TAG ARCHIVES FOR IRB administration

18
Apr2018

Not Quite Alone in the Wilderness

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18 Apr
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As a relative newcomer to the IRB administrator profession, one of my goals for the 2017 Advancing Ethical Resesarch Conference was to meet and develop a network of other professionals at institutions similar to my own. At my institution, I am the only full-time IRB administrator, and at times, it can feel like I am alone in the wilderness of IRB administration. While there are countless useful resources available online, there is often much more nuance and perspective to be gained by being able to bounce ideas and discuss pitfalls with a more experienced individuals Read more

8
Dec2017

Introducing the AER17 Blog Squad: Erik Williams

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8 Dec
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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

Introducing the AER17 Blog Squad: Sarah Luery

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7 Dec
Comments: 1

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

25
Oct2017

OHRP and FDA Release Final Guidance on IRB Meeting Minutes

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25 Oct
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Last month, the Department of Health and Human Services’ (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released final guidance on meeting minutes for IRBs who oversee human subjects research under FDA and/or HHS regulations. The final guidance includes a few small changes from the draft released in November 2015. This is the first time the two agencies have jointly issued guidance in this area; the guidance summarizes how the agencies believe IRBs and institutions should apply the federal regulations as they pertain to the creation of IRB meeting minutes. Read more