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As you prepare your continuing review submission, you may notice your study’s CLARA staff listing is out of date.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 The FDA has released a draft guidance entitled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, […]

  Research data storage options have expanded far beyond keeping paper records secure in a locked filing cabinet in a locked room. The CLARA new submission form has now been updated to collect more specific information about study data storage. All study data should be carefully stored, whether it’s protected health information (PHI) or not. […]

Foreign involvement in US-based research studies is getting closer scrutiny of late. While some allegations related to foreign influence have led to well-publicized faculty firings, there have been more such cases that remained off the public’s radar, according the head of NIH’s extramural research program. Institutional have also had to repay “hundreds of thousands of […]

We know that between their regular lives and their IRB responsbilities, our reviewers stay busy. We do, however, ask that you take the time to look over the entire agenda, even if you have no specific review assignments, and, if you do, not just the studies you’re assigned to, for each meeting you attend.  Some […]