Sarah Attwood and Melanie Flores
Integ Review IRB, USA
Title: Final revisions to the common rule- How will this affect human subject protection?
Biography
Biography: Sarah Attwood and Melanie Flores
Abstract
Have you considered how the revisions to the common rule may affect your next research project? There are a number of questions circulating on how these changes will be implemented effectively and efficiently within the academic communities and other institutions, but also the impact that they may have on all industry sponsored research. Important elements in the final rule issued include: The requirement for consent forms to provide potential research subjects with a better understanding; requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies; for studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement; the establishment of new exempt categories of research based on the level of risk they pose to participants; removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects and requirement that consent forms for certain federally funded clinical trials be posted on a public website. This session will look at the changes and discuss the impact on human subject protection, informed consent for research sites and IRBs.