Evidence map›Paper›PMID 25676061›Full record

ArticleClinical and translational science2015

Improving the Proficiency of Research Consent Administrators.

Elaine L Larson, Rachel Lally, Gabriella Foe, Gabriela Joaquin, Dodi D Meyer, Elizabeth G Cohn

Abstract read
In one paragraph

Article in Clinical and translational science, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Assessing usefulness and researcher satisfaction with consent form templates.Journal of clinical and translational science · 2017
    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.

Elaine L LarsonSchool of Nursing, Mailman School of Public Health, Columbia University, New York, New York, USA.
Rachel LallyHuman Research Protection Office, Columbia University, New York, New York, USA.
Gabriella FoeSchool of Continuing Studies, Columbia University, New York, New York, USA.
Gabriela JoaquinThe City College of New York, New York, New York, USA.
Dodi D MeyerCommunity Pediatrics, College of Physicians and Surgeons, Columbia University, New York, New York, USA.
Elizabeth G CohnCenter for Health Innovation, Adelphi University, Garden City, New York, USA.

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024156 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2006 to 2011
$53.0M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
Institutional Career Development CoreKL2TR001874 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GENKINGER, JEANINE M., SHIMBO, DAICHI · 2016 to 2025
$13.6M
NCATS NIH HHS KL2 TR001874NCATS NIH HHS UL1 TR000040NCRR NIH HHS UL1 RR024156
6 · The paper itself

Abstract

objectiveTo describe the development and testing of a module to improve consent administrators' skills when obtaining research consent from culturally and linguistically diverse and low literacy populations.

designDevelopment and psychometric testing of video module including community vignettes.

methodsFollowing initial content, face, and construct validity testing by experts, a field trial was conducted with pre- and postknowledge tests and satisfaction surveys completed by 112 consent administrators.

resultsMean score out of a possible 10 on pretest was 8.6 (±standard deviation [SD], 1.55) and on posttest was 9.1 (±SD, 1.2; paired t-test 95% confidence interval of difference: -0.18 to -0.88; two-tailed p = 0.003). The average years of experience with obtaining consent was 6.42 years (range: 0-35), but years of experience was not significantly associated with either pre- or posttest scores (p = 0.82 and 0.44, respectively). Most user evaluations were positive, although suggestions for improvements were made.

conclusionAlthough pretest scores were relatively high, training needs of research consent administrators for consenting diverse and low literacy populations may be unmet. We urge that institutional review boards, researchers, policymakers, educators, and bioethicists address the training needs of research consent administrators and we offer this training module as one potential resource and adjunct to such training.

Indexed as

Biomedical ResearchInformed ConsentEthics Committees, ResearchHumansbiomedical ethicsclinical researchhealth literacyinformed consent

Identifiers

PMID25676061
PMCPMC4531103

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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.