Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 (1994) / Chapter Skim
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5 Social and Ethical Considerations
5 Social and Ethical Considerations
Pages 108-127
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From page 108... ...
The "legal" world as it is more narrowly construed to mean federal policies and liability issues will be discussed in the following chapter. The social context may explain the differential treatment of men and women as scientific research participants, which raises the question of whether science is truly "value neutral" with respect to gender.
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From page 109... ...
There is a particular concern for the potential exploitation of disadvantaged individuals and communities who are ascribed lower status and power in our society; the principal protection against this possibility is the informed consent process. SCIENCE AND OBJECTIVITY As in all scientific endeavors, clinical studies seek to achieve results that are unbiased by the preconceptions or preferences of investigators, staff, or study participants.
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From page 110... ...
QUESTIONS OF GENDER Hem (1993) , writing on the issues of male bias and male norms in scientific and political discourse, offers a useful analogy to explain the power and pervasiveness of biases.
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From page 111... ...
2. Male norm refers to the tendency to perceive men's identity and experience as the characterization or standard of what it is to be a person and to portray female differences, where they occur, as "deviant." These lenses can operate independently or simultaneously and can affect observations regardless of the gender of the scientist-observer (women scientists can adopt the cultural values of male biases)
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From page 112... ...
According to this view, the low number of women scientists, particularly at the upper levels of the research hierarchy, is directly related to the level of women's participation in clinical studies and the amount of attention devoted to women's health concerns. Recent analyses of women's advancement in medical and scientific careers (e.g., by the NIH Office of Research on Women's Health)
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From page 113... ...
This can promote the misuse of scientific rationales to justify protectionism and current practices, but it can also compromise subsequent clinical practice by leaving clinicians and patients uncertain about the applicability of research findings to women. The male norm may play a role in the design of clinical studies that include only men, but that are focused on a disease or condition that affects both genders.
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From page 114... ...
One provision of the recently enacted NIH Revitalization Act requires that clinical research be designed and carried out in a manner that provides valid analyses of whether the variables under study affect women or members of racial and ethnic groups differently than other participants. In order to comply with the intent of the legislation, researchers will have to develop effective outreach, recruitment, and retention strategies and to employ scientific methods that are appropriate and valid for ethnically diverse populations.
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From page 115... ...
Related issues relevant to the recruitment, retention, and the protection of research participants through the informed consent process will be treated in the following section. Constructions of Race and Ethnicity Biology or Sociology?
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From page 116... ...
When researchers do not give sufficient attention to understanding when and how biological differences between races are the consequences of differential living conditions, they may draw erroneous conclusions about the role of biology in racial differences (Williams, 19931. This conceptual confusion has led to varying definitions of race across disciplines and to inconsistencies in the ways national health data systems and health research have defined race and ethnicity (Yu and Liu, 1992; Amaro, 1993; Williams, 1993, in press; Gamble and Blustein, 1994~.
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From page 117... ...
One Model of Health Does Not Fit All Groups Historically, the absence of comprehensive epidemiologic information on the health problems of Asians and Pacific Islanders, American Indians and Alaskan Natives, and Hispanics resulted in placing all these groups into a larger social category of "minorities" (Amaro and Vega, in press)
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From page 118... ...
In an effort to protect native peoples from potential abuse, the Indian Health Service has developed detailed guidelines to obtain informed consent for certain invasive procedures, especially those pertinent to reproduction (Lex and Norris, 19941. The infamous case of the Tuskegee syphilis study conducted by the U.S.
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From page 119... ...
Such research practices are indicative of a broader climate of unethical medical practices and violations of the reproductive rights of poor women and women from diverse racial and ethnic groups (Rodriguez-Trias, 1976; Gamble and Blustein, 19941. For example, public health fertility control campaigns targeted to increase the use of sterilization among women in Puerto Rico have resulted in inappropriate and uninformed use of this procedure (Presser, 1965; Scrimshaw and Pasquariella, 1970; Vasquez-Calzada, 1973; Rodriguez-Trias, 1976; Schensul et al., 1982~.
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From page 120... ...
and costly duplication of certain aspects of recruitment for each special population. Community Attitudes Towards Research Decisions regarding appropriateness of individual participation in clinical studies can be influenced by a communal perception of risk and benefit, leading to an overlay of motivation or resistance based on group or commu
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From page 121... ...
An example of community attitudes favoring participation of women in a study might be a grassroots movement in favor of participation in a study of breast cancer, a high-profile condition affecting a high proportion of women. An example of attitudes fostering resistance might be fears of African American women about participating in research based on stories of covert sterilizations in the past or the exploitation of African American men in the Tuskegee study.
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From page 122... ...
The informed consent process may become more complex in light of the issues discussed in the preceding sections, such as community attitudes toward research and the legacy of historical exploitation. Monetary compensation for participation in clinical research might be considered an undue influence in any potential subject population; the poorer the population, the more likely it is that such compensation might render poor women vulnerable to disproportionate experimentation (Yu, 19944.
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From page 123... ...
Societies stratified by gender, race, ethnicity, and socioeconomic status provide different "lenses" through which to see and understand social and scientific reality. These unconscious biases may permeate the entire scientific research process, influencing the research topics selected, the definition and operationalization of concepts examined, the study design, the method of data collection employed, and the research
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From page 124... ...
Investigators and IRBs should utilize the expertise of scholars with experience in studying these populations to avoid the weaknesses evidenced in earlier research. The history of government-sponsored health research and health care efforts in racial, ethnic, and socioeconomic subgroups has not been unblemished past unethical treatment has led individuals from these groups to be
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From page 125... ...
Knowledge of the history of health research in relevant racial or ethnic groups and an awareness of the cultural and political frames of reference employed by the members of these groups will enable researchers to avoid perpetuating the problems. Informed consent is the primary mechanism for protecting subjects from unethical treatment.
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From page 126... ...
In: Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, A Mastroianni, R
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From page 127... ...
Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, A Mastroianni, R
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