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Research and Reporting Methods |

Analysis of Informed Consent Document Utilization in a Minimal-Risk Genetic Study

Karl Desch, MD; Jun Li, PhD; Scott Kim, MD, PhD; Naomi Laventhal, MD; Kristen Metzger, MPH; David Siemieniak, MD; and David Ginsburg, MD
[+] Article and Author Information

From University of Michigan, Ann Arbor, Michigan, and City of Chicago, Department of Public Health, Chicago, Illinois.


Acknowledgment: The authors thank Joseph Antin, MD; David Hanauer, MD; and Eric D. Kodish, MD, for their comments and suggestions.

Grant Support: By National Institutes of Health grants R37HL039693 (Dr. Ginsburg) and K12HD028820 (Dr. Desch). Dr. Ginsburg is a Howard Hughes Investigator, and Dr. Kim is a Greenwall Faculty Scholar in Bioethics.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M10-2665.

Reproducible Research Statement:Study protocol: Available from Dr. Ginsburg (e-mail, ginsburg@umich.edu). Statistical code: Available from Dr. Li (e-mail, junzli@umich.edu). Data set: Available to eligible investigators through dbGaP at www.ncbi.nlm.nih.gov/gap.

Requests for Single Reprints: David Ginsburg, MD, 5028 Life Sciences Institute, 210 Washtenaw Avenue, Ann Arbor, MI 48109; e-mail, ginsburg@umich.edu.

Current Author Addresses: Drs. Desch and Laventhal: University of Michigan, Department of Pediatrics, Division of Neonatal-Perinatal Medicine, Mott Children's Hospital, Floor 5, Room 5790, 1500 East Medical Center Drive, 5254, Ann Arbor, MI 48109.

Dr. Li: Department of Human Genetics, 5789A Medical Science II, Box 5618, Ann Arbor, MI 48109-5618.

Dr. Kim: Bioethics Program, University of Michigan, 300 North Ingalls Street, 7C27, Ann Arbor, MI 48109.

Ms. Metzger: Chicago Department of Public Health, 2160 West Ogden Avenue, Chicago, IL 60612.

Dr. Siemieniak: University of Michigan, Life Sciences Institute, 210 Washtenaw Avenue, Ann Arbor, MI 48109.

Dr. Ginsburg: 5028 Life Sciences Institute Building, 210 Washtenaw Avenue, Ann Arbor, MI 48109.

Author Contributions: Conception and design: K. Desch, D. Siemieniak.

Analysis and interpretation of the data: K. Desch, J. Li, S. Kim, K. Metzger, D. Siemieniak, D. Ginsburg.

Drafting of the article: K. Desch, N. Laventhal, K. Metzger, D. Siemieniak.

Critical revision of the article for important intellectual content: K. Desch, J. Li, S. Kim, N. Laventhal, K. Metzger, D. Siemieniak, D. Ginsburg.

Final approval of the article: K. Desch, J. Li, S. Kim, N. Laventhal, D. Siemieniak, D. Ginsburg.

Provision of study materials or patients: K. Desch, D. Siemieniak.

Statistical expertise: J. Li, D. Siemieniak.

Obtaining of funding: D. Ginsburg.

Administrative, technical, or logistic support: K. Metzger, D. Siemieniak.

Collection and assembly of data: K. Desch, K. Metzger, D. Siemieniak.


Ann Intern Med. 2011;155(5):316-322. doi:10.7326/0003-4819-155-5-201109060-00009
Text Size: A A A

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.

Figures

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Figure 1.
Study flow diagram.

Online recruitment was logged by recording Internet activity on the study home page, eligibility screen page, and log-in usernames to the informed consent document page. Internet hits to the home page and eligibility page that were from study investigators (specific static IP addresses) or Internet “bots” (>100 hits/d) were removed. A total of 1758 login usernames and passwords were sent to persons who completed the eligibility screen, allowing them to log in and view the study informed consent document. Genotyping identified 5 sibling pair duplicates, and data from these 10 participants were removed. ICD = informed consent document; IP = Internet protocol.

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Figure 2.
Consent-time distribution.

The number of participants in each 10-second time bin is shown. The interval for expected reading times for comprehension at 200 to 300 words per minute (566 to 850 seconds) is indicated with a bracket. Each asterisk indicates a person who identified the hyperlink within the corresponding time bin.

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