Reversing the presumption: the IOM report on women in health research.

R. Macklin

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

On February 24, 1994, the Institute of Medicine (IOM) released its report entitled Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. That report highlighted principles of justice in calling for the inclusion of women in clinical studies. This article addresses one key feature of the report, the controversial recommendation that pregnant and lactating women be considered eligible for enrollment in clinical studies. This recommendation of the report effectively reverses the previously existing presumption that excluded pregnant women from most clinical studies and severely restricted enrollment of women of "childbearing potential." The committee explicitly rejected a view of pregnant women as "vulnerable," along with the paternalism inherent in denying women of childbearing potential the same autonomy granted to other competent adults enabling them to decide whether to volunteer as research subjects. The ethical principles used by the committee in reaching these conclusions are described.

Original languageEnglish (US)
Pages (from-to)113-116, 121
JournalJournal of the American Medical Women's Association
Volume49
Issue number4
StatePublished - Jul 1994

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National Academies of Science, Engineering, and Medicine (U.S.) Health and Medicine Division
Women's Health
Pregnant Women
Research
Paternalism
Research Subjects
Social Justice
Ethics
Volunteers
Clinical Studies

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Reversing the presumption : the IOM report on women in health research. / Macklin, R.

In: Journal of the American Medical Women's Association, Vol. 49, No. 4, 07.1994, p. 113-116, 121.

Research output: Contribution to journalArticle

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