Many study teams use flyers, advertisements, and/or things like social media posts to recruit potential research subjects. If written materials, in whatever format, are a part of your recruitment strategy, please take a look at UAMS IRB Policy 14.3 for a refresher on advertisement content. Because the IRB must determine that subject selection is equitable, […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
Following up on an audit at continuing review time
If your study has been audited during the most recent review period, you may have to do some additional reporting at your next continuing review (CR). Audits frequently find protocol deviations that the IRB asks you to report at CR. Help us confirm that you are meeting this reporting requirement. To do so, in your […]
New requirements related to publishing study results
All of those research findings – what happens to them when the study is over? Not enough happens to them, according to federal regulators who recently issued new rules about publishing clinical trial results. Clinicaltrials.gov was created, in part, to make it easier for the public to find out about research and research results. However, the […]
Little glitch in CITI training right now
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 […]
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 […]
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 […]
Only a few weeks left for the current blog quiz!
Don’t miss this chance to earn the most convenient 0.5 hours of Certified Research Specialist elective credit you’ll ever see! The current Research News and Tips blog quiz will be available through the end of the month. While we’ll post another one in the fourth quarter of the year, remember that you can earn up to […]
CITIprogram.org education requirements reminders
Few things are more frustrating than getting your new submission all shipshape, or submitting your continuing review form on time to get a renewal before it expires, only to get a contingency back indicating that somebody on your study staff needs to complete human subject protection training on citiprogram.org. The online course must be retaken […]