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introduction
conflicts of interest
distinctive characteristics of HSR
guiding values
ethical guidelines
analyzing a potential conflict of interest
implementation and enactment of the guidelines
conclusion
academyhealth ethical guidelines committee
committee action
conflict of interest resources
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APPENDIX C

Conflict of Interest Resources

Federal

  • • NIH Guide – Objectivity in Research
    http://grants2.nih.gov/grants/guide/notice-files/not95-179.html
  • • Miscellaneous CoI Information from the NIH Office of Extramural Research
    http://grants1.nih.gov/grants/policy/coi
  • • Frequently Asked Questions Concerning the Department of Health and Human Services Objectivity in Research Regulations and the National Science Foundation Investigator Financial Disclosure Policy http://grants1.nih.gov/grants/policy/coifaq.htm
  • • NIH Site Visit Mock Interview Questions
    http://www.ncura.edu/resources/Annualslides/Admin-NIHSITEVISITMOCKINTERVQUESTIONS.doc
  • • 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.html
  • • NSF COI Policy
    http://www.nsf.gov/bfa/cpo/gpm95/ch5.htm#ch5-6
  • • FDA “Guidance: Financial Disclosure by Clinical Investigators” (March 20, 2001)
    http://www.fda.gov/oc/guidance/financialdis.html
  • • GAO “Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest” (November 2001)
    http://www.aau.edu/research/gao.pdf
  • • Department of Veterans Affairs – Conflict of Interest in Research Handbook http://www.vard.org/forms/coi.htm
  • • OHRP 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

Associations/Societies

  • • AAMC Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research
    http://www.aamc.org/research/dbr/coi.htm
  • • AAMC Task Force on Financial Conflicts of Interest in Clinical Research – Individual and Institutional Guidance
    http://www.aamc.org/members/coitf/
  • • Washington Fax Article: AAMC conflict of interest proposal puts rebuttal burden on “financially interested researchers (12/20/01)
    http://www.washingtonfax.com/samples/2001/20011220a.html
  • • Association of American Universities – Conflict of Interest Resources http://www.aau.edu/research/conflict.html
  • • International Society for Pharmacoeconomics and Outcomes Research – Code of Ethics for Researchers http://www.ispor.org/workpaper/code_ethic.htm
  • • American Society of Clinical Oncology – Oversight of Research and Conflict of Interest Policies http://www.asco.org/ac/1,1003,_12-002144-00_18-0027455-00_19-0027456-00_20-001,00.asp
  • • American Anthropological Association – Ethics http://www.aaanet.org/committees/ethics/ethics.htm
  • • American Political Science Association – A Guide to Professional Ethics in Political Science http://www.apsanet.org/pubs/ethics.cfm
  • • American Sociological Association Code of Ethics http://www.asanet.org/members/ecoderev.html
  • • Ethical issues in CME, Clinical Research – From the May 2001 ACP-ASIM Observer, 2001
    http://www.acponline.org/journals/news/may01/ethicalprobs.htm
  • • Medical Professionalism Project
    http://www.professionalism.org

Universities

  • • 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
    www.ncura.edu/newsroom/newsletters/dec01/COI.doc
  • • Summary of Federal Laws Governing Independent Colleges and Universities from the Catholic University of America Office of General Counsel
    http://counsel.cua.edu/FEDLAW/index.htm
  • • Stanford University – Conflicts of Interest Resource http://www.stanford.edu/dept/DoR/Resources/coi.html
  • • Harvard University – Conflicts of Interest Resource http://www.hms.harvard.edu/integrity/conf.html#2s
  • • University of New Hampshire Policy on Financial Conflict of Interest in Research
    http://www.unh.edu/orps/Policies/financial_conflict_of_interest.htm
  • • University of Michigan Conflict-of-Interest Policy http://www.research.umich.edu/policies/um/conflict_procedures.html

Other

  • • Uniform Requirements for Manuscripts Submitted to Biomedical Journals http://www.icmje.org/index.html#ethic
  • • Canadian Medical Association Journal – Bioethics for clinicians: 17. Conflict of interest in research, education and patient care (CMAJ 1998;159:960-5)
    http://www.cma.ca/cmaj/series/bio-palm/bioethics17.htm
  • • 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.html
  • • Responsible Research: A Systems Approach to Protecting Research Participants, Institute of Medicine, October 2002
    http://www.nap.edu
  • • Sounding Board, “Nonfinancial Conflicts of Interest in Research” New England Journal of Medicine, Vol. 347(10): 759-61, September 2002
  • • Editorial, “Financial Associations of Authors” New England Journal of Medicine, Vol. 346(24):1901-02, June 2002
    http://content.nejm.org/cgi/content/full/346/24/1901
  • • Sounding Board, “Maintaining the Public Trust in Clinical Research” New England Journal of Medicine, Vol. 346(4):285-87, January 2002
  • • Lo, B, Wolf, L, Berkeley, A. “Conflict-of-Interest Policies for Investigators in Clinical Trials” New England Journal of Medicine, Vol. 343(22):1616-20, November 2000
    http://content.nejm.org/cgi/content/short/343/22/1616
  • • Emanuel, E, Steiner, D. “Institutional Conflict of Interest” New England Journal of Medicine, Vol. 332(4): 262-67, January 1995
    http://www.med.utah.edu/ethics/RCREthics/emanuel.html
  • • Speech on Conflict of Interest in Biomedical Research by David Korn, MD
    http://ohrp.osophs.dhhs.gov/coi/korn.htm
  • • Southwest Oncology Group Conflict of Interest Policy http://swog.org/Visitors/Policies.asp
  • • Fred Hutchinson Cancer Research Center Conflict of Interest www.fhcrc.org/admin/hr/pppm/p0911.htm

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