If you work on NIH-funded research, take note. The NIH policy on Good Clinical Practice training that took effect Jan. 1 applies to you. Investigators and site staff responsible for the management, conduct and oversight of NIH-funded clinical trials will need to complete Good Clinical Practice training. Per information available on the Office of Research […]

It’s not unusual for a study to require subjects to be fasting before a certain study procedure, such as a blood draw. What is unusual, we’ve noticed here at the IRB, is a new submission that adequately describes what is meant by “fasting” on the first go-around. Addressing the following items in the consent form and […]

Many UAMS programs require students, residents, or fellows to complete a research or quality improvement project. For many of these people, this will be the first time they’ve had to interact with an IRB. If you’ve been working in research for a while, you probably already know the ins and outs of submitting a project […]

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 […]