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.
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Updating IRB contact information in consent forms
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. […]
Help potential participants contact their insurance company
Medical insurance is a complicated thing. The decision to participate in a research study can also be a complicated thing. For many biomedical research studies, insurance coverage and research participation intersect. This intersection stems from many research studies involving study-specific medical procedures, in addition to the participants’ standard care. Consent form language routinely describes who […]
Single IRB Review workshop reports findings
Single IRB (sIRB) review, in which a single IRB acts as the reviewing IRB for all sites involved in a multisite study, was intended to simplify the IRB review process and eliminate having to deal with multiple IRBs’ requirements on a single study. A recent article in Journal of Clinical and Translational Science summarizes the […]
“Anonymous” data from wearables
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 […]
Draft FDA Guidance on Decentralized Clinical Trials
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 […]
Draft FDA Guidance on Electronic Records and Signatures
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 […]
FDA draft guidance on Electronic Systems/Records/Signatures
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 […]
FDA Warning Letter about research without an IND
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 […]
Mandated Reporter Language in Consent Forms
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. […]