The IRB occasionally fields queries about writing up research results for publication. Please note that the IRB has no input or oversight of the content of manuscripts or other publications. It is the researcher’s ethical responsibility to accurately reflect their research in any publications. The one thing the IRB asks related to publications is that if […]

Many interview and survey studies can be reviewed as exempt status research. Even though no formal written consent is required for such projects, the IRB will typically require that some kind of informed consent process will occur. That process would typically involve a short information sheet, for a focus group or interview study, or asking […]

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 […]

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.) […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]