TAG ARCHIVES FOR human subjects protections

29
Sep2020

I recommend all young professionals attend at least one PRIM&R Conference. PRIM&R has become an ever-growing repository of knowledge for research ethics and compliance, and the attending a conference will refresh your passion for research ethics. I felt my career path strengthening by establishing connections with likeminded individuals nationally and internationally. The willingness to collaborate, share, and advise could easily be witnessed in each session, break, and lunch period. I established new relationships that helped me understand the history of research ethics and IRBs in higher education. Operating a single staff IRB program can feel very isolating; the connections and knowledge gained from attending the PRIM&R SBER/AER Conference reduced the isolation I felt and gave me hope for the future of research ethics. Read more

17
Aug2020

As the world eagerly awaits a coronavirus vaccine, the vital role of biomedical research has become increasingly visible. But as researchers—whether they study humans or nonhuman animals—enjoy increased prominence and (in some corners) approval, the challenges of doing their work remain immense. And at a time like this, maintaining the highest ethical standards in research is more crucial than ever. Read more

23
Jul2020

The IRB at the University of Wisconsin-Stevens Point is quite small, and I was curious, in attending AER19 and connecting with other HRPP professionals, how we compared with other small institutions. As a young professional in a single-staff IRB office, I was also looking for tricks of the trade to improve my limited capabilities and address challenges that arise. Clear communication with campus stakeholders and planning small improvement objectives are effective measures when working against challenges like budget, capacity, and misconceptions. Read more

9
Jul2020

A team comprising Holly Taylor of the NIH Clinical Center’s Department of Bioethics; Susan Kornetsky of Boston Children’s Hospital; and Megan Kasimatis Singleton of the Johns Hopkins University School of Medicine, and myself recently completed a project examining how, in the absence of federal guidance, institutions are interpreting and applying the key information requirement and, specifically, whether and to what extent they are developing policies, guidance, templates, or other tools to help researchers and IRBs apply this provision of the Common Rule. We undertook this project as part of the Consortium to Advance Effective Research Oversight (AEREO)—a group of leaders in human research oversight, research ethics, and empirical methods dedicated to evaluating and improving the effectiveness of IRBs and HRPPs through empirical research. PRIM&R is pleased to share with the human research protections community the materials collected during this project as a public resource. Read more