Mildred K. Cho, PhD; David Magnus, PhD; Melissa Constantine, PhD, MPAff; Sandra Soo-Jin Lee, PhD; Maureen Kelley, PhD; Stephanie Alessi, JD; Diane Korngiebel, DPhil; Cyan James, PhD; Ellen Kuwana, MS; Thomas H. Gallagher, MD; Douglas Diekema, MD, MPH; Alexander M. Capron, LLB; Steven Joffe, MD, MPH; Benjamin S. Wilfond, MD
Acknowledgment: The authors thank Alex Thomas, MD, and Gary Ashwal of Booster Shot Media for their hard work to produce the creative and engaging videos for the survey; Ann Breese of Turner Research Network for providing her expertise on survey design and administration of online surveys; Philip Lavori at Stanford University for his contributions to survey design; Adrienne Meyer at the University of Washington for overall project management; and clinical collaborators Kris Patton at the University of Washington, Raj Munshi and Steve Seslar at Seattle Children's Hospital, and Steve Alexander and Glenn Chertow at Stanford Hospital and Clinics for recruiting patients for focus groups.
Grant Support: By the National Center for the Advancement of Translational Sciences at the National Institutes of Health (grants UL1 TR000423-07S1 [University of Washington and Seattle Children's Research Institute] and UL1 TR001085 [Stanford University]).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0166.
Reproducible Research Statement:Study protocol: Survey online and available to the public at the ROMP Ethics Study Web site (https://rompethics.iths.org). Statistical code and data set: Available through written agreement with the authors (contact Dr. Cho; e-mail, email@example.com).
Requests for Single Reprints: Mildred Cho, PhD, Stanford Center for Biomedical Ethics, Stanford University, 1215 Welch Road, Modular A, Stanford, CA 94305; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Cho, Magnus, Lee, and Ms. Alessi: Stanford Center for Biomedical Ethics, 1215 Welch Road, Modular A, Stanford, CA 94305.
Dr. Constantine: Division of Health Policy and Management, University of Minnesota, 420 Delaware Street Southeast, MMC 729, Minneapolis, MN 55455.
Dr. Kelley: Ethox Centre, Nuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford OX3 7LF, United Kingdom.
Dr. Korngiebel: Health Sciences Center, University of Washington, 1959 Northeast Pacific Street, Campus Box 357240, Seattle, WA 98195.
Dr. James: Institute for Public Health Genetics, University of Washington, 1705 Northeast Pacific Street, K253, Campus Box 353410, Raitt Hall, Seattle, WA 98195.
Drs. Diekema and Wilfond and Ms. Kuwana: Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, 1900 Ninth Avenue, M/S JMB-6, Seattle, WA 98101.
Dr. Gallagher: Department of Bioethics & Humanities, University of Washington, 4311 11th Avenue Northeast, Suite 230, Campus Box 356526, Seattle, WA 98195.
Mr. Capron: Gould School of Law, University of Southern California, 699 Exposition Boulevard, Los Angeles, CA 90089.
Dr. Joffe: Perelman School of Medicine, University of Pennsylvania, 3401 Market Street, Suite 320, Philadelphia, PA 19104.
Author Contributions: Conception and design: M.K. Cho, D. Magnus, S.S. Lee, M. Kelley, S. Alessi, D. Korngiebel, T.H. Gallagher, D. Diekema, A.M. Capron, S. Joffe, B.S. Wilfond.
Analysis and interpretation of the data: M.K. Cho, D. Magnus, M. Constantine, M. Kelley, S. Alessi, D. Korngiebel, C. James, T.H. Gallagher, D. Diekema, S. Joffe, B.S. Wilfond.
Drafting of the article: M.K. Cho, D. Magnus, M. Constantine, S.S. Lee, S. Alessi, E. Kuwana.
Critical revision of the article for important intellectual content: M.K. Cho, D. Magnus, M. Constantine, S. Alessi, C. James, E. Kuwana, T.H. Gallagher, D. Diekema, A.M. Capron, S. Joffe, B.S. Wilfond.
Final approval of the article: M.K. Cho, M. Constantine, S.S. Lee, M. Kelley, S. Alessi, D. Korngiebel, C. James, E. Kuwana, T.H. Gallagher, D. Diekema, A.M. Capron, S. Joffe, B.S. Wilfond.
Statistical expertise: M. Constantine.
Obtaining of funding: M.K. Cho, D. Magnus, B.S. Wilfond.
Administrative, technical, or logistic support: B.S. Wilfond.
Collection and assembly of data: M.K. Cho, M. Constantine, S. Alessi, D. Korngiebel, C. James, E. Kuwana, B.S. Wilfond.
The U.S. Office for Human Research Protections has proposed that end points of randomized trials comparing the effectiveness of standard medical practices are risks of research that would require disclosure and written informed consent, but data are lacking on the views of potential participants.
To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices.
Cross-sectional survey conducted in August 2014.
1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290).
Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices.
97% of respondents agreed that health systems should evaluate standard treatments. Most wanted to be asked for permission to participate in each of 3 scenarios (range, 75.2% to 80.4%), even if it involved only medical record review, but most would accept nonwritten (oral) permission or general notification if obtaining written permission would make the research too difficult to conduct (range, 70.2% to 82.7%). Most perceived additional risk from each scenario (range, 64.0% to 81.6%).
Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population.
Most respondents preferred to be asked for permission to participate in observational and randomized research evaluating usual medical practices, but they are willing to accept less elaborate approaches than written consent if research would otherwise be impracticable. These attitudes are not aligned with proposed regulatory guidance.
National Center for Advancing Translational Sciences at the National Institutes of Health.
Cho MK, Magnus D, Constantine M, Lee SS, Kelley M, Alessi S, et al. Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey. Ann Intern Med. ;162:690–696. doi: 10.7326/M15-0166
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Published: Ann Intern Med. 2015;162(10):690-696.
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