COVID-19 presents enormous challenges to research ethics oversight. Here, we’ve begun a collection of oversight-related resources in order to best prepare our community for the operational and review concerns brought on by the viral outbreak. Read more
Amid both promising and worrying signs in the development of treatments and vaccines for COVID-19, and in the context of a considerable amount of scrutiny of medical research, some researchers, ethicists, and advocates are working to make sure science doesn’t lose sight of a critical issue: diversity in the clinical trial participant pool. The distribution of research benefits to participants—and the consideration of race in subject selection—is tightly woven into the Belmont Report and has been a mainstay in research ethics discussion ever since. But despite the decades-long consideration of race and ethnicity in clinical trials, many trials still don’t enroll populations that reflect the diversity of the general populace or the group affected by the condition being studied. Read more
Are investigators at your institution engaging patient and community partners in research? Some of these partners will need training in human research protections—particularly if they will be responsible for recruiting participants, obtaining informed consent, or collecting data. CIRTification Online is a free web-based human research protections training program developed specifically for community research partners. Read more
The COVID-19 pandemic has brought many issues to the public’s attention that used to be of interest only to clinical research and drug development communities: clinical trial design, efficiency and timelines of clinical research studies, drugs’ approval process, and pre-approval access to investigational therapies are just a few. Read more
On June 18, 2020, PRIM&R hosted a webinar, Complexity in Clinical Trial Design: A Primer on Adaptive and Platform Trials. During this webinar, Luke Gelinas and Marianne Kearney Chase defined key terms, explored ethical and regulatory challenges, and provided strategies and examples to bridge the gap between IRBs and researchers in understanding adaptive trial designs. Following the webinar, Luke and Marianne reflected on the session and attendee feedback; we're pleased to share their response with the readers of Ampersand. Read more
In reflecting on the SBER19/AER19 opening remarks by PRIM&R's Executive Director, Elisa A. Hurley, PhD on the relevance of the Belmont Report today, I feel that the Belmont Report continues to be relevant and maybe more applicable than we think dat-to-day, especially for communities intertwined with their members. Though the Belmont Report is an old document, it can always be seen with new eyes and new perspectives. Read more
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
