Evidence map›Paper›PMID 28543423›Full record

ArticleThe Hastings Center report2017

Research with Pregnant Women: New Insights on Legal Decision-Making.

Anna C Mastroianni, Leslie Meltzer Henry, David Robinson, Theodore Bailey, Ruth R Faden, Margaret O Little, Anne Drapkin Lyerly

Abstract read
In one paragraph

Article in The Hastings Center report, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Anna C Mastroianni
Leslie Meltzer Henry
David Robinson
Theodore Bailey
Ruth R Faden
Margaret O Little
Anne Drapkin Lyerly

Funding

The PHASES Project: Pregnancy and HIV/AIDS-Seeking Equitable StudyR01AI108368 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAY, SUZANNE LOUISE, LYERLY, ANNE DRAPKIN · 2015 to 2024
$6.4M
Integrating Decision Making Studies into HIV Cure Trials: A real-time longitudinal assessmentR01AI127024 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI HENDERSON, GAIL E · 2016 to 2019
$2.2M
Advancing HIV Research in Pregnancy; ethics and engagementR56AI108368 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LYERLY, ANNE DRAPKIN · 2013 to 2013
$713k
NIAID NIH HHS R01 AI108368NIAID NIH HHS R01 AI127024NIAID NIH HHS R56 AI108368
6 · The paper itself

Abstract

U.S. researchers and scholars often point to two legal factors as significant obstacles to the inclusion of pregnant women in clinical research: the Department of Health and Human Services' regulatory limitations specific to pregnant women's research participation and the fear of liability for potential harm to children born following a pregnant woman's research participation. This article offers a more nuanced view of the potential legal complexities that can impede research with pregnant women than has previously been reflected in the literature. It reveals new insights into the role of legal professionals throughout the research pathway, from product conception to market, and it highlights a variety of legal factors influencing decision-making that may slow or halt research involving pregnant women. Our conclusion is that closing the evidence gap created by the underrepresentation and exclusion of pregnant women in research will require targeted attention to the role of legal professionals and the legal factors that influence their decisions.

Indexed as

Decision MakingLawyersPregnant PeopleClinical Trials as TopicDrug IndustryFemaleHumansLiability, LegalPregnancyResearch SubjectsRisk Management

Identifiers

PMID28543423
PMCPMC5533594

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.