Check one of your Certified Research Specialist requirements off your to-do list by attending an upcoming live class – and earn some SOCRA credit to boot. Dr. Thomas Cunningham of the Medical Humanities department is scheduled to present a class on Research Misconduct Friday, May 29, from 11 am to 1 pm. The class will take place in […]
PI change requires a full modification form, and not a staff-only modification
The PI is the one study staffer who cannot be changed using a “staff-only modification” form in CLARA. To change a PI in CLARA, please submit a regular modification form, and not a staff-only modification. Please ensure the new PI’s CV is uploaded to his or her profile in CLARA as well. Using a regular […]
IRB Member Handbooks are in
Additional copies of the IRB Member Handbook have arrived. Please send an email to paalediths@uams.edu if you need a copy. We are also bringing them to each week’s meeting to distribute as needed. Please note you do NOT need to replace an older edition of this book that you may already have. The changes in […]
Please write long when responding to audits
When drafting responses to research compliance audits, please feel free to write long. Include as much information as you think the IRB might find helpful in your responses. Audits are sent to the full IRB for review, and the more information the IRB has at its disposal, the faster the IRB can process a response. […]
Monday midday is the soft deadline for reviews
IRB Chair Allen Sherman reminds reviewers that it would be hugely helpful to have contingencies and notes for a Tuesday meeting entered into CLARA by noon on the Monday right before the meeting. Allen does at least a brief review of all agenda items, and sometimes needs time before the meeting to follow up on […]
A fresh start when drafting HIPAA authorization forms
When creating a new submission that requires a HIPAA research authorization, it can be tempting to pick up the HIPAA form that was approved for a previous study and try to revise it for the new project. Here’s a bit of advice about that: Don’t do it. Really. Start fresh with the HIPAA authorization template […]
Note or contingency?
Here’s a recap of the difference between a note and a contingency in CLARA: A contingency is an item that must be responded to before a submission can be approved. A note, on the other hand, is appropriate for anything you’d like to relay to the study team but does not require a response before […]
Upload documents separately rather than as protocol appendices
The IRB strongly discourages the attachment of study-related documents, such as consent forms, data collection tools, etc., directly to a protocol document as appendices. We prefer that these items be uploaded as separate documents with your CLARA submission. Separating them out makes them much less likely to be overlooked by a reviewer, and also simplifies […]
June has a fifth Tuesday — no IRB meeting that week
If you’re facing any looming approval deadlines, please remember that there will be no IRB meeting on Tuesday, June 30, which is a fifth Tuesday. The IRB meets only on the first four Tuesdays of each month. If you need something approved around that time, please be sure to get it submitted to the IRB […]
Early Tuskegee study critic dies
No recap of the history of human research protections is complete without a mention of the Tuskegee study, which studied the course of untreated syphilis in black men who were not given access to available effective treatment for the disease. While the study, which began in 1932, went on under the radar of most observers for […]