Advanced search
Publication Cover
Accountability in Research
Ethics, Integrity and Policy
Volume 10, 2003 - Issue 3
Submit an article Journal homepage
150
Views
19
CrossRef citations to date
0
Altmetric
Reviews

Research Accountability and Financial Conflicts of Interest in Industry Sponsored Clinical Research: A Review

Patricia M. Tereskerz Center for Biomedical Ethics, University of Virginia, School of Medicine, Charlottesville, VA, USA
Pages 137-158 | Published online: 08 Sep 2010

  • American Association of Medical Colleges (AAMC) . 2002 . Protecting subjects, preserving trust, promoting progress II: Principles and recommendations for oversight of an institution's financial interests in human subjects research . October Available at http://www.aamc.org/members/coitf/.
  • Andrews , L. B. 2000 . Money is putting people at risk in biomedical research . Chronicle of Higher Education , 10 March : B4
  • Angell , M. 2000 . Is academic medicine for sale? . New England Journal of Medicine , 342 : 508 – 510 .
  • 2003a . JAMA Decries Early End to Study . Wall Street Journal , 23 April : D4 Associated Press
  • Associated Press. (6/9/2003a). Harvard may relax policies on financial ties to drug companies [cited 9 June 2003]. Available from http://www.boston.com.
  • Association of American Universities . October 2001a . Task Force on Research Accountability , Report on individual and institutional financial conflicts of interest October ,
  • Association of American Universities . 2001b . Framework document on Managing Financial Coi's . October [cited May 1993] Available from http://www.aau.edu/reports/ frwkCOI'S.html
  • AUTM Licensing Survey FY . 1999 . Survey Summary. , 17 Northbrook, Ill : Association of University Technology Managers 2000 .
  • Bekelman , J. E. , Yan , L. and Gross , C. P. 2003 . Scope and impact of financial coi's in biomedical research. . The Journal of the American Medical Association , 289 : 454 – 65 .
  • Bero , L. A. and Rennie , D. 1996 . Influences on the quality of published drug studies . Int J Technol Assess Health Care , 12 (2) : 209 – 37 .
  • Birch , D. M. and Cohn , G. 24 June 2001a . How a cancer trial ended in betrayal with billions at stake, research universities become partners in commerce-and medicine pays a price. , Series: Of patients and profits 24 June , WL 6162959 : The Baltimore Sun .
  • Birch , D. M. and Cohn , G. 25 June 2001b . The changing creed of Hopkins science. What once was heresy is now the mission: a partnership with business to advance research , Series: Of profits and patients 25 June , WL 6162994 : The Baltimore Sun .
  • Birch , D. M. and Cohn , G. 26 June 2001c . Standing up to industry as corporations increasingly hold their purse strings, many researchers feel pressed to deliver favorable results , 26 June , WL 6163085 : Baltimore Sun .
  • Blumenthal , D. 1997 . Withholding research results in academic life science: With holding evidence from a national survey of faculty. . The Journal of the American Medical Association , 277 : 1224 – 8 .
  • Blumenthal , D. , Campbell , D. G. , Causion , N. and Seashore , L. K. 1996 . Participation of life-science faculty in research relationships with industry . New England Journal of Medicine , 335 : 1734 – 9 .
  • Board , W. and Wade , N. 1982 . Betrayers of the truth. , New York : Simon and Schuster .
  • Bodenheimer , T. 2000 . Uneasy alliance-clinical investigators and the pharmaceutical industry . New England Journal of Medicine , 342 : 1539 – 44 .
  • Boyd , E. and Bero , L. 2000 . Assessing faculty financial relationships with industry: A case study. . The Journal of the American Medical Association. , 184 : 2209 – 14 .
  • Brennan , T. A. 1994 . Buying editorials. . New England Journal of Medicine. , 331 (10) : 673 – 5 .
  • Bruce , M. P. and Rennie , D. 2003 . Stopping medical research to save money. . A broken pact with researchers and patients. The Journal of the American Medical Association. , 289 : 2128 – 31 .
  • Bulkeley , W. M. 2000 . Publication broke rules on disclosure . Wall Street Journal , 24 February WLWSJ 3019181
  • Chalmers , I. 1990 . Underreporting research is scientific misconduct. . The Journal of the American Medical Association , 263 : 105 – 8 .
  • Chaudhry , S. , Schroter , S. , Smith , R. , DeAngelis , C. , Drazen , J. , Hoey , J. , Hojgaard , L. , Horton , R. , Kotzin , S. , Nicholls , M. , Nylenna , M. , Overbeke , A. , Sox , H. , Van Der Weyden , M. and Wilkes , M. 2002 . Does declaration of competing interests affect readers' perceptions? A randomized trial. . BMJ , 325 : 1391 – 2 .
