title: Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey.
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.
  
  
  METHODS
  Cross-sectional survey conducted in August 2014.
  
  
  METHODS
  Web-based questionnaire.
  
  
  METHODS
  1095 U.S. adults sampled from an online panel (n = 805) and an online convenience river sample (n = 290).
  
  
  METHODS
  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%).
  
  
  CONCLUSIONS
  Use of hypothetical scenarios and a nonprobability sample that was not fully representative of the U.S. population.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  National Center for Advancing Translational Sciences at the National Institutes of Health.
authors: Mildred K
authors: MK
authors: Cho
authors: David
authors: D
authors: Magnus
authors: Melissa
authors: M
authors: Constantine
authors: Sandra Soo-Jin
authors: SS
authors: Lee
authors: Maureen
authors: M
authors: Kelley
authors: Stephanie
authors: S
authors: Alessi
authors: Diane
authors: D
authors: Korngiebel
authors: Cyan
authors: C
authors: James
authors: Ellen
authors: E
authors: Kuwana
authors: Thomas H
authors: TH
authors: Gallagher
authors: Douglas
authors: D
authors: Diekema
authors: Alexander M
authors: AM
authors: Capron
authors: Steven
authors: S
authors: Joffe
authors: Benjamin S
authors: BS
authors: Wilfond
mesh_terms: D000328:Adult; D000368:Aged; D001290:Attitude; D035843:Biomedical Research; D015510:Clinical Medicine; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D011795:Surveys and Questionnaires; D055815:Young Adult