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IMPROVING PATIENT CARE

Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional SurveyAttitudes Toward Risk and Informed Consent for ROMP

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; and Benjamin S. Wilfond, MD
[+] Article, Author, and Disclosure Information

This article was published online first at www.annals.org on 14 April 2015.


From Stanford University, Stanford, California; University of Minnesota, Minneapolis, Minnesota; University of Oxford, Oxford, United Kingdom; University of Washington and Seattle Children's Research Institute, Seattle, Washington; University of Southern California, Los Angeles, California; and University of Pennsylvania, Philadelphia, Pennsylvania.

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, micho@stanford.edu).

Requests for Single Reprints: Mildred Cho, PhD, Stanford Center for Biomedical Ethics, Stanford University, 1215 Welch Road, Modular A, Stanford, CA 94305; e-mail, micho@stanford.edu.

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.


Ann Intern Med. 2015;162(10):690-696. doi:10.7326/M15-0166
Text Size: A A A

Background: 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.

Objective: To assess attitudes of U.S. adults about risks and preferences for notification and consent for research on medical practices.

Design: Cross-sectional survey conducted in August 2014.

Setting: Web-based questionnaire.

Patients: 1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290).

Measurements: Attitudes toward risk, informed consent, and willingness to participate in 3 research scenarios involving medical record review and randomization of usual medical practices.

Results: 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%).

Limitation: Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population.

Conclusion: 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.

Primary Funding Source: National Center for Advancing Translational Sciences at the National Institutes of Health.

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Comment
Posted on May 13, 2015
Lois Shepherd, J.D.,Ruth Macklin, Ph.D., Nancy M.P. King, J.D., Alice Dreger, Ph.D., Nolan A. Wages, Ph.D.
University of Virginia, Albert Einstein College of Medicine, Wake Forest, Northwestern University Feinberg School of Medicine
Conflict of Interest: None Declared

Cho et al. argue that current requirements for informed consent may not actually show “respect for persons”—a longstanding research ethics principle—because those requirements are not supported by the public. They portray their study results as showing that many research participants would prefer to waive documentation for consent or even consent itself for “research on medical practices” (“ROMP”). Thus, we are told, the current regulatory environment listens to a “consent-requiring minority” at the expense of a “research-supporting majority.”

But that’s not what their study shows. True, their claim that a large percentage of the public supports research on medical practices is borne out by the study—but that is hardly a novel finding and tells us nothing about consent. The important question is whether participation in that research should continue to require voluntary, informed consent.

Contrary to the claim that there is a “consent-requiring minority,” the overwhelming majority of those surveyed in the ROMP Study do not want to be research subjects without their consent, even research involving only medical records review and not an alteration in their care. Even when asked about a study that seems to carry little risk of harm, about a third of those surveyed said that the research should not take place at all unless the consent of subjects was obtained. Of those willing to allow the research to proceed without specific consent, disclosure was vastly preferred over “no notification” of the research. Moreover, it is troubling that none of the scenarios or survey questions explains what might cause obtaining consent to make a study “too difficult to carry out.” Legitimate reasons exist to waive consent, but many other reasons may tempt investigators but fail to satisfy potential subjects and IRBs.

We strongly support research on current medical practices and also acknowledge the importance of testing empirical data and conceptual arguments against each other.  We are also aware that crafting and analyzing surveys in terms that are independent of their authors’ agendas are difficult tasks. And we fear that the ROMP investigators’ apparent goal of substantially revising consent requirements for much research may have overly influenced the collection and analysis of their supporting data.

Lois Shepherd, J.D.
Center for Biomedical Ethics and Humanities,
School of Medicine, and School of Law, University of Virginia
Charlottesville, VA

Ruth Macklin, Ph.D.
Epidemiology and Population Health,
Albert Einstein College of Medicine
Bronx, NY

Nancy M.P. King, J.D.
Department of Social Sciences and Health Policy, Wake Forest
School of Medicine, and Center for Bioethics, Health,
and Society, Wake Forest University
Winston-Salem, NC

Alice Dreger, Ph.D.
Medical Humanities and Bioethics Program,
Northwestern University Feinberg School of Medicine
Chicago, IL

Nolan A. Wages, Ph.D.
Translational Research & Applied Statistics University of Virginia
Charlottesville, VA

 

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