• 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 […]

  • Two sure-fire ways to slow down your review and approval

    • 03.20.2018

    We’ve noticed some issues that are almost guaranteed to get you a minor prereview contingency from the IRB office these days. We thought we’d address them on our blog so you can minimize approval delays: –In new submissions: Failing to request the correct kind of waiver relating to the consent process and documentation. Consent process […]

  • Discussions of NIH’s new clinical trials requirements for the rest of us

    • 03.20.2018

    We’ve found some more reports about the new NIH rules pertaining to clinical trials that we thought we’d share with the UAMS research community. One of the biggest changes is the expansion of NIH’s definition of “clinical trial,” which will apply to some UAMS and ACH researchers who are now conducting NIH-funded “clinical trials,” which […]

  • 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 […]

  • Quick CLARA reminders

    • 02.27.2018

    We review a whole lot of CLARA new submission forms in the IRB office, meaning we tend to notice patterns in the forms. Here are a few questions that tend to trip up study teams, and reminders for how to complete them. Subjects section: –How many subjects do you anticipate consenting to meet this goal? […]

  • 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 […]

  • Submissions that are complete get reviewed faster

    • 01.31.2018

    When approving research, the IRB is required to make certain determinations, as spelled out in UAMS IRB Policy 7.1. The IRB therefore needs complete information about projects before it can review and approve a new submission. While we can very occasionally make exceptions, by doing things like issuing an approval letter saying we approve what […]