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Patient Outcomes Research Teams: Managing Conflict of Interest References Agency for Health Care Policy and Research (AHCPR). Program Note. Medical Treatment Effectiveness Research. Rockville, Md.: AHCPR, March 1990. American Medical Association Councils on Scientific Affairs and on Ethical and Judicial Affairs. Conflicts of Interest in Medical Center/Industry Research Relationships. Journal of the American Medical Association 263:2790–2793, 1990. American Medical Association Council on Ethical and Judicial Affairs. Gifts to Physicians From Industry. Journal of the American Medical Association 265:501, 1991. Asch, D. PORT Research Compared to Clinical Research: Conflicts of Interest in Patient Outcomes Research. Paper commissioned for the IOM study of conflicts of interest in PORTs, 1990. Association of Academic Health Centers (AAHC). Conflicts of Interest in Academic Health Centers. Policy Paper No. 1. Washington, D.C.: AAHC, 1990. Association of American Medical Colleges (AAMC). Guidelines for Dealing with Faculty Conflicts of Commitment and Conflicts of Interest in Research. Washington, D.C.: AAMC, February 1990. Avorn, J., Cehn, M. and Hartley, R. Scientific Versus Commercial Sources of Influences on the Prescribing behavior of Physicians. American Journal of Medicine 73:4–8, 1982. Barber, B. The Logic and Limits of Trust. New Brunswick, N.J.: Rutgers University Press, 1983. Bergner, M. Advances in Health Status Measurement: The Potential to Improve Experimental and Non-Experimental Data Collection. Pp. 23–32 in Vol. I Medical Innovation at the Crossroads: Modern Methods of Clinical Investigation. Gelijns, A.C., ed. Washington, D.C.: National Academy Press, 1990. Blumenthal, D., Gluck, M., Louis, K., et al. Industrial Support of University Research in Biotechnology. Science 231:242-231, 1986a. Blumenthal, D., Gluck, M., Louis, K., et al. University-Industry Research Relationships in Biotechnology: Implications for the University . Science 232:1361–1366, 1986b. Booth, W. Conflict of Interest Eyed at Harvard. Science 242:1497–99, 1988. Cantekin, E.I., McGuire, T.W., and Potter, R.L. Biomedical Information, Peer Review, and Conflict of Interest as They Influence Public Health. Journal of the American Medical Association 263:1427–1430, 1990. Colloton, J.W. Academic Medicine's Changing Covenant with Society. Academic Medicine 64:55–60, 1989. Culliton, B. NIH, Inc.: The CRADA Boom. Science 245:1034–1036, 1989. Deyo, R.A., Cherkin, D., and Conrad, D. The Back Pain Outcome Assessment Team. Health Services Research 25:733–737, 1990. Department of Health and Human Services (DHHS). Standards of Conduct . Regulations

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Patient Outcomes Research Teams: Managing Conflict of Interest Which Apply to All HHS Officers and Employees. Personnel Pamphlet Series No. 6. Washington, D.C.: Government Printing Office, 1989a. DHHS. NIH Guide For Grants and Contracts. Special Issue. Bethesda, Md.: DHHS, September 15, 1989b. Eddy, D.M. Variations in Physician Practice: The Role of Uncertainty. Health Affairs 3:73–89, Summer 1984. Eddy, D.M. Should We Change the Rules for Evaluating Medical Technologies? Pp. 117–134 in Vol. 1. Medical Innovation at the Crossroads: Modern Methods of Clinical Investigation. Gelijns, A.C., ed. Washington, D.C.: National Academy Press, 1990. Eddy, D.M., Hasselblad, V., and Shachter, R. An Introduction to a Bayesian Method for Meta-Analysis: The Confidence Profile Method. Pp. 101–116 in Vol. 1. Medical Innovation at the Crossroads: Modern Methods of Clinical Investigation. Gelijns, A.C., ed. Washington, D.C.: National Academy Press, 1990. Eisenberg, R.S. Academic Freedom and Academic Values in Sponsored Research. Texas Law Review 66:1363–1404, 1988. Frankel, M.S. Preface. Pp. i–iv in Biotechnology: Professional Issues and Social Concerns, DeForest, P., Frankel, M.S., Poindexter, J.S., and Weil, V., eds. Washington, D.C.: American Association for the Advancement of Science, 1988. Freund, D.A., Dittus, R.R., Fitzgerald, J., et. al. Assessing and Improving Outcomes: Total Knee Replacement. Health Services Research 25:723–726, 1990. Fries, J.F. and Spitz, P. The Hierarchy of Patient Outcomes. Pp. 25–35 in Quality of Life Assessments in Clinical Trials. Spilker, B., ed. New York City, N.Y.: Raven Press, 1990. Fuchs, V.R. and Garber, A.M. The New Technology Assessment. New England Journal of Medicine 323:673–677, 1990. Gluck, M.E., Blumenthal, D., and Stoto, M.A. University-Industry Relationships in the Life Sciences: Implications for Students and Post-Doctoral Fellows. Research Policy 16:327–336, 1987. Grobstein, C. Academic-Corporate Interactions: Is There an Indirect Alternative? Pp. 43–48 in Biotechnology: Professional Issues and Social Concerns. DeForest, P., Frankel, M.S., Poindexter J.S., and Weil, V., eds. Washington, D.C.: American