Study teams and regulatory teams have different perspectives when it comes to executing research protocols, due simply to the different day-to-day responsibilities of a study team member versus a regulatory team member. While the ultimate goal of any research protocol is to generate new knowledge while protecting the rights and welfare of research subjects, sometimes study and regulatory teams differ on how to best achieve this goal. I have been fortunate enough to have worked as both a study and regulatory team member and have gained insight into how these teams differ and how they can best work together to ensure that research protocols run smoothly and achieve the highest standards of ethical research conduct. Read more
TAG ARCHIVES FOR collaboration
In July, PRIM&R collaborated with CITI Program to host the advanced-level webinar Data and Safety Monitoring: Advanced Issues and Case Studies. Expanding on introductory knowledge in the module Data and Safety Monitoring in Human Subjects Research, part of CITI Program’s Biomedical Basic course, this webinar described ways in which the IRB, the data and safety monitoring board (DSMB), the investigator, and the sponsor can work together to ensure scientific integrity and subject safety in clinical trials. Summaries of government and non-government organizations’ guidance as well as interactive case studies offered strategies for handling complex situations that may arise during data and safety monitoring, including when and how to report adverse and unanticipated events, when a DSMB is needed, and what is considered a conflict of interest. Read more
PRIM&R's IBC Boot Camp, which takes place September 18-19 in Denver, CO, will provide information, tools, and guidance for IBC, IRB, and IACUC professionals to help them keep compliance intersections from turning into compliance roadblocks. Attendees will learn strategies for improving integration and communication among regulatory groups and investigators to best support research that is ethical, collaborative, and interdisciplinary. IBC personnel will have opportunities for benchmarking, sharing resources such as SOPs, and networking with colleagues in the field. Read more
PRIM&R's Regional Connections Program is designed to encourage research ethics professionals in a given geographic area to connect and build relationships. To that end, we offer support to individuals and institutions who would like to organize and host a Regional Connections event for their community. In this post, Kirstin Morningstar, MBA, CIP, CPIA, regulatory services director, Mary-Colette Lybrand, MS, CCRP, CIP, regulatory services manager, and Alyson Stearns, CIP, regulatory services specialist, in the Office of Research Administration at the University of Texas at Arlington share more about an innovative Regional Connections event initiated by their institution. Read more
With the 2015 Institutional Animal Care and Use Committee (IACUC) Conference rapidly approaching, our staff is busy getting ready to welcome more than 600 professionals from across the fields of animal care and use and research ethics to our hometown, Boston, MA. Amid all our planning, we found ourselves wondering: How has the IACUC Conference changed over the years? The conference is always a great opportunity to learn about the latest insights, best practices, and challenges in the field, but how have those transformed in recent years?
We dug into our archives to look at the 2005 IACUC Conference [...] Read more