Regional ethics organizations for protection of human research participants

Centralized and Non-Centralized Ethics Review: A Five Nation Study

“…Rather than concentrate on the influence of the various factors on the current structure of these systems, we have chosen to use the systems we have studied to inform us about the strengths and weaknesses of each system. Some of the points that have come out in our analyses have been outlined in other documents (e.g., McDonald, 2000a,b;Emanuel et al, 2004;Pentz, 2004;Wagner et al, 2004;Wood et al, 2004;Ad Hoc Advisory Group, 2005).…”

Institutional Review Boards

“…[30][31][32][33][34][35] Reform proposals off er changes to address some of the various factors that are problematic for IRBs and for those who use them. Yet, reform eff orts have been somewhat paralyzed by the tension between those who fi nd the current system inadequate and those who fi nd it too overreaching.…”

“…Many proposals for reforming or updating guidance and regulations have recommended single or central review for multisite studies. 10,[28][29][30][31]35 Lingering resistance to adopting central or single review for multisite trials appears to be based on concerns about the importance of local context, local accountability and liability, discomfort with relinquishing control over the review, uncertainty about the quality of review by other IRBs, and logistical concerns such as cost-sharing. 30,54 Th ere is a paucity of data evaluating how single or central review compares to review at local sites regarding quality of review, satisfaction, resource use, or effi ciency.…”

Taking Stock of the Ethical Foundations of International Health Research: Pragmatic Lessons from the IU–Moi Academic Research Ethics Partnership

“…23 For example, most guidance documents recommend that obtaining the voluntary informed consent from the research participant and the approval of a duly constituted local institutional ethics review committee are mandatory prerequisites for conducting research with human subjects. But one can satisfy these general requirements and still face challenging new questions: for example, whether alternatives to local review (such as regional or centralized review) should be considered under certain circumstances, 24,25 or whether placebo controls can be used when there is an existing (but very expensive) standard of care. On this latter issue, commentators have been split, with some arguing that one universal standard should prevail, 26 while others like Resnik argued "we should not expect single standard of research to govern all study designs."…”