The rapid proliferation of new digital health applications, tools, and technologies is reshaping the health care and research environments. Companies that develop these products may not have strong foundations in health care norms and ethics standards, and, in the the absence of FDA oversight, these products may not have been developed with an explicit focus on safety and effectiveness. It is important for IRBs to have the knowledge and strategies for evaluating these tools' adequacy to protect the data, privacy, and confidentiality of research subjects in trials involving digital health technologies. On February 8, PRIM&R hosted the webinar to provide guidance for IRBs in the assessment of new technologies in the health care field. Presenters answer follow-up questions from the webinar for readers of Ampersand. Read more
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Imagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious heart condition. Unfortunately, you are struggling to locate and enroll enough eligible participants and your study is at risk of not completing. Then you discover a Facebook support group for precisely the condition you are studying. The group is open: you do not need to be invited or to suffer from the condition to become a member—anyone can join. Here are the eligible participants you have been looking for! Read more
This week’s Research Ethics Roundup examines new findings from the FDA on juvenile animal studies for pediatric clinical development, the research community’s response to Apple’s ResearchKit, and why experts think more funding is needed for tuberculosis research. Read more
In January, PRIM&R welcomed three new members to its Board of Directors, including Elizabeth A. Buchanan, PhD. PRIM&R recently had the opportunity to speak with Dr. Buchanan about her experiences in the field as well as her involvement with PRIM&R. Read more
Recently, PRIM&R hosted a webinar titled Institutional Review Board (IRB) Review of mHealth Research: Best Practices and Future Challenges , presented by John Wilbanks and Jeremy Block, PhD, MPP.
In recent years, digital and mobile health (mHealth) technologies have increased dramatically with the proliferation of smartphones, apps, and wearable data devices where users generate data. Rapid, widespread collection of personal health data from a broad cross-section of individuals is now possible on a scale unthinkable only a few years ago. As our society as a whole and the research community adopts these technologies, IRBs need to anticipate and address the challenges in achieving compliance and protecting human [...] Read more