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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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. "8 Recruitment and Retention of Women in Clinical Studies: Theoretical Perspectives and Methodological Considerations." 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

individual variation within cultural groups, these differences can generally be seen in the life patterns of men and women today.

The life development pattern for men in early and middle adulthood is primarily focused on career achievement, with parenting generally relegated to a secondary role. After the attainment of career goals in mid-life, men's primary focus is thought to shift away from career issues and toward the enrichment of relationships with family and community.

Conversely, in early adulthood, the lives of women revolve primarily around their parenting responsibilities, which often take precedence over their career aspirations. Contrary to popular belief, studies of women with an "empty nest" suggest that women experience mid-life differently than men. Free from the parenting responsibilities of small children, women at mid-life are finally free to satisfy their individual needs for achievement by focusing their energies on their own career aspirations. Thus, the life pattern of women and men at early and middle adulthood appears to be remarkably different.

GENDER DIFFERENCES: IMPLICATIONS FOR RESEARCH

Scientific evidence and clinical experience suggest that there may be significant differences in the recruitment and retention of male and female subjects. For example, as the primary caretaker of children, a young woman with a family may be hesitant to enroll in a study that presents potential risks to her safety and livelihood, and ultimately that of her children. A working mother may also be hesitant to participate because she may be unable to incorporate the behavioral requirements of the study into her daily schedule in which she already experiences stress from conflicting role demands.

For example, a young mother may wish to reserve her annual or sick leave for the days when her children are ill, rather than a half or whole day of study-related health assessments. Women who agree to participate in a study may also experience some life crises in her family, such as a serious illness of a child, that may limit her short- and long-term ability to conform to the requirements of a study protocol.

There are also generational differences among women that are important to acknowledge. For example, women over the age of 65—who did not grow up in the era of self-help, preventive medicine, or communal exercise such as aerobic dancing—may be less willing to participate in studies that conflict with their prevailing beliefs about health. These beliefs may include such ideas as not taking hormone replacement because they feel well and believe that "if it's not broken, don't fix it"; or not participating in a study involving group exercise because they feel uncomfortable undressing and exercising with strangers. Women in this age group also may be unwilling to agree to participate in a study without discussing the study with their spouse or family.

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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)