Evidence map›Paper›PMID 26908544›Full record

ArticleClinical trials (London, England)2016

Research involving pediatric stem cell donors: A way forward.

David Wendler, Nirali N Shah, Michael A Pulsipher, Terry Fry, Christine Grady

Abstract read
In one paragraph

Article in Clinical trials (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

David WendlerDepartment of Bioethics, NIH Clinical Center, Bethesda, MD, USA dwendler@nih.gov.
Nirali N ShahPediatric Oncology Branch, National Cancer Institute, Bethesda, MD, USA.
Michael A PulsipherKeck School of Medicine of USC and Children's Hospital Los Angeles, Los Angeles, CA, USA.
Terry FryPediatric Oncology Branch, National Cancer Institute, Bethesda, MD, USA.
Christine GradyDepartment of Bioethics, NIH Clinical Center, Bethesda, MD, USA.

Funding

Optimizing the graft versus leukemia effect for pediatric ALLZIABC011295 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FRY, TERRY · 2010 to 2018
$4.8M
Intramural NIH HHS Z99 CL999999
6 · The paper itself

Abstract

The most suitable donor for younger patients who undergo hematopoietic stem cell transplantation in the research setting is frequently a minor sibling. These cases raise the question of whether minors who serve as stem cell donors for research subjects should be regarded as research subjects themselves. Regarding pediatric donors as research subjects ensures that an Institutional Review Boards reviews their involvement and determines whether it is appropriate. Yet, Institutional Review Boards must follow the US regulations for pediatric research, which were designed for patients and healthy volunteers, not for healthy donors. As a result, regarding pediatric donors as research subjects also can pose unnecessary obstacles to appropriate and potentially life-saving research. This article considers a new way to address this dilemma. The federal research regulations allow for waiver of some or all of the included requirements when they are unnecessary for a study or a class of studies. We argue that this option offers a way to ensure that the involvement of pediatric donors receives sufficient review and approval without inadvertently undermining valuable and potentially life-saving research.

Indexed as

AdolescentBiomedical ResearchChildChild, PreschoolEthics Committees, ResearchHematopoietic Stem Cell TransplantationHumansInfantResearch SubjectsStem Cell ResearchTissue and Organ ProcurementUnited StatesdonorpediatricregulationsTransplantation

Identifiers

PMID26908544
PMCPMC4965294

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.