A duty to participate in research: Does social context matter?

American Journal of Bioethics

Volumn 8, Issue 10, 2008, Pages 28-36

  De Melo Martin, Inmaculada ^a  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

Author keywords

Biomedical research practices; Injustices; Moral duty; Research participation; Social value

Indexed keywords

ECONOMICS; ETHICS; HEALTH INSURANCE; HUMAN; HUMAN EXPERIMENT; INJURY; MEDICAL RESEARCH; MINORITY GROUP; MORALITY; RESEARCH ETHICS; RESEARCH SUBJECT; REVIEW; SOCIAL BEHAVIOR; SOCIAL ENVIRONMENT; UNITED STATES;

BIOMEDICAL RESEARCH; ETHICS, RESEARCH; HUMAN EXPERIMENTATION; HUMANS; INSURANCE, HEALTH; MINORITY GROUPS; MORAL OBLIGATIONS; RESEARCH SUBJECTS; SOCIAL ENVIRONMENT; SOCIAL RESPONSIBILITY; THERAPEUTIC HUMAN EXPERIMENTATION; UNITED STATES; WOUNDS AND INJURIES;

EID: 56049086856     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265160802393017     Document Type: Review

References (83)

1. Aiello A. E., King, N. B., and Foxman, B. 2006. Ethical conflicts in public health research and practice: Antimicrobial resistance and the ethics of drug development. American Journal of Public Health 96(11): 1910-1914.
2. Allhoff, F. 2005. Free-riding and research ethics. American Journal of Bioethics. 5(1): 50-51.
3. Angell, M. 2004. The truth about the drug companies: How they deceive us and what to do about it. New York, Y: Random House.
4. Ayanian, J. Z., Cleary, P. D., Keogh, J. H., Noonan, S. J., David-Kasdan, J. A., and Epstein, A. M. 2004. Physicians' beliefs about racial differences in referral for renal transplantation. American Journal of Kidney Diseases 43(2): 350-357.
5. Baghai T. C., Volz, H. P., and Moller, H. J. 2006. Drug treatment of depression in the 2000s: An overview of achievements in the last 10 years and future possibilities. World Journal of Biological Psychiatry 7(4): 198-222.
6. Beh, H. 2005. Compensation for research injuries. IRB 27(3): 11-15.
7. Bero, L. A., and Rennie, D. 1996. Influences on the quality of published drug studies. International Journal of Technology Assessment in Health Care. 12(2): 209-237.
8. Betancourt, J. R., and Maina, A. W. 2004. The Institute of Medicine reports "unequal treatment": Implications for academic health centers. The Mount Sinai Journal of Medicine 71(5): 314-321.
9. Brassington, I, 2007. John Harris' argument for a duty to research. Bioethics 21(3): 160-168.
10. Brody, H. 2007. Hooked. Ethics, the medical profession, and the pharmaceutical industry. Lanham, MD: Rowman and Littlefield.
11. Cairns, C. P., and Viswanath, K. 2006. Communication and colorectal cancer screening among the uninsured: data from the Health Information National Trends Survey (United States). Cancer Causes Control 17(9): 1115-1125.
12. Caplan, A. L. 1984. Is there a duty to serve as a subject in biomedical research? IRB (5): 1-5.
13. Chan, A. W., and Altman, D. G. 2005. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ 330(7494): 753.
14. Chan, A. W., Hrobjartsson, A., Haahr, M. T., Gotzsche, P. C., and Altman, D. G. 2004. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. Journal of the American Medical Association 291(20): 2457-2465.
15. Childress, J. F. 1976. Compensating injured research subjects: I. The moral argument. Hastings Center Report 6(6): 21-27.
16. Chopra, S. S. 2003. MSJAMA: Industry funding of clinical trials: benefit or bias? JAMA Journal of the American Medical Association 290(1): 113-114.
17. Clark, L. T., and Lingegowda, U. 2005. Acute coronary syndromes in black Americans: Is treatment different? Should it be? Current Cardiology Reports 7(4): 249-254.
18. Code of Federal Regulations. 2005. 45 C.F.R. §46.116(a)(6).
