Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey
Submit a Comment
Contributors must reveal any conflict of interest. Comments are moderated. Please see our information for authorsregarding comments on an Annals publication.
Abstract
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.
Get full access to this article
View all available purchase options and get full access to this article.
References
1.
Drazen JM, Solomon CG, Greene MF. Informed consent and SUPPORT [Editorial]. N Engl J Med. 2013;368:1929-31. [PMID: 23593944] doi: 10.1056/NEJMe1304996
2.
Hudson KL, Guttmacher AE, Collins FS. In support of SUPPORT—a view from the NIH. N Engl J Med. 2013;368:2349-51. [PMID: 23738511] doi: 10.1056/NEJMp1306986
3.
Macklin R, Shepherd L, Dreger A, Asch A, Baylis F, Brody H, et al. The OHRP and SUPPORT—another view [Letter]. N Engl J Med. 2013;369:e3. [PMID: 23803134] doi: 10.1056/NEJMc1308015
4.
Magnus D, Caplan AL. Risk, consent, and SUPPORT. N Engl J Med. 2013;368:1864-5. [PMID: 23597408] doi: 10.1056/NEJMp1305086
5.
Wilfond BS, Magnus D, Antommaria AH, Appelbaum P, Aschner J, Barrington KJ, et al. The OHRP and SUPPORT [Letter]. N Engl J Med. 2013;368:e36. [PMID: 23738513] doi: 10.1056/NEJMc1307008
6.
LR Buchanan; Office of Human Research Protections. Human research protections under federalwide assurance (FWA) 5960. Birmingham, AL: U.S. Department of Health and Human Services; 2013. Accessed at www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf on 23 March 2015.
7.
Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, et al; SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010;362:1959-69. [PMID: 20472937] doi: 10.1056/NEJMoa0911781
8.
U.S. Department of Health and Human Services. Draft guidance on disclosing reasonably foreseeable risks in research evaluating standards of care. Washington, DC: Federal Register; 2014. Accessed at https://federalregister.gov/a/2014-29915 on 23 March 2015.
9.
NIH Collaboratory. Demonstration projects 2015. Accessed at www.nihcollaboratory.org/demonstration-projects/Pages/default.aspx on 11 February 2015.
10.
U.S. Department of Health and Human Services. Protection of human subjects, 45 C.F.R. § 46.111(a)(2) (2009). Accessed at www.hhs.gov/ohrp/policy/ohrpregulations.pdf on 23 March 2015.
11.
Faden RR, Beauchamp TL, Kass NE. Informed consent, comparative effectiveness, and learning health care. N Engl J Med. 2014;370:766-8. [PMID: 24552325] doi: 10.1056/NEJMhle1313674
12.
Faden RR, Kass NE, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep. 2013;Spec No:S16-27. [PMID: 23315888] doi: 10.1002/hast.134
13.
Kass N, Faden R, Tunis S. Addressing low-risk comparative effectiveness research in proposed changes to US federal regulations governing research. JAMA. 2012;307:1589-90. [PMID: 22511685] doi: 10.1001/jama.2012.491
14.
OHRP and standard-of-care research [Editorial]. N Engl J Med. 2014;371:2125-6. [PMID: 25390459] doi: 10.1056/NEJMe1413296
15.
Lantos JD, Spertus JA. The concept of risk in comparative-effectiveness research. N Engl J Med. 2014;371:2129-30. [PMID: 25390458] doi: 10.1056/NEJMhle1413301
16.
Magnus D, Wilfond BS. Research on medical practices and the ethics of disclosure. Pediatrics. 2015;135:208-10. [PMID: 25583909] doi: 10.1542/peds.2014-3578
17.
U.S. Department of Health and Human Services. Protection of human subjects, 45 C.F.R. § 46.116(d)(1) (2009). Accessed at www.hhs.gov/ohrp/policy/ohrpregulations.pdf on 23 March 2015.
18.
Collins D. Pretesting survey instruments: an overview of cognitive methods. Qual Life Res. 2003;12:229-38. [PMID: 12769135]
19.
Research on Medical Practices Research Team. Which medication is best? [video]. Seattle, WA: Institute of Translational Health Science; 2014. Accessed at https://rompethics.iths.org/?page_id=97 on 4 September 2014.
20.
Research on Medical Practices Research Team. Approaches to ROMP [video]. Seattle, WA: Institute of Translational Health Science; 2014. Accessed at https://rompethics.iths.org/?page_id=99 on 4 September 2014.
21.