  • Cho , M. , Shohara , R. , Schissel , A. and Drummond , R. 2000 . Policies on faculty coi's at U.S. universities. . The Journal of the American Medical Association. , 284 (1) : 2203 – 8 .
  • Council on Governmental Relations . 1999 . The Bayh-Dole Act: A Guide to the Law and Implementing Regulations . September
  • Davidoff , F. and others . 2001 . Sponsorship, authorship, and accountability. . New England Journal of Medicine. , 343 : 1621 – 6 .
  • Davidson , R. A. 1986 . Source of funding and outcome of clinical trials. . Journal of General Internal Medicine. , 1 : 155 – 8 .
  • DeAngelis , C. D. 2000 . Coi's and the public trust . The Journal of the American Medical Association , 284 : 2237 – 8 . (And articles cited therein)
  • Department of Health and Human Services (DHHS) . 2003 . Draft "Financial relationships and interest in research involving human subjects: guidance for human subject protection . 31 March
  • Drazen , J. M. 2002 . Institutions, contracts, and academic freedom. . New England Journal of Medicine. , 347 : 132 – 1363 .
  • Drazen , J. M. and Curfman , G. 2002 . Financial associations of authors. . New England Journal of Medicine. , 346 (24) : 1901 – 2 .
  • Duecker , K. S. 1997 . Biobusiness on campus: Commercialization of university-developed biomedical technologies . Food and Drug L J. , 52 : 453
  • Emanuel , E. and Steiner , D. 1995 . Institutional conflict of interest. . New England Journal of Medicine. , 332 : 262 – 7 .
  • Flanagin , A. , Carey , L. A. , Fontanarosa , P. B. , Phillips , S. , Pace , B. , Lundberg , G. and Rennie , D. 1998 . Prevalence of articles with honorary authors and ghost authors in peer-reviewed medical journals. . The Journal of American Medical Association. , 280 : 222 – 4 .
  • Food and Drug Administration (FDA) . 2001 . Guidance for industry: Choice of control group and related issues in clinical trials .
  • Friedberg , M. , Saffran , B. , Stinson , T. J. , Nelson , W. and Benn , C. L. 1999 . Evaluation of coi's in economic analyses of new drugs used in oncology. . The Journal of American Medical Association. , 282 : 1453 – 7 .
  • General Accounting Office (GAO) . 2001 . Report to the ranking minority member. Subcommittee on Public Health, Committee on Health, Education, Labor, and Pensions . U.S. Senate , November GAO-02-89
  • Guidelines for Dealing with Faculty Conflicts of Commitment and Coi's in Research. (1990) , Washington DC : AAMC .
  • Guterman , L. 2001 . 12 medical journals issue joint policy on research supported by business . Chronicle of Higher Education , 5 October
  • Harvard Medical School Office of Public Affairs . 2001 . News release. Leading NIH-funded medical schools agree on guidelines that would strengthen coi's policies of virtually all schools, hospitals, and research institutes [cited 8 February]. Available from: http://www.hms.harvard.edu/news/releases/020901 conflict.html. Consensus statement on co's policies for academic institutions. Available from http:// www.hms.harvard.edu/news/releases/conflictguidelines.html
  • 1990 . Hippocrates Meets Mammon . The Economist Newspaper Ltd , September 22 : 95
  • International Committee of Medical Journal Editors . 2001 . Uniform requirements for manuscripts submitted to biomedical journals . Available at http://www.icmje.org
  • Kelves , D. J. 2001 . Principles, property rights, and profits: Historical reflections on university/industrial tensions. . Accountability in Research , 8 (4) : 293 – 307 .
  • Krimsky , S. 1999 . Coi's and cost-effectiveness analysis. . The Journal of American Medical Association , 282 : 1474 – 5 .
  • Krimsky , S. and Rothenberg , L. S. 2001 . Coi's policies in science and medical journals: editorial practices and author disclosures. . Science and Engineering Ethics. , 7 : 205 – 18 .
  • Krimsky , S. , Rothenberg , L. S. , Stott , P. and Kyle , G. 1998 . Scientific journals and their authors' financial interests: a pilot study. . Psychother. Psychosom. , 67 : 194 – 201 .
  • Kuszler , P. C. 2001 . Curing coi's in clinical research: Impossible dreams and harsh realities . Widener L. Symp. J. , 8 : 115
  • Lawrence , Arthur J. 2001 . Assistant Surgeon General from Mary Faith Marshall . Chairperson for NHRPA, 23 August correspondence available from http://ohrp.osophs.dhhs.gov/nhrpac/doc≍report.htm
  • Lexchin , J. , Bero , L. A. , Djulbegovic , B. and Clark , O. 2003 . Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. . BMJ. , 326 : 1167 – 70 .
