Pregnant Women Permissible Regulations Cautious Practice A US Perspective Anna C Mastroianni JD MPH Professor of Law University of Washington School of Law Associate Director Institute for Public Health Genetics ID: 621534
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Research With Pregnant WomenPermissible Regulations, Cautious Practice: A US Perspective
Anna C. Mastroianni, JD, MPH
Professor of Law, University of Washington School of Law
Associate Director, Institute for Public Health Genetics
Seattle, USA
Leslie Meltzer Henry, JD, PhD
Professor of Law, University of Maryland Carey School of Law
Core Faculty, Johns Hopkins Berman Institute of Bioethics
Baltimore, USASlide2
Orientation United States permits pregnant women’s participation in research under conditions specified in regulations and official guidances
Facilitated through local IRB review with national oversight
“Subpart B”
[A
dditional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research]
regulations set up ethical framework, with extensive reach and international influence
Permissibility stymied by regulatory and other legal obstaclesSlide3
Any FunderResearch Conducted at an FWA Institution Inside or Outside of the United StatesAny Funder
Research Team Member Affiliated with FWA Institution Inside or Outside of the United States
The Reach of Subpart BSlide4
US Regulatory Approach to Common Ethical IssuesSlide5
US Regulatory Approach to Common Ethical Issues Benefit-RiskSlide6
Standard: “reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women [or] fetuses …”
Process
: Decision by Secretary of Health and Human Services, after consultation with expert panel, public comment, and public meeting
Additional Mechanism for Approving Research with Pregnant WomenSlide7
US Regulatory Approach to Common Ethical Issues: Paternal ConsentInform of “reasonably foreseeable impact of the research on the fetus”Additional consent of father required if research holds out prospect of direct benefit solely to the fetus Exceptions: unavailability, incompetence, temporary incapacity, pregnancy resulted from rape or incest.Slide8
Default Approach De Facto Exclusion of Pregnant WomenMany researchers and institutional review boards (IRBs) continue to regard pregnancy as a near-automatic cause for exclusion, regardless of the costs of exclusion or the magnitude or likelihood of the risks of participation.
A. Lyerly, M. Little & R. Faden. The second wave: toward responsible inclusion of pregnant women in research.
Real-Life Implications
Fewer than 20 FDA-approved drugs are approved for use during pregnancy
Mean time for determining risk of medication in pregnancy: 27 years post-drug approvalSlide9
Legal Obstacles Lawyers are active and influential participants in decisionmaking throughout the research process
Regulatory Ambiguity and Inconsistency
Legal Risk Management
Litigation Climate and “Long Tail” Liability Concerns
Insurance Availability
Compensation Availability
Venue-Specific Laws
International Complexity
Fetal Protection LawsSlide10
Acknowledgments