TAG ARCHIVES FOR IRB administration

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

4
Feb2016

PRIM&R’s Comments in Response to OHRP’s and FDA’s Draft Guidance on IRB Meeting Minutes

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4 Feb
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PRIM&R submitted comments to the Department of Health and Human Services’ (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) in response to their jointly released draft guidance on meeting minutes for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. Read more

19
Jan2016

Unpacking OHRP’s and FDA’s Draft Guidance on IRB Meeting Minutes

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19 Jan
Comments: 1

In November 2015, the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) jointly released draft guidance for institutional review boards (IRBs) who oversee human subjects research under the FDA and/or DHHS regulations. This is the first time the agencies have jointly issued specific guidance on IRB meeting minutes. Read more