Evidence map›Paper›PMID 31850290›Full record

ReviewFrontiers in pediatrics2019

Waived Consent in Perinatal/Neonatal Research-When Is It Appropriate?

Wade D Rich, Anup C Katheria

Open access · goldAbstract readReview
In one paragraph

Review in Frontiers in pediatrics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 13% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
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

2 authors at 1 institution in 1 country.

Wade D RichNeonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, United States.
Anup C KatheriaNeonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA, United States.
Sharp Mary Birch Hospital for Women & Newborns · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Informed consent is a process ensuring that subjects enrolled in research are appropriately informed of the risks and benefits. While this process is well-defined when it is possible and practical to obtain consent prior to the research intervention, it can be less clear in cases of deferred or waived consent. Defining minimal risk, such as when research is attempting to determine which of two currently practiced interventions is safest and/or most effective, is critical to moving forward in establishing appropriate care in newborns. For perinatal/neonatal research the challenge lies between the ethical justification for approaching women in labor or under medication vs. the scientific integrity of excluding a number of subjects that may potentially benefit the most from an intervention. Researchers must work with their IRBs as well as families who have participated in trials to determine the most appropriate method for obtaining informed consent from expectant parents. Clinical researchers and IRBs ultimately need to find a middle ground for the appropriate use of deferred or waived consent.

Indexed as

ethicsinformed consentneonalalresuscitationwaiver

Identifiers

PMID31850290
PMCPMC6901905
OpenAlexW2991556505

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.