• Record review studies also involve “human subjects”

    • 11.8.2017

    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 […]

  • Investigational drug studies need investigators’ brochures to be reviewed

    • 11.6.2017

    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 […]

  • Great education opportunity at UAMS next week

    • 11.3.2017

    Some of the biggest sessions at next week’s Advancing Ethical Research conference in San Antonio will be available remotely on the UAMS campus, thanks to the UAMS Office of Research Compliance. The conference, organized each year by Public Responsibility in Medicine and Research (PRIM&R), is the big human subject research conference each year, where thousands of […]

  • Even a minor protocol change can mean a lot of things need updates

    • 11.1.2017

    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 […]

  • Holidays, inclement weather, can complicate IRB meeting scheduling

    • 11.1.2017

    It’s that time of year again — winter (which is kinda of feeling like potentially a real thing so far this year) and the holidays both loom. Keep that in mind in your end-of-year planning if you have approval deadlines you really, truly need to meet. Here’s a reminder that, for reasons that are a […]

  • Joint OHRP and FDA guidance on meeting minutes

    • 10.27.2017

    The federal Office for Human Research Protections and the Food and Drug Administration have released a joint guidance addressing the requirements for IRB meeting minutes. We are excited about this for at least two reasons. First, we love it when OHRP and FDA work together on something. The two agencies have separate regulations, and while […]

  • Scary goings-on in the CLARA document files

    • 10.27.2017

    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 […]

  • Your weekly workload may vary, aka insight into how we assign agenda items and reviewers

    • 10.18.2017

    First, we at the IRB office and throughout the UAMS/ACH research community want to thank all of our members for their IRB service. We know that you have a lot going on in your lives, and we are grateful for the not-inconsiderable time and effort you devote to your IRB obligations. Our longest-term members may […]

  • Important Reminders About Emergency Use of a Test Article

    • 10.17.2017

    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 […]

  • A glorious day in the world of Certificate of Confidentiality procurement

    • 09.15.2017

    Oct. 1 is when the new policy pertaining to NIH’s issuance of certificates of confidentiality (CoC) takes effect, according to a recent NIH Blog post. Under the new policy, CoCs “will be issued automatically to NIH funded grants, cooperative agreements, contracts and intramural research projects research funded wholly or in part by the NIH that […]