(Extension!) New Common Rule: Federal Policy for the Protection of Human Subjects

IMPORTANT:  This article was updated on April 30, 2018, to reflect an update on Common Rule implementation. 

On April 19, 2018, HHS released an NPRM proposing to delay the general compliance date for the revised Common Rule until January 21, 2019. A 30-day comment period will be open until May 21, 2018.

In addition to delaying the general compliance date, the NPRM proposes to allow institutions to implement three "burden-reducing provisions" of the revised rule during the delay period:

Subaward FAQ:  IRB and IACUC Protocols

My collaborator will be working with human or animal subjects. What do we need to do?

You must submit an application to Georgia Tech’s Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC).

All research projects involving human or animal subjects require submission (full or shell submission based on the specific circumstances which vary case-by-case, project-by-project).

What is Controlled Unclassified Information?

December 31: DFARS/NIST 800-171 and New Mandatory Standards for Federal Research

The National Institute of Standards and Technology’s (NIST) Special Publication 800-171 aims to consolidate the Federal government’s procedures for handling Controlled Unclassified Information (CUI), including CUI found in systems operated by federal contractors such as Georgia Tech. In the spirit of open government, these regulations aim to share government data with appropriate entities such as research universities, while keeping it out of the hands of prohibited audiences.

New Federal IRB Regulations Coming January 19, 2018

Updates coming!  Be on the lookout for changes in Federal IRB regulations.

Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality

Under the new policy, as of October 1, 2017, NIH funded researchers will no longer have to request a Certificate of Confidentiality (CoC), nor will they receive an actual certificate. The CoC will be issued automatically to NIH-funded grants, cooperative agreements, contracts and intramural research projects research funded wholly or in part by the NIH that collects or uses identifiable, sensitive information. Compliance with the requirements of the law will become a term and condition of award.

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