The New York Times had a recent article about the so-called survivors of thalidomide, who are the people who experienced birth defects associated with use of the drug during pregnancy. The article is interesting on several levels. It tells the stories of thalidomide survivors, their use of social media to find each other, and their […]

We’ve noticed a few things in new submissions regarding data and sample handling and storage that slow down approvals. Here are some reminders of things to keep in mind when drafting protocols and CLARA completing new submission forms: UAMS Administrative Guide Policy 3.2.01 requires research data, reports, and analyses to be kept for “7 years […]

Determining the appropriate time to close a study can be trickier than you might think. If you’ve completed your study and all that’s left is writing manuscripts and disseminating your findings, can you close the study in CLARA? How about if you’ve completed all your subject interaction and data collection, but have not finished analyzing […]

When the IRB reviews written consent forms, we try to keep in mind formatting issues that make it easier for study teams to ensure the forms are completed correctly. If you send us a consent form that has signature components split across pages (e.g. the subject signature on one page, and the subject signature date […]

The Arkansas Clinical Data Repository managed by TRI is a valuable resource, allowing you relatively straightforward access to vast stores of patient data. We encourage researchers across campus to use this resource whenever possible for their studies. (Hint: Patient data can often be provided without identifiers, which could mean your study is not subject to […]

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 […]

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 […]

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 […]

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 […]

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. […]