Selecting subjects for participation in clinical research: One sphere of justice

Journal of Medical Ethics

Volumn 25, Issue 1, 1999, Pages 31-36

  Weijer, Charles ^a  

^a DALHOUSIE UNIVERSITY   (Canada)

Author keywords

Cinical trials; Eligibility determination; Justice; Medical ethics; Patient participation; US National Institutes of Health; Women

Indexed keywords

CLINICAL RESEARCH; CLINICAL TRIAL; HUMAN; JUSTICE; MEDICAL ETHICS; PRACTICE GUIDELINE; REVIEW;

EID: 0033003151     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.25.1.31     Document Type: Review

References (36)

1. Dresser R, Wanted single, white male for medical research. Hastings Center Report 1992; 22: 24-9.
2. Department of Health and Human Services, National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register 1994; 59: 14508-13.
3. Sherwin S. Women in clinical studies: a feminist view, and DeBruin DA. Justice and the inclusion of women in clinical studies: a conceptual framework. In: Mastroianni AC, Faden R, Federman D, eds. Women and health research: ethical and legal issues of including women in clinical studies. Volume ii: workshop and commissioned papers. Washington, DC: National Academy Press, 1994: 11-17, 127-50.
4. Walzer M. Spheres of justice: a defence of pluralism and equality. New York: Basic Books, 1983.
5. See reference 4: 7.
6. See reference 4: 19.
7. See reference 4: 88.
8. Patterson JT. The dread disease: cancer and modern American culture. Cambridge, MA: Harvard University Press, 1987.
9. See reference 8: 47.
10. See reference 8: 124.
11. See reference 8: 78.
12. Committee on Labor and Public Welfare, United States Senate. National program for the conquest of cancer: report of the national panel of consultants on the conquest of cancer. Washington, DC: US Government Printing Office, 1971: 1.
13. See reference 4: 84.
14. Begg CB, Engstrom PF. Eligibility and extrapolation in cancer clinical trials. Journal of Clinical Oncology 1987; 5: 962-98.
15. Jones JH. Bad blood: the Tuskegee syphilis experiment. New York: Free Press, 1993.
16. Mastroianni AC, Faden R, Federman D, eds. Women and health research: ethical and legal issues of including women in clinical studies. Volume I. Washington, DC: National Academy Press, 1994: 75-83.
17. Food and Drug Administration. General consideration for the clinical evaluation of new drugs. Washington, DC: US Government Printing Office, 1977. Publication no: HEW (FDA) 77-3040.
18. General Accounting Office. Women's health: FDA needs to ensure more study of gender differences in prescription drug testing. Washington, DC: US Government Printing Office, 1992. Publication no: GAO/HRD-93-17. See also reference 3: 151-73.
19. Ungerleider RS, Friedman MA. Sex, trials, and datatapes. Journal of the National Cancer Institute 1991; 83: 6-7.
20. Ayanian JZ, Epstein AM. Differences in the use of procedures between women and men hospitalized for coronary artery disease. New England Journal of Medicine 1991; 325: 221-5; and Steingart RM, Packer M, Hamm P, Coglianese ME, Gersh B, Geltman EM et al. Sex differences in the management of coronary artery disease. New England Journal of Medicine 1991; 325: 226-30.
21. Ayanian JZ, Epstein AM. Differences in the use of procedures between women and men hospitalized for coronary artery disease. New England Journal of Medicine 1991; 325: 221-5; and Steingart RM, Packer M, Hamm P, Coglianese ME, Gersh B, Geltman EM et al. Sex differences in the management of coronary artery disease. New England Journal of Medicine 1991; 325: 226-30.
22. Council on Ethical and Judicial Affairs, American Medical Association. Gender disparities in clinical decision making. Journal of the American Medical Association 1991; 266: 559-62.
23. See reference 16: 108-27, 175-202.
24. See reference 4: 240.
25. See reference 16: 113.
26. Patterson WB, Emanuel EJ. The eligibility of women for clinical research trials. Journal of Clinical Oncology 1995; 13: 293-9.
27. See reference 25: 297.
28. See reference 4: 84.
29. Trimble EL, Carter CC, Cain D, Freidlin B, Ungerleider RS, Friedman MA. Representation of older patients in cancer treatments trials. Cancer 1994; 74 (suppl): 2208-14.
30. Giovanazzi-Bannon S, Rademaker A, Lai G, Benson AB. Treatment tolerance of elderly cancer patients entered onto phase ii clinical trials: an Illinois cancer center study. Journal of Clinical Oncology 1994; 12: 2447-52; and Christman K, Muss HB, Case LD, Stanley V. Chemotherapy of metastatic breast cancer in the elderly: the Piedmont oncology association experience. Journal of the American Medical Association 1992; 268: 57-62.
31. Giovanazzi-Bannon S, Rademaker A, Lai G, Benson AB. Treatment tolerance of elderly cancer patients entered onto phase ii clinical trials: an Illinois cancer center study. Journal of Clinical Oncology 1994; 12: 2447-52; and Christman K, Muss HB, Case LD, Stanley V. Chemotherapy of metastatic breast cancer in the elderly: the Piedmont oncology association experience. Journal of the American Medical Association 1992; 268: 57-62.
32. Hughes JR. Exclusion of "Noncompliant" individuals from clinical trials. Controlled Clinical Trials 1993; 14: 176-7.
33. Harrison K, Vlahov D, Jones K, Charron K, Clements ML. Medical eligibility, comprehension of the consent process, and retention of injection drug users recruited for an HIV vaccine trial. Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology 1995; 10: 386-90.
34. See reference 16: 128-74.
35. Yusuf S, Held P, Teo KK. Selection of patients for randomized controlled trials: implications of wide or narrow eligibility criteria. Statistics in Medicine 1990; 9: 73-86.
36. Bero L, Rennie D. The Cochrane Collaboration. Preparing, maintaining, and disseminating systematic reviews of the effects of health care. Journal of the American Medical Association 1995; 274: 1935-8.