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

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 Requirements...

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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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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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