In March, PRIM&R hosted the webinar Electronic Informed Consent: Ethical, Regulatory, and Practical Implications. Presented by Cheryl Grandinetti, PharmD, a health science policy analyst at the FDA, and Christian Simon, PhD, a bioethicist at the University of Iowa who conducts research on electronic informed consent (eIC), this webinar helped attendees understand the definition of eIC, grasp its regulatory requirements and context for using it in FDA-regulated clinical trials, better anticipate the challenges and benefits associated with eIC, and recognize how investigators and IRBs can promote its ethical and effective use. The presenters were joined by additional panelists Leonard Sacks, MD from the FDA and [...] Read more
Though I have now returned home from New Orleans, I have brought both the great connections and the great experiences with me. The widely varied backgrounds and perspectives of 2017 IACUC Conference (IACUC17) attendees is an asset to those coming to learn about IACUC administration. Read more
At this year's 2017 IACUC Conference (IAUC17), PRIM&R was pleased to present Marcy Brown, BS, MA, CMAR, CPIA, with the 2016 ARENA Legacy Award. Ms. Brown serves as the animal welfare regulatory compliance lead of Pfizer Global Research and Development in La Jolla, California. Read more
This week’s Research Ethics Roundup examines why legal experts are advising against voluntary compliance of Common Rule changes, President Trump’s plan for the National Institutes of Health (NIH)’s budget, the debate over whether technology can replace animal models in research, and the reaction to President Trump’s pick for Food and Drug Administration (FDA) Commissioner. Read more
Greetings from the Big Easy! While New Orleans was apparently bestowed this moniker for its laid-back nature, in reality it’s just the opposite. This city is teeming with life and vibrancy.It seems like the perfect backdrop for PRIM&R’s 2017 IACUC Conference and my pre-conference workshop, IACUC101TM: The Basics. Like New Orleans, this day-long workshop had much to offer. One could say it was like drinking from a fire hose—there was an overflow of information, materials, and perspectivesin the best possible way. Read more
One of my goals for attending the 2016 Advancing Ethical Research Conference (AER16) was to figure out a plan for how to address a growing need on my campus. Each year, we have more students interested in research. This means the Ethical Research Board (ERB) at my institution needs a clear path to support the faculty in the design and incorporation of research into their coursework and a way to educate students on how to create and conduct an ethical research project, all without overwhelming its members. The majority of our projects are social, behavioral, and educational research (SBER), and most are minimal risk, but as I mentioned in a previous post we are a new board, still working on our procedures and policies. I waited to discuss this goal in my wrap-up post intentionally – my questions were not necessarily addressed in a single session, but rather over the course of the the four days, through a series of sessions, networking luncheons, conversations, and panels.