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 […]
Blog
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 […]
Free services for investigators, there for the asking
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” […]