Attention to difference and women's consent to research

IRB Ethics and Human Research

Volumn 20, Issue 6, 1998, Pages 6-11

  Eckeneiler, Lisa A ^a  

^a OLD DOMINION UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; FEMALE; FREEDOM; HUMAN; HUMAN EXPERIMENT; HUMAN RELATION; INFORMED CONSENT; LEGAL LIABILITY; MENTAL CAPACITY; METHODOLOGY; MINORITY GROUP; PATIENT SELECTION; PERSONAL AUTONOMY; POVERTY; PREGNANCY; PREGNANT WOMAN; PRENATAL EXPOSURE; RESEARCH SUBJECT; SOCIOECONOMICS; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

FEMALE; FREEDOM; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; LIABILITY, LEGAL; MENTAL COMPETENCY; MINORITY GROUPS; PATIENT SELECTION; PERSONAL AUTONOMY; POVERTY; PREGNANCY; PREGNANT WOMEN; PRENATAL EXPOSURE DELAYED EFFECTS; RESEARCH DESIGN; RESEARCH SUBJECTS; RESEARCHER-SUBJECT RELATIONS; SOCIOECONOMIC FACTORS; UNITED STATES; WOMEN;

EID: 0032195262     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3564413     Document Type: Article

References (59)

1. The provisions for children and prisoners are discussed in 45 CFR 46.401-409 and 45 CFR 46.301-306. Although never finalized, guidelines for research on the institutionalized mentally disabled were proposed. See Department of Health, Education, and Welfare. Proposed regulations on research involving those institutionalized as mentally disabled. Federal Register 1978; 17(43):53950-6.
2. The National Bioethics Advisory Commission is presently developing guidelines for research on the cognitively impaired. Commentaries include: Dresser R. Mentally disabled research subjects: the enduring policy issues. JAMA 1996; 276(1):67-72;
3. Karlawish JHT, Sachs GA. Research on the cognitively impaired: lessons and warnings from the emergency research debate. Journal of the American Geriatrics Society 1997; 45(4):474-81;
4. Marwick C. Bioethics commission examines informed consent from subjects who are decisionally incapable. JAMA 1997; 278(8):618-9.
5. For final rules on emergency research see: Informed consent and waiver of informed consent requirements in certain emergency research. Federal Register 1996; 61(192):51497-533.
6. For a discussion of cultural pluralism and informed consent, see Gostin LO. Informed consent, cultural sensitivity, and respect for persons. JAMA 1995; 274(10):844-5.
7. See Hamilton JA. Women and health policy: on the inclusion of females in clinical trials. In Sargent CF, Bretell CB, eds. Gender and Health: An International Perspective. Englewood Cliffs, N.J.: Prentice Hall, 1996:298-9;
8. Merkatz, RB, Temple R, Solomon S, et al. Women in clinical trials of new drugs: a change in Food and Drug Administration policy. NEJM 1993; 329(4):292-6.
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11. Caschetta MB. The identity politics of biomedical research: clinical trials, medical knowledge, and the female body. SIECUS Report 1993; 22(1):3.
12. Hamilton JA, Parry B. Sex-related difference in clinical drug response: implications for women's health. Journal of the American Medical Women's Association 1983; 38(5): 126-32; see also Note 2, Merkatz et al. 1993.
13. For example, see Bell NK. Women and AIDS: too little, too late? In Holmes HB, Purdy LM, eds. Feminist Perspectives in Medical Ethics. Bloomington: Indiana University Press, 1992:46-62;
14. Wenger NK, Speroff L, Packard B. Cardiovascular health and disease in women. NEJM 1993; 329(4):247-56.
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16. See note 3, Gurwitz et al. 1992; Raskin R. Age-sex differences in response to antidepressant drugs. Journal of Nervous and Mental Disease 1974; 159(2):120-30;
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19. Ayanian JZ, Epstein AM. Differences in the use of procedures between men and women hospitalized for coronary heart disease. NEJM 1991; 325(4):221-5;
20. Tobin JN, Wassertheil-Smoller S, Wexler JP, et al. Sex bias in considering coronary bypass surgery. Annals of Internal Medicine 1987; 107(1):19-25;
21. Wenger NK. Gender, coronary artery disease, and coronary bypass surgery. Annals of Internal Medicine 1990; 112(8):557-8.
22. Merton V. The exclusion of pregnant, pregnable, and once pregnable people (a.k.a. women) from biomedical research. American Journal of Law & Medicine 1993; 19(4):384.
23. National Institutes of Health. NIH guidelines on the inclusion of women and minorities as subjects in clinincal research. Federal Register 1994; 59(59):14507-13;
24. Food and Drug Administration. Guidelines for the study and evaluation of gender differences in the clinical evaluation of drugs. Federal Register 1993; 58(139):39405-16;
25. Food and Drug Administration. Investigational new drug applications: proposed amendment to clinical hold regulations for products intended for life-threatening disease. Federal Register 1997; 62(185):49946-54.
26. See note 12, National Institutes of Health 1994:14509.
27. 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. Washington, D.C.: U.S. Government Printing Office, 1979: 5-6.
28. Seeker B. Destroying the right/power to decide: the gender politics of incompetence labeling. Presented at International Social Philosophy Conference, De Pere, Wisconsin, 16 August 1996;
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30. Fisher SM. In the Patient's Best Interest: Women and the Politics of Medical Decisions. New Brunswick, N.J.: Rutgers University Press, 1988.
31. See Harding S. Rethinking standpoint epistemology: what is 'strong objectivity'? In Alcoff L, Potter E, eds. Feminist Epistemologies, New York: Routledge, 1993:49-82;
32. Lloyd G. The Man of Reason: 'Male' and 'Female' in Western Philosophy. Minneapolis: University of Minnesota Press, 1984.
