We encourage our reviewers to use the “Question of the Month” feature on the Public Responsibility in Medicine & Research (PRIM&R) web page as a prompt about ethical questions in research. Per the website, “each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and […]
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.
Research participation basics for potential subjects, and others
We know the federal Office for Human Research Protections (OHRP) mainly through its interactions with researchers and research sites. Now, however, OHRP has made available a wealth of resources for potential research subjects and others interested in research. The About Research Participation web page has videos and other resources describing research concepts. One aspect we […]
Great education opportunity at UAMS next week
Some of the biggest sessions at next week’s Advancing Ethical Research conference in San Antonio will be available remotely on the UAMS campus, thanks to the UAMS Office of Research Compliance. The conference, organized each year by Public Responsibility in Medicine and Research (PRIM&R), is the big human subject research conference each year, where thousands of […]
Holidays, inclement weather, can complicate IRB meeting scheduling
It’s that time of year again – winter (which is kinda of feeling like potentially a real thing so far this year) and the holidays both loom. Keep that in mind in your end-of-year planning if you have approval deadlines you really, truly need to meet. Here’s a reminder that, for reasons that are a […]
Joint OHRP and FDA guidance on meeting minutes
The federal Office for Human Research Protections and the Food and Drug Administration have released a joint guidance addressing the requirements for IRB meeting minutes. We are excited about this for at least two reasons. First, we love it when OHRP and FDA work together on something. The two agencies have separate regulations, and while […]
Your weekly workload may vary, aka insight into how we assign agenda items and reviewers
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 […]
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 […]