News

We now have a Final Rule - Coming on January 21, 2019!

June 18, 2018

From our friends at the Office for Human Research Protections (OHRP):

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies are issuing a Final Rule to delay for an additional 6 months the general compliance date for changes recently made to the revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule).

This policy was originally promulgated as a Common Rule in 1991, and was revised on January 19, 2017 (82 Fed. Reg. 7149) (the revised Common Rule is also known as the “2018...

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GDPR is here!

May 27, 2018

What is the GDPR?

The GDPR, effective May 25, 2018, is a far-reaching regulation applicable to organizations with European Economic Area (“EEA”) based operations and certain non-EEA organizations that process personal data of individuals in the EEA. The EEA includes the 28 states of the European Union and four additional countries: Iceland, Liechtenstein, Norway and Switzerland. The GDPR aims to protect individuals’ fundamental rights to data protection and the free flow of personal data.

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Revised Rule Delayed! Again!

April 19, 2018

The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies announced a Notice of Proposed Rulemaking (NPRM) proposing to delay for an additional 6 months the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (the “Common Rule”).

In a final rule published on January 19, 2017, federal departments and agencies made revisions to the Common Rule (the “2018 Requirements”). The 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19...

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Minor Changes to Review Distribution

April 19, 2018
As the IRB office will have two staff members on leave from mid-May to mid-August, 2018, we have made some minor revisions to our IRB review distribution.  We have updated our distribution page to reflect these changes and those areas of the university that are affected by this revision have been notified by email.  Questions?  Feel free to contact us at (617) 496-2847 or cuhs@harvard.edu Read more about Minor Changes to Review Distribution

New NIH Clinical Trial definition is delayed

March 22, 2018

According to the just published DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2018, "The agreement appreciates efforts NIH has taken to increase transparency and improve oversight of its clinical trials and recognizes that the results of NIH-funded clinical trials have not always been reported in a timely manner, reducing the potential benefit from the findings. The agreement urges NIH to continue to address this problem through enhanced registration and reporting through ClinicalTrials.gov. There is concern, however, that in...

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Welcome to the HRPP Toolkit!

January 25, 2018

The Policies, Procedures, Guidance, and Documents that are part of the Human Research Protection Program at Harvard University Area IRB are collectively known as the “Toolkit”.   The Toolkit consists of “living” documents that will be updated as our regulatory landscape changes. We will also provide additional guidance and IRB decision aids to assist the research community through the IRB review process. Here is an overview of the components of the Toolkit:

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Breaking News – Revised Rule Now Delayed Until July 19, 2018

January 18, 2018

A notice of an unpublished document was filed on Thursday, January 17, 2018 at 4:15 pm to announce the January 22, 2018 publication of a “Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects”.  As stated in the document:

“This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the...

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New NIH Certificate of Confidentiality Policy - Effective October 1, 2017

October 2, 2017

Effective October 1, 2017, Certificates of Confidentiality (CoC) will be issued automatically for applicable NIH awards as part of the award terms and conditions.  (See notice here - https://grants.nih.gov/grants/guide/notice-files/NOT-OD-17-109.html)

NIH will not determine applicability; this is now the responsibility of the awardee institution and investigators. The policy applies to research commenced or ongoing on or after December 13, 2016.

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