19. Croghan, T. W., and Pittman, P. M. 2004. The medicine cabinet: What's in it, why, and can we change the contents? Health Affairs (Millwood) 23(1): 23-33.
20. Danis, M., Linde-Zwirble, W. T., Astor, A., Lidicker, J. R., and Angus, J. R. 2006. How does lack of insurance affect use of intensive care? A population-based study. Critical Care Medicine 34(8): 2043-2048.
21. DeNavas-Walt, C., Proctor, B. D., and Lee, C. H. 2006. U.S. Census Bureau, current population reports, P60-231, income, poverty, and health insurance coverage in the United States: 2005. Washington, DC: US Government Printing Office.
22. Editorial. 2006. Research versus treatment for neglected diseases. Lancet. 367(9509): 448.
23. Elliott, C. 2003. Better than well: American medicine meets the American dream. New York, NY: W. W. Norton.
24. Elston, D. M. 2007. Community-acquired methicillin-resistant Staphylococcus aureus. Journal of the American Academy of Dermatology 56(1): 1-16.
25. Emanuel, E. J., Wendler, D., and Grady, C. 2000. What makes clinical research ethical? Journal of the American Medical Association 283: 2701-11.
26. Evans, H. M. 2004. Should patients be allowed to veto their participation in clinical research? Journal of Medical Ethics 30(2): 198-203.
27. Evans, S., and Pocock, S. 2001. Societal responsibilities of clinical trial sponsors. Lack of commercial pay off is not a legitimate reason for stopping a trial. BMJ 322: 569-570.
28. Furth, S. L., Garg, P. P., Neu, A. M., Hwang, W., Fivush, B. A., and Powe, N. R. 2000 Racial differences in access to the kidney transplant waiting list for children and adolescents with end-stage renal disease. Pediatrics 106(4): 756-761.
29. Gotzsche, P. C., Hrobjartsson, A., Johansen, H. K., Haahr, M. T., Altman, D. G., and Chan, A. W. 2006. Constraints on publication rights in industry-initiated clinical trials. Journal of the American Medical Association 295(14): 1645-1646.
30. Green, C. R., Anderson, K. O., Baker, T. A. et al. 2003. The unequal burden of pain: Confronting racial and ethnic disparities in pain. Pain Medicine 4(3): 277-294.
31. Gregory, P. C., LaVeist, T. A. and Simpson, C. 2006. Racial disparities in access to cardiac rehabilitation. Journal of Physical Medicine & Rehabilitation 85(9): 705-710.
32. Hampton, T. 2006. Health research funding losing ground. Journal of the American Medical Association 296(10): 1219-1220.
33. Harris, J. 2005. Scientific research is a moral duty. Journal of Medical Ethics 31(4): 242-248.
34. Heres, S., Davis, J., Maino, K., Jetzinger, E., Kissling, W., and Leucht, S. 2006. Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison studies of second-generation antipsychotics. American Journal of Psychiatry 163(2): 185-194.
35. Herrera, C. D. 2003. Universal compulsory service in medical research. Theoretical Medicine and Bioethics 24(3): 215-231.
36. Hinman, A. R., Orenstein, W. A., Santoli, J. M., Rodewald, L. E., and Cochi, S. L. 2006. Vaccine shortages: history, impact, and prospects for the future. Annual Review of Public Health 27: 235-259.
37. Iltis, A. S. 2005. Stopping trials early for commercial reasons: the risk-benefit relationship as a moral compass. Journal of Medical Ethics 31(7): 410-414.
38. Institute of Medicine (IOM). 2002a. Responsible research: A systems approach to protecting research participants. Washington, DC: National Academy Press.
39. Institute of Medicine (IOM). 2002b. Care without coverage. Too little, too late. Washington, DC: National Academy Press.
40. Institute of Medicine (IOM). 2002c. Unequal treatment: Confronting racial and ethnic disparities in health care. Washington, DC: National Academy Press.
