Harms of Excluding Pregnant Women From Clinical Research: The Case of HIV-Infected Pregnant Women
Kass, Nancy E.
Taylor, Holly A.
King, Patricia A.
Journal of Law, Medicine and Ethics. 1996 Spring; 24(1): 36-46.
...It is our purpose (1) to describe how pregnant and nonpregnant HIV-infected women are included in clinical research; (2) to trace federal policies concerning the inclusion of pregnant women in clinical research; (3) to document the inclusion of HIV-infected pregnant and nonpregnant women in clinical trials; (4) to discuss issues relevant to whether sponsors or institutions could be liable if harm were to result from pregnant women's inclusion in as well as the implications of restricting pregnant women's access to AIDS research; and, finally, (5) to provide policy recommendations concerning the circumstances in which HIV-infected pregnant women ought to be included in clinical research. It should be noted from the outset that we focus on pregnant women because current regulations generally prohibit the inclusion of pregnant women in clinical research. Clearly, further research is necessary concerning the extent to which adverse reproductive outcomes are male-mediated and whether liability and other concerns might arise in the future by virtue of including in research men of reproductive potential.
Aids; Animal Experimentation; Clinical Trials; Clinical Research; Consent; Decision Making; Drugs; Discrimination; Ethics; Ethics Committees; Federal Government; Females; Fetuses; Food; Government; Government Regulation; Guidelines; Harm; Health; HIV Seropositivity; Human Experimentation; Informed Consent; Injuries; Justice; Legal Liability; Liability; Minority Groups; Nontherapeutic Research; Paternalism; Pregnant Women; Prenatal Injuries; Regulation; Reproduction; Research; Research Ethics; Research Ethics Committees; Rights; Risks and Benefits; Selection of Subjects; Social Discrimination; Therapeutic Research; Women's Health;
Showing items related by title, author, creator and subject.
Dickert, Neal; Kass, Nancy; Paasche-Orlow, Michael; Taylor, Holly (2005-01)Although the informed consent process is crucial to protecting human research subjects, there are cases when particular information within the consent form may present risks to those subjects. In this paper, we examine a ...