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 […]

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 […]