41. Jones, H. J. 1993. Bad Blood: The Tuskegee Syphilis Experiment. New York, NY: Free Press.
42. Jonas, H. 1969. Philosophical reflections on experimenting with human subjects. Daedalus 98: 219-47.
43. Jorgensen, A. W., Hilden, J., Gotzsche, P. C. 2006. Cochrane reviews compared with industry supported meta-analyses and other meta-analyses of the same drugs: systematic review. The British Medical Journal 333(7572): 782.
44. Katz, M. L., Mueller, L. V., Polyakov, M., and Weinstock, S. F. 2006. Where have all the antibiotic patents gone? Nature Biotechnology 24(12): 1529-1531.
45. King, D. A., Peckham, C., Waage, J. K., Brownlie, J., and Woolhouse, M. E. 2006. Epidemiology. Infectious diseases: preparing for the future. Science 313(5792): 1392-1393.
46. Kresse, H., Belsey, M. J., and Rovini, H. 2007. The antibacterial drugs market. Nature Reviews. Drug Discovery 6(1): 19-20.
47. Lievre, M., Menard, J., Bruckert, E. et al. 2001. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. The British Medical Journal 322: 603-605.
48. Marshall, E. 2006. Drug trials. Violent reaction to monoclonal antibody therapy remains a mystery. Science 311(5768): 1688-1689.
49. Mathers, C. D., and Loncar, D. 2006. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Medicine 3(11): 2011-2030.
50. Mello, M. M., Clarridge, B. R., and Studdert, D. M. 2005a. Academic medical centers' standards for clinical-trial agreements with industry. New England Journal of Medicine 352(21): 2202-2210.
51. Mello, M. M., Clarridge, B. R., and Studdert, D. M. 2005b. Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors. Accountability in Research 12(3): 163191.
52. Moses, H. 3rd, Dorsey, E. R., Matheson, D. H., and Thier, S. O. 2005. Financial anatomy of biomedical research. Journal of the American Medical Association. 294(11): 1333-42.
53. National Bioethics Advisory Commission (NBAC). 2001. Ethical and policy issues in research involving human participants, report and recommendations. Bethesda, MD: US Government Printing Office.
54. Nelson, K. M., Chapko, M. K., Reiber, G., and Boyko, E. J. 2005. The association between health insurance coverage and diabetes care; data from the 2000 Behavioral Risk Factor Surveillance System. Health Services Research 40(2): 361-372.
55. Norrby, S. R., Nord, C. E., and Finch, R. 2005. European Society of Clinical Microbiology and Infectious Diseases. Lack of development of new antimicrobial drugs: a potential serious threat to public health. Lancet Infectious Diseases 5(2): 115-119.
56. Noskin, G. A., Rubin, R. J., Schentag, J. J. et al. 2005. The burden of Staphylococcus aureus infections on hospitals in the United States: An analysis of the 2000 and 2001 Nationwide Inpatient Sample Database. Archives of Internal Medicine 165(15): 1756-1761.
57. Offit, P. A. 2005. Why are pharmaceutical companies gradually abandoning vaccines? Health Affairs (Millwood) 24(3): 622-630.
58. Ohayon, M. M. 2007. Epidemiology of depression and its treatment in the general population. Journal of Psychiatric Research 41(3-4): 207-13.
59. Omoloja, A., Stolfi, A., and Mitsnefes, M. 2006. Racial differences in pediatric renal transplantation-24-year single center experience. Journal of the National Medical Association 98(2): 154-157.
60. Orentlicher, D. 2005. Making research a requirement of treatment: Why we should sometimes let doctors pressure patients to participate in research. Hastings Center Report 35(5): 20-28.
61. Paasche-Orlow, M. K., and Brancati, F. L. 2005. Assessment of medical school institutional review board policies regarding compensation of subjects for research-related injury. American Journal of Medicine 118(2): 175-180.
