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 […]

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: or GCP […]

Many study teams use flyers, advertisements, and/or things like social media posts to recruit potential research subjects. If written materials, in whatever format, are a part of your recruitment strategy, please take a look at UAMS IRB Policy 14.3 for a refresher on advertisement content. Because the IRB must determine that subject selection is equitable, […]

If your study has been audited during the most recent review period, you may have to do some additional reporting at your next continuing review (CR). Audits frequently find protocol deviations that the IRB asks you to report at CR. Help us confirm that you are meeting this reporting requirement. To do so, in your […]

All of those research findings – what happens to them when the study is over? Not enough happens to them, according to federal regulators who recently issued new rules about publishing clinical trial results. Clinicaltrials.gov was created, in part, to make it easier for the public to find out about research and research results. However, the […]

Because of an administrative issue involving CITI (the people who run the human subject protection training we require to be taken at citiprogram.org), UAMS does not, for the time being, appear on the list of institutions with which one can affiliate. Ordinarily this problem could be resolved fairly quickly. these, however, are not ordinary time. […]

Think back to 20 years ago – who, at that time, could have predicted what we’re able to do with genetic information now? In particular, who would have predicted that some private companies would own their own genetic databases? An interesting, or perhaps concerning, consideration with these private databases is that the use of these […]

Principal investigators (PIs) are ultimately responsible for everything that occurs on research at their sites. Few things irk monitors and auditors (including those from agencies such as the Food and Drug Administration) than hearing, “Well, that’s not my fault. That’s the study coordinator’s responsibility,” from a PI, in response to a finding. The Duke Clinical Research […]

Remember that the document titles you type in in CLARA are what will be listed in your final approval letter. It’s worth taking a few minutes to type in complete, easy-to-read, descriptive names to make it easy for reviewers to see what’s what and to later be able to determine just what it is your […]

When completing a new submission form in CLARA, you’ll encounter a question that reads, “What is the lay summary of this study?” As you answer this question, keep in mind your intended audience. The language used in this response should be easy to read and understandable to someone who hasn’t been in a science class […]