Oct. 1 is when the new policy pertaining to NIH’s issuance of certificates of confidentiality (CoC) takes effect, according to a recent NIH Blog post. Under the new policy, CoCs “will be issued automatically to NIH funded grants, cooperative agreements, contracts and intramural research projects research funded wholly or in part by the NIH that […]

The revised Common Rule’s changing definition of vulnerable populations is the focus of Public Responsibility in Medicine and Research (PRIM&R) director Eliza Hurley’s most recent PRIM&R blog post. Dr. Hurley has some interesting comments about the removal of pregnant women as a vulnerable population, a change she describes as  “welcome and long overdue.” She also […]

The IRB has welcomed Ashley Block to its office staff. Ashley has worked in research and research administration for more than 15 years at UAMS. For the past 7 years, she was the Project Manager at the Research Division of the Section of Birth Defects in the College of Medicine, Department of Pediatrics at UAMS. She […]

The Stanford Prison Experiment, which occurred in August 1971, is one of those projects that gets mentioned in basically ALL educational material addressing research ethics. We know a lot about the study’s general outlines, but we don’t hear a lot directly from the people involved anymore. A Stanford publication recently made a 2011 article about […]

The news about the Tuskegee study became public 45 years ago this summer. The federally funded study, which involved leaving syphilis untreated in African-American men for decades to follow its course, even after effective treatment became available, is one of the seminal events leading to the development of human subject protection regulations, policy, and best […]

In IRB-land, we use a variation of what might be called “Notice and Choice” regarding subjects’ allowing access to their private information. We tell people up front what their private information might be used for, including in the future as well as for the current project, and then give them the choice to opt in […]

In a perfect world, clinical trial participant populations would perfectly reflect the population from which they’re drawn. Those of us living in the real world, however, know that attracting and retaining a truly representative can be difficult. Different populations face different barriers to joining clinical trials, and UAMS and ACH researchers encounter people of a […]

As noted in a recent IRB Research News and Tips blog item, the revised Common Rule will require some changes to the current way we present and document key elements of informed consent information. We have yet to hear specifics about how those new requirements, slated to take effect in January 2018, are to be […]

A couple of things happened recently that got us thinking about the IRB approval criterion that requires informed consent information to be provided “in language understandable to the subject.” First, we prereviewed some industry study consent forms that were between 20 and 40 single-spaced pages, full of big words about serious disease. If I had […]

Q. How can I search for a specific blog item that I know I’ve seen, but I don’t know when? A. Short answer: If you know of a way, do let us know, because we haven’t been able to figure one out.  Long answer: Someone had a great idea that we thought we’d share. If […]