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: The name should include the document type, the version number, and the version date. Example: XYZ Protocol Version 3 14Nov2014. If the item you’re naming has a version number and date printed on it, the version number and date you type […]
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: Risks to subjects are […]
Requesting a Waiver of Documentation of Consent in CLARA
Some studies do not require the investigator to obtain the formal written consent of subjects using an IRB-approved consent form. The circumstances in which documentation of consent can be waived are described in UAMS IRB Policy 15.3 (see section II.B). Please note, however, that even when a waiver of documentation of consent is requested/granted, some […]
True or False? Federal Regulations Require Consent Forms to be Written at an 8th-Grade Reading Level
FALSE. You may have heard that consent forms should be written at a reading level that’s no higher than what an 8th-grader could understand. However, this bit of conventional wisdom is just that – conventional wisdom, and not a regulatory requirement. Instead, regulations at 21 CFR 50.20 and 45 CFR 46.116 require information given to […]
Please upload CVs to your CLARA profile, not to individual projects
CLARA allows researchers to add their CVs to their CLARA profiles, rather than requiring the CV to be uploaded as a document to individual protocols. Including the CV in the profile automatically links the CV with each of that person’s studies. This is a change from our old system; in ARIA, CVs had to be […]
Expand your browser window to see the “Review and Submit” button
We often get calls from researchers asking about the status of a modification or contingency response they submitted weeks ago. However, these items aren’t submitted to the IRB unless you hit the “Review and Submit” button at the lower right of the browser window. This button can sometimes be hidden if your screen is not […]