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 […]
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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 […]
We are all research subjects — even if we don’t think of ourselves that way
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? […]
Time’s running out for a quick and easy half-hour of education credit
The target date to post our next Research News Blog quiz is June 30. That goal means you only have a few days left to get your 0.5 hours of Certified Research Specialist education credit on our current blog quiz. Go to learnondemand.org, and enter “IRB” in the search box at upper right to access […]
Dissension (within limits) is not necessarily a bad thing
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 […]
NICE review reminder now appears on approval letters
You may have noticed some new text at the end of your new submission approval letters, encouraging you to request a NICE review. New Investigation Consult and Education reviews are a free, voluntary service provided by the UAMS Office of Research Compliance (ORC) for newly approved studies. You can request a NICE review for any study that has just […]
Some common factors behind research misconduct
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 […]