Informed consent is an important component of ethical research. Unfortunately, data show that research participants do not always understand key features of the research they participate in. At the same time, consent documents are increasingly becoming longer, more technical, and complex. This project aims to test a simpler, more concise consent form against the standard consent form in a variety of research projects. Both consent forms contain all the elements required by federal regulations, and are approved by an IRB. Participants in these trials are randomized to receive either the standard or the concise consent form and then asked to complete a questionnaire that tests their comprehension of study information and their satisfaction with the process. Our hypothesis is that comprehensionn will be similar in both groups and satisfaction higher in the group that receives the concise form. Two studies with healthy volunteers and a study of 4000 patient volunteers from around the world are complete and published. Given our data, investigators and institutions may be encouraged to write forms that are easier to read and shorter. Further analysis related to changes in consent forms is ongoing, as is research into new forms of disclosing information in the consent process.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIACL010531-10
Application #
9780119
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
10
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
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Country
Zip Code
Grady, Christine (2017) Informed Consent. N Engl J Med 376:e43
Grady, Christine; Touloumi, Giota; Walker, A Sarah et al. (2017) A randomized trial comparing concise and standard consent forms in the START trial. PLoS One 12:e0172607
Dickert, Neal W; Eyal, Nir; Goldkind, Sara F et al. (2017) Reframing Consent for Clinical Research: A Function-Based Approach. Am J Bioeth 17:3-11
Grady, Christine (2015) Enduring and emerging challenges of informed consent. N Engl J Med 372:2172
Enama, Mary E; Hu, Zonghui; Gordon, Ingelise et al. (2012) Randomization to standard and concise informed consent forms: development of evidence-based consent practices. Contemp Clin Trials 33:895-902
Mandava, Amulya; Pace, Christine; Campbell, Benjamin et al. (2012) The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries. J Med Ethics 38:356-65
Stunkel, Leanne; Benson, Meredith; McLellan, Louise et al. (2010) Comprehension and informed consent: assessing the effect of a short consent form. IRB 32:1-9