggregated, which totals $5000 or more.  The same is true for holdings of stock, stock options, or other ownership interests.  Intellectual property rights and interests, such as patents and copyrights, must be reported as significant financial interests when income from those rights meets the $5000 or more threshold.  Investigators’ reimbursed or sponsored travel related to her/his institutional responsibilities also must be reported.  Sponsored travel occurs when an investigator’s travel is paid directly to the service provider by an outside party, so the exact amount may not be easily available.

Is there anything I don’t have to report?

Yes, there are some significant financial interests which you do not have to report.  Investigators do not have to report salary, royalties or other remuneration paid by the institution if the investigator is a current employee or appointee.  Investigators do not have to report remuneration from intellectual property rights assigned to the institution and agreements to share in any royalties therefrom.  If the investigator is a commercial/for-profit entity, and the investigator holds ownership in the entity, that does not have to be reported.  Income from investments such as mutual funds and retirement accounts are not reportable as long as the investigator does not directly control investment decision-making.  If an investigator derives income from lectures, seminars, or teaching engagements, it is not reportable if the sponsoring institution is: a federal, state or local government agency; an institution of higher education as defined in federal law (20 U.S.C. 1000 a); an academic teaching hospital, medical center or research institute affiliated with an institution of higher education.
If the investigator derives income from serving on advisory committees/review panels if said committees/panels are sponsored by the same kinds of institutions delineated in the previous example, that income is not reportable.

Who decides if my significant financial holdings are a conflict and what happens then?

The institution to which the grant is awarded decides whether an investigator’s significant financial holdings are a conflict.  That judgment is informed by whether a reasonable person could infer that such a significant financial holding could directly and significantly affect the design, conduct or reporting of the NIH-funded grant.  Furthermore, after the institution identifies the significant financial holding as a conflict, the institution must develop and implement a management plan.  That plan may include the reduction of or elimination of the significant financial interest.

Is there any help available to understand the new requirements?

Yes.  Before an investigator starts any PHS/NIH-funded research, s/he must be provided training on financial conflict of interest.  Each investigator must also be provided training every four years after the initial training.  Immediate training is provided when the institution’s financial conflict of interest policy changes in a way that affects investigator disclosure requirements; an investigator is new; or an investigator is determined to be noncompliant with the institution’s policy or management plan.

Summary:

The Public Health Service/National Institutes of Health have issued a new financial conflict of interest regulation which increases investigator disclosure.  The disclosure threshold has been lowered and all financial holdings – with some exceptions – of the investigator (spouse and dependent children) above the threshold must be disclosed.  The institution now determines whether a significant financial holding is a conflict and what further action is required.  The underlying principle of the regulation is the restoration of public trust that unbiased research is carried on their behalf.  Over the past few years, public trust has been eroded and research arrangements (public private partnerships) have become more complex.  The regulation increases research transparency and reporting.

 

[Note:  For the purposes of this article, NIH is used interchangeably with the Public Health Service (PHS). However, the regulation applies to the entire PHS.]

 

For further information please refer to the Federal Register, Vol. 76; No. 165, August 25, 2011; Part IV; Department of Health and Human Services; 42 CFR Part
50; 45 CFR Part 94; [Docket Number NIH-2010-0001]; RIN 0925-AA53; Responsibility of Applicants for Promoting Objectivity in Research for which
Public Health Service Funding is Sought and Responsible Prospective Contractors; Action: Final Rule; pages 53256-53293