Are decentralized clinical trials (DCTs) here to stay? Probably – they proved their worth during the COVID pandemic. DCTs are trials in which some or all study activities occur away from traditional clinical trial sites. These trials can be more convenient for participants, thereby facilitating enrollment and diversity of subject populations. The FDA has a […]

The continued evolution of electronic systems has caused us all, including the Food and Drug Administration (FDA) to have to scramble to keep up with changes. The FDA recently released a draft guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers. While this guidance is not final, it may […]

The discussion about the use of electronic systems in research continues, with the FDA releasing a draft guidance titled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers.” While the guidance is a draft, it appears to touch on most of the topics we hear about when discussing the use of […]

Investigational drug studies must have an IND granted by the FDA before they begin. Unsurprisingly in this regulated world, the definition of “investigational drug” can vary, but in summary, if a study needs an IND, it better have one before it gets started. Figuring out what needs an IND and what doesn’t is tricky, tricky […]

Arkansas law requires people working in certain capacities to report things like suspected abuse, an intent to harm self or others, or a positive result on certain infectious disease tests to the authorities. Many of the people who interact with research subjects fall into this “mandated reporter” category, so this reporting requirement applies to them. […]

The federal Office for Human Research Protections (OHRP) appears to be facing the same kind of, um, resource constraints many other human subject research institutions are also facing, per a recent article in Report on Research Compliance. A large percentage of its positions are vacant, per the report. OHRP is the agency that oversees human […]

The CLARA new submission form requires study teams to provide a so-called “lay summary” about their study. Consider the lay summary an opportunity to summarize the study and highlight any important points someone would want to know as they’re reviewing the study. Providing complete information in this section will speed your review and approval. For […]

Protocol amendments often entail changes to consent forms. However, sometimes a revised protocol is ready for submission before the revised consent form is. When is it acceptable to submit a protocol change before the new consent form is ready? This practice should be avoided when possible, according to a recent blog post by WCG IRB. […]

The HIPAA Research Authorization template has been updated with one big and a couple of little changes. The revised form is now posted on the IRB’s website’s “Templates, Training, and Tools” page. The little changes include some minor wording changes to clarify what we’re trying to convey in the form. Specifically, we now state that […]

The Willowbrook study, in which institutionalized, mentally disabled children were deliberately infected with hepatitis, will be the topic of the next Research Ethics Book and Journal Club meeting, scheduled for March 10 at 10 am. Location and the in-person v. Zoom decisions are still being finalized, but it’s not too early to save the date […]