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 […]
The HIPAA questions on the new submission form
When completing a new submission form in CLARA, please pay close attention to the questions related to HIPAA and respond individually to each one. We understand that some of the questions may seem like forehead-slappers, such as a request to explain why access to the protected health information is necessary in a chart review study. […]
The IRB needs to see projects BEFORE they’re carried out
The IRB staff has noticed an uptick in recent weeks of IRB submissions describing projects that have already been completed. Fortunately, none of the projects in question met the regulatory definition of research requiring IRB review. However, please note that the IRB cannot review or approve projects that have already been completed. In fact, researchers […]
Including the FDA in consent and HIPAA authorization forms
The Food and Drug Administration (FDA) has oversight over some, but not 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 drugs and […]
IRB members can agree to disagree. Really.
IRB votes don’t have to be unanimous, or even close to unanimous. Reasonable people can have differing valid viewpoints, and there’s no need to wait until it looks as though everybody agrees on whatever’s being discussed to make a motion. If you are getting the sense during the meeting that further discussion would do nothing […]