So you’ve submitted a modification, the IRB had a question on it that was returned to you as a contingency, and now you’re responding. And then you remember you just received some new information from the sponsor that the IRB needs to see, or that you need to make a change to a study document […]
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.
New online blog quiz can earn you 0.5 hours of CRS credit
The next IRB Research News and Tips blog quiz is now available at learnondemand.org. Log in at the site, type “IRB” into the search box, and get started on earning the most convenient 0.5 hours of Certified Research Specialist education credit you’ll ever see. (At least until next quarter, when we’ll post a new quiz.) […]
Change to the modification review process
Beginning January 3, 2017, ALL modifications submitted on studies with approved CLARA budgets will route through the Research Finance Team for review BEFORE they are sent to the IRB. What this means for investigators is that modification reviews and approvals may take a bit longer than they have in the past. This new procedure pertains […]
Remember: A contingency isn’t real until it shows up in a letter to you
We at the IRB have taken steps to increase the transparency of the review process. This change is typically a good thing, but can also create opportunities for miscommunication. IRB reviews of submissions can take hours or days to complete. The reviewer may start and stop working on it several times, drafting notes and contingencies […]
What to do when the person who needs to sign a consent form isn’t in the room with you?
Sometimes the person whose signature needs to be on a consent form isn’t able to meet face-to-face with an investigator during the consent process. Examples include the parent of a hospitalized infant who was transported here, the out-of-town legally authorized representative (LAR) of a hospitalized patient, or someone considering joining a telemedicine study. Fortunately, both […]
Consent process waivers and Consent documentation waivers are two different things
UAMS IRB Policy 15.3 describes the criteria that must be met when you either want to skip the consent process entirely (consent process waiver), or to not collect signed consent documents (consent documentation waiver). Please note that a consent process waiver and a consent documentation waiver are two different things. Different criteria apply to each, and the […]
No IRB Meeting December 27th
The IRB has cancelled its meeting scheduled for December 27th, due to a lack of available members that day. That’s the day after the UAMS Christmas holiday and, like many of the rest of us, our reviewers have other commitments that week. Our blog item of Nov. 22 mentioned the possibility of no IRB meeting […]
Clinicaltrials.gov rule change imminent
January 18, 2017, is the date the final rule for ClinicalTrials.gov and the new National Institutes of Health (NIH) policy regarding clinical trials registration are slated to take effect. The new ClinicalTrials.gov rule will make some previously optional elements required and will change some options available to choose from in the various drop-down boxes. Two significant […]
IRB calendar reminders
A few things to keep in mind, if you are facing any imminent IRB approval deadlines: There will be no IRB meeting on Tuesday, Nov. 29, or Tuesday, Jan. 31, as those are both fifth Tuesdays, and the board meets only on the first four Tuesdays of each month. As of now, our meeting for […]
Requirements for who must take Good Clinical Practice (GCP) training just changed
NIH clinical trials: NIH-funded investigators and clinical trial staff who are currently involved in the conduct, oversight, or management of clinical trials must complete Good Clinical Practice (GCP) training prior to the first of the year, per an NIH policy released in September. GCP training requirements can be met one of two ways: Completing the […]