Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials

Social Science and Medicine

Volumn 66, Issue 12, 2008, Pages 2495-2505

  Fisher, Jill A ^a  

^a ARIZONA STATE UNIVERSITY   (United States)

Author keywords

Clinical trials; Pharmaceutical industry; Physician investigators; Private sector; Research ethics; USA

Indexed keywords

DRUG; ETHICS; PRIMARY HEALTH CARE; PRIVATE SECTOR; RESEARCH;

ADULT; AGED; ARTICLE; BIOETHICS; CLINICAL RESEARCH; CONTROLLED STUDY; DRUG INDUSTRY; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; MALE; MEDICAL PRACTICE; ORGANIZATION AND MANAGEMENT; PHYSICIAN; PRIMARY MEDICAL CARE; RESEARCH ETHICS; UNITED STATES;

CLINICAL PROTOCOLS; CLINICAL TRIALS AS TOPIC; CONTRACT SERVICES; DRUG INDUSTRY; ETHICS, RESEARCH; HUMANS; INTERPROFESSIONAL RELATIONS; PHYSICIAN-PATIENT RELATIONS; PHYSICIANS; PRIMARY HEALTH CARE; PRIVATE SECTOR; UNITED STATES;

NORTH AMERICA; UNITED STATES;

EID: 43449110738     PISSN: 02779536     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.socscimed.2008.02.001     Document Type: Article

References (48)

