Skip to main content

Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 (1994) / Chapter Skim
Currently Skimming:

1 Introduction
Pages 27-35

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 27...
... Several other bills concerning this issue are currently pending before Congress. In order to responsibly and effectively respond to these concerns and initiatives, the research community must examine the available empirical evidence; determine the nature, scope, and severity of the problem; and then recommend action based on this assessment.
Read the entire page →
From page 28...
... Without this foundation of understanding, the committee believed it could not build reasoned ethical and legal arguments to support recommendations concerning future research policy. STRUCTURE OF REPORT This report was prompted by concerns that there has been insufficient attention in biomedical research to women's health conditions, and that studies of conditions affecting both genders may not be generalizable to women if they rely primarily on male participants.
Read the entire page →
From page 29...
... Finally, based on full consideration of all these factors, the committee makes specific recommendations for the fair and effective inclusion of women and women's health interests in clinical research. While these recommendations address legal and ethical issues, they necessarily involve scientific and social considerations as well.
Read the entire page →
From page 30...
... Clinical studies include randomized clinical trials of treatments and preventive interventions, as well as observational, behavioral, psychosocial, and medical outcomes studies. The committee acknowledges that some of the more complex ethical and legal issues arise in the context of clinical trials of drugs, and the report distinguishes such trials from other studies when appropriate (see below and Chapter 41.
Read the entire page →
From page 31...
... This information is almost always available before any generalized clinical testing is done in humans. The two exceptions are the completion of the second-generation animal reproductive exposure studies, which generally are not completed until the middle of Phase II (primary efficacy and safety human tests)
Read the entire page →
From page 34...
... are conducted primarily to determine appropriate adult human dosage. Factors evaluated during these initial clinical trials include rate and extent of absorption by the routes chosen for administration.
Read the entire page →
From page 35...
... A Phase IV study may be a condition of FDA approval to market a drug if the uncertainty about a drug's safety or efficacy does not warrant delaying its release on the market, or it may be initiated by a pharmaceutical company to further substantiate drug safety and efficacy and to support marketing claims (IOM, 19851. Phase IV studies may be controlled or observational.
Read the entire page →

Key Terms

  • clinical trials
  • drug development
  • legal issues
  • approval process
  • clinical trial

  • clinical investigation
  • male participants
  • health conditions
  • initial clinical
  • fda guidelines

  • therapeutic benefit
  • issues arise
  • lactating women
  • backgrounds throughout
  • terms underrepresentation

  • empirical evidence
  • effectively respond
  • human tests
  • hidden influences
  • initial testing

  • determine carcinogenicity
  • close observation
  • evaluation activities
  • compelling ethical
  • drug safety

  • potential constraints
  • widely employed
  • historical context
  • roles common
  • effective inclusion


    • This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
    More information on Chapter Skim is available.