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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers (1999)
Institute of Medicine (IOM)

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. "11 Impact of Current Federal Regulations on the Inclusion of Female Subjects in Clinical Studies." Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press, 1999.

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers

59.  

See Institute of Medicine, Expanding Access to Investigational Therapies for HIV Infection and AIDS 7. Washington, D.C.: National Academy Press (1991).

60.  

Statement of Dr. Leslie Wolfe, submitted to the Task Force on Opportunities for Research on Women's Health, June 3, 1991 (on file with the author), at p. 8.
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Front Matter (R1-R14)
1 Women's Participation in Clinical Research: From Protectionism to Access (1-10)
2 Women in Clinical Studies: A Feminist View (11-17)
3 Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trials (I) (18-22)
4 Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trial (II) (23-28)
5 Ethical Issues Related to the Inclusion of Women of Childbearing Age in Clinical Trials (29-34)
6 Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (I) (35-40)
7 Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (II) (41-44)
8 Recruitment and Retention of Women in Clinical Studies: Theoretical Perspectives and Methodological Considerations (45-51)
9 Recruitment and Retention of Women of Color in Clinical Studies (52-56)
10 Recruitment and Retention of Women in Clinical Studies: Ethical Considerations (57-64)
11 Impact of Current Federal Regulations on the Inclusion of Female Subjects in Clinical Studies (65-83)
12 Brief Overvew of Constitutional Issues Raised by the Exclusion of Women from Research Trials (84-90)
13 Liability Exposure for Exclusion and Inclusion of Women as Subjects in Clinical Studies (91-102)
14 Liability Exposure When Offspring Are Injured Because of Their Parents' Participation in Clinical Trials (103-112)
15 Compensation for Research Injuries (113-126)
16 Justice and the Inclusion of Women in Clinical Studies: A Conceptual Framework (127-150)
17 Women's Representation as Subjects in Clinical Studies: A Pilot Study of Research Published in JAMA in 1990 and 1992 (151-173)
18 Racial Differentials in Medical Care: Implications for Research on Women (174-191)
19 Health Status of American Indian and Alaska Native Women (192-215)
20 Ethical and Legal Issues Relating to the Inclusion of Asian/Pacific Islanders in Clinical Studies (216-231)
21 The Inclusion of Latino Women in Clinical and Research Studies: Scientific Suggestions for Assuring Legal and Ethical Integrity (232-240)
Appendix: Author Biographies (241-248)