This month’s Research Ethics Roundup looks at why French authorities launched an oversight unit specific to first-in-human research, a massive study on golden retrievers and the implications for clinical research, Bioethics International’s work on improving trial transparency for phase I human subjects, and a new incentive program from the US Department of Agriculture’s Animal and Plant Health Inspection Service (USDA, APHIS) designed to improve communication between government investigators and facilities. Read more
The zombie apocalypse has arrived and is threatening the survival of the human race. Researchers have developed a treatment that might restore zombies to normal health and non-infectivity. There is a reasonable probability that the treatment will work as a cure but not as a protective measure. Failure of the treatment would be fatal for the subject. Potential study participants will not have the capacity to give consent. To the contrary, they will vigorously resist participation. No other possible treatments are known. There are no functioning governmental authorities, so the fate of humanity rests on your IRB. Time is of the essence. Read more
The National Institutes of Health (NIH) has sponsored the RAND Corporation, in cooperation with the Scripps Translational Sciences Institute, to conduct a survey of IRBs. Read more
This fall marks the whirlwind one-year mark of my entry into the research compliance field, and what a year it has been! I have been fortunate to be able to attend several conferences and workshops, including PRIM&R’s IRB 101SM & 201, focused on human subjects protections and research integrity. These in-person learning experiences were invaluable but I’ve also been extremely impressed by the collegial and collaborative nature within this profession as a whole—even in the informal discussions and debate that happen on the IRB Forum and on the newly-created SBER network. These resources, available through PRIM&R, ignited my interest in research ethics questions as a whole and helped me to engage with larger issues in human subjects protection outside of my day-to-day work responsibilities. Read more
I’m very excited about the opportunity to be a member of the Blog Squad for the 2017 Advancing Ethical Research Conference (AER17). As an IRB coordinator at Arizona State University, I attended my first AER conference in 2016, and I learned that the best part of PRIM&R is the community it builds. Through conference sessions and roundtables, PRIM&R brings together stakeholders from across the spectrum—policy makers, board members, staff, researchers—to discuss, present, debate, and learn from one another. The AER conferences give us incredible opportunities to converse and come to collaborative understandings of regulations and ethical considerations surrounding human subjects protections. With changes being implemented soon, learning from one another will be more important than ever. Read more
I am very excited to have attended my fourth Advancing Ethical Research Conference—and my first as a member of the Blog Squad!
I am an IRB Administrator at the University of Southern California specializing in social behavioral research. I initially became familiar with the IRB from the PI perspective when my master’s thesis went through IRB review in grad school. I thought the process seemed interesting, and the protections very important. After graduation, when an opening came up at my undergrad alma mater to become an IRB administrative assistant, I jumped at the opportunity. And when my colleague at the IRB left later that year, I applied for and was ultimately accepted to fill his shoes as an IRB Administrator. Read more