Analysis of informed consent document utilization in a minimal-risk genetic study.

BACKGROUND

The signed informed consent document certifies that the process of informed consent has taken place and provides research participants with comprehensive information about their role in the study. Despite efforts to optimize the informed consent document, only limited data are available about the actual use of consent documents by participants in biomedical research.

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.

PRIMARY FUNDING SOURCE

National Institutes of Health.