Investigators are increasingly collaborating with community partners in research projects. These community partners typically don’t have much research experience and don’t work at research institutions, meaning they may not have too much human subject protection background. However, they play a vital role in making research opportunities available to populations around Arkansas. The UAMS IRB and […]
FDA finalizes informed consent guidance
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 This guidance finalizes a draft guidance that dates to 2014.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 […]
A proposal regarding IRBs
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 […]
Clinical Research and Abortion Restrictions
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.
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 […]