Opportunity to Comment on Proposed Changes to Financial Conflict of Interest Regulations

One of my activities is representing NIGMS on the NIH Financial Conflict of Interest Panel. This group has put substantial time and effort into updating the financial conflict of interest regulations that apply to NIH grant applicants. The proposed changes to the regulations are reflected in a recently released notice of proposed rulemaking (link no longer available) that is now open for comment. You may submit comments electronically or by mail as long as they are received by July 20, 2010.

Although responsibility for reporting and managing financial conflicts of interest would remain with the grantee institution, several of the proposed changes would affect individual investigators. For example, investigator disclosure requirements would be expanded to include all significant financial interests related to the investigator’s institutional responsibilities. In addition, the dollar threshold for disclosure of significant financial interests would be $5,000 (it’s currently $10,000), and this amount would apply to both payments and equity interests. Equity interest of any amount in non-publicly traded entities is considered a significant financial interest and would have to be disclosed.

Investigators would also be required to complete financial conflict of interest training before engaging in NIH-funded research and every 2 years thereafter.

I encourage you to look over the proposed rulemaking document as well as to learn how your institution will be implementing the new financial conflict of interest policy.

UPDATE: The comment period on the proposed changes to financial conflict of interest regulations has been extended to August 19. For more details, see the NIH Guide.

8 comments on “Opportunity to Comment on Proposed Changes to Financial Conflict of Interest Regulations

  1. These new proposals are more stringent than my current university has, and thus NIH grantees would be a disadvantage in disclosure vis-a-vis their peers. This would create a negative disincentive to applying to NIH. I see this as solution to a non-problem.
    I am strongly opposed to these more invasive questions.

  2. The changes in the proposed rules will require additional paper work. Our university already has a well defined COI policy in place that addresses the potential for conflict. It would be best for each university/institution to establish rules to govern its faculty rather than a national policy that will create additional administrative burdens.

  3. I am fine with lowering the amount necessary to constitute a conflict.

    I disfavor increasing the training (and retraining and retraining…) to once every two years. Too much imposed training leads only to contempt for the rules. At the University of California, for instance, we are burdened with a constant drivel of enforced training programs (including recently one on ergonomics) that bleed our time with a thousand tiny cuts. Why not limit the number of trainings to no more than the average frequency of an R01–once every four years?

    I am also concerned about the expansion of the rules to cover Phase I SBIRs. Many of the institutions being funded, especially since the Great Recession began, are small with minimal administrative capacity. They do not have the administrative resources of a major research University. At this time, when the Government is trying to revive commerce and the driver that small businesses provide, adding a burdensome regulation seems particular inopportune.

    Full disclosure–I have founded a small research enterprise that applies for SBIRs, so I am certainly conflicted here. But also perhaps educated in the potential pitfalls.

  4. I chair the University of Colorado at Boulder COI committee that reports to the VC for Research. The lower dollar threshold, expanded training, and the broader inclusion of funding mechanisms are worrisome. But concerns about these pale in comparison to our distress about the proposed requirement to that the University have a public website listing the investigators with significant financial interests (SFI) that includes the value of the equity or income from the activity that are generated by the SFI. Sarah did not mention this part of the proposed rules, and perhaps she could clarify. The text is in the middle of the 11th page of the posted document, “the Institution shall make available via a publicly accessible Web site information concerning any SFI”. The formal response from our campus will focus on this invasion of privacy, particularly since it discloses assets that are not held by or controlled by the University.

    • Many journals (N Engl J Med 361(19):1896-1997, 2009) and institutions already have policies that include public disclosure of SFIs as a management tool. One Web site that the NIH FCOI committee discussed as an example was the Stanford School of Medicine’s, which includes information on consulting, royalty payments, equity and service on boards of directors in the individual profiles of faculty researchers.

      Note that the proposed regulations would only apply to SFIs that exist during the funding period of the NIH grant. PIs would have the option of eliminating SFIs prior to accepting NIH funding, and eliminated SFIs would not be subject to public disclosure.

      I encourage anyone with comments on the proposed regulations to submit them via the guidelines published in the Federal Register so that they will be taken into consideration when the rules are finalized.

  5. Sarah – Thanks once again for the information about the public disclosure of SFIs. We have now investigated the Stanford site, which indicates that the PI has income in excess of the threshold amount. However, the proposed regulations include “The information that the Institution makes available via a publicly accessible web site shall include, at a minimum, the following: the Investigator’s name; the Investigator’s position with respect to the research project; the nature of the significant financial interest; and the approximate dollar value of the significant financial interest (dollar ranges are permissible: less than $20,000; less than $50,000; less than $100,000; less than or equal to $250,000; greater than $250,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.” Having to state the approximate value of the income or equity is quite different from stating that an investigator is over the threshold. We are still concerned about the nature of this disclosure.
    Best – Mark

  6. Please note that the comment period on the proposed changes to financial conflict of interest regulations has been extended to August 19. For more details, see the NIH Guide.

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