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Hurricane Florence

At this time, we do not anticipate any disruption to Advarra's IRB meeting schedule, timelines or regular office hours due to Hurricane Florence.

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Updated IRB Meeting Schedule for Week of September 24

Advarra’s offices will be open Monday, September 24th.  The training event will have no other impact on IRB/IBC meetings or regular office hours.

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Updated IRB Policy on Blood Volumes in Research

Advarra has updated its IRB policy for documenting total blood volume in research.

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Updated IRB Policies for Research Involving Minors

Advarra has updated its IRB policies for research involving minors. This includes policies on obtaining a child’s assent as well as parental consent requirements.

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Updated IRB Policy on ICH-GCP Compliance for Research Conducted in the US

Advarra has updated its IRB policy on applying ICH-GCP Guidelines to US research.

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Proposed Changes Released for Review of Gene Therapy Research

NIH has published a proposal to amend the NIH Guidelines to streamline oversight for human gene transfer research and reduce duplicative regulatory reporting requirements.

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Advarra’s Approach to Common Rule Revisions

Advarra will implement the Common Rule revisions, including the 3 burden-reducing provisions, on the new effective date of January 21, 2019.

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20th Annual Human Subject Protection Conference

Human Subject Protection: Roll With ItOctober 4, 2018Northern Kentucky Convention Center, Covington, KY

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Compliance Date for Common Rule Revisions Delayed an Additional 6 Months

US federal departments and agencies have published a final rule delaying the revised Common Rule general compliance date to January 21, 2019.

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Holiday Meeting Schedule – Memorial Day

Advarra’s offices will be closed all day Monday, May 28th. The IRBs and IBCs will not meet on Monday, May 28th.

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GDPR Data Protection Regulation Effective May 25, 2018

The EU's General Data Protection Regulation (GDPR) goes into effect May 25, 2018. While the regulation is intended to cover EU personal data, non-EU entities may still be impacted.

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IRB Reference Materials Now Available in Advarra CIRBI Platform

Reference materials and guidance documents for working with Advarra’s IRB are now available in the Advarra Center for IRB Intelligence (CIRBI) Platform.

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