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 […]
Remember — please don’t delete previous versions of documents
Responding to IRB contingencies often involved making changes to previously submitted documents. When uploading revised documents, please remember to not delete previous versions of the documents you’ve changing. The IRB will need to keep those on hand to be able to compare changes and to document all the iterations of a particular item. If the […]
Privacy, data confidentiality, and community engagement in an online, genome-sequencing age
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 […]
Does clinicaltrials.gov have a dark side?
Clinicaltrials.gov, a database maintained by the National Library of Medicine at the National Institutes of Health, lists research studies involving human subjects. Certain types of studies are required to be listed at clinicaltrials.gov, and, per the clinicaltrials.gov website, study registrations have increased as more sponsors and investigators voluntarily register their studies. But as interesting as […]
Certificates of Confidentiality, and what they can, and can’t, do
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 […]
NIH Issues Policy on Single IRB Review of Multisite Studies
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 […]
When, and why, does the IRB need grant applications, and what is the IRB supposed to do with them?
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 […]
Study: Safety concerns, costs, placebos are impediments to study enrollment
Fears of side effects, potential higher costs, or being assigned to the placebo group dissuade people from enrolling in clinical trials, according to a new study that was the subject of a recent stat.com article. Those of us who work in research know that we have to be careful when approaching potential subjects regarding studies. While […]
Research-related problems at NYU
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.
CLARA new submission forms — Why we have them, and why we need you to complete them carefully
The new submission form may be the longest, most involved form in the CLARA system. When creating a new submission, you’ll be asked a lot of questions – everything from the number and age range of subjects to risks of the research to whether you’ll be collecting any biological samples. You may be tempted to […]