Recommendations Report: Harmonization of Financial Disclosures in Biomedical Journals [December 2021]
The Association of American Medical Colleges, American Society of Clinical Oncology, Council of Medical Specialty Societies, JAMA, and Memorial Sloan Kettering Cancer Center hosted a symposium at the AAMC's headquarters on February 12, 2019. Leaders from across the biomedical research community came together to discuss harmonizing requirements for disclosure of authors financial interests and relationships in biomedical journals. One key outcome from the symposium was the establishment of the Working Groups on Harmonization, tasked with developing principles and recommendations for implementation across the research community. In December 2021, the host organizations released the final recommendations from the Working Groups on Harmonization for public feedback (Harmonization of Financial Disclosure Reporting in Biomedical Journals: A Shared Responsibility). To read the report and learn about next steps for implementation of the recommendations, visit AAMC’s Harmonizing Financial Disclosures in Biomedical Journals webpage.
Centers for Medicare and Medicaid Services 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), implementing section 6002 of the Affordable Care Act. According to the final rule, manufacturers are required to annually report to CMS certain payments or transfers of value made to physicians and teaching hospitals. Reports about payments from industry to physicians and teaching hospitals are made publicly available on CMS’ Open Payments website on an annual basis (on or by June 30). The AAMC has worked closely with the CMS Open Payments team to develop educational resources for teaching hospital and physicians. To access these resources and for additional information on Open Payments, visit AAMC's Open Payments webpage.
Department of Health and Human Services Office of Inspector General Reports on COI, Foreign Influence, and Integrity of NIH Funded Research
- Report: NIH Has Made Strides in Reviewing FCOIs in Extramural Research, But Could Do More
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.
- Report: 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
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.
- Report: Vetting Peer Reviewers at NIH's Center for Scientific Review: Strengths and Limitations
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. It is 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.
NIH Guide Notice: Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components
The NIH issued a Guide Notice (July 2019) related to 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. The 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 has developed a series of briefs on foreign influence, focusing on the government’s 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
Department of Health and Human Services Final Rule on Financial Conflicts of Interest in Federally-Funded Research
On August 23, 2011, the Department of Health and Human Services issued the 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.” The AAMC submitted a joint letter (August 2010) responding to the Notice of Proposed Rulemaking.
Following issuance of the final rule, the AAMC began the Conflicts of Interest Metrics Project, designed to measure the cost and impact of the final rule on medical schools and teaching hospitals one year before implementation of the regulations and several years following. AAMC collected 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. See AAMC Resources (below) for information about the COI Metrics Project, including access to the final results.
Conflicts of Interest Metrics Project
The AAMC released the final results from the COI Metrics Project in December 2020. To learn more about the COI Metrics Project and other AAMC activities related to the HHS final rule on Conflicts of Interest, visit the AAMC COI Metrics webpage. Access the Final Report (Measuring the Impact of the Public Health Service Regulations on Conflicts of Interest).
The AAMC Convey Global Disclosure System was 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.
- Request a Convey Demo
- Convey in the News
- JAMA Editorial - A Proposal from the International Committee of Journal Editors
A Proposal From the International Committee of Medical Journal Editors (ICMJE) describing the proposed revisions to the ICMJE’s author COI disclosure form, and stating that that the ICMJE will accept disclosures from repositories that meet certain criteria. The only currently available repository consistent with such criteria is Convey. A Disclosure Form for Work Submitted to Medical Journals (January 2020).
- New England Journal of Medicine (NEJM) Opinion Letter by Jeffrey Drazen, Editor in Chief of NEJM
Letter from the editor in chief describing NEJM’s role in Convey, encouraging “all involved in medical care, research or education to adopt Convey.” For Full Disclosure in Medicine (New York Times, September 2018).
- JAMA Editorial - A Proposal from the International Committee of Journal Editors
Evaluating Grant Opportunities from Private Foundations
The AAMC developed the resource Evaluating Grant Opportunities from Private Foundations to assist institutions that are considering responding to a call from foundations or corporate sponsors to conduct research or develop educational curricula or content. This resource provides key questions to guide institutions through a thoughtful decision-making process.
Forum on Conflict of Interest in Academe (FOCI-Academe)
The AAMC Forum on Conflict of Interest in Academe provides a forum for the leadership in the biomedical arena who oversee and manage conflicts of interest to promote the highest ethical and professional standards in the conduct of their institutions as they carry out their missions of patient care, research, education, business, and service. For additional information, including how to join the FOCI community, visit AAMC's Forum on Conflict of Interest in Academe webpage.
AAMC Comment Letters and Reports
- AAMC Letter to White House Office of Science and Technology Policy in response to a Request for Information on the American Research Environment (January 2020 letter)
- AAMC Diagram on the Public Health Service Final Rule on FOCI (Overview Diagram)
- AAMC Task Force Report: In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making (June 2010)
- AAMC-AAU Advisory Committee Report: Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research (February 2008)
- AAMC Task Force Report: Industry Funding of Medical Education (June 2008)
COI News and Additional Resources
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). Related: 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)
- Conflict of Interest in Medical Research, Education, and Practice (National Academies of Sciences, Engineering, and Medicine, April 2009)
For questions, contact Heather Pierce, JD, MPH, Senior Director, Science Policy and Regulatory Counsel at firstname.lastname@example.org or (202) 478-9926 or Daria Grayer, JD, MA, Senior Lead Specialist, Science Policy and Regulations at email@example.com or (202) 741-5474.