Evidence map›Paper›PMID 33044907›Full record

ArticleAJOB empirical bioethics

The Meaning of Informed Consent: Genome Editing Clinical Trials for Sickle Cell Disease.

Stacy Desine, Brittany M Hollister, Khadijah E Abdallah, Anitra Persaud, Sara Chandros Hull, Vence L Bonham

Open access · hybridAbstract read
In one paragraph

Article in AJOB empirical bioethics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 34% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Restoring vision using optogenetics without being blind to the risks.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2022
    Review
  10. Editing outside the body: Ex vivo gene-modification for β-hemoglobinopathy cellular therapy.Molecular therapy : the journal of the American Society of Gene Therapy · 2021
    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

6 authors at 1 institution in 1 country.

Stacy DesineSocial and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA.
Brittany M HollisterSocial and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0001-9913-4663
Khadijah E AbdallahSocial and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA.
Anitra PersaudSocial and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA.
Sara Chandros HullDepartment of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0001-8742-4997
Vence L BonhamSocial and Behavioral Research Branch, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0002-3649-5442
National Institutes of Health · US

Funding

Insights into Sickle Cell Trait and Sickle Cell DiseaseZIAHG200394 · NHGRI · NATIONAL HUMAN GENOME RESEARCH INSTITUTE · PI BONHAM, VENCE L · 2014 to 2025
$3.8M
Examining the Equitable Integration of Genomics in Health Care and SocietyZIAHG200403 · NHGRI · NATIONAL HUMAN GENOME RESEARCH INSTITUTE · PI BONHAM, VENCE L · 2019 to 2025
$1.3M
Intramural NIH HHS ZIA HG200394Intramural NIH HHS ZIA HG200403
6 · The paper itself

Abstract

backgroundA first therapeutic target of somatic genome editing (SGE) is sickle cell disease (SCD), the most commonly inherited blood disorders, affecting more than 100,000 individuals in the United States. Advancement of SGE is contingent on patient participation in first in human clinical trials. However, seriously ill patients may be vulnerable to overestimating the benefits of early phase studies while underestimating the risks. Therefore, ensuring potential clinical trial participants are fully informed prior to participating in a SGE clinical trial is critical.

Indexed as

Access to InformationGene EditingGenetic TherapyInformed ConsentAdolescentAdultAgedAnemia, Sickle CellAttitudeChildComprehensionFocus GroupsHealth LiteracyHealth Services Needs and DemandHumansMiddle Agedclinical trialsCRISPRinformed consentSickle cell diseasesomatic genome editing

Identifiers

PMID33044907
PMCPMC7710006
OpenAlexW3092048969

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.