Association for the Advancement of Science, 1988. Gunsalus, C.K., and Brown, J. Conflict of Interest in the University Setting: I Know It When I See It. Research Management Review 13–25, Fall 1989. Hamburg, D.A. and Nightingale, E.O. Science for Health in the Future. Health Affairs 3:94–109, Winter 1984. Hanna, K. Collaborative Research in Biomedicine: Resolving Conflicts. Pp. 33–47 in Government and Industry Collaboration in Biomedical Research and Education. Washington, D.C.: National Academy Press, 1989. Harvard University Faculty of Medicine. Policy on Conflicts of Interest and Commitment. Cambridge, Mass.: March, 1990. Healy, B., Campeau, L., Gray, R., et al. Conflict of Interest Guidelines for a Multicenter Clinical Trial of Treatment after Coronary-Artery Bypass-Graft Surgery. New England Journal of Medicine 320:949–951, 1989. Inman, W.H. Prescription-Event Monitoring: An Example of Total Population Post-Marketing Drug Surveillance. Pp. 68–77 in Vol. 1. Medical Innovation at the Crossroads: Modern Methods of Clinical Investigation. Gelijns, A.C., ed. Washington, D.C.: National Academy Press, 1990. Institute of Medicine (IOM). The Responsible Conduct of Research in the Health Sciences . Washington, D.C.: National Academy Press, 1989. IOM. Clinical Practice Guidelines: Directions for a New Program. Field, M.J. and Lohr, K.N., eds. Washington, D.C.: National Academy Press, 1990.

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Patient Outcomes Research Teams: Managing Conflict of Interest Journal of the American Medical Association. Instructions for Authors. 264:1054, 1990. Jenike, M.A. (Letter to the editor) Relations Between Physicians and Pharmaceutical Companies: Where to Draw the Line. New England Journal of Medicine 322:557, 1990. Johns Hopkins University School of Medicine (JHUSM). Faculty Policies . Baltimore, Md.: JHUSM, 1990. Krimsky, S. University Entrepreneurship and the Public Purpose. Pp. 34–42 in Biotechnology: Professional Issues and Social Concerns. DeForest, P., Frankel, M.S., Poindexter, J.S., and Weil, V., eds. Washington, D.C.: American Association for the Advancement of Science, 1988. Lave, J. PORTs: Their Impact on Health Services Research, Technology Innovation, and Payment Policy. Paper commissioned for the IOM study of conflicts of interest in PORTs, 1990. Lohr, K.N. Outcome Measurement: Concepts and Questions. Inquiry 25:37–50, 1988. Louis, K., Blumenthal, D., Gluck, M.E., et al. Entrepreneurs in Academe: An Exploration of Behaviors Among Life Scientists. Administrative Science Quarterly 34:110–131, 1989. Lundberg, G.D. Statement before the U.S. Congress, House Committee on Government Operations. Is Science for Sale? Conflicts of Interest vs. the Public Interest. Washington, D.C.: U.S. Government Printing Office, 1989. Lundberg, G.D., and Flanagin, A. New Requirements for Authors: Signed Statements of Authorship Responsibility and Financial Disclosure. Journal of the American Medical Association 262:2003–2004, 1989. Lurie, N., Rich, E.C., Simpson, D.E., et al. Pharmaceutical Representatives in Academic Medical Centers: Interaction with Faculty and Housestaff. Journal of General Internal Medicine 5:240–243, 1990. MacCordy, E.L. The Impact of Proprietary Arrangements on Universities. Pp. 12–19 in Biotechnology: Professional Issues and Social Concerns . DeForest, P., Frankel, M.S., Poindexter J.S., and Weil, V., eds. Washington, D.C.: American Association for the Advancement of Science, 1988. Marshall, E. When Commerce and Academe Collide. News and Comment 248:152–156, 1990. McNeil, B., and Roberts, M. The Evolution and Current Status of Conflict of Interest Regulation in Biomedical Science. Paper commissioned for the IOM study of conflicts of interest in PORTs, 1990. Morris, D.J. (Letter to the editor) A Call About Erythropoietin: Conflict of Interest or Investment Opportunity? Journal of the American Medical Association 264:334, 1990. Mulley, A.G. Jr. The Role of Decision Analysis in the Translation of Research Findings into Clinical Practice. Pp 78–87 in VoL 1 Medical Innovation at the Crossroads: Modern Methods of Clinical Investigation . Gelijns, A.C., ed. Washington, D.C.: National Academy Press, 1990. National Institutes of Health/Alcohol, Drug Abuse and Mental Health Administration (NIH/ADAMHA). Cooperative Research and Development Agreement. Patent Policy Board, April 24, 1989a. NIH/ADAMHA. Policy Statement on Cooperative Research and Development Agreements and Intellectual Property Licensing. Patent Policy Board, March 27, 1989b. National Research Council (NRC). The National Research Council Policy on Potential Sources of Bias and Conflict of Interest in Studies and Related Activities. Washington, D.C., November 1, 1989. Office of Technology Assessment (OTA). The Impact of Randomized Clinical Trials on Health Policy and Medical Practice. Washington, D.C.: U.S. Government Printing Office, 1983.

