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 […]

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 […]

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 […]

“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. […]

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 […]

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 […]

It seems we hear each week of some new menace to our long-term health, whether it’s an emerging new condition or something that has been around for a while taking on new importance. Clinical research is one key to helping deal with these threats by developing effective treatments and bringing them to market. But what […]

As you prepare your continuing review submission, you may notice your study’s CLARA staff listing is out of date. While amendments are typically not allowed at continuing review, one exception is that you can, in fact, make changes to your staff listing, with some restrictions. Since the IRB will not approve revised documents at continuing […]

Ideally, new FDA-regulated products should be tested in populations that are similar to those that would eventually use the product after approval. However, ensuring the diversity of clinical trial populations has been an ongoing challenge. The FDA has released a draft guidance entitled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, […]