62. Peterson, E. D., Shaw, L. K., DeLong, E. R., Pryor, D. B., Califf, R. M., and Mark, D. B. 1997. Racial variation in the use of coronary-revascularization procedures. Are The differences real? Do they matter? New England Journal of Medicine 336(7): 480-486.
63. Psaty, B. M., and Rennie, D. 2003. Stopping medical research to save money. Journal of the American Medical Association 289: 2128-2131.
64. Resnik, D. B. 2006. Compensation for research-related injuries. Ethical and legal issues. Journal of Legal Medicine 27(3):263-287.
65. Rhodes, R. 2005a. Rethinking research ethics. American Journal of Bioethics 5(1): 7-28.
66. Rhodes, R. 2005b. Response to Commentators on "Rethinking Research Ethics" American Journal of Bioethics 5(1): W15-W18.
67. Robert Wood Johnson Foundation (RWJF). 2005. Going without: America's uninsured children. Washington, DC. Available at: http://www.rwjf.org/files/ newsroom/ckfresearchreportfinal.pdf (accessed October 14, 2008).
68. Ross, J. S., Bradley, E. H., and Busch, S. H. 2006. Use of health care services by lower-income and higher-income uninsured adults. Journal of the American Medical Association 295(17): 2027-2036.
69. Schulman, K. A., Seils, D. M., Timbie, J. W. et al. 2002. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. New England Journal of Medicine 347(17): 1335-1341.
70. Scott, L .D. 2003. Research-related injury: Problems and solutions. Journal of Law and Medical Ethics 31(3): 419-428.
71. Shah, R. V., Albert, T. J., Bruegel-Sanchez, V., Vaccaro, A. R., Hilibrand, A. S., and Grauer, J. N. 2005. Industry support and correlation to study outcome for papers published in Spine. Spine 30(9): 1099-1104.
72. Shapshay, S., and Pimple, K. D. 2007. Participation in biomedical research is an imperfect moral duty: A response to John Harris. Journal of Medical Ethics 33(7): 414-417.
73. Sharp, R. R., and Yarborough, M. 2005. Additional thoughts on rethinking research ethics. American Journal of Bioethics 5(1): 40-42.
74. Smedley, B. D., Stith, A. Y., and Nelson, A. R. 2003. Unequal treatment: Confronting racial and ethnic disparities in healthcare. Washington, DC: National Academies Press.
75. Stanley, A., DeLia, D., and Cantor, J. 2007. Racial disparity and technology diffusion: The case of cardioverter defibrillator implants,1996-2001. Journal of the National Medical Association 99(3): 201-207.
76. Stevens, G. D., Seid, M., and Halfon, N. 2006. Enrolling vulnerable, uninsured but eligible children in public health insurance: Association with health status and primary care access. Pediatrics 117(4): e751-759.
77. Tammemagi, C. M. 2007. Racial/ethnic disparities in breast and gynecologic cancer treatment and outcomes. Current Opinion in Obstetrics & Gynecology 19(1): 31-36.
78. Tapper, M. L. 2006. Emerging viral diseases and infectious disease risks. Haemophilia 12(suppl 1): 3-7.
79. United States (US) Department of Labor, Bureau of Labor Statistics (BLS), News, Bureau of Labor Statistics. 2007. The employment situation. January 2007. Washington, DC: BLS.
80. Wachbroit, R., and Wasserman, D. 2005. Research participation: Are we subject to a duty? American Journal of Bioethics 5(1): 48-49.
81. Wenzel, R. P. 2004. The antibiotic pipeline-challenges, costs, and values. New England Journal of Medicine 351(6): 523-526.
82. Wood, A. J. J. A proposal for radical changes in the drug-approval process. New England Journal of Medicine 355: 618-623.
83. Yach, D., Hawkes, C., Gould, C. L., and Hofman, K. J. 2004. The global burden of chronic diseases: Overcoming impediments to prevention and control. JAMA Journal of the American Medical Association 291(21): 2616-2622.