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. (shrink)

Because many institutions struggle to determine how best to support their institutional review board programs, we conducted an exploratory study to identify the individual, group, and institutional factors that may influence commitment to the role responsibilities of being on an IRB. We defined this commitment as consisting of time spent preparing for IRB meetings, views of the importance of serving on an IRB, time dedicated to IRB activities relative to other academic committee service, and willingness to attend IRB meetings. Our (...) study suggests that member commitment to IRB role responsibilities may be related to adequate compensation for time spent on IRB activities, serving on an IRB whose chair fosters a supportive group dynamic, IRB size, length of tenure, efficiency of protocol review, receiving training on the ethical and regulatory requirements for research with humans, and attendance of principal investigators at convened meetings. (shrink)