Subjects' views of obligations to ensure post-trial access to drugs, care and information: qualitative results from the experiences of participants in clinical trials (EPIC) study

Journal of Medical Ethics

Volumn 35, Issue 3, 2009, Pages 183-188

  Sofaer, N ^a   Thiessen, C ^a   Goold, S D ^b   Ballou, J ^c   Getz, K A ^d   Koski, G ^e   Krueger, R A ^f   Weissman, J S ^g  

^a HARVARD UNIVERSITY   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c MATHEMATICA POLICY RESEARCH   (United States)

^d TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e HARVARD MEDICAL SCHOOL   (United States)

^f UNIVERSITY OF MINNESOTA   (United States)

^g MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; ETHICS; FEMALE; HEALTH CARE DELIVERY; HUMAN; INFORMATION PROCESSING; MALE; MIDDLE AGED; MORALITY; MULTICENTER STUDY; PATIENT CARE; PSYCHOLOGICAL ASPECT; QUESTIONNAIRE; RESEARCH SUBJECT; UNITED STATES;

ADULT; AGED; CLINICAL TRIALS AS TOPIC; CONTINUITY OF PATIENT CARE; FEMALE; FOCUS GROUPS; HEALTH SERVICES ACCESSIBILITY; HUMANS; MALE; MIDDLE AGED; MORAL OBLIGATIONS; PHARMACEUTICAL PREPARATIONS; QUESTIONNAIRES; RESEARCH SUBJECTS; UNITED STATES; YOUNG ADULT;

EID: 66549104254     PISSN: 03066800     EISSN: 14734257     Source Type: Journal    
DOI: 10.1136/jme.2008.024711     Document Type: Article

References (42)

1. Nuffield Council on Bioethics. The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics, 2002.
2. CIOMS. International ethical guidelines for biomedical research involving human subjects. Geneva: CIOMS, 2002.
3. Glantz LH, Annas GJ, Grodin MA, et al. Research in developing countries: taking "benefit" seriously. Hastings Cent Rep 1998;28:38-42.
4. Grady C. The challenge of assuring continued post-trial access to beneficial treatment. Yale J Health Policy Law Ethics 2005;5:425-35.
5. National Bioethics Advisory Commission. Ethical and policy issues in international research: clinical trials in developing countries. Bethesda, MD: National Bioethics Advisory Commission, 2001.
6. Hutt LE. Freebies for subject 641: a discussion of the ethical prospect of providing drug trial subjects with post-trial access to the drug tested-a Canadian perspective. Health Law J 1998;6:169-87.
7. Cooley D. Distributive justice and clinical trials in the third world. Theor Med Bioeth 2001;22:151-67.
8. Pace C, Miller FG, Danis M. Enrolling the uninsured in clinical trials: an ethical perspective. Crit Care Med 2003;31(3 Suppl):S121-5.
9. Lo B, Padian N, Barnes M. The obligation to provide antiretroviral treatment in HIV prevention trials. AIDS 2007;21:1229-31.
10. Ananworanich J, Cheunyam T, Teeratakulpisarn S, et al. Creation of a drug fund for post-clinical trial access to antiretrovirals. Lancet 2004;364:101-2.
11. Emanuel EJ, Wendler D, Killen J, et al. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis 2004;189:930-7.
12. Crouch RA, Arras JD. AZT trials and tribulations. Hastings Cent Rep 1998;28:26-34.
13. London AJ. Justice and the human development approach to international research. Hastings Cent Rep 2005;35:24-37.
14. Kolata G, Eichenwald K. Stopgap medicine, a special report: for the uninsured, drug trials are health care. New York Times 22 June 1999:A1.
15. Anon. Trial volunteers 'left in lurch'. BBC news 24 December 2007. http://news.bbc.co.uk/go/pr/fr/-/1/hi/health/7155572.stm (accessed 20 Nov 2008).
16. 45 CFR $46 (2005)
17. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. Ferney-Voltaire: World Medical Association, 2008.
18. UNAIDS. Ethical considerations in HIV preventive vaccine research: UNAIDS guidance document. Geneva: UNAIDS, 2000.
19. India Council of Medical Research. Ethical guidelines for biomedical research on human participants. New Delhi: Indian Council of Medical Research, 2006.
20. Fernandez CV, Kodish E, Weijer C. Informing study participants of research results: an ethical imperative. IRB 2003;25:12-19.
21. Shalowitz D, Miller F. Disclosing individual results of clinical research: implications of respect for participants. JAMA 2005;294:737-40.
22. Kass N, Hyder A. Attitudes and experiences of US and developing country investigators regarding US human subjects regulations. Ethical and policy issues in international research: clinical trials in developing countries II: commissioned papers. Bethesda, MD: National Bioethics Advisory Commission, 2002:B1-B220.
23. Partridge AH, Hackett N, Blood E, et al. Oncology physician and nurse practices and attitudes regarding offering clinical trial results to study participants. J Natl Cancer Inst 2004;96:629-32.
24. Partridge A, Wong JS, Knudsen K, et al. Offering participants results of a clinical trial: sharing results of a negative study. Lancet 2005;365:963-4.
25. Pace C, Grady C, Wendler D, et al. Post-trial access to tested interventions: the views of IRB/REC chair, investigators, and research participants in a multinational HIV/AIDS study. AIDS Res Hum Retroviruses 2006;22:837-41.
26. Shaffer DN, Yebei VN, Ballidawa JB, et al. Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in Western Kenya. J Med Ethics 2006;32:55-60.
27. Krueger RA, Casey MA. Focus groups: a practical guide for applied research. 3rd edn. Thousand Oaks CA: Sage Publications, 2000.
28. Miles M, Huberman AM. Qualitative data analysis: an expanded sourcebook. 2nd edn. Thousand Oaks, CA: Sage Publications, 1994.
29. Brandt AM. Behavior, disease, and health in the twentieth-century United States: the moral valence of individual risk. In: Brandt AM, Rozin P, eds. Morality and health. New York: Routledge, 1997:53-78.
30. Meier B. Participants left uninformed in some halted medical trials. New York Times 30 October 2007:C1.
31. HR 3580, 110th Cong, 1st Sess §801 (1997).
32. Merritt M, Grady C. Reciprocity and post-trial access for participants in antiretroviral therapy trials. AIDS 2006 11;20:1791-4.
33. Shapiro HT, Meslin EM. Ethics issues in the design and conduct of clinical trials in developing countries. N Engl J Med 2001;345:139-42.
34. Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 1982;5:319-29.
35. Richardson HS, Belsky L. The ancillary-care responsibilities of medical researchers: an ethical framework for thinking about the clinical care that researchers owe their subjects. Hastings Cent Rep 2004, Jan-Feb;34:25-33.
36. Miller PB, Weijer C. Fiduciary obligation in clinical research. J Law Med Ethics 2006;34:424-40.
37. Lemmens T, Elliott C. Guinea pigs on the payroll: the ethics of paying research subjects. Account Res 1999;7:3-20.
38. Daniels N, Sabin J. Setting limits fairly: can we learn to share medical resources? New York, NY: Oxford University Press, 2002.
39. Goldfarb NM. Why minorities should participate in clinical research. J Clin Res Best Pract 2005;1.
40. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Compensating for research injuries: the ethical and legal implications of programs to redress injured subjects. Washington, DC: Government Printing Office; 1982.
41. Leape LL. Reporting of adverse events. N Engl J Med 2002;347:1633-8.
42. Scott LD. Research-related injury: Problems and solutions. J Law Med Ethics 2003;31:419-28.