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 The FDA recently released a draft guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers.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FDA draft guidance on Electronic Systems/Records/Signatures
The discussion about the use of electronic systems in research continues, with the FDA releasing a draft guidance titled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers.”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. […]
Report recommends assessing IRB inspection program; evaluate IRB effectiveness
OHRP and FDA should conduct risk assessments annually to ensure they are routinely inspecting enough IRBs, according to a newly released report from the federal General Accounting Office (GAO). The GAO was asked to review independent IRBs, the processes used to protect human subjects, and standards of IRB quality. The agency found that independent IRBs […]
OHRP facing resource constraints
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 […]
Completing the new submission form’s “Lay Summary”
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 and Consent Form Changes
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. […]