title: A comparison of institutional review board professionals' and patients' views on consent for research on medical practices.
abstract: In the context of research on medical practices, which includes comparative effectiveness research and pragmatic clinical trials, empirical studies have begun to raise questions about the extent to which institutional review boards' interpretations and applications of research regulations align with patients' values. To better understand the similarities and differences between these stakeholder groups, we compare and contrast two surveys: one of institutional review board professionals and one of patients, which examine views on consent for research on medical practices.
  
  
  
  We conducted online surveys of two target populations between July 2014 and March 2015. We surveyed 601 human subjects research professionals out of 1500 randomly selected from the Public Responsibility in Medicine and Research membership list (40.1% response rate), limiting analysis to 537 respondents who reported having had institutional review board experience. We also surveyed 120 adult patients out of 225 approached at subspecialty clinics in Spokane, Washington (53.3% response rate). Our survey questions probed attitudes about consent in the context of research on medical practices using medical record review and randomization. The patient survey included three embedded animated videos to explain these concepts.
  
  
  
  A majority of institutional review board professionals distinguished between consent preferences for medical record review and randomization, ranked clinicians as the least preferred person to obtain participant consent (54.6%), and viewed written or verbal permission as the minimum acceptable consent approach for research on medical practices using randomization (87.3%). In contrast, most patients had similar consent preferences for research on medical practices using randomization and medical record review, most preferred to have consent conversations with their doctors rather than with researchers for studies using randomization (72.6%) and medical record review (67.0%), and only a few preferred to see research involving randomization (16.8%) or medical record review (13.8%) not take place if obtaining written or verbal permission would make the research too difficult to conduct. Limitations of our post hoc analysis include differences in framing, structure, and language between the two surveys and possible response bias.
  
  
  
  Our findings highlight a need to identify appropriate ways to integrate patient preferences into prevailing regulatory interpretations as institutional review boards increasingly apply research regulations in the context of research on medical practices. Dialogue between institutional review boards and research participants will be an important part of this process and should inform future regulatory guidance.
authors.affiliation: Stanford Center for Biomedical Ethics, Stanford, CA, USA stephaniekraft@stanford.edu.
authors.forename: Stephanie Alessi
authors.initials: SA
authors.lastname: Kraft
authors.affiliation: Stanford Center for Biomedical Ethics, Stanford, CA, USA.
authors.forename: Mildred K
authors.initials: MK
authors.lastname: Cho
authors.affiliation: Division of Health Policy and Management, University of Minnesota, Minneapolis, MN, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Constantine
authors.affiliation: Stanford Center for Biomedical Ethics, Stanford, CA, USA.
authors.forename: Sandra Soo-Jin
authors.initials: SS
authors.lastname: Lee
authors.affiliation: Ethox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
authors.forename: Maureen
authors.initials: M
authors.lastname: Kelley
authors.affiliation: Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, WA, USA.
authors.forename: Diane
authors.initials: D
authors.lastname: Korngiebel
authors.affiliation: Institute for Public Health Genetics, University of Washington, Seattle, WA, USA.
authors.forename: Cyan
authors.initials: C
authors.lastname: James
authors.affiliation: Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA, USA.
authors.forename: Ellen
authors.initials: E
authors.lastname: Kuwana
authors.affiliation: Human Subjects Division, University of Washington, Seattle, WA, USA.
authors.forename: Adrienne
authors.initials: A
authors.lastname: Meyer
authors.affiliation: Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA, USA.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Porter
authors.affiliation: Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA, USA.
authors.forename: Douglas
authors.initials: D
authors.lastname: Diekema
authors.affiliation: USC Gould School of Law, University of Southern California, Los Angeles, CA, USA.
authors.forename: Alexander M
authors.initials: AM
authors.lastname: Capron
authors.affiliation: Providence Medical Research Center, Spokane, WA, USA.
authors.forename: Radica
authors.initials: R
authors.lastname: Alicic
authors.affiliation: Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA, USA.
authors.forename: Benjamin S
authors.initials: BS
authors.lastname: Wilfond
authors.affiliation: Stanford Center for Biomedical Ethics, Stanford, CA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Magnus
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D035843:Biomedical Research / Q000941:ethics*; D057186:Comparative Effectiveness Research / Q000941:ethics* / Q000379:methods*; D028744:Ethics Committees, Research; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D010358:Patient Participation / Q000523:psychology*; D010820:Physicians / Q000523:psychology*; D012107:Research Design; D011795:Surveys and Questionnaires; D014481:United States
keywords: Research on medical practices; comparative effectiveness research; informed consent; pragmatic trials; research ethics