You wouldn’t want your Protected Health Information (PHI) strewn all over campus, readily available online, or being talked about in elevators, would you? Research subjects feel the same way about their PHI, which they agree to share when they sign up for certain types of research. Here are some reminders about safeguarding PHI in the […]
Further developments in the case of Henrietta Lacks’ immortal cells
Most of us working in research know the story of Henrietta Lacks, a woman whose cells were collected from her without her knowledge or consent in 1951. The so-called HeLa cells have been extensively used in research ever since, without her family’s knowledge or approval for much of that time. An attorney representing some members […]
A view of how clinical trials are done on the outside
Chicago Magazine recently published a piece about the AbbVie Clinical Pharmacology Research Unit, a Illinois phase 1 clinical trial managed by a pharmaceutical company. Some of the issues mentioned make us wonder if they’re shared with our local study subject population. Some key take-aways: The article is a very engaging read – we encourage you […]
$4.3 million HIPAA penalty upheld for Texas cancer center
The theft of an unencrypted laptop and the loss of unencrypted thumb drives led to a $4.3 million fine levied against the MD Anderson Cancer in Texas recently. An administrative law judge recently upheld the determination and fine, according to the federal Office of Civil Rights (OCR). The UAMS IRB tries to minimize the chances […]
Reviewing reportable new information reports: A recap
If you’re assigned to review a reportable new information report (RNI), here are a couple of reminders and resources that may be helpful:
How to write so subjects can understand, aka think like a texter
Our thanks to Twitter stranger Gabriel Hernandez, from whom we shamelessly borrowed the following gem about clear writing: Me, by text: I can’t, sri. Me, by email: I’m sorry, but I unfortunately cannot be present. Me, when writing an academic paper or research protocol: I am henceforth unwillingly prevented from being able to be there. […]
Two blog quizzes now available for CRS credit
The learnondemand.org website now has not one, but TWO IRB Blog quizzes available. Each is worth 0.5 hours of elective education credit toward the earning or renewal of your Certified Research Specialist credential. To access the quizzes, go to learnondemand.org and type “IRB” into the search box at upper right.
Please write notes, comments, contingencies, discussion topics in CLARA
As a reminder to our reviewers, please remember to note any comments, contingencies, notes, or topics for discussion in CLARA before the meeting, keeping in mind the chair has asked for reviews to be completed by noon Monday. Having everything documented in CLARA provides a record for the IRB of topics discussed, makes everything visible to everyone […]
How to get fewer contingencies from the IRB reviewers and office
Well, we can’t promise to make contingencies go away altogether, but you know what they say – Happy IRB office staffers/reviewers write fewer contingencies. Here are a few tips to keep the IRB happier and contingencies at bay:
A proposal regarding research in a prison population
Research involving prisoners entails several extra layers of regulatory oversight, due to prisoners’ status as a vulnerable population. Those regulatory restrictions stem from historical concerns about inmates’ abilities to make truly voluntary decisions about whether to join a study, and fears over exploitation of a readily available population. One group of would-be researchers suggests the prison […]