24
May2019

Approximately 80% of the US population has a social media account. Social media can be a powerful research tool for recruiting subjects and for conducting research. As regulatory professionals tasked with protecting research subjects, it’s important to understand the unique risks and benefits of social media use for research.Luckily, at PRIM&R’s 2018 Advancing Ethical Research Conference, there was a session devoted solely to the complex issues related to research on social media. Read more

23
May2019

New laws on adoption of research animals have been ratified by nearly a dozen US States, with more pending. In large part, the measures require due consideration by research programs of adoption of dogs and cats once research is complete. Do these new laws do what they claim to do? Do they “save animals” from euthanasia, as some proponents are claiming? Or do they not really add much to the practices already used by many animal research programs? Read more

17
May2019

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

13
May2019

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