If you’re planning to lead, or join, a multisite study that uses a single IRB to oversee all sites, please let us know by sending an email to singleIRB@uams.edu. Single IRB review works two different ways. The UAMS IRB can serve as the IRB of record for a multisite study, in which other cites cede […]
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.
CLARA is the entire Institution’s Research Submission System
When creating a new CLARA submission, please remember CLARA sends studies to several administrative offices, and not just to the UAMS IRB. In fact, the IRB is the last place your study will go once you’ve “signed and submitted” it in CLARA. Pharmacy, legal, hospital compliance, Research Regulatory Affairs, and biosafety are just some of […]
Reminders about safeguarding Protected Health Information
You wouldn’t want your Protected Health Information (PHI) strewn all over campus, readily available online, or being talked about in elevators, would you? Research subjects feel the same way about their PHI, which they agree to share when they sign up for certain types of research. Here are some reminders about safeguarding PHI in the […]
$4.3 million HIPAA penalty upheld for Texas cancer center
The theft of an unencrypted laptop and the loss of unencrypted thumb drives led to a $4.3 million fine levied against the MD Anderson Cancer in Texas recently. An administrative law judge recently upheld the determination and fine, according to the federal Office of Civil Rights (OCR). The UAMS IRB tries to minimize the chances […]
How to write so subjects can understand, aka think like a texter
Our thanks to Twitter stranger Gabriel Hernandez, from whom we shamelessly borrowed the following gem about clear writing: Me, by text: I can’t, sri. Me, by email: I’m sorry, but I unfortunately cannot be present. Me, when writing an academic paper or research protocol: I am henceforth unwillingly prevented from being able to be there. […]
Two blog quizzes now available for CRS credit
The learnondemand.org website now has not one, but TWO IRB Blog quizzes available. Each is worth 0.5 hours of elective education credit toward the earning or renewal of your Certified Research Specialist credential. To access the quizzes, go to learnondemand.org and type “IRB” into the search box at upper right.
How to get fewer contingencies from the IRB reviewers and office
Well, we can’t promise to make contingencies go away altogether, but you know what they say – Happy IRB office staffers/reviewers write fewer contingencies. Here are a few tips to keep the IRB happier and contingencies at bay: –When you’re notifying the IRB of a temporary study closure of any kind, e.g. closure to enrollment […]
When should I have my study documents translated during the new submission process?
Investigators studying non-English speaking populations usually plan ahead and get any documents subjects will see translated before the study begins. The IRB sometimes receive new submissions with study documents already submitted in both English and the language of interest. While the IRB will eventually need to see both versions, it may save you some time/hassle […]
Revising an informed consent form — will you reconsent?
When you revise an informed consent form, the IRB will consider whether you need, or plan, to addressing the following items in your modification form will allow the IRB to review and approve your revised form more quickly: –Does the change affect any subjects currently on study? The IRB needs to know whether current subjects might […]
Two sure-fire ways to slow down your review and approval
We’ve noticed some issues that are almost guaranteed to get you a minor prereview contingency from the IRB office these days. We thought we’d address them on our blog so you can minimize approval delays: –In new submissions: Failing to request the correct kind of waiver relating to the consent process and documentation. Consent process […]