PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Considerations for Inclusion of Adolescent Patients in Adult Oncology Clinical Trials," which was published in the Federal Register on June 4, 2018.
We applaud the draft guidance’s recommendation that adolescent patients with cancer be enrolled in disease- and target- appropriate adult oncology research, provided certain conditions are met. Presently, adolescents with cancer need to [...] Read more
On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of the revised Common Rule. [Update] On July 25, OHRP issued a Federal Register Notice and the community and public has until August 24, 2018 to Read more
Duke Morrow, MDiv, DMin, one of the speakers of the recent PRIM&R webinar Exploring and Enhancing Diversity for IACUCs and IRBs, presented registrants with a helpful metaphor for conducting a comprehensive IRB/IACUC review of a proposal—bread making. Bread making is a step-by-step process that takes time, care, love, and some elbow grease. This wonderful analogy helped us understand the influence of diverse viewpoints as the “ingredients” for a complete review of research proposals. So, let us review IRB/IACUCs through the lens of making bread. Read more
As we wrap up Member Appreciation Month, PRIM&R would like to highlight some of our members—individuals who work daily to advance ethical research on a daily basis. Today, we highlight Connor Bryant, Research Coordinator at Liberty University in Lynchburg, VA. Mr. Bryant shared with us what has shaped his professional experience so far and how PRIM&R events and programs connect him to the larger research ethics community. Read more
“Well, it depends” is something I think we’ve all said to a student or faculty researcher when they ask when a project requires IRB review. These gray areas get especially complicated when it comes to program improvement projects and ethnographic research. Furthermore, I think a lot of researchers submit to the IRB as insurance or just out of habit. It is important to remember, however, that not all activities that researchers may be involved in–even if they are employing research skills–are research. Read more