Evidence map›Paper›PMID 33455521›Full record

ArticleThe American journal of bioethics : AJOB2022

A New Ethical Framework for Assessing the Unique Challenges of Fetal Therapy Trials.

Saskia Hendriks, Christine Grady, David Wasserman, David Wendler, Diana W Bianchi, Benjamin E Berkman

Abstract read
In one paragraph

Article in The American journal of bioethics : AJOB, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Bilateral renal agenesis: fetal intervention and outcomes.Pediatric nephrology (Berlin, Germany) · 2025
    Review
  11. Ethical Considerations in Fetal Cardiology.Journal of cardiovascular development and disease · 2024
    Review
  12. Article
  13. Review
  14. Review
  15. Considering Reprogenomics in the Ethical Future of Fetal Therapy Trials.The American journal of bioethics : AJOB · 2022
    Article
  16. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Saskia HendriksNational Institutes of Health.ORCID 0000-0003-3574-2306
Christine GradyNational Institutes of Health.
David WassermanNational Institutes of Health.
David WendlerNational Institutes of Health.
Diana W BianchiNational Institutes of Health.
Benjamin E BerkmanNational Institutes of Health.

Funding

Prenatal Treatment of Down Syndrome to Improve Brain Development and NeurocognitionZIAHG200399 · NHGRI · NATIONAL HUMAN GENOME RESEARCH INSTITUTE · PI BIANCHI, DIANA · 2017 to 2025
$11.1M
Research and clinical care without informed consentZIACL010537 · CLC · CLINICAL CENTER · PI WENDLER, DAVID S · 2014 to 2025
$0k
Intramural NIH HHS Z99 CL999999
6 · The paper itself

Abstract

New fetal therapies offer important prospects for improving health. However, having to consider both the fetus and the pregnant woman makes the risk-benefit analysis of fetal therapy trials challenging. Regulatory guidance is limited, and proposed ethical frameworks are overly restrictive or permissive. We propose a new ethical framework for fetal therapy research. First, we argue that considering only biomedical benefits fails to capture all relevant interests. Thus, we endorse expanding the considered benefits to include evidence-based psychosocial effects of fetal therapies. Second, we reject the commonly proposed categorical risk and/or benefit thresholds for assessing fetal therapy research (e.g., only for life-threatening conditions). Instead, we propose that the individual risks for the pregnant woman

Indexed as

Fetal TherapiesFetusEthics, MedicalFemaleHumansPregnancyPregnant Peopleethics, researchfetal diseasesFetal therapiespregnancyrisk benefit assessmenttherapies, investigational

Identifiers

PMID33455521
PMCPMC8530458

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.