Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies: Volume 2: Workshop and Commissioned Papers (1994) / Chapter Skim
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10 Recruitment and Retention of Women in Clinical Studies: Ethical Considerations
10 Recruitment and Retention of Women in Clinical Studies: Ethical Considerations
Pages 57-64
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From page 57... ...
. should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion...." Of primary concern is that incentives offered to prospective subjects may be so great as to become an "ulterior form of constraint" which will overcome or overwhelm the individual's capacity to exercise free power of choice; such incentives are commonly called "undue inducements." Id the literature on inducements or incentives, some are usually considered unproblematic.
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From page 58... ...
In general, IRBs do not seem to worry very much about cash payments or other material inducements in situations in which the risk is acceptably low or in which the risks appear to be in reasonable proportion to the anticipated direct health-related benefits to the subject. In such cases, Mere is a tendency to let market factors determine the amount of payments.
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From page 59... ...
A statement that participation is voluntary ... and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled." The philosopher Lisa Newton argues that the completely unfettered freedom
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From page 60... ...
~ some clinical trials such plans have been rather elaborate. For example, in the Multiple Risk Factor Intervention Trial protocol, the investigators enlisted the aid of an investigative services film in locating subjects with whom they had lost contact for 12 months or more.
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From page 61... ...
Perhaps this should alert us to the need to involve in the design of such clinical trials people who are sensitive to such possibilities. COSTS OF INVOLVING WOMEN AS RESEARCH SUBJECTS Some sponsors of research,both industrial and governmental, have claimed that inclusion of women as research subjects raises the costs of doing research to the extent Cat their exclusion is justified on ethical grounds.
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From page 62... ...
If instead, the first administration of this drug to women who could and did become pregnant took place in the relatively unmonitored context of clinical practice, then, as with thalidomide, the association between the drug and the anomaly would not be established until hundreds or thousands of babies were born with the anomaly. As with thalidomide, each obstetrician would believe the anomaly she or he observed was one of the unusual cases that occurred "naturally." Women also are excluded from "basic research" designed not to develop drugs but rather to understand basic physiological processes.
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From page 63... ...
While this would satisfy the claims of equal access to putative benefits, it would not necessarily result in the development of either knowledge or products that were especially relevant to either men or women. At least theoretically, such an open door policy might make it much more difficult to develop knowledge or products especially relevant to either gender.
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From page 64... ...
1993. International Ethical Guidelines for Biomedical Research Involving Human Subjects.
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