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Patient Outcomes Research Teams: Managing Conflict of Interest Pashos, C.L. and McNeil, B.J. Consequences of Variation in Treatment for Acute Myocardial Infarction. Health Services Research 25:717–722, 1990. Patrick, D.L. Assessing Health-Related Quality of Life Outcomes. Pp. 137–151 in Effectiveness and Outcomes in Health Care. Washington, D.C.: National Academy Press, 1990. Patrick, D.L., and Bergner, M. Measurement of Health Status in the 1990s. Annual Review Public Health 11:165–83, 1990. Patrick, D.L., and Deyo, R.A. Generic and Disease-Specific Measures in Assessing Health Status and Quality of Life. Medical Care 27(Suppl):S217–232, 1989. Public Health Service. PHS Grants Policy Statement. DHHS Pub. No. (OASH) 82–50,000 (rev.). Washington, D.C., January 1987. Relman, A.S. (Editorial) Economic Incentives in Clinical Investigation. New England Journal of Medicine 320:933–934, 1989. Relman, A.S. New ''Information for Authors"—and Readers. New England Journal of Medicine 324:56, 1990. Rettig, R. Medical Technology in a Changing Health Care Environment. Pp. 98–117 in Charting the Future of Health Care. Meyer, J.E., and Lewin, M. E., eds. Washington, D.C.: American Enterprise Institute for Public Policy Research, 1987. Rodwin, M.A. Physicians' Conflicts of Interest. New England Journal of Medicine 321:1405–1408, 1989. Roper, W.L., Winkenwerder, W., Hackbarth, G.M., et al. Effectiveness in Health Care. An Initiative to Evaluate and Improve Medical Practice. New England Journal of Medicine 319:1197–1202, 1988. Schonberg, S.E. (Letter to the editor) Relations Between Physicians and Pharmaceutical Companies: Where to Draw the Line. New England Journal of Medicine 323:200, 1990. Schroeder, S.A., Zones, J.S., and Showstack, J.A. Academic Medicine as a Public Trust. Journal of the American Medical Association 262:803–812, 1989. Spilker, B., ed. Quality of Life Assessments in Clinical Trials. New York City, N.Y.: Raven Press, 1990. Steinberg, E.P., Bergner, M., Sommer, A., et al. Variations in Cataract Management: Patient and Economic Outcomes. Health Services Research 25:727–731, 1990. Thacker, S.B. Meta-Analysis: A Quantitative Approach to Research Integration. Pp. 88–100 in Vol I Medical Innovation at the Crossroads: Modern Methods of Clinical Investigation. Gelijns, A.C., ed. Washington, D.C.: National Academy Press, 1990. Thomas, L. The Youngest Science. New York, N.Y.: The Viking Press, 1983. U.S. Congress, House Committee on Government Operations. Federal Response to Misconduct in Science: Are Conflicts of Interest Hazardous to Our Health? Hearing before a Subcommittee of the Committee on Government Operations, House of Representatives, September 29, 1988. Washington, D.C.: U.S. Government Printing Office, 1989a. U.S. Congress, House Committee on Government Operations. Is Science for Sale? Conflicts of Interest vs. the Public Interest. Hearing before a subcommittee of the Committee on Government Operations, House of Representatives, June 13, 1989. Washington, D.C.: U.S. Government Printing Office, 1989b. U.S. Pharmacopeial Convention. Section 9 in Rules and Procedures of the General and Executive Committees of Revision for 1990–1995 , Standards of Conduct. n.p. n.d. Wennberg, J.E. Dealing with Medical Practice Variations: A Proposal for Action. Health Affairs 3:6–21, Summer 1984. Wennberg, J.E. The Structure and Methods of PORTs: Sources of Bias. Paper

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