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 […]
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 […]
Problems or questions with your assignments? Please let the office know EARLY
If you are unable to review your agenda items for any reason, please let the office know well in advance of the IRB meeting so your studies can be reassigned. For example, if you have a conflict, or are out of pocket and won’t have computer access before the meeting, please let us know. Also […]
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 […]
What is the IRB looking for when it reviews recruitment materials?
The IRB asks that all materials used to recruit study subjects be submitted to the IRB before use. These materials include items such as recruitment flyers and brochures and the content of any advertisements, letters, emails, or social media postings that will be seen by potential participants. The IRB will review these materials to ensure […]
Please provide complete information on the HIPAA questions in new submissions
CLARA’s new submission form includes a section specific to HIPAA. If you indicate that you will be accessing existing PHI for your project, you will be asked to “Describe the PHI that will be accessed for the research.” The IRB asks that you briefly summarize the specific information to be accessed, e.g. diagnosis, treatment history, […]