As we work our way through a review of the criteria for approval, please keep in mind that these criteria should guide our study reviews and the drafting of contingencies sent back to study teams. The second criterion for approval is “Risks to subjects are reasonable in relation to anticipated benefits, if any, and the […]

When participating in those lively, and sometimes lengthy, discussions at IRB meetings, it can be easy to forget that IRB approval is based on on just a handful of criteria. Upcoming IRB Members Blog items will provide a refresher of these criteria. These criteria should underpin all the contingencies the IRB sends back to investigators. […]

When you’re drafting contingencies during your study reviews, you’ll notice an “attach to letter” box at the bottom of the contingency box, as shown here:   When drafting contingencies before a meeting, please do not check “attach to letter.” Checking this box makes the draft contingency visible to the study team, even before a contingency […]

When you’re reviewing a study, you’ll sometimes notice that a submission is missing a document. Your first temptation may be to email the study team to ask them to upload the missing item. However, please keep in mind that once a study has been assigned to an agenda, PIs cannot make any more changes to […]

When it’s your week to serve on an IRB committee, please try to have all of your assigned reviews done and any comments or draft contingencies entered into CLARA no later than Monday, the day before the meeting. The chair aims to have assignments completed and the agenda made available to members by Wednesday the […]

PIs have an opportunity to appeal IRB decisions, such as not approving a proposed modification, or a finding of serious or continuing noncompliance. To do so, they draft a written appeal request and send it, along with any supporting documentation, to the IRB office, where staff then assign it to an agenda using the “office […]

Investigators will sometimes submit items to the IRB on an Excel Spreadsheet. This is most common at Continuing Review for PIs who use the Events and Deviations Table template that is available on the IRB’s website. This table is in the form of a spreadsheet with two worksheets on it. When looking at these tables, […]

Everybody knows the IRB reviews research. However, that’s not the IRB’s only role in research oversight. The IRB at UAMS also acts as the UAMS Privacy Board for HIPAA-related research issues. A Privacy Board is a review body established to act upon requests for a waiver or an alteration of the HIPAA Authorization requirement under […]

Investigator-initiated studies involving drugs or devices may cause you to wonder if the study needs review by the UAMS Office of Research Regulatory Affairs (formerly known as the Research Support Center). With luck, the various prereview processes each study undergoes should catch the need for a regulatory review before the new submission shows up on […]

When reviewing items in CLARA, particularly contingency responses, you’ll notice that the author’s name of a particular comment will be visible, and will sometimes have a “Principal Investigator” notation next to it. This notation only indicates that the person responding, who is often a study staffer and not the PI, is acting on the PI’s […]