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 […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
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 […]
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.
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? […]
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 […]
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 […]
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 […]