Recent posts on this blog have highlighted the fact that, in the final analysis, we are all basically research subjects creating research data, whether we know it or not. Sometimes our environments also get manipulated without our being aware  – does anybody remember the Facebook study that caused much wringing of hands? And here’s a […]

The issue of whether, and how much, to compensate subjects for research participation is something IRBs and researchers struggle with. Is a particular compensation scheme affordable given available funding? Will the proposed compensation be so high as to unduly influence the target population’s decision to join a study? Or is it so low that it […]

CLARA allows reviewers and IRB office staff to make two different types of notations on studies they’re reviewing – “Notes” and “Contingencies.” There are important differences between the two, and using them correctly will improve workflows and speed up submission processing (and that can mean shorter meetings!). Here is a refresher on how to use […]

“If it’s not written down, it didn’t happen.” That saying has been used in reference to documenting medical procedures (you can’t bill for it if you don’t document it) and also to conducting research (you can’t prove that you did it unless there’s a documentation trail showing you did it). It also applies to IRB discussions, […]

The use of big datasets that are just kind of Out There – and that may have been created without the intent of using them for research –  continues to be discussion topic. Below are links to a few articles we’ve noticed on this issue. Wired published a piece about some of the confusion on […]

Move over, Framingham Heart Study and Nurses Health Initiative studies – there’s a new kid on the block. A new federal project, initiated as part of the Precision Medicine Initiative , aims to enroll a million volunteers willing to provide genetic and lifestyle information in an attempt to better understand what causes disease, and how to […]

Some research may touch on sensitive or potential illegal behaviors, such as drug addiction. Or a subject’s research participation may be of interest in a legal matter; for example, a parent in a custody battle may seek access to the other parent’s medical information. In cases like these, a Certificate of Confidentiality can be a […]

The National Institutes of Health has released its final policy on single-IRB review of multisite studies. In short, NIH wants non-exempt human subject research carried out at multiple sites to be reviewed by a single IRB of record when those studies are NIH funded. The nuts and bolts of implementing single IRB review of multisite studies […]

If you look closely at UAMS IRB Policy 10.3, you’ll notice that it lists “grant application” as a required element of a submission. (Item IV.A.6, in case you’re wondering.) When and why does the IRB need these, and what is the board supposed to do with them? First, we only need these if a study […]

A recent New York Times story describes the closing of eight studies at New York University’s psychiatric research center, due to problems noted with the research. Please take a look at the story and think of any of the issues it raises should be taken into consideration as we review studies here.