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Randomized Controlled Trial
. 2020 Oct;15(4):252-260.
doi: 10.1177/1556264620913455. Epub 2020 Apr 3.

Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial

Erin Rothwell  1 , Erin Johnson  1 , Bob Wong  1 , Aaron Goldenberg  2 , Beth A Tarini  3 , Naomi Riches  1 , Louisa A Stark  1 , Christina Pries  4 , Carrie Langbo  5 , Elizabeth Langen  6 , Jeffrey Botkin  1
Affiliations
Randomized Controlled Trial

Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research: A Randomized Controlled Trial

Erin Rothwell et al. J Empir Res Hum Res Ethics. 2020 Oct.

Abstract

Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet "app") with standard brochure-based consent in the Michigan BioTrust for Health. Results indicated higher knowledge scores for the video and app groups as well as significantly higher scores on satisfaction, amount of information, and clarity with the information provided. More research is needed to find the right amount of information for informed decision-making, and additional feasibility studies are needed to assess implementation strategies.

Trial registration: ClinicalTrials.gov NCT03141307.

Keywords: biospecimens; bloodspots; consent; multimedia; newborn screening.

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References

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