The Association of American Universities (AAU), and the Association of American Medical Colleges (AAMC) submitted a response to the National Institutes of Health (NIH) regarding the “Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractor.” In their response they cited similar principles that guided the Associations’ 2008 Report, which argues that:
“A principled partnership between the academic community and industry is
essential if we are to realize the promise of biomedical research.”
“although such collaboration can also create serious conflicts of interest, these pressures compel academic institutions to reaffirm their highest values of protecting the integrity of their research, the wellbeing of the human subjects who participate in it, and the trust of the public.”
Expanding the Scope of the Regulations and Disclosure of Interests
The Associations believe that greater transparency, consistency and ease of implementation for universities and medical schools could be achieved by removing the Bayh-Dole exemption of SBIRs and STTRs.
They believe that a distinction between “disclosing” and “reporting” should be preserved.
Definition of “Significant Financial Interest” (SFI)
The Associations further acknowledge that the existing thresholds of more than $10,000 income or more than $10,000 stock plus more than 5% ownership interest should be lowered. As a result, they want to change the designation of those financial interests that must be routinely disclosed to the PHS from “significant financial interests” to “disclosable financial interests.”
They want to eliminate the exemption for reporting royalties from the applicant institution, “equity interests,” and “ownership interests in the institution.”
The Associations support retaining the exemption for “[i]ncome from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities, and income from service on advisory committees or review panels for public or nonprofit entities.”
Identification and Management of Conflicts by Institutions
AAU and AAMC want large institutions (defined as greater than 50 employees) that receive one or more PHS research grants be required to establish an institutional committee to review financial reports from investigators.
The Associations strongly oppose prescribed standards for management plans because of the enormous variety of potential conflicts and research projects. Furthermore, they strongly assert that PHS not prescribe specific standards for the management, reduction, or elimination of particular types of FCOI, and instead advocate an array of management, elimination, and reduction options.
The Associations also oppose financial thresholds for investigators.
Assuring Institutional Compliance
The Associations believe current enforcement is adequate, and they support legislation now pending in Congress to require pharmaceutical, device, and medical supply companies to disclose payments of various kinds to physicians. In fact, the AAMC also supports related efforts by the Medicare Payment Advisory Committee regarding disclosure of industry payments to physicians and others.
AAU and AAMC strongly oppose any requirement relating to accreditation of conflicts of interest programs generally, beyond their support of The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
Requiring Institutions to Provide Additional Information
The Associations support a requirement for additional information such as the nature and amount of the financial interest and conflict.
Institutional Conflict of Interest
“An institution may have a conflict of interest in human subjects research whenever the financial interests of the institution, or of an institutional official acting within his or her authority on behalf of the institution, might affect—or reasonably appear to affect—institutional processes for the conduct, review, or oversight of human subjects research.”
Editorial
Ultimately, the response by AAU is a slight overreaction, and they have taken COI to a new level which is not necessarily serving their members. They did at least call for limited intrusion on the medical research process.
In the end, if their recommendations are accepted there will be fewer researchers able to submit for grants, a total loss of emphasis on translational medicine (developing therapies that actually do something good, and more done on pure research).
The relationships with industry allow scientist to see firsthand what works in patients and learn from the private sector. Science is an enterprise that should focus more on results and less on who supported who's research. If we cross the divide of "government sanctioned" science as some how being better than private sector supported science in the end we all loose.