Research on Medical Practices Research Team. Informing or asking [video]. Seattle, WA: Institute of Translational Health Science; 2014. Accessed at https://rompethics.iths.org/?page_id=101 on 4 September 2014.
22.
Research on Medical Practices Research Team. General population and patient survey. Seattle, WA: Institute of Translational Health Science; 2014. Accessed at https://rompethics.iths.org/wp-content/uploads/2014/10/Patient-Survey.pdf on 4 September 2014.
23.
U.S. Census Bureau. Current population survey (CPS). Suitland, MD: U.S. Census Bureau; 2013. Accessed at www.census.gov/hhes/www/cpstables/032014/perinc/toc.htm on 11 February 2015.
24.
Centers for Disease Control and Prevention. National Health Interview Survey: 2012 data release. Hyattsville, MD: Centers for Disease Control and Prevention. Accessed at www.cdc.gov/nchs/nhis/nhis_2012_data_release.htm on 11 February 2015.
25.
Callegaro M, Disogra C. Computing response metrics for online panels. Public Opinion Quarterly. 2008;72:1008-32.
26.
Baker R, Blumberg S, Brick JM, Couper MP, Courtwright M, Dennis M, et al. AAPOR report on online panels. Deerfield, IL: American Association for Public Opinion Research; 2010. Accessed at www.aapor.org/AAPORKentico/AAPOR_Main/media/MainSiteFiles/AAPOROnlinePanelsTFReportFinalRevised1.pdf on 1 February 2015.
27.
Research!America. Research enterprise survey. Alexandria, VA: Research!America; 2010. Accessed at www.researchamerica.org/uploads/ResearchEnterprisePoll.pdf on 1 November 2014.
28.
Damschroder LJ, Pritts JL, Neblo MA, Kalarickal RJ, Creswell JW, Hayward RA. Patients, privacy and trust: patients' willingness to allow researchers to access their medical records. Soc Sci Med. 2007;64:223-35. [PMID: 17045717]
29.
Hull SC, Sharp RR, Botkin JR, Brown M, Hughes M, Sugarman J, et al. Patients' views on identifiability of samples and informed consent for genetic research. Am J Bioeth. 2008;8:62-70. [PMID: 19003716] doi: 10.1080/15265160802478404
30.
Trinidad SB, Fullerton SM, Bares JM, Jarvik GP, Larson EB, Burke W. Informed Consent in Genome-Scale Research: What Do Prospective Participants Think? AJOB Prim Res. 2012;3:3-11. [PMID: 23493836]
31.
Mazor KM, Sabin JE, Goff SL, Smith DH, Rolnick S, Roblin D, et al. Cluster randomized trials to study the comparative effectiveness of therapeutics: stakeholders' concerns and recommendations. Pharmacoepidemiol Drug Saf. 2009;18:554-61. [PMID: 19402030] doi: 10.1002/pds.1754
32.
U.S. Department of Health and Human Services. Protection of human subjects, 45 C.F.R. § 46.116 (2009). Accessed at www.hhs.gov/ohrp/policy/ohrpregulations.pdf on 23 March 2015.
33.
Baquet CR, Commiskey P, DanielMullins C, Mishra SI. Recruitment and participation in clinical trials: socio-demographic, rural/urban, and health care access predictors. Cancer Detect Prev. 2006;30:24-33. [PMID: 16495020]
Comments
Sign In to Submit A CommentInformation & Authors
Information
Published In
Annals of Internal Medicine
Volume 162 • Number 10 • 19 May 2015
Pages: 690 - 696
History
Published online: 19 May 2015
Published in issue: 19 May 2015
Keywords
Copyright
© 2015 American College of Physicians.
Authors
Metrics & Citations
Metrics
Citations
If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. For an editable text file, please select Medlars format which will download as a .txt file. Simply select your manager software from the list below and click Download.
For more information or tips please see 'Downloading to a citation manager' in the Help menu.
Download article citation data for:
Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey. Ann Intern Med.2015;162:690-696. [Epub 19 May 2015]. doi:10.7326/M15-0166
Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey. Ann Intern Med.2015;162:690-696. [Epub 19 May 2015]. doi:10.7326/M15-0166
View More
Login Options:
Purchase
You will be redirected to acponline.org to sign-in to Annals to complete your purchase.
Access to EPUBs and PDFs for FREE Annals content requires users to be registered and logged in. A subscription is not required. You can create a free account below or from the following link. You will be redirected to acponline.org to create an account that will provide access to Annals. If you are accessing the Free Annals content via your institution's access, registration is not required.
Create your Free Account
You will be redirected to acponline.org to create an account that will provide access to Annals.
Comment
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