title: Stakeholders' Views of Alternatives to Prospective Informed Consent for Minimal-Risk Pragmatic Comparative Effectiveness Trials.
abstract: As interest in comparative effectiveness research grows, questions have emerged regarding whether it is ever acceptable to alter informed consent requirements for research when patients are randomly assigned to widely-used therapies. This paper reports on interviews with Institutional Review Board members and researchers and on focus groups with patients from Geisinger and Johns Hopkins health systems. The objective was to elicit participants' views of the acceptability of four different disclosure and authorization models for low-risk pragmatic comparative effectiveness trials of widely-used therapies. Results suggest that although participants valued autonomous choice, many also believed that it was acceptable to streamline information disclosure and to use an opt-out process for eligible individuals who would prefer not to participate. This provides some preliminary evidence that relevant stakeholders find alternatives to traditional informed consent acceptable for low-risk pragmatic comparative effectiveness trials of widely-used therapies as long as a sufficient amount of choice is preserved.
authors.affiliation: Program Officer at the Patient Centered Outcomes Research Institute (PCORI). All of the work described in this manuscript was completed while Dr. Whicher was a Ph.D. candidate at the Johns Hopkins Bloomberg School of Public Health and a research coordinator at the Johns Hopkins Berman Institute of Bioethics and does not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee. She received her Ph.D. and M.H.S. from the Johns Hopkins Bloomberg School of Public Health in Baltimore, MD and her B.A. from Colgate University in Hamilton, NY.
authors.forename: Danielle
authors.initials: D
authors.lastname: Whicher
authors.affiliation: Deputy Director for Public Health in the Berman Institute of Bioethics and the Phoebe R. Berman Professor of Bioethics and Public Health at the Johns Hopkins Bloomberg School of Public Health in the Department of Health Policy and Management. She received her Sc.D. from the Johns Hopkins Bloomberg School of Public Health in Baltimore, MD and her B.A. from Stanford University in Stanford, CA.
authors.forename: Nancy
authors.initials: N
authors.lastname: Kass
authors.affiliation: Andreas C. Dracopoulos Director and Philip Franklin Wagley Professor at the Johns Hopkins Berman Institute of Bioethics. She received her Ph.D. and M.P.H. from the University of California, Berkeley in Berkeley, CA, her M. A. from the University of Chicago in Chicago, Il and her B.A. from the University of Pennsylvania in Philadelphia, PA.
authors.forename: Ruth
authors.initials: R
authors.lastname: Faden
mesh_terms: D000328:Adult; D057186:Comparative Effectiveness Research; D030881:Disclosure / Q000592:standards*; D028744:Ethics Committees, Research; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000592:standards*; D008297:Male; D008875:Middle Aged; D064792:Pragmatic Clinical Trials as Topic; D014481:United States