TAG ARCHIVES FOR Blog Squad

29
Sep2020

AER19 Blog Squad: Reflections on a PRIM&R Conference

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29 Sep
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I recommend all young professionals attend at least one PRIM&R Conference. PRIM&R has become an ever-growing repository of knowledge for research ethics and compliance, and the attending a conference will refresh your passion for research ethics. I felt my career path strengthening by establishing connections with likeminded individuals nationally and internationally. The willingness to collaborate, share, and advise could easily be witnessed in each session, break, and lunch period. I established new relationships that helped me understand the history of research ethics and IRBs in higher education. Operating a single staff IRB program can feel very isolating; the connections and knowledge gained from attending the PRIM&R SBER/AER Conference reduced the isolation I felt and gave me hope for the future of research ethics. Read more

21
Sep2020

AER19 Blog Squad: The Confusion of Mobile Medical Devices

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21 Sep
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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

31
Aug2020

AER19 Blog Squad: The Secrets of Big Data—Public, Private, or What?

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31 Aug
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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

23
Mar2020

AER19 Blog Squad: Is There a Bright Side to Noncompliance Investigations?

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23 Mar
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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

4
Feb2020

AER19 Blog Squad: Let’s Talk About Sex

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4 Feb
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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