IRB Members

  • Another chapter in the debates over research findings

    • 03.22.2018

    There’s been no shortage of discussion about the validity of published research findings, and whether any apparent discrepancies can be attributed to honest errors or to research misconduct. We’ve found some additional chapters in that debate that we thought we’d share. They involve diet-related research overseen by well-known researcher Brian Wansink. You may not know […]

  • Challenges seen in building of massive patient bio- and databank

    • 03.20.2018

    Large databanks, such as those created by ambitious, long-term study like the Framingham Heart Study or the Nurses’ Health Study, can be a real gold mine when other investigators use their previously collected data to do their own research. The National Institutes of Health is slated to start recruiting this spring for its proposed All […]

  • Assessing capacity to consent

    • 03.12.2018

    Study teams and IRBs need to pay close attention to the consent process when preparing (or reviewing) a study that may enroll people whose capacity to consent is impaired. Study team members may also encounter potential subjects whose ability to provide consent is questionable, for whatever reason. What are some of the things IRBs and […]

  • A scholarly look at the subject reimbursement issue

    • 03.1.2018

    Paying subjects for research participation can be a sticky issue, and it sometimes feels like we rely on gut feelings to decide what’s an appropriate amount of payment, how it should be disbursed, and whether payment unduly influences the decision to participate. Some human subject research ethics experts took a more scholarly approach. The New […]

  • IRB Questions of the Month

    • 02.28.2018

    Our thanks once again to PRIM&R’s Ampersand blog and to First Clinical Research for sharing some thought-provoking Questions of the Month with the IRB community. February’s question addresses the exclusion from a phase 2 drug trial of a certain class of people, specifically people “Educated or employed as an attorney.” The drug in question is […]

  • Concerns about placebo use in a childhood asthma study leads to changes

    • 02.13.2018

    Ethics reviewers wrestle with the issue of using placebos in research because of the fear that withholding a treatment from the controls may be denying controls access to a helpful treatment. And as our IRB members know, the IRB makes separate risk determinations for different groups in FDA-regulated investigational studies involving children, because different groups […]

  • Short, to-the-point, and hot off the presses: The FDA’s information sheet on subject payment

    • 01.29.2018

    Paying subjects for their research participation engenders quite a lot of discussion, both among research teams and on the IRB. The Food and Drug Administration (FDA) recently released an information sheet regarding its current thinking on paying subjects. The FDA, like the UAMS IRB, feels that payment should accrue as the subject progresses through the […]

  • A summation of what the Revised Final Rule delay means for us

    • 01.18.2018

    Public Responsibility in Medicine and Research (PRIM&R), upon whom we rely for updates in the world of human subject protections, has come through again with a recap of how the delay in the implementation of the revised Common Rule affects us here on the ground. Some highlights worth mentioning: The current Common Rule requirements described […]

  • Revised Common Rule Effective and Compliance Date Delayed 6 Months…for now

    • 01.17.2018

    That sound you hear is a giant sigh of relief from a whole lot of institutions subject to OHRP oversight. Late this afternoon, we received word of the planned Federal Register Publication of an interim Final Rule, delaying the effective and compliance date of the Revised Common Rule until July 19, 2018, which is 6 […]

  • 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 […]