TY - JOUR
T1 - Attitudes toward risk and informed consent for research on medical practices
T2 - A cross-sectional survey
AU - Cho, Mildred K.
AU - Magnus, David
AU - Constantine, Melissa
AU - Lee, Sandra Soo Jin
AU - Kelley, Maureen
AU - Alessi, Stephanie
AU - Korngiebel, Diane
AU - James, Cyan
AU - Kuwana, Ellen
AU - Gallagher, Thomas H.
AU - Diekema, Douglas
AU - Capron, Alexander M.
AU - Joffe, Steven
AU - Wilfond, Benjamin S.
N1 - Funding Information:
The study was funded by the National Center for Advancing Translational Sciences at the National Institutes of Health. The funding source did not participate in the design, conduct, or analysis of the study or in the decision to submit the manuscript for publication.
Funding Information:
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]).
PY - 2015
Y1 - 2015
N2 - 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.
AB - 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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U2 - 10.7326/M15-0166
DO - 10.7326/M15-0166
M3 - Article
C2 - 25868119
AN - SCOPUS:84937511959
SN - 0003-4819
VL - 162
SP - 690
EP - 696
JO - Annals of Internal Medicine
JF - Annals of Internal Medicine
IS - 10
ER -