The CLARA Portal Facilitator (yes, that’s a real person; that position used to be known as the CLARA gatekeeper) no longer routinely performs in-depth content reviews of new submissions before sending them on to the IRB for review. However, that level of prereview is still available at no charge to research teams who request it, […]
A reminder to plan ahead — and to keep an eye on the calendar!
Please keep a close eye on the calendar when planning ahead to submit continuing reviews or any other submissions that have an approval deadline. If items need to go to full board, they should come to the IRB no later than the listed submission deadline to ensure placement on the agenda you’d like them to […]
Confidentiality of data and privacy of subjects
The seventh criterion for approval [45 CFR 46.111(a)(7)] requires the IRB to determine that, when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data. Subject privacy can be a concern at several different points in the research process. Does the research under review require a […]
Uploading documents and writing comments in response to contingencies
So, you’ve submitted a new submission, modification, or continuing review form in CLARA, and now the IRB has sent back a contingency that requires you to upload some new or revised documents. You prepare the documents, log into CLARA, click on the protocol, click on the documents tab, and then you’re stuck. The “upload new documents” […]
How to check your study’s status in CLARA
Wondering where your study is in the review process? The “History” tab in CLARA documents everything that has happened to a study since its submission. It will let you know where in the review process your study is. This feature is a big change from the IRB’s old submission system, ARIA. There was no way […]
Looking up forms and documents in CLARA
Sometimes when you’re reviewing a study modification or continuing review (CR), you’ll want to look up previous study documents or CRs or other forms. Finding previously submitted items is easy in CLARA. For a study that migrated into CLARA from ARIA, if you want to look up something that was migrated over from ARIA, first […]
Get CRS credit for attending upcoming education classes
Credit hours for the Certified Research Specialist program will be available for several upcoming classes: Advanced Research Ethics, Tuesday, April 14th, from 8 am to 12 noon; IDW 114A/B Essentials of Quality Human Research, Wednesday, April 29th, from 9 am to 3:15pm; IDW 114A/B Genetic and Genomic Research, Wednesday, May 13th, from 11:30am to 12:30 […]
Data monitoring, safety, and the 6th criterion for approval
The sixth criterion for approval of research reads, “When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects” [45 CFR 46.111(a)(6)]. This criterion is particularly applicable to studies looking at new treatments or other interventions that may have an impact on subjects’ health, safety, or well-being. […]
A thought about gift card reimbursements
Using gift cards to compensate study subjects for their participation is fairly common among studies that offer reimbursements for time and inconvenience. The IRB does not require too many specifics about what kind of gift card will be offered in submissions. The IRB will typically accept language along the lines of “a $25 gift card” as […]
Do you know where your reviewer handbook is?
Do you remember getting one of these books when you joined the IRB? (Older editions had a different cover – but those still count as the real item.) Haven’t seen your copy around lately? If so, please let Edith Paal in the IRB office know via email at paalediths@uams.edu. We like to keep enough of […]