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Research with Pregnant Women: New Insights on Legal Decision-Making
- Source :
- The Hastings Center report. 47(3)
- Publication Year :
- 2017
-
Abstract
- Although pregnant women rely on medical interventions to treat and prevent a wide variety of health conditions, they are frequently excluded or underrepresented in clinical research. The resulting dearth of pregnancy-specific evidence to guide clinical decisionmaking routinely exposes pregnant women, and their future offspring, to risk of uncertain harms for uncertain benefits. The two legal factors regularly cited as obstacles to such research are the federal regulatory scheme and fear of liability. This article reveals a far more nuanced and complex view of the legal context. First, legal professionals may—at any time from product conception to marketing—influence decisions about research with pregnant women. Second, factors not previously articulated in the literature may prompt legal professionals to slow or halt such research. They include: financial interests, regulatory ambiguity, obstacles to risk management, and site-specific laws unrelated to research. Any efforts to promote the ethical inclusion of pregnant women in research must acknowledge the role of legal decisionmakers and address their professional concerns.
- Subjects :
- Health (social science)
Inclusion (disability rights)
Drug Industry
Research Subjects
Decision Making
030226 pharmacology & pharmacy
Article
03 medical and health sciences
Lawyers
0302 clinical medicine
Pregnancy
Humans
030212 general & internal medicine
Product (category theory)
Legal profession
Human services
Legal decision
health care economics and organizations
Clinical Trials as Topic
Risk Management
business.industry
Health Policy
Liability
Liability, Legal
Public relations
humanities
Variety (cybernetics)
Philosophy
Issues, ethics and legal aspects
Clinical research
Female
Pregnant Women
Psychology
business
Social psychology
Subjects
Details
- ISSN :
- 1552146X
- Volume :
- 47
- Issue :
- 3
- Database :
- OpenAIRE
- Journal :
- The Hastings Center report
- Accession number :
- edsair.doi.dedup.....183b288eb8059a87e7d454d0c2e30a72