Center for Health & Pharmaceutical Law & Policy Submits Comments on Conflicts of Interest in Research to the National Institutes
Posted Aug 25 2010 8:04pm
On August 19, 2010, on behalf of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy , Seton Hall Law Professors Kathleen Boozang and Carl Coleman, along with Research Fellow Kate Greenwood, submitted comments on the National Institutes of Health’s proposed revisions to its regulations governing conflicts of interest in federally-funded research. While the Center’s November 2009 White Paper Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight endorsed limits on conflicts of interest beyond those that the NIH has proposed, the revised regulations are a step in the right direction and in its comments the Center commends the NIH for its decisive action on this issue.
Briefly, the Center:
Supports the NIH’s proposal that that researchers disclose to their institutions any significant financial interest that “reasonably appears to be related to the Investigator’s institutional responsibilities,” with “institutional responsibilities” defined to include “activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.” This comports with the Center’s recommendation in the White Paper that investigators not be charged with determining for themselves whether one or more of their financial interests could be affected by a specific research project.
Supports the NIH’s decision to significantly lower the monetary threshold at which a researcher’s financial interest becomes “significant” to $5,000, but argues that a lower threshold would be better. Collection of data about all of a researcher’s relationships with industry, even those that fall below the proposed $5,000 threshold, would facilitate better conflict of interest assessment and management and make possible research into the effects of conflicts on research integrity and human subject welfare.
Supports the NIH’s decision not to exclude income from non-profit entities for lectures and similar engagements from the definition of significant financial interest and its conclusion that any equity interest in a non-publicly traded entity is significant, as are any and all intellectual property rights, but encourages the agency to revisit its decision to shield from disclosure (1) equity interests held by investigators in commercial or for-profit institutions and (2) royalties and other remuneration other than salary paid to an investigator by an institution that appoints or employs him or her.
Notes that the draft revised regulations do not address the White Paper’s criticisms that the conflict of interest regulations place no “substantive limits on the kinds of conflicts that may exist” and fail to put forth “a required minimum response for conflicts that pose the greatest risks to participants and the integrity of the research” and encourages the NIH to consider again the benefits of setting forth required minimum responses to those conflicts that are the most problematic.
Supports the NIH’s decision to require that grantees provide “sufficient information to enable the [agency] to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Institution’s management plan.”
Supports the requirement in the draft revised regulations that any significant financial interest that (1) is still held by a principal investigator or senior/key person, (2) is related to PHS-funded research, and (3) is a financial conflict of interest must be disclosed to the public via the world wide web.
Supports the draft revised regulations’ requirement that investigators complete training on “the Institution’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of these regulations” before the commencement of research and then at least once every two years. As recommended in the Center’s White Paper, it would be beneficial for the training to include as well a discussion of the nature of conflicts of interest and their potential for harm.
Recommends that the agency adopt its own suggestion that institutions be required to “maintain up-to-date, written, enforced policies” on institutional conflicts of interest, as they are for investigator conflicts, and that these policies be made publicly available via the world wide web. The nudge this requirement would provide is necessary because institutions have been slow to develop and adopt policies on institutional conflicts.
Recommends that the section of the regulations devoted to remedies be revised to include a non-exclusive list of potential enforcement actions such as temporary withholding of cash payments pending correction of the deficiency, suspension or termination of the contract or grant in whole or in part, monetary assessments and penalties, and suspension or debarment from eligibility for future contracts or grants.
The Center’s comments in their entirety are available here .
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy . The Center is a think tank that fosters dialogue, scholarship, and policy solutions to critical issues in health and pharmaceutical law. As part of its mission, it convenes policymakers, consumer advocates, the medical profession, industry, and government in the search for concrete solutions to the ethical, legal, and social questions presented in the health and pharmaceutical arenas. The Center also runs a compliance training program covering the state and federal laws governing the development and marketing of drugs and medical devices.