by Jackie Tekiela, MS, CIP, Institutional Review Board (IRB) Administrator at Wheaton Franciscan Healthcare

The National Cancer Institute (NCI) recently completed a two-year effort to revise the NCI informed consent template, resulting in shorter and more concise informed consent documents. In session A18, titled Rewriting the National Cancer Institute (NCI) Informed Consent Template, Jeanne M. Adler, RN, MPH, CCRP, presented the background, method, and rationale behind the changes. Throughout the presentation Jeanne offered specific examples of language and excerpts from the draft template.

In preparing the template, working [...] Read more


By Amy Davis, JD, MPH, Senior Director for Publications and Programs at PRIM&R

There was a lot of talk about alternative models of institutional review board (IRB) review at PRIM&R’s 2011 Advancing Ethical Research (AER) Conference:

  • There is the Advance Notice of Proposed Rulemaking’s (ANPRM) request for comments on a proposed requirement that all domestic, multi-site research rely on central IRBs;
  • There are National Institutes of Health (NIH) research grants that favor central IRB models;
  • The National Cancer Institute (NCI) is piloting a central IRB model; and
  • The Department of Veterans’ Affairs relies on [...] Read more