• Trial halted after infant deaths

    • 07.31.2018

    A study involving pregnant women and fetuses was terminated early in The Netherlands after the deaths of 11 neonates. We post this here as a reminder of some of the things the IRB has in the back of its mind when reviewing studies, and that investigators think about when they develop and join studies.

  • Right to Try versus Expanded Access — What’s what here?

    • 07.31.2018

    There has been significant discussion lately about making it possible for patients to access drugs that are not yet approved for use in certain cases. Desperate patients might view this access as their last, best hope — even though the risks and benefits of these items are not yet fully known. Right to try laws […]

  • New email for single IRB use

    • 07.25.2018

    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 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 […]

  • CLARA is the entire Institution’s Research Submission System

    • 07.25.2018

    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 […]

  • Tuskegee, and a whistleblower

    • 07.16.2018

    A recent Washington Post article and podcast got us started looking around for more information about the notorious Tuskegee experiment, which, according to the Post author, “destroyed the trust many African Americans held for medical institutions — a legacy that persists today.” Clicking around the internet for more information led us to an American Scholar […]

  • Returning individual results to subjects, in 300+ pages

    • 07.13.2018

    Considerations and recommendations for returning individual results to human research participants are the focus of a newly released report by the National Academy of Sciences. The full report exceeds 300 pages, but the executive summary runs to a much more manageable 27 pages. The NIH’s Office of Science Policy has a blog item about the […]

  • Reminders about safeguarding Protected Health Information

    • 07.13.2018

    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 […]

  • Further developments in the case of Henrietta Lacks’ immortal cells

    • 07.13.2018

    Most of us working in research know the story of Henrietta Lacks, a woman whose cells were collected from her without her knowledge or consent in 1951. The so-called HeLa cells have been extensively used in research ever since, without her family’s knowledge or approval for much of that time. An attorney representing some members […]

  • A view of how clinical trials are done on the outside

    • 06.26.2018

    Chicago Magazine recently published a piece about the AbbVie  Clinical Pharmacology Research Unit, a Illinois phase 1 clinical trial managed by a pharmaceutical company. Some of the issues mentioned make us wonder if they’re shared with our local study subject population. Some key take-aways: —“AbbVie touts altruism as a motive for volunteering. If chosen, “you […]

  • $4.3 million HIPAA penalty upheld for Texas cancer center

    • 06.22.2018

    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 […]