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:
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 […]
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 […]
New Plain Language consent template available on IRB website
The complicated language we often see in consent forms has long frustrated subjects, IRB reviewers, and researchers. In an effort to make consent forms more readily understandable, the UAMS Center for Health Literacy, with input from others on campus, has developed a Plain Language consent form template that researchers can adapt to their studies. The […]
Is subject compensation the best-kept secret in research?
The issue of whether, and how much, to compensate subjects for research participation is something IRBs and researchers struggle with. Is a particular compensation scheme affordable given available funding? Will the proposed compensation be so high as to unduly influence the target population’s decision to join a study? Or is it so low that it […]
What to do with your data after you finish your study? And when do I tell the IRB of my plans?
All studies eventually end. Do you know what you’ll do with your research data once your study’s over? In fact, you’ll be asked to start thinking about what you plan to do with your data long term as you complete your new submission form in CLARA. The Risks section includes several questions about data storage, […]