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 […]
Doing a chart review study? Consider AR-CDR as your data source
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 […]
What the IRB has been up to, day in and day out
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 […]
Updated FWA information (aka how many acronyms can fit into a single blog item?)
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 […]
Study: Informed consent documents remain problematic
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 […]
CLARA accounts for non-UAMS/ACH employees
The IRB office occasionally get requests for CLARA account creation for a someone who is not affiliated with UAMS or ACH. These typically come from people at outside institutions that use the UAMS IRB, such as the Clinton School of Public Service, or from people collaborating with UAMS or ACH investigators. The new account request […]
New Questions in CLARA
Some new questions have been added to the CLARA new submission form to allow us to better track the types of research being done on campus. First, some questions related to foreign involvement in research have been added to the Contracts section. These questions will help ensure any studies being done outside the US, or […]
“Anonymized,” my eye
“Computer scientists have developed an algorithm that can pick out almost any American in databases supposedly stripped of personal information,” is the overline on this New York Times article about the relative ease of identifying supposedly anonymized data. And “there are mountains of anonymized data circulating worldwide, all of it at risk,” the author writes. […]
The changing definition of “identifiable”
These days, the concept of “identifiability” is moving target. Per the Revised Common Rule (RCR), something is identifiable if the subject’s identity “is or may be readily ascertained by the investigator.” The RCR also states federal departments implementing the RCR will review the notion of identifiability at least once every 4 years, and any technologies […]
“Anonymized” data may not be so anonymous after all
One definition of a human subject, per the Revised Common Rule, is a living individual about whom an investigator obtains, uses, studies, analyzes, or generates identifiable private information (emphasis added). Generally, data recorded without identifiers is not considered to be human subject data, because the identity of the subject cannot be “readily ascertained by the investigator or […]