Document Detail

Impact of detailed informed consent on research subjects' participation: a prospective, randomized trial.
MedLine Citation:
PMID:  18022787     Owner:  NLM     Status:  MEDLINE    
This study was undertaken to measure potential research subjects' participation in a survey research design, based on level and type of informed consent required before enrollment. In this prospective, randomized trial, 300 eligible Emergency Department participants were randomized to one of three groups: verbal consent (n = 100), limited written consent (n = 100), and detailed written consent with signature (n = 100). The consent was related to a self-administered patient satisfaction survey. The primary outcome was level of participation, where participation was categorized as full, limited, or refusal. Ninety-five percent confidence intervals (CI) constructed about proportions were used to assess differences in participation rates between the three consent groups. Among 300 participants, no demographic differences were found between groups for age or gender. Participants who were randomized to complete the detailed written consent had a significantly lower rate of full participation (72%) when compared to those randomized to verbal consent (85%; mean difference between groups 13%, 95% CI 2% to 24%) and to those with limited written consent (84%; mean difference between groups 12%, 95% CI 1% to 23%). Participants randomized to detailed written consent also had a significantly higher refusal rate (23%) when compared to those in the limited written group (12%; mean difference between groups -11%, 95% CI -21% to -1%). The length and type of informed consent required affected potential research subject participation in a survey research design. Participants who were asked to sign a detailed written informed consent document had a lower rate of participation compared to those with verbal or limited written consent.
Catherine A Marco
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-11-26
Journal Detail:
Title:  The Journal of emergency medicine     Volume:  34     ISSN:  0736-4679     ISO Abbreviation:  J Emerg Med     Publication Date:  2008 Apr 
Date Detail:
Created Date:  2008-03-14     Completed Date:  2008-07-10     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8412174     Medline TA:  J Emerg Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  269-75     Citation Subset:  IM    
Department of Emergency Medicine, St. Vincent Mercy Medical Center, Toledo, Ohio 43608-2691, USA.
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MeSH Terms
Aged, 80 and over
Confidence Intervals
Consent Forms / statistics & numerical data*
Emergency Service, Hospital
Middle Aged
Patient Satisfaction
Research Subjects / psychology

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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