As we wrap up Member Appreciation Month, PRIM&R would like to highlight some of our members—individuals who work daily to advance ethical research on a daily basis. Today, we highlight Kristin Bacon, MPH, CIP, who works as the IRB Coordinator at the University of Hawai’i. Read more
In collaboration with First Clinical Research, we bring you the Clinical Research Ethics Question of the Month: You are a member of an IRB reviewing a study of a marketed drug for treating depression. Previous studies of this drug have shown minimal side effects. They have also shown a very high, enduring placebo effect. In fact, the symptoms of most study participants improved, regardless of whether they received the study drug or the placebo. This study has a twist: The goal is not to assess the efficacy of the drug, but to assess the efficacy of participating in a study of the drug. In other words, the study itself is the treatment under investigation. Read more
To celebrate Member Appreciation Month, PRIM&R would like to highlight some of our members—individuals who work daily to advance ethical research on a daily basis. Today, we highlight Erik Williams, who works as the Compliance Coordinator at Arizona State University. Read more
For investigators, IRB members, and IRB staff alike, the revised Common Rule’s new exempt category at 45 CFR 46.104(d)(4)(iii) was a dream come true. The so-called HIPAA Exemption eliminates IRB review for research use of retrospectively or prospectively collected “identifiable health information when that use is regulated by the HIPAA Privacy Rule as health care operations, research, or for public health activities […].” Applying the HIPAA Exemption is not quite as simple as it might seem, though, as I learned at the 2018 Advancing Ethical Research Conference (AER18) session, appropriately titled “Just When You Thought You Understood the Health Insurance Portability and Accountability Act of 1996.” Read more
The last few years have seen a growing call across the research enterprise to increase transparency around animal research—why we do it, why it’s important, and what it has accomplished. I also wonder whether there is another layer of transparency we ought to be promoting—namely, transparency about the ethical dimensions of animal research and its oversight. Specifically, how might being more open about the ethical issues and questions that are part of the day-to-day work of those involved in animal research serve our collective goals of educating and engaging the public; increasing their understanding, trust, and support for the animal research enterprise; and reframing the public conversation? Read more
To celebrate Member Appreciation Month, PRIM&R would like to highlight some of our members—individuals who work daily to advance ethical research on a daily basis. Today, we highlight Crystal Lijadu, who works as the IRB Administrative Coordinator at Thomas Jefferson University. Read more
