Does CLARA sometimes start sending you weird error messages, or seem to hang up while you’re working in it? If so, the first thing to do is check which browser you’re using. CLARA works best in the Chrome browser. It is prone to error messages and other weird actions when opened in other browsers. Also, while […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
The continuing debate over the validity of research findings
While reading our copy of Rigor Mortis: How Sloppy Science Creates Worthless Cures, Crushes Hopes, and Wastes Billions, we were reminded of some earlier discussions about whether published research findings hold up under scrutiny. The 2005 paper titled Why Most Published Research Findings are False by John P.A. Ioannidis is probably one of the most-discussed publications in this area. […]
Another chapter in the debates over research findings
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
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
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
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
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
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
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
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 […]