September 27, 2019 - The Department of Health and Human Services Office of Inspector General (OIG), released three reports related to financial conflicts of interest (FCOI), foreign influence, and the steps the National Institutes of Health (NIH) is taking to protect the integrity of NIH funded research.
- NIH Has Made Strides in Reviewing FCOIs in Extramural Research, But Could Do More - This report focuses on whether the NIH has addressed the gaps in the Agency’s oversight of investigator FCOI, previously identified in its 2008 report, NIH COI in Extramural Research. The OIG recommends that the NIH perform quality assurance reviews of FCOI information in its online system and use the information about foreign affiliations obtained during the pre-award reporting process to make determinations about whether to revise its financial conflict review process.
- The NIH Has Limited Policies, Procedures, and Controls in Place for Helping to Ensure That Institutions Report All Sources of Research Support, Financial Interests, and Affiliations - This report discusses whether the NIH has policies and processes in place to ensure the reporting of all sources of research support, including financial interests and affiliations. The OIG recommended that NIH ensure that the 1,013 institutions identified as not having FCOI policies posted on their website, post those policies as required. Other recommendations included, enhancing the NIH FCOI monitoring program, review grantee websites to ensure FCOI policies are publicly accessible, and implement procedures to ensure institutions have FCOI policies.
- Vetting Peer Reviewers at NIH's Center for Scientific Review: Strengths and Limitations - In this report, the OIG recommends that the NIH take steps to address concerns related to vetting peer reviewer nominees, recommending that the NIH update its guidance on vetting peer reviewers to identify potential foreign affiliations that may impact research integrity. The OIG also recommended that the NIH coordinate with HHS’ Office of National Security to develop an approach for identifying peer reviewer nominees that require additional vetting.
July 10, 2019 - NIH issued a guide notice referencing existing regulations and policies related to recent concerns about undue foreign influence in research at U.S. institutions. COI issues are central to the concerns that have been raised about researchers who receive support from foreign institutions or governments for their research activities. NIH expects institutions to review disclosed significant financial interests (SFI) to determine whether those SFIs are conflicts of interest, but NIH independently reviews other sources of support related to specific grant applications to ensure that the agency avoids scientific, budgetary, or commitment overlap. The AAMC is developing a series of issue briefs on undue foreign influence, focusing on government efforts to address the issue and the institutional response.
- Issue Brief #1: NIH Policies and Guidance to the Grantee Community
- Issue Brief #2: Federal Agency Policies and Regulations
February 12, 2019 - The Association of American Medical Colleges, American Society of Clinical Oncology, Council of Medical Specialty Societies, JAMA, and Memorial Sloan Kettering Cancer hosted a symposium at the AAMC's headquarters (655 K Street NW, Washington, DC) on February 12, convening leaders from across the biomedical research community, including representatives from academic institutions, journals, publishers, professional associations and societies, government officials, industry, as well as conflicts of interest experts, ethicists, researchers and patient/public representatives. Symposium attendees participated in facilitated table discussions, outlining the actions needed to standardize the submission of financial interest disclosures by authors to journals, and the need to build greater transparency around journal disclosure requirements to foster a system that is clear and functional. For more information about the symposium or opportunities to stay engaged on this issue, visit Harmonizing Financial Disclosures in Biomedical Journals.
September 20, 2018 - Media coverage of the failure of a physician to disclose relevant industry relationships in his articles in peer reviewed journals reminded the academic medicine community of our shared obligation to facilitate the disclosure of timely, accurate, and complete information about academic medicine’s relationships with industry and preserve the public’s trust in the research enterprise. The AAMC is continuing to work with member institutions, other associations and societies, journals, and the continuing education community to develop tools and resources to help institutions and individuals manage the disclosure of conflicts of interest.
Institutions can consider the following:
Remind faculty of the importance of full disclosure, not only to your institution, but in other writing, speaking and teaching situations, as well as grant applications.
