Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 (1994) / Chapter Skim
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3 Justice in Clinical Studies: Guiding Principles
3 Justice in Clinical Studies: Guiding Principles
Pages 75-83
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From page 75... ...
The Belmont Report states that "injustice arises from social, racial, sexual and cultural biases institutionalized in society." Women as a class were not the primary concern of the National Commission's work. In sketching the historical background related to justice in research, its report cited the following examples of injustices: 75
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From page 76... ...
For example, procedural justice applies to a wide variety of social, legal, and institutional matters in which achieving a fair or unbiased result is dependent on adherence to a set of well-ordered procedures, such as the legal requirements of due process. The notion of compensatory justice goes beyond that of fairness in distribution in an attempt to remedy or redress past wrongs.
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From page 77... ...
, but the same concern applies to subgroups of women such as women of color, diverse ethnic groups, and older women. For the overall biomedical research agenda to comply with the requirements of justice, studies must not only include women as well as men, but also women and men from different age cohorts and different racial and ethnic groups.
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From page 78... ...
But even when women are not categorically excluded, justice may still be violated in particular research programs or in the overall national research agenda. This violation of justice can take several different forms.
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From page 79... ...
For example, the research agenda has historically neglected many important questions regarding women's health needs, yet there has been a substantial body of research directed at gaining control over women's reproductive capacity (Sherwin, 19941. This concentration on women's reproductive role not only assumes the conventional view that women are, by nature, to be responsible and available for reproductive activities; it has the
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From page 80... ...
Acceptance of the view that men are the norm, and women deviant or problematic for the conduct of biomedical research, serves to perpetuate the practice of excluding women so that the scientific results of studies are not "confounded" (see discussion of male norm in Chapter 5~. According to this view, remedies for past injustices would require paying special attention to women in the research agenda.
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From page 81... ...
Where it is established that women or other groups have not received a fair allocation of research attention or resources, justice may require that the research agenda provide preferential treatment in these areas. To set a just research agenda for the nation may thus require more than a reordering of priorities.
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From page 82... ...
STATEMENT OF GUIDING PRINCIPLES Based on the foregoing examination, the committee recommends three general principles of justice with regard to issues of inclusion of both genders in the conduct of clinical research: The scientific community and the institutions that support it must ensure that scientific advances in medicine and public health fairly benefit all people, regardless of gender, race, ethnicity, or age. Therefore, the national research agenda must ensure that medical research promotes the health and well-being of both women and men.
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From page 83... ...
Women and men should be enrolled as participants in clinical studies in a manner that ensures that research yields scientifically generalizable results applicable to both genders. These principles guide the committee's deliberations in the following chapters, which examine the challenges to applying these principles, and achieving equity in clinical studies, that arise from four specific areas: scientific considerations (Chapter 41; social and ethical considerations (Chapter 51; legal considerations (Chapter 6~; and issues surrounding risks to reproduction and offspring (Chapter 7~.
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