A Tool Kit to Enhance the Informed Consent Process for Community-Engaged Pediatric Research

The informed consent process for research should ensure that research participants receive sufficient information regarding the details of their involvement, comprehend the provided information, and grasp the voluntary nature of their participation. An unsurprising consequence of the sometimes lengt...

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Bibliographic Details
Published in:IRB 2016-09, Vol.38 (5), p.8-14
Main Authors: Heerman, William J., White, Richard O., Hotop, Annie, Omlung, Karen, Armstrong, Sharelle, Mathieu, Irene, Sherwood, Nancy E., Barkin, Shari L.
Format: Article
Language:English
Subjects:
Bioethics
Child
Clinical trials
Community-Based Participatory Research
Humans
Informed Consent
Medical research
Pediatrics
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Summary:The informed consent process for research should ensure that research participants receive sufficient information regarding the details of their involvement, comprehend the provided information, and grasp the voluntary nature of their participation. An unsurprising consequence of the sometimes lengthy, complex, and burdensome process is that individuals who consent to participate in research often do so without truly being "informed." Here, Heerman et al describe the development of a theory-based enhanced informed consent process that integrates health-literacy approaches into the presentation of the elements of informed consent and into the overall informed consent process. They also provide recommendations for how future studies could test the efficacy of an enhanced approach to informed consent.
ISSN:0193-7758
2578-2355
2326-2222
2578-2363