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.

We recently posted an item addressing how we can’t avoid creating analyzable data in this wired world. Whenever we scan our grocery store loyalty card, or post something online, or even start a Google search, we’re contributing to a dataset somewhere. Can this data be used in research? What are the ethics of doing so? […]

Our IRB comprises multiple people because we want to get a diversity of opinions represented on the board. So it’s not unexpected to find that not everybody agrees on a particular submission. Votes on motions do not need to be unanimous – motions need only a majority of the vote to pass. Everyone who has served […]

Getting additional training is one common requirement for investigators who are subjects of noncompliance determinations. While full-blown misconduct findings are rare, they do happen, and often have their roots in compliance-related problems. A recent article in the journal Nature found that investigators subject to action by their home institutions (e.g. having their research privileges suspended) aren’t necessarily […]

This child was younger than the usual 7-year-old cutoff we typically use for obtaining assent, and this involves treatment, not research, but this is a powerful story about a child’s decisions for medical care, and the debate over the extent adults should be involved  in those decisions. Trigger warning –  this is potentially a multiple-tissue story.

A speaker at April’s annual AAHRPP conference (yes, the same AAHRPP that accredits us) mentioned that, whether we know it or not, we are all research subjects. Every time we swipe a store’s loyalty card to get a discount, we create analyzable data. Ditto for using electronic activity and health trackers like FitBits, MapMyWalk, or […]

Sometimes you read a media report about study results, and all you can do is think, “Wow, that sounds so cool!” Unless, of course, you work at an IRB. Then you also can’t help but think about the risks and benefits, and how a study like this would be handled at your institution. How do […]