Since I started working for our IRB in 2010, we have seen an increase of studies using software and medical apps. The uses of the software vary greatly and involve using software to monitor sleep, physical activity, diet diary, mental health among many other uses. This makes the application of device regulation quite confusing, and discussion, with case examples, among IRB professionals can be incredibly useful in exploring how best to apply the regulations and guidance. Read more
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At PRIM&R's 2019 Advancing Ethical Research Conference, Ivor Pritchard, PhD, discussed the relation between public, private, and social information in his session, The Secrets of Big Data: Public, Private or What? (B15). Dr. Pritchard asked, what are the risks and confidentiality provisions for social information?
First, the concept of social information can be described as neither publicly nor privately available, but information provided in controlled settings. As an example, data gathered from a classroom or an online chatroom are neither public nor private in that the subject is a) not alone and b) not everyone has access to that environment. Then, what are the risks to subjects in social experiments (experiments conducted in public settings like [...] Read more
How does your organization view noncompliance investigations? Are they seen as an opportunity for learning and growth? If we are honest, many of us would not volunteer to learn or grow our HRPPs through a noncompliance investigation. We want to get through it and hope it does not occur again. That is wishful thinking and is not the wisest approach to addressing and mitigating noncompliance. The AER19 session, “How to Investigate, Mitigate, Report and Learn from Noncompliance—Avoiding Pitfalls and Seizing Opportunities for Improvement” inspired me to believe that there can be a bright side through the process of noncompliance investigations. Read more
Women are two-thirds of the world’s blind population, and there is no clear evidence for the cause of this alarming statistic. Dr. Janine Austin Clayton’s keynote address, "It’s About Quality Construction—Advancing a Foundational Framework for Rigorous Research Relevant to the Health of Women," at AER19 began with this disturbing fact as she described her path from being an ophthalmologist to the Director for NIH’s Office of Research on Women’s Health (ORWH). As she discussed this, and other startling statistics regarding women’s health in the United States, it caused me to wonder why gender and sex are not routinely considered in study design. How are studies ensuring that women (and sex as a biological variable) are integrated into the design of animal and human research studies so that knowledge and treatments gained from these studies can be generalizable and effective for both men and women? Read more
IRB Administrators face evolving challenges in their day-to-day work, especially around setting clear expectations for human research protection policies, to clearly communicating those policies to researchers with diverse skill sets. In September 2019, I attended PRIM&R's IRB Administrator Boot Camp in Orlando, Florida to strengthen my skills and learn strategies for successfully carrying out daily responsibilities related to IRB oversight and the protection of participants in constrained contexts. I also benefited from talking with other IRB administrators, sharing ideas and experiences. Read more