33. Gamble VN. Under the shadow of Tuskegee: African-Americans and health care. American Journal of Public Health 1997; 87(11):1773-8.
34. Sherwin S. Gender, race, and class in the delivery of health care. In Sherwin S. No Longer Patient: Feminist Ethics and Health Care. Philadelphia: Temple University Press, 1992:222-40.
35. Seaman B. Free and Female. New York: Fawcett, 1972:180-1.
36. As well, see Mouton CP, Harris S, Rovi S. Barriers to Black women's participation in cancer clinical trials. Journal of National Medical Association 1997;89:721-7;
37. Allen M. The dilemma for women of color in clinical trials. Journal of American Medical Women's Association 1994; 49(4):105-9.
38. Department of Health and Human Services. Protection of human research subjects: proposed rule. Federal Register 1998; 63:27793-804, p. 27800.
39. Oberman M. Real and perceived legal barriers to the inclusion of women in clinical trials. In Dan AJ, ed. Reframing Women's Health: Multidisciplinary Research and Practice. Thousand Oaks, Calif.: Sage, 1994:266-76; see note 11, Merton 1993:400-2.
40. Groups whose experience and culture find expression and, moreover, define social norms.
41. Those whose experience and culture do not find expression in the dominant society.
42. Tannen D. You Just Don't Understand: Women and Men in Conversation. New York: William Morrow and Co., 1990.
43. Yu ESH. Ethical and legal issues relating to the inclusion of Asian/Pacific Islanders in clinical studies. In Mastroianni AC, Faden R, Federman D, eds. Women and Health Research: Ethical and Legal 'Issues of Including Women in Clinical Studies, vol. 2. Washington, D.C.: National Academy Press, 1994:216-31.
44. Mahowald MB. The feminization of poverty: its impact on women's and children's health. In Mahowald MB. Women and Children in Health Care: An Unequal Majority. New York: Oxford University Press, 1993:217-35.
45. Goldberg C. Cutting a lifeline to AIDS study. New York Times, 30 January 1996;
46. Murphy TF. Women and drug users: the changing face of HIV clinical trials. QRB 1991; 17:26-32.
47. This notion, indeed, is reminiscent of a standard expressed in the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. More specifically, when research is carried out in a "developing country" by sponsors and investigators from a "developed country," and this research is designed to develop a diagnostic, preventive, or therapeutic product, the standard set forth in the Guidelines is that there must be assurance that the product, once developed, will be made reasonably available to the inhabitants of the country in which the research is carried out. I am thankful to Robert J. Levine for drawing this important connection to my attention. To return to my specific point, however, the stronger position, whose defense is beyond the scope of this paper, is that given the potential for exploitation, poor women should not be recruited for research that presents more that minimal risk, except where the investigational intervention holds some prospect for direct health benefit to them, or where the research is likely to yield generalizable knowledge about a condition that disproportionately affects the poor.
48. Frederiksen MC. Clinical trials in pregnancy. Food and Drug Law Journal 1993; 48(2): 195-6;
49. Charo A. Protecting us to death: women, pregnancy, and clinical research trials. Saint Louis Law Journal 1993; 38(1):135-88.
50. Kass NE, Taylor HA, King PA. Harms of excluding pregnant women from clinical research: the case of HIV-infected pregnant women. Journal of Law, Medicine & Ethics 1996; 24(1):36-46.
51. Baylis F. Women and health research: working for change. Journal of Clinical Ethics 1996; 7(3):229-42.
52. The Pregnancy Discrimination Act of 1978, and the following Supreme Court cases also support this view: Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990); Griswold v. Connecticut, 381 U.S. 479 (1965); Roe v. Wade, 410 U.S. 113 (1973); and International Union, United Automobile, Aerospace, and Agricultural Implement Workers v. Johnson Controls Inc., 499 U.S. 187 (1991).
53. See note 31, Johnson Controls 1991.
54. As of this writing, proposed changes to Subpart B of 45 CFR 46 embrace a strengthened role for the consent process in research with pregnant women. Save for one notable suggested revision - that the consent of the woman alone is adequate - the proposed regulations are no less restrictive with respect to their inclusion than those in place. See note 19, Department of Health and Human Services 1998.
55. It is important to add that these suggestions should not be interpreted as an argument for asking a research subject to waive her entitlement to litigate. These issues are discussed in great detail by legal commentators. See: Gorenberg H, White A. Off the pedestal and into the arena: toward including women in experimental protocols. N.Y.U. Review of Law and Social Change 1991-1992; 19:223-8; see note 11, Merton. 1993:402-14;
56. Rothenberg KH. Gender matters: implications for clinical research and women's health care. Houston Law Review 1996; 32:1259-63.
57. Also instructive is the work of Lucinda Finley. See Finley L. Female trouble: the implications of tort reform for women. Tennessee Law Review 1997; 64:847-79.
58. Department of Health and Human Services, Office of the Inspector General. Institutional Review Boards: A Time for Reform. Washington, D.C.: Office of Inspector General, 1998;
59. Eckenwiler LA. Women and the Ethics of Clinical Research: Broadening Conceptions of Justice. Doctoral Dissertation. University of Tennessee, Knoxville, Tennessee, 1997.