The chair of Harvard’s chemistry and chemical biology department was arrested this week after prosecutors alleged he made a false statement to the federal government about a financial relationship with the Chinese government, according to this New York Times story. He was one of three scientists accused of foreign-influence-research-crimes this week, according to the story. […]

While we’re over here discussing whether the language in our HIPAA authorization forms meets regulatory requirements, Google is digging away at a trove of what’s been described as “tens of millions” of individuals’ health data, according to published reports. The Wall Street Journal first reported on this so-called “Project Nightingale.” (Please excuse the formatting of […]

We’re seeking your input as part of our continuing quality improvement at the IRB. Translation: We’d like some input on what we do well, and where we need to improve. To that end, everyone in CLARA who’s listed as being either a PI or has having “managing CLARA responsibilities” will receive an email with “IRB […]

Despite being the most specific individual identifier we currently know of, federal regulators still don’t consider DNA to be individually identifiable material. To be fair, the federal Office for Human Research Protections has said it will reconsider the notion of “identifiability” every 4 years, with whole genome sequencing likely to be one of the first […]

A recent Des Moines Register article describes a federal inquiry regarding human subject research conducted at a center for people with severe intellectual disabilities. The story includes links to previous reporting on the matter. We note the story indicates the request for information came from the Justice Department’s Civil Rights Division, and not from the […]

In a move that likely has all kinds of downstream implications, the genetic testing company 23andMe has announced it is working with a partner to improve clinical trial recruiting, according to a recent article in the online publication STAT. 23andMe already describes its research platform as “currently the world’s largest consented, recontactable database for genetic […]

If you’re planning a chart review study, before submitting, please give some thought to whether you could get your study data from the AR-CDR rather than directly from medical records. The AR-CDR (it stands for Arkansas Clinical Data Repository) is a vast collection of data extracted from EPIC and other, older, medical records systems. It […]

Ever wonder how the IRB office and board spend their time? We serve the research communities of UAMS and ACH, and we also pick up the occasional study from the Clinton School of Public Service and the Arkansas Department of Health. We have right around 1,000 open human subject research protocols in CLARA right now […]

The federal Office for Human Research Protections (OHRP) requires institutions like ours to maintain a current Federalwide Assurance (FWA) for the Protection of Human Subjects. Outside IRBs that review research done here, industry sponsors, and others sometimes ask study teams for the current FWA number and expiration date. (Of course the federal government gives each […]

The thought of a 17,000-word-long consent form causes our eyes to glaze over – that’s more than 30 pages of single-spaced text. But apparently such a thing exists, according to a recent study about consent forms from IDE studies, accepted for publication in the journal Contemporary Clinical Trials and reported on at the Regulatory Affairs […]