The Committee on the Use of Human Subjects (CUHS) serves as the Institutional Review Board for the Cambridge and Allston campuses at Harvard University. Human subjects research at Harvard University is guided by the ethical principles set forth in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research). The minimum standards are set by the Department of Health and Human Services regulations at 45 CFR part 46 and the Food and Drug Administration’s regulations at 21 CFR part 50 and 21 CFR part 56.

News & Announcements

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A notice of an unpublished document was filed on Thursday, January 17, 2018 at 4:15 pm to announce the January 22, 2018 publication of a “Federal Policy for the Protection of Human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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Are You Conducting an NIH Clinical Trial?

September 22, 2017

As part of the NIH initiative to improve the quality and transparency of NIH supported research, a suite of initiatives have been launched. These initiatives include dedicated funding opportunity announcements for clinical trials, Good Clinical Practice training, enhanced registration and results reporting on ClinicalTrials.gov, and required use of single IRBs for multi-site studies... Read more about Are You Conducting an NIH Clinical Trial?

*NEW* Human Subjects Research Training Guide for International Enumerators

August 25, 2017

Conducting research in international locations is challenging in a number of ways: working with foreign governments, additional regulations and policies, and lack of infrastructure (such as internet accessibility) to name just a few. Based on your feedback we recognize that the human subject training requirements for foreign enumerators, who are part of the study team, have been challenging and that the content of the current training is not practical or easily understood by those who are not familiar with U.S. federal regulations.

In response, the IRB office...

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