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 […]
Using surgically removed tissue specimens in research
Some research projects anticipate the use of tissue that has been removed surgically. If you plan to use fresh tissue in a research project, please remember that UAMS Policy requires most tissue to be cleared through the Hospital Pathology Department before it can be used for research. There are a few exceptions – they’re listed […]
A reminder about consent form reading levels
Just a friendly note from your local IRB reminding research team to try to make informed consent materials read at somewhere in the grades 4 through 8 range. We know that sounds like a low reading level, but in most cases, it’s doable. It’s also appropriate for most studies. Health literacy can be low in […]
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 […]
Minimal risk research, the FDA, and consent waivers and alterations
Well, while we freely admit to muttering under our breath about some FDA research requirements, we want to take this opportunity to shout from the rooftops about a new FDA guidance indicating the agency will not object to the IRB waiving or altering informed consent requirements in some minimal risk research. This guidance – which […]
NIH policy changes related to human subject studies
We recently received word from NIH about policy changes that people who conducted NIH-funded human subject research, or who seek to apply for NIH support for such research, need to know about it. The correspondence is below. Please contact the Office of Research and Sponsored Programs for more information about these changes. If you are […]
Two sure-fire — and avoidable — contingencies
Since we all – research teams and IRB alike – like to see research proposals get approved quickly, we thought we’d point out a couple of issues we’ve been seeing a lot of lately that will get you a contingency. — Incorrectly stacked documents. If your clean and tracked-changes copies of documents are not stacked correctly, […]
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 […]
At long last — Draft FDA guidance on Part 11 compliance
The Food and Drug Administration, continuing its long tradition of issuing timely guidance, has issued a draft guidance about 21 CFR Part 11 – the regulation pertaining to the use of electronic records and electronic signatures in clinical investigations. A summary of the draft guidance is available here. The comment about “timely guidance” should be […]
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 […]