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Public Comments

FasterCures Comments on NIH’s Proposed Rule Making on Conflict-of-Interest Regulations
Jul 08, 2009

To: Jerry Moore
NIH Regulations Officer
NIH Office of Management Assessment

From: Margaret Anderson
Chief Operating Officer
FasterCures

Subject: Comments on “Responsibility of Applicants for Promoting Objectivity in Research for
Which Public Health Service Funding Is Sought and Responsible Prospective
Contractors” [Docket No. NIH-2008-0002]

Thank you for the opportunity to provide comments on NIH’s advanced notice of proposed rule making on conflict-of-interest (COI) regulations.

FasterCures' mission is to identify ways to accelerate the discovery and development of new therapies for the treatment of deadly and debilitating diseases both in the United States and around the globe. The organization was founded in 2003 under the auspices of the Milken Institute to aggressively catalyze systemic change in cure research and to make the complex machinery that drives breakthroughs in medicine work for all of us faster and more efficiently. FasterCures is independent and non-partisan. Our primary mission is to improve the lives of patients by improving the research environment, research resources, and research organizations.

We agree with the five principles laid out in the notice for ensuring the objectivity of research. But while public trust in the scientific process and the results of research is critical, it is matched in the public and in Congress by a desire to see the results of publicly funded research translated more efficiently and effectively into improved human health. That translation is nearly impossible without building relationships and collaborations among all the entities and sectors that fund and conduct medical research – governments, universities, philanthropic foundations, voluntary health associations, independent research institutes, and industry. These relationships do not always represent a “conflict” of interest; they frequently represent a “convergence” of interest.

We encourage NIH to carefully consider what behaviors it wishes to guard against and the best means for achieving its goals. It may be that the best means are improving compliance with and enforcement of existing regulations rather than making them stricter or more onerous. Many of the recent high-profile cases of conflict-of-interest infractions would not have been avoided by, for instance, lowering the threshold for “significant financial interest”; these investigators simply were not complying with existing regulations. Setting policy based on the activities of exceptions or outliers is not good practice. Changing the culture and ensuring appropriate oversight can protect against conflicts that damage the public interest without creating unnecessary barriers to legitimate activities.

We believe that many issues related to conflicts of interest might be resolved by simply making an effort to standardize definitions and disclosure forms, institute more effective training (not just more training) on ethics issues, and hold leadership accountable for ethical conduct.

Early this year FasterCures published the recommendations of a task force headed by Nobel Laureate Dr. David Baltimore, suggesting to the new Administration a framework within which to refresh the NIH’s Intramural Research Program, to give it a distinct mission and identity in the service of improving public health. In the course of preparing the task force’s report, we heard many times in interviews with scientists inside and outside NIH that the agency’s current ethics policy governing individual conflicts of interest has had a sometimes stifling effect on recruitment and retention of clinical investigators. In the view of some, it has prevented or impeded important collaborations in translational and clinical research. While there is a genuine need for clear ethics guidelines, the current policies have the potential to inhibit NIH’s ability to serve national needs, by hindering collaboration between the public and private sector that is critical to bringing research findings to development.

NIH’s survey of its staff in the immediate aftermath of the 2005 policy change for its own employees showed that:

  • More than 50% of scientists believed the rules were too restrictive and that they would negatively impact NIH’s ability to complete its mission;
  • Almost 75% of scientists (and almost 90% of tenured/tenure track scientists) believed the rules would negatively impact recruitment and retention;
  • Almost 25% of scientists believed the rules would negatively impact them personally, and almost 20% were actively looking for or considered looking for a position outside NIH; and
  • Almost half of all respondents felt that NIH should have just enforced existing rules better rather than strengthening the rules.

We concur with comments submitted by the Federation of American Societies for Experimental Biology, that “the principal focus of the regulation should be to encourage disclosure and, if necessary, management of COI and perceived COI. Proscription or prohibition of beneficial relationships between academia and industry should be avoided.” We would add that NIH should make a significant effort to avoid actions that may have the unintended consequence of proscribing or prohibiting ethically acceptable relationships that accelerate the translation of research into cures.

We also agree with comments submitted by the American Association of Medical Colleges and the American Association of Universities that institutional conflicts of interest policies are much needed, but again ones that allow legitimate and ethical interactions to occur between academic researchers and industrial partners. This extends also the NIH’s Intramural Research Program.

Thank you again for the opportunity to comment during this process.
 

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