First, we at the IRB office and throughout the UAMS/ACH research community want to thank all of our members for their IRB service. We know that you have a lot going on in your lives, and we are grateful for the not-inconsiderable time and effort you devote to your IRB obligations. Our longest-term members may […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
A glorious day in the world of Certificate of Confidentiality procurement
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 […]
Vulnerable subjects under the revised Common Rule
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 […]
Say hello to the new IRB staffer, Ashley Block
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 […]
Following up with Stanford Prison Experiment participants, and some commentary on behavioral research in general
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 […]
Lessons from the Tuskegee study still felt today
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 […]
What kind of enticement will prompt people to relinquish privacy?
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 […]
Overcoming barriers to clinical trial enrollment
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 […]
We’re not the only ones wondering about new informed consent regulations
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 […]
Simplifying informed consent language
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 […]