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.
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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 […]
Screening adult populations for capacity to consent
Adult subjects are routinely assumed to be able to weigh the potential risks and benefits of joining a research study. However, functional abilities can vary depending upon the population, and can even fluctuate in a particular individual, due to mental or physical health changes. So what kind of things does the IRB look for when reviewing […]
Children, assent, quality-of-life, and life and death decisions
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.
We are all research subjects — even though we may not know it
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 […]