When submitting study modifications, please clarify in your submission whether any subjects are currently on study and, if so, if they will be affected by the change. For example, will anybody need to be reconsented, or will any study activities that directly involve the subjects change? If this information is included up front, the IRB […]
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Review ALL documents linked to a form, not just the bolded ones
Sometimes when reviewing an agenda item, you’ll notice that some of the documents linked to the form you’re reviewing will have bolded titles in CLARA, while others won’t. Please don’t take the bolding as a sign that only those documents with a bolded title need reviewing. The bolding could result from several things, none of […]
Is your study subject to FDA review? Edit documents accordingly
The Food and Drug Administration (FDA) has oversight over some, but by no means all, of the research that comes through the UAMS IRB. When submitting studies, please confirm that your consent and HIPAA authorization forms correctly reflect whether the FDA will have access to study records. Projects that involve FDA-regulated products such as investigational […]
Those massive reports we sometimes see at continuing review? You don’t have read the whole thing.
It’s not unusual for sponsors of multisite studies to draft long, periodic reports summarizing overall study progress. We recently saw one in the IRB that was more than 160 pages long submitted with a continuing review (CR). Please note that if you see one of these in a CR you are reviewing, you are NOT […]
New submission reviews
When reviewing new submissions for an agenda, please keep in mind that you can discuss any questions or issues with the other assigned reviewer or the IRB chair before the meeting. You also have the option of getting in touch with the study staff directly. However, in case you want to maintain the anonymity of […]
Minimizing the possibility of coercion or undue influence in the consent process
For studies that involve an informed consent process, the new submission form requires a response to the query, “Explain how the possibility of coercion or undue influence will be minimized in the consent process.” We see a lot of variety in the responses to this query. However, what we don’t see a lot of are […]
Two hints for completing continuing review forms
Hint No. 1 – When completing your study’s continuing review form, please remember NOT to include with the form any document amendments you’re hoping to get approved. The IRB no longer reviews amended documents with continuing reviews, and hasn’t done so since we switched from ARIA to CLARA. In some cases, the IRB may have […]
The “budget modification” notation —
Occasionally you’ll notice an item on a meeting agenda that includes a “budget modification” tag. These items should be reviewed in the normal way. The “budget modification” language indicates that the item in question has resulted in a change in the study’s budget, which is handled in another office and not by the IRB. So […]
Age ranges do matter!
When drafting your protocol, please pay close attention to how the subjects’ age range is described in the text. Different regulatory requirements apply to different ages, which is why the IRB may send contingencies asking you to be very, very specific when describing how old your participants are. For example, when we see an age […]
A Resource for IRB Members
The American Association of Public Opinion Research (AAPOR) has some publications and resources available online that will be of interest to IRB members. AAPOR recently announced the release of what it calls “updated and expanded resources for researchers who conduct surveys subject to institutional review board (IRB) review.” Although the announcement focused on researchers, the […]