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. […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
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 […]
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 […]
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 […]
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 […]
Tips for completing the new submission form in CLARA
Paying close attention to each question on the CLARA new submission form and writing responses that include the specific information requested will help your study get through the review and approval process faster. Each new submission form query addresses a key piece of information that either the IRB or another institutional office needs to approve […]