1. Appelbaum P.S., Lidz C.W., and Meisel A. Informed consent: Legal theory and clinical practice (1987), Oxford University Press, New York, NY
2. Barber B. Informed consent in medical therapy and research (1980), Rutgers University Press, New Brunswick, NJ
3. Barber B., Lally J.J., Makarushka J.L., and Sullivan D. Research on human subjects: Problems of social control in medical experimentation (1973), Russell Sage Foundation, New York, NY
4. Bodenheimer T. Uneasy alliance: clinical investigators and the pharmaceutical industry. New England Journal of Medicine 342 20 (2000) 1539-1544
5. Bosk C. All God's mistakes: Genetic counseling in a pediatric hospital (1995), University of Chicago Press, Chicago, IL
6. Campbell N.D. Discovering addiction: The science and politics of substance abuse research (2007), University of Michigan Press, Ann Arbor
7. Caplan A. Due consideration: Controversy in the age of medical miracles (1998), John Wiley & Sons, Inc, New York, NY
8. Cauteren H.V., Bentley P., Bode G., Cordier A., Coussement W., Heiningand P., et al. The industry view on long-term toxicology testing in drug development of human pharmaceuticals. Pharmacology & Toxicology 86 Suppl. I (2000) 1-5
9. Corrigan O.P. Empty ethics: the problem with informed consent. Sociology of Health and Illness 25 (2003) 768-792
10. Davis A.M., Hull S.C., Grady C., Wilfond B.S., and Henderson G.E. The invisible hand in clinical research: the study coordinator's critical role in human subjects protection. Journal of Law, Medicine, & Ethics 30 (2002) 411-419
11. DeVries R.G. How can we help? From "sociology in" to "sociology of" bioethics. Journal of Law, Medicine, & Ethics 32 (2004) 279-292
12. Epstein S. Impure science: Aids, activism, and the politics of knowledge (1996), University of California Press, Berkeley
13. Evans J.H. Playing God?: Human genetic engineering and the rationalization of public bioethical debate (2002), University of Chicago Press, Chicago, IL
14. Faden R.R., and Beauchamp T.L. A history and theory of informed consent (1986), Oxford University Press, New York, NY
15. Featherstone K., and Donovan J.L. "Why don't they just tell me straight, why allocate it?": the struggle to make sense of participating in a randomised controlled trial. Social Science & Medicine 55 (2002) 709-719
16. Fisher J.A. Co-ordinating 'ethical' clinical trials: the role of research coordinators in the contract research industry. Sociology of Health and Illness 28 6 (2006) 678-694
17. Fisher J.A. Procedural misconceptions and informed consent: insights from empirical research on the clinical trials industry. Kennedy Institute of Ethics Journal 16 3 (2006) 251-268
18. Fisher J.A. Ready-to-recruit" or "Ready-to-consent" populations?: informed consent and the limits of subject autonomy. Qualitative Inquiry 13 8 (2007) 875-894
19. Fisher, J. A. (in press). Medical research for hire: The political economy of pharmaceutical clinical trials. New Brunswick, NJ: Rutgers University Press.
20. Fox R.C. Advanced medical technology - social and ethical implications. Annual Review of Sociology 2 (1976) 231-268
21. Gray B.H. Human subjects in medical experimentation: A sociological study of the conduct and regulation of clinical research (1975), R.E. Krieger, Huntington, NY
22. Halpern S.A. Lesser harms: The morality of risk in medical research (2004), University of Chicago Press, Chicago, IL
23. HarrisInteractive. (2004). Most physicians do not participate in clinical trials because of lack of opportunity, time, personnel support and resources. Available online: http://www.harrisinteractive.com/news/printerfriend/index.asp?NewsID=811 (Last accessed 1 March 2008).
24. Hedgecoe A. The politics of personalized medicine: Pharmacogenetics in the clinic (2004), Cambridge University Press, New York
25. Hoeyer K., Dahlager L., and Lynoe N. Conflicting notions of research ethics: the mutually challenging traditions of social scientists and medical researchers. Social Science & Medicine 61 (2005) 1741-1749
26. Hornblum A.M. Acres of skin: Human experiments at holmesburg prison (1998), Routledge, New York, NY
27. Jones J.H. Bad blood: The Tuskegee syphilis experiment (1981), Free Press, New York, NY
28. Kassirer J.P. On the take: How America's complicity with big business can endanger your health (2005), Oxford University Press, New York
29. Klein J.E., and Fleischman A.R. The private practicing physician-investigator: ethical implications of clinical research in the office setting. Hastings Center Report 32 4 (2002) 22-26
30. Konrad M. Narrating the new predictive genetics: Ethics, ethnography, and science (2005), Cambridge University Press, Cambridge
31. Lader E.W., Cannon C.P., Ohman E.M., Newby L.K., Sulmasy D.P., Barst R.J., et al. The clinician as investigator: participating in clinical trials in the practice setting. Circulation 109 (2004) 2672-2679
32. Lederer S.E. Subjected to science: Human experimentation in American before the Second World War (1995), Johns Hopkins University Press, Baltimore, MD
33. Lemmens T., and Freedman B. Ethics review for sale? Conflict of interest and commercial research ethics review. Milbank Quarterly 78 4 (2000) 547-584
34. Miller F.G., Rosenstein D.L., and DeRenzo E.G. Professional integrity in clinical research. Journal of the American Medical Association 280 (1998) 1449-1454
35. Miller F.G., and Shorr A.F. Ethical assessment of industry-sponsored clinical trials: a case analysis. Chest 121 4 (2002) 1337-1342
36. Mirowski P., and Van Horn R. The contract research organization and the commercialization of scientific research. Social Studies of Science 35 4 (2005) 503-548
37. Morris N., and Balmer B. Volunteer human subjects' understandings of their participation in a biomedical research experiment. Social Science & Medicine 62 (2006) 998-1008
38. Mueller M.-R. Science versus care: physicians, nurses and the dilemma of clinical research. In: Elston M.A. (Ed). The sociology of medical science and technology (1997), Blackwell, Oxford
39. Petryna A. Clinical trials offshored: on private sector science and public health. BioSocieties 2 1 (2007) 21-40
40. Pham H.H., Devers K.J., May J.H., and Berenson R. Financial pressures spur physician entrepreneurialism. Health Affairs 23 2 (2004) 70-81
41. Rainville B. Strategic outsourcing with contract research organizations: targeting corporate goals. Drug Information Journal 36 1 (2002) 77-81
42. In: Reverby S. (Ed). Tuskegee's truths: Rethinking the Tuskegee syphilis study (2000), University of North Carolina Press, Chapel Hill
43. Sage W.M. The forgotten third: liability insurance and the medical malpractice crisis. Health Affairs 23 4 (2004) 10-21
44. Steinbrook R. Gag clauses in clinical-trial agreements. New England Journal of Medicine 352 21 (2005) 2160-2162
45. Temple R., and Ellenberg S.S. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues. Annals of Internal Medicine 133 6 (2000) 455-463
46. Tu H.T., and Ginsburg P.B. Losing ground: Physician income, 1995-2003 (2006), Center for Studying Health System Change, Washington, DC
47. Zussman R. Intensive care: Medical ethics and the medical profession (1992), University of Chicago Press, Chicago
48. Zussman R. Sociological perspectives on medical ethics and decision-making. Annual Review of Sociology 23 (1997) 171-189