Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 (1994) / Chapter Skim
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Executive Summary
Executive Summary
Pages 1-26
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The committee was asked to examine the ethical and legal implications of policies that seek broader inclusion of women in clinical studies, including pregnant women and women of childbearing potential. In its analysis, the committee was asked to pay particular attention to the participation of
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The regulations and guidelines stemming from this legislation also were designed to protect against fetal injury in their restrictions on the inclusion of pregnant women and women of childbearing potential in drug trials. In recent years, guidelines and regulations put in place to protect research subjects have been challenged by claims that they are overprotective and overly exclusive, and therefore detrimental to the health of the very persons they were intended to protect.
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The NIH Revitalization Act's mandate that ORWH create a registry focused solely on women's health and the collection of women's health data is too narrow without information on men's health issues and men's levels of participation in such studies, monitoring of the relative levels of participation in the future will be difficult and open to bias. The committee supports the efforts of NIH to establish a registry of clinical studies and recommends that such a registry include information on the participation of women and men and on the racial and ethnic composition of participants in such studies, as well as the research questions addressed, that such information be reasonably accessible to investigators and the public, and that the scope of the studies included in the registry be comprehensive.
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NIH should also consider and take precautions against problems that might be posed by such a registry, particularly with private industry involvement, including considerations of confidentiality, insurance reimbursement implications, endorsement of studies through inclusion in registry, access to non-peer-reviewed studies, administrative burden, and cost considerations. JUSTICE IN CLINICAL STUDIES: GUIDING PRINCIPLES Concerns about justice in the conduct of biomedical research involving human subjects received little attention until the publication in 1978 of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research's Belmont Report.
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Some of the known gender differences in response to treatments are related to physiological differences between the genders. Important examples include hormonal differences, particularly the variation in drug response by women during different stages of the menstrual cycle, the physiological changes that accompany pregnancy and lactation (conditions that carry the additional concern of the effect of drugs on the fetus and nursing infant)
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These true gender differences (and differences associated with gender, e.g., weight) have implications for the design of clinical trials, the subset of clinical studies that provides the most rigorous and reliable test of the effectiveness and safety of new drugs and treatment interventions.
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The committee recommends that investigators proposing research involving human subjects provide a reasonable review of the evidence and plausibility of gender-specific effects relevant to their research, and that studies be required to be designed with sufficient power to detect subgroup differences only when such a review indicates that such a design is warranted. When there is no information concerning possible gender differences, however, the investigator should, when feasible, include both genders in sufficient number to detect differences.
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The committee recommends that NIH assist investigators in this effort by: (1) identifying, developing, and disseminating alternative methods for detecting or formulating hypotheses about gender differences and (2)
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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 groups has not been unblemished past unethical treatment has led individuals from these groups to be wary of participation in current studies.
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Informed consent is the primary mechanism for protecting subjects from unethical treatment. NIH, IRBs, and investigators must work together to tailor the consent process so that it will be effective for every group that participates in clinical studies.
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These policies govern research funded, conducted, or otherwise regulated by the federal government, its agencies, and departments. The policies vary: some appear to promote inclusion of both genders, others refer to inclusion of women and racial and ethnic groups, and others specify conditions applicable to women of childbearing potential and pregnant women.
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Both individuals and organizations involved in the conduct of research must deal with another set of legal considerations liability. Fear of potential legal liability has been cited as one of the reasons that women of childbearing age and pregnant women have traditionally been excluded from clinical trials of drugs.
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A special set of concerns in the research area stems from the differing bases for liability according to which party is a defendant. A pharmaceutical company, for example, might be sued on the basis of strict liability, while a researcher ordinarily would be sued only on the basis of negligence in the informed consent process.
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Any new compensation scheme focusing only on such injuries poses especially difficult problems with regard to establishing causation and averting large numbers of questionable recoveries. The committee recommends that NIH thoroughly review the area of compensation for research injury in general and that consideration of implementation of any compensation scheme include attention to prenatal and preconceptual injuries to children resulting from a parent's participation in a clinical study.
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It is the responsibility of investigators and IRBs to assure that the informed consent process includes an adequate discussion of risks to reproduction and potential offspring, including, where appropriate, an adequate discussion of relevant considerations of birth control. The committee recommends that the participant be permitted to select voluntarily the contraceptive method of his or her choice where there are no relevant study-dependent, scientific reasons for excluding certain contraceptives (e.g., drug interaction)
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The committee recommends that a review be undertaken of existing birth defects monitoring programs to critically define what they are capable of doing and suggest improvements and reasonable expectations for their use. in the context of encouraging clinical research to advance the medical management of pregnant women who are or may become ill, the committee reviewed the current Department of Health and Human Services (DHHSJ regulations concerning the involvement of pregnant women as research subjects.
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Rather, it is urging that the prevailing presumption regarding the participation of pregnant women in clinical trials and other intervention studies be shifted from one of exclusion to one of inclusion. The committee believes that a strengthened informed consent process can address specific concerns regarding the inclusion of pregnant women in clinical studies.
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The committee recommends that OPRR revise and reissue subpart B of the DHHS regulations for the Protection of Human Subjects, titled "Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women, and Human
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The present emphasis placed by NIH on the recruitment of diverse population groups into clinical research is a strong initial step in the pursuit of equity in clinical studies. Where earlier versions of the current NIH policy on inclusion of women in clinical studies simply encouraged investigators to include women in study populations, more recent policy statements require that "clear and compelling" rationales be given for the exclusion of women from proposed research.
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The Investigator Immediate Actions NIH already requires investigators to report the composition of study populations, which keeps investigators aware of the need to involve diverse populations. It is important that individual investigators be aware of both the state of the science and the state of clinical practice with respect to Render and other subaroun differences in their areas of research.
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The committee recommends that IRBs, IRGs, TEGs, scientific advisory councils, and NIH management become more directly involved with investigators in activities that promote development of more inclusive study designs. Measures recommended by the committee, such as IRB review of protocols for study population composition and NIH provision of opportunities for investigator training and access to needed databases, facilitate investigator efforts to realize the goal of greater inclusion.
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As Soon as Feasible Each IRG and TEG should recruit members with expertise in the area of gender, racial, and ethnic differences or persons sensitive to gender and racial and ethnic concerns. Furthermore, every member of IRGs and TEGs should receive training and education on evaluation of study population composition and gender, racial, and ethnic differences.
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NIH should require that proposals for clinical studies include in their literature reviews the following: the extent to which an evidentiary base exists for suspecting gender or other subgroup differences relevant to the proposed research; the demographic characteristics of subjects in past similar research; groups for which the proposed study might have
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NIH should assist investigators in the effort to detect gender differences by: (1) identifying, developing, and disseminating alternative methods for detecting or formulating hypotheses about gender differences and (2)
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It would also help to prevent the introduction into the literature of analyses based on insufficient data- analyses that could ultimately do a disservice to subgroups by fostering seemingly valid but erroneous conclusions.
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