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Research News

  • Another tool to help with the informed consent process

    • 01.8.2018

    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 […]

  • Still in a holding pattern regarding the revised Common Rule

    • 01.5.2018

    Will we, or won’t we, have to comply with the revised Common Rule in a few short weeks? That’s the big question to which there’s still no solid answer as of this writing. January 19, 2018, has a big, red circle around it on our calendar. That’s the date the revised Common Rule is slated […]

  • IRB Meeting Scheduling, Fifth Tuesdays, Bad Weather, Quorum, Etc.

    • 01.5.2018

    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, […]

  • A quick and simple word about creating assent materials

    • 12.20.2017

    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 […]

  • Author: Research disputes head to court, create barrier

    • 12.11.2017

    Research findings and publications can lead to more than just heated discussions and letters to the editor. It turns out they can also lead to lawsuits, according to a recent New York Times column. Its author goes on to discuss the chilling effects legal action can have on the research enterprise. Author Aaron E. Carroll […]

  • The final* Revised Final Rule

    • 11.24.2017

    Remember that asterisk in our blog items that talked about the final* Revised Common Rule? Well, it’s still there. Most of the Revised Common Rule was, and still is as of this writing, slated to take effect in January 2018. However, even its authors agree that the revised rule introduces a lot of changes to […]

  • Holiday bonus for the learnondemand.org blog quiz

    • 11.24.2017

    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 […]

  • Research participation basics for potential subjects, and others

    • 11.24.2017

    We know the federal Office for Human Research Protections (OHRP) mainly through its interactions with researchers and research sites. Now, however, OHRP has made available a wealth of resources for potential research subjects and others interested in research. The About Research Participation web page has videos and other resources describing research concepts. One aspect we […]

  • Record review studies also involve “human subjects” unless…

    • 11.8.2017

    In research, the regulatory definition of a “human subject” encompasses more than just living, breathing, actual humans. In fact, a┬áresearch study that involves accessing identifiable medical records┬áinvolves 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 […]