HIPAA has been confusing for all of us as it applies to research. Even though we’ve been dealing with it for years, we still see scenarios that make us wonder whether HIPAA applies to a particular study and, if so, how to best meet HIPAA requirements. One thing to keep in mind is that HIPAA […]

Some great ideas regarding language to use during the informed consent process has come to us via firstclinical.com. Basic Concepts for Informed Consent covers some of the foundational elements behind the concept of truly informed consent, and translates them into language subjects are likely to understand. It addresses some of the issues that can be […]

As we turn the calendars to 2018, here’s a reminder to keep an eye on any deadlines that you must meet with IRB submissions. Remember the UAMS IRB Committee meets on the first four Tuesdays of every month, so there is an “off” week in any month during which there’s a fifth Tuesday. January, May, […]

When a study proposes to include people who can communicate but cannot provide their own consent, the IRB will typically require some sort of assent process or document be used to explain the proposed research to the subject. This requirement is most often seen in studies involving minor children age 7 and up. Please keep […]

The 4th quarter IRB Research News and Tips blog quiz is now available at learnondemand.org! Get the most convenient 0.5 hours of Certified Research Specialist elective credit around. To access the quiz, go to the learnondemand.org link and type “IRB” in the search box at upper right. Please note you have to complete the entire […]

In research, the regulatory definition of a “human subject” encompasses more than just living, breathing, actual humans. In fact, a research study that involves accessing identifiable medical records involves human subjects, even if the investigators will have no direct contact with the study participants. Federal regulations governing research define human subjects as living individuals about whom an […]

When putting together a submission for study involving an investigational drug, please make sure the submission includes the related investigator’s brochure (the IB). The IB contains important safety information about the drug the IRB will need to see before it can review the study. All investigational drugs will have an IB provided by the study […]

Remember – when you need to change something in an approved study, please review the entire submission to make sure you catch and amend everything that needs changing. For example, even a minor protocol amendment, such as changing a study’s end date, or a staffer’s phone number, might require changing the new submission form, the […]

Well, we must admit we’ve been a little spooked lately by some of the document stacking issues we’ve seen in CLARA. Nothing chills our bones quite as much as seeing tracked-changes and clean copies of revised documents in a single stack. We shiver in horror whenever we have to send something back to have you […]

The Food and Drug Administration (FDA) has strict requirements regarding the emergency use of test articles to treat patients. Failure to follow those requirements can create big headaches for investigators and institutions. Here’s a refresher on some of the key elements of emergency use of test articles. First, emergency use, per the FDA regulation at […]