Concerns about a biologic product used in procedures at a New York hospital prompted a complaint by a researcher against his supervisor, according to a recent New York Times article. The Food and Drug Administration (FDA) had issued a warning letter to the product manufacturer, citing concerns about the manufacturing process and also stating the […]

In a field full of acronyms, here are two more. GDPR refers to the European Union’s General Data Protection Regulation and SPIND refers to Single Patient Investigational New Drug application, which is a type of expanded access program for investigational drugs. We now have available some good resources about the GDPR and SPINDs. The GDPR […]

The federal Food and Drug Administration (FDA) has released the final version of its guidance on informed consent. This guidance finalizes a draft guidance that dates to 2014. This guidance addresses a lot of those random little questions that we don’t often think about. For example, page 27 indicates that when a subject provides consent […]

Are IRBs inherently conflicted in their work? Whether they’re part of an institution or a private, independent IRB, they have stakeholders who have an interest in IRB review outcomes, and who potentially can exert pressure on IRBs, according to a recent article in Nature Medicine. Authors Jonathan M. Green and Stephen Rosenfeld, who both have […]

A recent publication in the journal Science claims that changing laws related to abortion availability can have implications for the review and conduct of some clinical research. Click on the link to read these authors’ thoughts on the topic and some of their suggestions for addressing these issues.

Since the IRB now works largely remotely, we are changing the recommended IRB contact information to be added to consent forms. Instead of suggesting people call the IRB office during normal business hours, please add the below language to consent materials. The consent template on the UAMS website is also updated to include this language. […]

Will research teams and IRBs have to rethink how they view data collected from wearable devices? A recent paper finds that supposedly anonymous data from wearables that measure things like heart rate, gait, and other parameters can be used to reidentify individuals. The authors report that “…reidentification risks from wearable device data are higher than […]

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 […]