Because of an administrative issue involving CITI (the people who run the human subject protection training we require to be taken at citiprogram.org), UAMS does not, for the time being, appear on the list of institutions with which one can affiliate. Ordinarily this problem could be resolved fairly quickly. these, however, are not ordinary time. […]
Ownership and research use of genetic material
Think back to 20 years ago – who, at that time, could have predicted what we’re able to do with genetic information now? In particular, who would have predicted that some private companies would own their own genetic databases? An interesting, or perhaps concerning, consideration with these private databases is that the use of these […]
A reminder to PIs: The Buck Stops Here
Principal investigators (PIs) are ultimately responsible for everything that occurs on research at their sites. Few things irk monitors and auditors (including those from agencies such as the Food and Drug Administration) than hearing, “Well, that’s not my fault. That’s the study coordinator’s responsibility,” from a PI, in response to a finding. The Duke Clinical Research […]
Full reaccreditation of our Human Research Protection Program
Good news! Our most recent application to the Association for the Accreditation of Human Research Protection Programs (AAHRPP) was approved last week, so we are now fully reaccredited for another five years! According to the organization, “AAHRPP accreditation indicates that your organization follows rigorous standards for ethics, quality, and protections for human research.” UAMS was initially accredited […]
Plain language consent form templates
Making informed consent information understandable to participants has long been a challenge, as we at the IRB well know. Reading levels of many consent forms often exceed the recommended no-great-than-8th-grade guideline. The UAMS Center for Health Literacy has been working on coming up with ways to make working with some IRB staff, TRI, and others on […]
Naming documents in CLARA — a refresher on Dos and Don’ts
Remember that the document titles you type in in CLARA are what will be listed in your final approval letter. It’s worth taking a few minutes to type in complete, easy-to-read, descriptive names to make it easy for reviewers to see what’s what and to later be able to determine just what it is your […]
A change in audit reviews
If you’ve ever been assigned an audit, you may have seen a form in CLARA called the assessment of noncompliance. IRB office staffers have been routinely completing that form as they prepare audits and audit responses for board review. Well, like so many other things, that form dates from the “BC” (Before CLARA) era, and we […]
Evaluating staffers’ CITI training status
Study staffers’ CITI training status is something that comes up a lot during IRB meetings. All study staffers listed in CLARA who interact with subjects or with identifiable data must be current on CITI training. A couple of things to keep in mind when evaluating whether someone’s CITI training is up to date: A study staffer […]
We are all research subjects — what does this mean for IRB reviews?
Recent posts on this blog have highlighted the fact that, in the final analysis, we are all basically research subjects creating research data, whether we know it or not. Sometimes our environments also get manipulated without our being aware – does anybody remember the Facebook study that caused much wringing of hands? And here’s a […]
The lay summary on the new submission form — for whom is it written?
When completing a new submission form in CLARA, you’ll encounter a question that reads, “What is the lay summary of this study?” As you answer this question, keep in mind your intended audience. The language used in this response should be easy to read and understandable to someone who hasn’t been in a science class […]