TAG ARCHIVES FOR sber

26
Mar2018

Research conducted in international settings poses particular challenges for the reviewing IRB, as it must possess adequate knowledge of laws and regulations in the country where the research is taking place, and be sensitive to the area’s cultural norms, in order to appropriately evaluate the study. Social, behavioral, and educational research (SBER) in particular may involve the study of stigmatized health conditions or behaviors, and may require the recruitment of marginalized populations and minors. Conducting research on these topics is important, but it is equally essential that IRBs and researchers mitigate the risk of social consequences that might result from subjects’ participation in the study, such as rejection in their communities or conflict within their families. The regulations regarding human subjects protections vary greatly between countries as well, which can lead to additional difficulties for IRBs. Read more

13
Feb2018

One of my favorite parts of attending PRIM&R's annual Advancing Ethical Research Conference is that it refocuses my efforts on what really matters. In the year since the last conference, I've processed countless exempt 2 determinations, requests for waivers of signed consent, and study team member modifications. I have been doing this while also contributing to new institutional policies and procedures, software requirements, and workflows in order to comply with the revised Common Rule. Some days, we all feel drowned in an ocean of regulations and rules—some days, we all get the Regulatory Robot Blues. However, the first keynote speaker at the 2017 Social, Behavioral, and Educational Research Conference reminded me of why human subjects research protection is my passion. Read more

30
Jan2018

Just before I left for San Antonio, I held an educational session with my IRB members, focusing on the revisions to the Common Rule that were likely to have the greatest impact on our processes. As an institution focused primarily on social, behavioral, and educational research (SBER), it seems likely that a large number of our currently expedited review projects will become exempt projects, especially under .104(d)(2) and .104(d)(3). Read more

8
Dec2017

I’m very excited about the opportunity to be a member of the Blog Squad for the 2017 Advancing Ethical Research Conference (AER17). As an IRB coordinator at Arizona State University, I attended my first AER conference in 2016, and I learned that the best part of PRIM&R is the community it builds. Through conference sessions and roundtables, PRIM&R brings together stakeholders from across the spectrum—policy makers, board members, staff, researchers—to discuss, present, debate, and learn from one another. The AER conferences give us incredible opportunities to converse and come to collaborative understandings of regulations and ethical considerations surrounding human subjects protections. With changes being implemented soon, learning from one another will be more important than ever. Read more

7
Dec2017

I am very excited to have attended my fourth Advancing Ethical Research Conference—and my first as a member of the Blog Squad! I am an IRB Administrator at the University of Southern California specializing in social behavioral research. I initially became familiar with the IRB from the PI perspective when my master’s thesis went through IRB review in grad school. I thought the process seemed interesting, and the protections very important. After graduation, when an opening came up at my undergrad alma mater to become an IRB administrative assistant, I jumped at the opportunity. And when my colleague at the IRB left later that year, I applied for and was ultimately accepted to fill his shoes as an IRB Administrator. Read more

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