TAG ARCHIVES FOR IRB administration

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

11
Aug2017

AER16 Blog Squad: Since the conference, how have things changed?

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11 Aug
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PRIM&R invites members of our conference Blog Squads to reflect on the conference they attended in an additional post six months after the event. In this post, AER16 Blog Squad member Seth Hall reflects on how he's applied what he learned at AER16 to his day-to-day work. Read more

26
Jul2017

From PI to IRB Administrator: Lessons Learned

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26 Jul
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PRIM&R invited members of our Emerging Professionals Working Group (EPWG) to write about topics of relevance to their work and to the research ethics community. In this post, Sarah Luery describes her experience as a principal investigator (PI) and master’s student submitting to the IRB, and shares tips (now as an IRB Administrator) to demystify the IRB process. Read more

13
Feb2017

Reflect, Reframe, Remember: Takeaways from AER16

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13 Feb
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This year’s Advancing Ethical Research (AER) Conference provided me with the depth of knowledge I was expecting, but also with a new perspective that I had not anticipated. Full disclosure: I went to this conference assuming the pre-conference program would be most applicable and useful to my job. The pre-conference that I attended, IRB201, was, indeed, amazing. I walked away having memorized the 45 CFR 46.111 criteria for IRB review and approval and the ability to apply them to a protocol (or at least a practice protocol). Over the last few weeks, this new skill has carried me far; it has substantially refined my pre-review process, allowing me to more thoroughly and efficiently deliver an IRB protocol to my IRB administrator for her review. As one of just four IRB staff members at my institution, anything that streamlines the process and decreases burden is welcomed, and my newfound efficiency has not gone unnoticed or unappreciated. Read more

14
Jul2016

Webinar Follow-up: Making Good Meetings Happen for IACUCs and IRBs

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14 Jul
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For those involved with the ethical oversight of research involving animals or human subjects, committee meetings are a regular part of the job. IACUC and IRB staff and chairs are tasked with ensuring that those meetings run smoothly and are conducted in accordance with federal regulations. During this webinar, presenters shared recommendations and best practices for preparing for, conducting, and following up on committee meetings from the perspectives of a chair and coordinator. Consideration was also given to procedural and interpersonal aspects of IACUC and IRB meetings. Read more