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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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Integration Updates: Complete List

Since November 2017, the Advarra team (formerly Chesapeake IRB and Schulman IRB) has been keeping clients informed of our work to integrate our processes and policies through emails, website postings and other communications.

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Advarra Unveils New Website and United Brand

Advarra, the premier provider of institutional review board (IRB), institutional biosafety committee (IBC) and research compliance services in North America, unveils a new website with a united brand.

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IRB Submissions to Advarra: Electronic Platform Routing and Data Migration

Beginning May 1, all new study submissions to Advarra’s IRB will be made through the Advarra Center for IRB Intelligence (CIRBI) Platform.

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