Conflict of Interest
Introduction
What is Conflict of Interest (CoI)?
University of Miami CoI Policies
Web Resources for CoI
Introduction
The increasing involvement of academic researchers and educators with industry and private entrepreneurial ventures has raised the potential for Conflict of Interest (CoI). These conflicts arise from the opportunities a faculty member or staff member might have to benefit financially from the outcome of research or other professional activities conducted as an employee of the University of Miami. UM CoI Policy
Federal granting agencies (NIH, FDA, NSF) require grantee institutions to take steps to insure that faculty and staff receiving federal funds do not use their positions to promote financial gain for themselves or their families. Institutions receiving federal funds are required to have written policies on Conflict of Interest and to provide a mechanism for faculty and staff to disclose such conflicts.
According to federal policies, the institutional CoI policy must include ”financial interests, gifts, gratuities and favors, nepotism, and other areas such as political participation and bribery. These rules must also indicate how outside activities, relationships, and financial interests are reviewed by the responsible and objective institution official(s). “ In addition, the institution has the responsibility for maintaining objectivity in research by ensuring that the design, conduct, or reporting of research will not be biased by any conflicting financial interest of investigators responsible for the research in accord with the provisions of PHS regulations 42 CFR Part 50, Subpart F, and 45 CFR Part 94. (http://grants2.nih.gov/grants/guide/notice-files/not95-179.html).
What is Conflict of Interest / Conflict of Commitment
- Conflict of Commitment: Full-time members of the Faculty are expected to devote their primary professional loyalty, time, and energy to their teaching, research, administrative responsibilities and where applicable patient care through the University of Miami Medical Group. Outside financial interests and activities should not interfere with the primacy of these commitments
- Conflict of Interest: An actual or potential conflict of interest exists when the Vice Provost for Research reasonably determines that a Significant Financial Interest could affect the design, conduct, or reporting of the research or educational activities funded by a Governmental Agency.
Conflict of Interest not only pertains to research activities, but also to how faculty and staff conduct business for and with the University of Miami.
Thus, a Conflict of Interest would also exist in “Situations in which University personnel or students use their position for the purpose of obtaining private gain for themselves or others, such as those with whom they have family, business or other ties. An indirect Conflict of Interest can occur when University personnel or students are considered to have proprietary interests in any supplier to the University of goods or services from which the employee or any member of their immediate family receive compensation or have financial interest. An investment in a publicly held company of less than 1% of its outstanding stock will not be regarded as indirect interest.
Current policies are designed to nurture scientific discovery and an entrepreneurial activities. However, conflicts of interest must be recognized and managed to maintain high ethical standards and to protect the investigators and the institution from charges of bias. Two extremely important points to remember are:
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“Conflicts of interest are ubiquitous in academic life, indeed all professional life; conflicts of interest can never be eliminated. Moreover, the existence of conflicts of interest has to be accepted and not equated with scientific misconduct” (Korn 2000).
On the other hand,
- “Financial conflicts of interest are not inherent to the research enterprise. They’re entirely optional - unlike intellectual or personal conflicts of interest to which they’re often compared” (Angell 2000).
In Korn’s view conflicts of interest are inescapable; what matters is whether professional misconduct actually ensues. Angell, on the other hand takes the position that failing to forgo financial interests that pose conflicts is in and of itself a form of research misconduct.
Follow the link for a more detailed discussion of “Conflicts of Interest in Human Subjects Research” by Robin Fiore Ph.D. Florida Atlantic University. This excellent paper is published in the CITI program for the protection of human research subjects.
University of Miami CoI Policies
- University of Miami CoI Policy
- Clarification of UM CoI Policy
- Additional information on conflict of Interest at the University of Miami
Web resources on conflicts of interest
Bioethics resources on the web
http://www.nih.gov/sigs/bioethics/conflict.htmlObjectivity in Research - NIH GUIDE, Volume 24, Number 25, July 14, 1995. Provides regulations establishing standards and procedures to be followed by institutions that apply for research to ensure that the design, conduct, or reporting of research funded under PHS grants, cooperative agreements or contracts will not be biased by any conflicting financial interest of those investigators responsible for the research.
NIH Policy on Financial conflict of Interest http://grants2.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm
NSF COI Policy
http://www.nsf.gov/bfa/cpo/gpm95/ch5.htm#ch5-6FDA "Guidance: Financial Disclosure by Clinical Investigators" (March 20, 2001)
http://www.fda.gov/oc/guidance/financialdis.htmlGAO "Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest" (November 2001)
http://www.aau.edu/research/gao.pdf (PDF)NIH Guide - Financial Conflicts of Interest and Research Objectivity: Issues for Investigators and Institutional Review Boards, June 5, 2000
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-040.htmlOHRP Draft Interim Guidance - Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider When Dealing with Issues of Financial Interests and Human Subject Protection
http://ohrp.osophs.dhhs.gov/nhrpac/mtg12-00/finguid.htm
CoI STATEMENTS from ASSOCIATIONS
AAMC Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research (Adopted by the Executive Council of the AAMC February 22, 1990)
http://www.aamc.org/research/dbr/coi.htmAAMC Task Force on Financial Conflicts of Interest in Clinical Research
http://www.aamc.org/members/coitfAAMC Task Force on Financial Conflicts of Interest in Clinical Research - Charter and Charge
http://www.aamc.org/members/coitf/chartercharge.htmAAMC Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research
http://www.aamc.org/research/dbr/coi.htmAAU Report on Individual and Institutional Conflict of Interest
http://www.aau.edu/research/conflict.html
Other Information
AHRP CoI
http://www.researchprotection.org/COI/COI.htmlNIH Conflict of Interest Workshop Summary
http://grants.nih.gov/grants/policy/coi/COIworkshopsum.doc (MS Word) http://grants.nih.gov/grants/policy/coi/COIworkshopsum.pdf (PDF)NCURA: Conflict of Interest: What's An Institution to Do?
(Article by Beth H Israel, Executive Director, Office of Projects and Grants for Columbia University)
http://www.ncura.edu/newsroom/newsletters/dec01/COI.doc (MS Word)Washington Fax Article: AAMC conflict of interest proposal puts rebuttal burden on "financially interested" researchers (12/20/2001)
http://www.washingtonfax.com/samples/2001/20011220a.htmlFrom the Canadian Medical Association Journal - Bioethics for clinicians: 17. Conflict of interest in research, education and patient care (CMAJ 1998;159:960-5)
http://www.cmaj.ca/cgi/reprint/159/8/960.pdfFrom Activism and Medicine "An Incomplete Bibliography of Online Readings Related to Conflicts of Interest" (articles from 1999 to 2002)
http://home.cwru.edu/activism/conflictbib.htmlFrom the New England Journal of Medicine, an article entitled "Institutional Conflict of Interest" Volume 332(4) 26 Jan 1995 pp 262-267
http://www.med.utah.edu/ethics/RCREthics/emanuel.htmlSummary of Federal Laws Governing Independent Colleges and Universities from the Catholic University of America Office of General Counsel
http://counsel.cua.edu/FEDLAW/index.htmNIH Site Visit Mock Interview Questions
http://www.ncura.edu/resources/Annualslides/Admin-NIHSITEVISITMOCKINTERVQUESTIONS.doc (MS Word)Speech on Conflict of Interest in Biomedical Research by David Korn, M.D.
http://ohrp.osophs.dhhs.gov/coi/korn.htmHarvard University Press Release (1/23/01)
http://www.hms.harvard.edu/news/releases/conflict_guidelines.html