Ethical Issues in Clinical Research on Fracture Prevention in Patients with Osteoporosis

Journal of Bone and Mineral Research

Volumn 18, Issue 6, 2003, Pages 1110-1115

  Fost, Norman ^a,b  

^a UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^b University of Wisconsin Health   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CALCIUM; PLACEBO; VITAMIN D; ZIDOVUDINE;

BONE DENSITY; CLINICAL RESEARCH; CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; FRACTURE; HEALTH CARE COST; HEALTH CARE ORGANIZATION; HEALTH CARE POLICY; HUMAN; INFORMED CONSENT; MEDICAL DECISION MAKING; MEDICAL ETHICS; MEDICAL SOCIETY; MEDICOLEGAL ASPECT; OSTEOPOROSIS; PATIENT RIGHT; RANDOMIZED CONTROLLED TRIAL;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

CLINICAL TRIALS; HUMANS; INFORMED CONSENT; OSTEOPOROSIS; RESEARCH DESIGN;

EID: 0142091176     PISSN: 08840431     EISSN: None     Source Type: Journal    
DOI: 10.1359/jbmr.2003.18.6.1110     Document Type: Conference Paper

References (38)

1. Brandt AM 1978 Racism and research: The case of the Tuskegee syphilis study. Hastings Cent Rep 8:21-29.
2. Jones James H 1993 Bad blood: The Tuskegee Syphilis Experiment, New and Expanded Edition. Free Press, New York, NY, USA.
3. Beecher HK 1966 Ethics and clinical research. N Engl J Med 274:1354-1360.
4. Advisory Committee on Human Radiation Experiments 1996 Research ethics and the medical profession: Report of advisory committee on human radiation experiments. JAMA 276:403-409.
5. 45CFR46 Protection of Human Subjects, Revised Dec 2001. (First published May 30, 1974).
6. Capron A, Donaldson S, Raisz L, Swift S 2003 Osteoporosis panel summary. J Bone Miner Res 18:1160-1162.
7. Melton LJ 2003 Adverse outcomes of osteoporotic fractures in the general population. J Bone Miner Res 18:1139-1141.
8. Declaration of Helsinki 2003 Available online at http://www.wma.neffe/policy/17-c_e.html. Accessed on April 6, 2003.
9. Food and Drug Administration 2003 FDA information sheets. Available online at http://www.fda.gov/oc/ohrt/irbs/toc4.html. Accessed on April 6, 2003.
10. Levine R 2003 Placebo controls in clinical trials of new therapies for osteoporosis. J Bone Miner Res 18:1154-1159.
11. Levine R 1999 The need to revise the Declaration of Helsinki. N Engl J Med 341:531-534.
12. URL: http://ohsr.od.nih.gov/nuremberg.php3. Accessed on April 6, 2003.
13. Heaney RP 2003 Ethical issues in the design of osteoporosis clinical trials: The state of the question. J Bone Miner Res 18: 1117-1120.
14. Rothman KJ, Michels KB 1994 The continuing unethical use of placebo controls. N Engl J Med 331:394-398.
15. Temple R, Ellenberg S 2000 Placebo controlled trials and activecontrol trials in the evaluation of new treatments. Part I: Ethical and scientific issues. Ann Intern Med 133:455-463.
16. Levine RJ 1986 Ethics and Regulation of Clinical Research, 2nd ed. Yale Univ. Press, New Haven, CT, USA.
17. Jonas H 1970 Philosophical reflections on experimenting with human subjects. In: Freund PA (ed.) Experimentation With Human Subjects. George Braziller, New York, NY, USA.
18. Temple RJ 2003 Study design in osteoporosis. J Bone Miner Res 18:1129-1132.
19. Ellenberg SS 2003 Scientific and ethical issues in the use of placebo and active controls in clinical trials. J Bone Miner Res 18:1121-1124.
20. Fried C 1974 Medical Experimentation: Personal Integrity and Social Policy. Elsevier, New York, NY, USA.
21. Freedman B 1987 Equipoise and the ethics of clinical research. N Engl J Med 317:141-145.
22. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1978. DHEW Publication No. (OS) 78-0012, Appendix I, DHEW Publication No. (OS) 78-0013, Appendix II. DHEW Publication (OS) No. 78-0014. Washington, DC, USA.
23. Schloendorff vs Society of New York Hospital. 1914 Court of Appeals of NY. 211 NY 125, 105 NE 92.
24. Wikler DI 1978 The central ethical problem in human experimentation and three solutions. Clin Res 26:380-388.
25. Angell M 1997 The ethics of clinical research in the Third World. N Engl J Med 337:847-949.
26. Lurie P, Wolfe SM 1997 Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. N Engl J Med 337:853-856.
27. Varmus H, Satcher D 1997 Ethical complexities of conducting research in developing countries. N Engl J Med 337:1003-1005.
28. Russell Sage Foundation 1972 The Jewish Chronic Disease Hospital Study. In: Katz J (ed.) Experimentation With Human Beings. Russell Sage Foundation, New York, NY, USA.
29. Thompson DF 1993 Understanding conflict of interest. N Engl J Med 329:574-576.
30. Burman WJ, Reves RR, Cohn DL, Schooley RT 2001 Breaking the camel's back: Multicenter clinical trials and local institutional review boards. Ann Intern Med 134:152-157.
31. Levine RJ 2001 Institutional review boards: A crisis in confidence. Ann Intern Med 134:161-163.
32. Applebaum PS, Roth LH, Lidz CW, Benson P, Winslade W 1987 False hopes and best data: Consent to research and the therapeutic misconception. Hastings Cent Rep 17:20-24.
33. Rosenblatt M 2003 Is it ethical to conduct placebo-controlled clinical trials in the development of new agents for osteoporosis? An industry perspective. J Bone Miner Res 18:1142-1145.
34. Kanis JA, Alexandre J-M, Bone HG, Abadie E, Brasseur D, Chassany O, Durrleman S, Lekkerkerker JFF, Caulin F 2003 Study design in osteoporosis: A European perspective. J Bone Miner Res 18:1133-1138.
35. Khosla S 2003 Surrogates for fracture endpoints in clinical trials. J Bone Miner Res 18:1146-1149.
36. Fost NC. 1975 A surrogate system for informed consent. JAMA 233:800.
37. Fost NC and Farrell PM 1989 A prospective randomized trial of early diagnosis and treatment of cystic fibrosis: A unique ethical dilemma. Clin Res 37:495-500.
38. Love RR, Fost N 1997 Ethical and regulatory challenges in a randomized controlled trial of adjuvant treatment for breast cancer in Vietnam. J Invest Med 45:423-431.