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There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies.

Women and Health Research, Volume 2, addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation.

The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal.

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Suggested Citation

Institute of Medicine. 1994. 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. https://doi.org/10.17226/2343.

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Publication Info

261 pages |  6 x 9 | 

ISBNs: 
  • Paperback:  978-0-309-05040-1
  • Ebook:  978-0-309-17686-6
DOI: https://doi.org/10.17226/2343
Chapters skim
Front Matter i-xiv
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

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