Use relevant current events as an opportunity to recommit to the institution’s obligation to facilitate transparency about the ways in which faculty and industry may be collaborating, and the processes that are in place to review and manage those relationships.
- Encourage faculty to review the information posted about them publicly on the Open Payments website, and to ensure its accuracy as well as consistency with complete disclosures in all aspects of their professional responsibilities.
- Learn more about Convey, the disclosure system developed by the AAMC to streamline and standardize the disclosure of financial interests to institutions, journals, and other organizations at www.convey.org or by emailing firstname.lastname@example.org.
Convey is a global disclosure system built to standardize the reporting of financial interests and relationships with external entities. It provides a web-based repository for individuals, who can enter and securely maintain records of financial interests to disclose directly to any organization that uses the system. For organizations that collect disclosure information, Convey features a streamlined disclosure process tailored to each organization. Convey: Global Disclosure System
Request a demo of Convey here.
- For Full Disclosure in Medicine (New York Times, Sep. 30, 2018): Opinion Letter by Jeffrey Drazen, Editor in Chief of the New England Journal of Medicine, describes NEJM's role in the central repository and encourages “all involved in medical care, research or education to adopt Convey.”
Department of Health and Human Services' Rule on Financial Conflicts of Interest in Federally-Funded Research
On August 23, 2011, the Department of Health and Human Services issued a final rule revising the regulations entitled "Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors."
AAMC Conflicts of Interest Metrics Project
AAMC worked with member medical schools and teaching hospitals to measure the effect and effectiveness of the HHS final rule on financial conflicts of interest in federally-funded research using aggregate data about participating institutions' conflict of interest review systems, disclosures made by investigators to the institution, and financial conflicts of interest identified and reported to federal funding agencies. Key Results from the COI Metrics Project (AAMC Analysis in Brief, April 2015)
- AAMC Report on Institutional Approaches to Implementing the Final NIH Rule on Financial Conflicts of Interest (March, 2012)
- HHS Final Rule (August 25, 2011)
- AAMC-AAU-ACE-APLU Comment Letter in Response to NPRM (August 17, 2010)
CMS Open Payments Rules and Database
On February 8, 2013, the Centers for Medicare and Medicaid Services (CMS) issued the final rule, "Transparency Reports and Reporting of Physician Ownership or Investment Interests" (78 FR 9458) which implements section 6002 of the Affordable Care Act. CMS' publicly available website contains information about the financial relationships between physicians, teaching hospitals, applicable manufacturers and GPOs. Manufacturers are required to annually report to CMS certain payments or transfers of value made to physicians and teaching hospitals. For more information on the Sunshine Act and Open Payments, visit AAMC's Open Payments webpage.
- The Integrity of our Research Depends on the Full Disclosure of Industry Relationships (AAMC News, December 2018)
- Top Cancer Researcher Fails to Disclose Corporate Financial Ties in Major Research Journals (NYT, September 2018)
- Journal of the American Medical Association (JAMA) - Conflict of Interest Theme Issue (May 2017) subscription required
- Strategies for Addressing a Broader Definition of Conflicts of Interest (JAMA, Ross E. McKinney, Jr. MD; Heather H. Pierce JD, MPH, May 2017)
- NIH Disclosure Rules Falter (Nature News, September 2015)
- Public Health Service FCOI Regulation Overview Diagram
- In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making (Report of an AAMC Task Force on Financial Conflicts of Interest in Clinical Care, June 2010)
- Conflict of Interest in Medical Research, Education, and Practice (National Academies of Sciences, Engineering, and Medicine, April 2009)
- Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research (AAMC-AAU Advisory Committee on Financial Conflicts of Interest in Human Subjects Research, February 2008)
- Industry Funding of Medical Education (Report of an AAMC Task Force, June 2008)
For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at email@example.com or (202) 478-9926 or Daria Grayer, JD, MA, Senior Lead Specialist, Science Policy and Regulations at firstname.lastname@example.org or (202) 741- 5474.