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executive summary

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

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APPENDIX C

Conflict of Interest Resources

Federal

NIH Guide – Objectivity in Research

Miscellaneous CoI Information from the NIH Office of Extramural Research

Frequently Asked Questions Concerning the Department of Health and Human Services Objectivity in Research Regulations and the National Science Foundation Investigator Financial Disclosure Policy

NIH Site Visit Mock Interview Questions

NIH Guide – Financial Conflicts of Interest and Research Objectivity: Issues for Investigators and Institutional Review Boards, June 5, 2000

NSF COI Policy

FDA “Guidance: Financial Disclosure by Clinical Investigators” (March 20, 2001)

GAO “Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest” (November 2001)

Department of Veterans Affairs - Conflict of Interest in Research Handbook 1200.13

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

Associations/Societies

AAMC Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research

AAMC Task Force on Financial Conflicts of Interest in Clinical Research – Individual and Institutional Guidance

Washington Fax Article: AAMC conflict of interest proposal puts rebuttal burden on “financially interested researchers” (12/20/01)

Association of American Universities – Conflict of Interest Resources

International Society for Pharmacoeconomics and Outcomes Research – Code of Ethics for Researchers

American Society of Clinical Oncology – Oversight of Research and Conflict of
Interest Policies

American Anthropological Association – Ethics

American Political Science Association – A Guide to Professional Ethics in Political Science

American Sociological Association Code of Ethics

Ethical issues in CME, Clinical Research – From the May 2001 ACP-ASIM Observer, 2001

Medical Professionalism Project

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

Summary of Federal Laws Governing Independent Colleges and Universities
from the Catholic University of America Office of General Counsel

Stanford University – Conflicts of Interest Resource

Harvard University – Conflicts of Interest Resource

University of New Hampshire Policy on Financial Conflict of Interest in Research

University of Michigan Conflict-of-Interest Policy

Other

Uniform Requirements for Manuscripts Submitted to Biomedical Journals

Canadian Medical Association Journal – Bioethics for clinicians: 17. Conflict of interest in research, education and patient care (CMAJ 1998; 159:960-5)

Activism and Medicine. “An Incomplete Bibliography of Online Readings Related to Conflicts of Interest” (articles from 1999 to 2002)

Responsible Research: A Systems Approach to Protecting Research Participants, Institute of Medicine, October 2002

Sounding Board, “Nonfinancial Conflicts of Interest in Research,” New England Journal of Medicine, September 2002, Vol. 347, No. 10, pp. 759-61.

Drazen, J.M. and G.D. Curfman, “Financial Associations of Authors,” New England Journal of Medicine, June 2002, Vol. 346, No. 24, pp. 1901-02.

Sounding Board, “Maintaining the Public Trust in Clinical Research,” New England Journal of Medicine, January 2002, Vol. 346, No. 4, pp. 285-7.

Lo, B. et al. “Conflict-of-Interest Policies for Investigators in Clinical Trials,” New England Journal of Medicine, Vol. 343, No. 22, pp. 1616-20, November 2000

Emanuel, E., and D. Steiner. “Institutional Conflict of Interest,” New England Journal of Medicine, January 1995, Vol. 332, No. 4: pp. 262-7.

Speech on Conflict of Interest in Biomedical Research by David Korn, MD

Southwest Oncology Group Conflict of Interest Policy

Fred Hutchinson Cancer Research Center Conflict of Interest

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