  • Lo , B. , Wolf , L. E. and Berkeley , A. 2000 . Conflict-of-interest policies for investigators in clinical trials. . New England Journal of Medicine , 343 : 1616 – 20 .
  • Maatz , C. T. 1993 . University physician-research coi's: The inadequacy of current controls and proposed reform. . High Tech. L. J. , 7 : 137 – 88 .
  • Martin , J. and Kasper , D. L. 2000 . In whose best interest? Breaching the academic-industrial wall. . New England Journal of Medicine , 343 : 2646 – 9 .
  • McCrary , S. V. , Anderson , C. B. Jakovlijevic , J. 2000 . A national survey of policies on disclosure of coi's in biomedical research. . New England Journal of Medicine , 343 : 1621 – 6 .
  • Miller , F. H. 2001 . Trusting doctors: Tricky business when it comes to clinical research. . B.U.L. Rev. , 81 : 421 – 43 .
  • Moses , H. and Martin , J. B. 2001 . Academic relationships with industry: A new model for biomedical research. . The Journal of American Medical Associates , 285 : 933 – 5 .
  • Nathan , D. G. and Weatherall , D. J. 2002 . Academic freedom in clinical research. . New England Journal of Medicine , 347 (17) : 1368 – 71 .
  • National Institutes of Health (NIH) . 2000 . Conference on Human Subject Protection and Financial Conflicts of Interest Transcript. J Sugarman. Raising Ethical Questions Concerning Conflict of Interest Throughout the Process of Clinical Research [cited 16 August] . Available from http://ohrp.osophs.dhhs.gov/coi8-15.html
  • Office of Inspector General . 2000 . Recruiting human subjects: sample guidelines for practice . : 1 – 23 .
  • Office of Inspector General . 2000 . Recruiting human subjects: pressures in industry sponsored clinical research . June : 1 – 79 .
  • PhRMA adopts principles for conduct of clinical trials and communication of clinical trial results. (2001). Available from http://www.phrma.org.
  • Public Health Service . 1995 . Responsibility of applicants for promoting objectivity in research. http://grants.nih.gov/grants/guide/notice-files/not95-179.html
  • Public Health Service . 2001 . Draft interim guidance. Financial relationships in clinical research: Issues for institutions, clinical investigators, and IRBs to consider when dealing with issues of financial conflicts of interests and human subject protection [cited 10 January 2001] . Available from http://ohrp.osophs.dhhs.gov/nhrpac/mtg12-00/finguid.html
  • Rochon , P. A. , Berger , P. B. and Gordon , M. 1998 . The evolution of clinical trials: Inclusion and representation. . CMAJ , 159 : 1372 – 4 .
  • Rodwin , M. 1993 . Medicine, money, and morals , 225 Oxford University Press .
  • Schulman , K. A. , Seils , D. M. Timbie , J. W. 2002 . A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. . New England Journal of Medicine. , 347 (17) : 1335 – 41 .
  • Shamoo , A. E. and Resnik , D. B. 2003 . Responsible Conduct of Research. , London : Oxford University Press .
  • Spece , R. G. , Shim , D. S. and Buchanan , A. E. 1996 . Conflicts of interest in clinical practice and research. , New York : Oxford University Press .
  • Stelfox , H. T. , Chua , G. , O'Rourke , K. and Detsky , A. S. 1998 . Coi's in the debate over calcium-channel antagonists. . New England Journal of Medicine , 338 : 101 – 6 .
  • Stolberg , S. G. 2000 . Teenager's death is shaking up field of human gene-therapy experiments . New York Times , 27 January WL 12394777
  • Stolberg , S. G. 2001 . Scientists often mum about ties to industry . New York Times , 25 April
  • Tereskerz, P. M. and J. D. Moreno (n.d.) Ten Steps to Developing a National Agenda to Address Financial Coi's in Industry Sponsored Clinical Research. Submitted for publication.
  • Thompson , J. , Baird , P. and Downie , J. 2002 . Report of the committee of inquiry on the case involving Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. Toronto: Canadian Association of University Teachers, 2001 cited in Nathan, DG and Weatherall DJ. Academic Freedom in Clinical Research. . New England Journal of Medicine , 347 : 1368 – 71 .
  • Tilden , V. P. 2000 . Preventing scientific misconduct-times have changed. . Nursing Research , 49 (5) : 243
  • Wolfe , S. 2000 . Transcript. Conference on Human Subject Protection and Financial Coi's. Plenary Presentation [cited 16 August 2000] . Transcript. Available from http://ohrp.osophs.dhhs.gov/coi's8-16.html

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.