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. […]
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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 […]
Audit reviews need noncompliance determinations
When reviewing audits, please remember that the IRB must also vote on a noncompliance determination after its audit review. The noncompliance options are minor noncompliance, serious noncompliance, and continuing noncompliance. Definitions for each are listed in UAMS IRB Policy 12.6. The IRB may also, at its discretion, decide that a particular audit is so clean […]
Keeping it simple when drafting contingencies
Keeping contingencies as clear and to-the-point as possible will simplify discussion of them in the meetings and the PI’s ability to respond to them. Please limit contingencies to a single concept or requirement whenever possible. Embedding multiple requirements or requests for information into a single contingency can lead to the PI overlooking one of the […]
CITI training requirements for investigators new to UAMS
The UAMS IRB requires all UAMS study staff engaged in research to complete human subject protection training once every three years. If you are new to UAMS from another institution, you may have already have done such training through citiprogram.org at your previous workplace. To meet the UAMS training requirements, you might only have to […]
A reminder about document names in CLARA (and please don’t use commas or underscores)
When typing in document names in CLARA, please keep the following points in mind: IRB letters pick up the document names you type in when listing approved items. If the names are complete and accurate, you’ll have clear documentation of the specific items approved.
The IRB does not require CRFs to be submitted for review
Please note that the IRB does not require investigators to submit case report forms (CRFs) to the IRB for review. CRFs are designed to be specific to study sponsors’ data collection and analysis needs, and when they are submitted, the IRB does not review them closely. Also, submitting a CRF with a new submission has […]
Keep the criteria for approval in mind when reviewing studies
It can be difficult to remember, when you’re deep into the review of a complicated new submission, that there are only eight regulatory criteria for the approval of human subject research. These criteria are listed in more detail in UAMS IRB Policy 7.1 and at 45 CFR 46.111. A summary follows: These criteria are derived […]