Evidence map›Paper›PMID 35506484›Full record

ReviewPrenatal diagnosis2022

A new ethical framework to determine acceptable risks in fetal therapy trials.

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

Open access · greenAbstract readReview
In one paragraph

Review in Prenatal diagnosis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 11% of its field
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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
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

6 authors at 2 institutions in 1 country.

Saskia HendriksDepartment of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0003-3574-2306
Christine GradyDepartment of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
David WassermanDepartment of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
David WendlerDepartment of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
Diana W BianchiSection on Prenatal Genomics and Fetal Therapy, Center for Precision Health Research, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0001-9270-5267
Benjamin BerkmanDepartment of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
National Institutes of Health Clinical Center · USNational Institutes of Health · US

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
Intramural NIH HHS ZIA HG200399
6 · The paper itself

Abstract

objectiveFetal therapy trials pose complex ethical challenges because risks and benefits to both fetuses and pregnant persons must be considered. Existing regulatory guidance is limited and many proposed ethical frameworks have unnecessarily restrictive criteria that would block the development and implementation of important new fetal therapies. We aimed to develop a new ethical framework for assessing the risks and benefits of fetal therapy trials.

methodsWe reviewed existing regulatory and ethical guidance on fetal therapy trials. We used conceptual analysis to design a new ethical framework, which is grounded in general ethical principles for clinical research.

resultsWe propose a new framework for assessing the risks and benefits of fetal therapy trials. We suggest that the potential benefits of a fetal therapy trial - for the fetus, the pregnant person, and society - should outweigh the risks for the fetus and the pregnant person. Furthermore, the risk-benefit profile for just the fetus and the risk-benefit profile for just the pregnant person should be appropriate.

conclusionsWe hope that this new framework will permit important studies while protecting pregnant persons and fetuses from disproportionate harms.

Indexed as

FetusPrenatal CareFemaleHumansPregnancyRisk Assessment

Identifiers

PMID35506484
PMCPMC10134777
OpenAlexW4225398016

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.