Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study
Objective: To examine the use of online consent documents in a minimal-risk genetic study.
Design: Prospective sibling cohort enrolled as part of a genetic study of hematologic and common human traits.
Setting: University of Michigan Campus, Ann Arbor, Michigan.
Participants: Volunteer sample of healthy persons with 1 or more eligible siblings aged 14 to 35 years. Enrollment was through targeted e-mail to student lists. A total of 1209 persons completed the study.
Measurements: Time taken by participants to review a 2833-word online consent document before indicating consent and identification of a masked hyperlink near the end of the document.
Results: The minimum predicted reading time was 566 seconds. The median time to consent was 53 seconds. A total of 23% of participants consented within 10 seconds, and 93% of participants consented in less than the minimum predicted reading time. A total of 2.5% of participants identified the masked hyperlink.
Limitation: The online consent process was not observed directly by study investigators, and some participants may have viewed the consent document more than once.
Conclusion: Few research participants thoroughly read the consent document before agreeing to participate in this genetic study. These data suggest that current informed consent documents, particularly for low-risk studies, may no longer serve the intended purpose of protecting human participants, and the role of these documents should be reassessed.
Read the full article:
Desch K, Li J, Kim S, Laventhal N, Metzger K, Siemieniak D, Ginsburg D. Analysis of informed consent document utilization in a minimal-risk genetic study. Ann Intern Med. 2011 Sep 6;155(5):316-22. PMID: 21893624
Labels: for researchers, from the literature
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