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.

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News & Announcements

ESTR unavailable Friday, Oct. 23rd through Monday, Oct. 26th

October 19, 2020

There will be a minor update to the ESTR-IRB, Agreements-DUA, and Data Safety systems. These suite of applications will be unavailable from Friday, October 23 at 5:00 pm until Monday, October 26 at 5:00 am. A “system maintenance” page will be posted while the update is taking place. Any users in the system when the site becomes unavailable will be automatically logged out while the update takes place. This release incorporates some minor enhancements and bug fixes, along with enhanced background integration...

Read more about ESTR unavailable Friday, Oct. 23rd through Monday, Oct. 26th

Undergraduate Research Ethics Training now posted

October 19, 2020

The Undergraduate Research Training Program (URTP) is a comprehensive platform to create better prepared undergraduate researchers. As part of the program, in-person training sessions are held at various dates throughout the academic year. The in-person training sessions are an alternative to the standard online CITI training. The sessions have been developed with students in mind: they are 90 minutes in length, interactive, and developed with enthusiasm and energy.

... Read more about Undergraduate Research Ethics Training now posted

Revised Harvard Research Data Security Policy Effective July 15, 2020

July 8, 2020

The University, working with stakeholders, has revised the Harvard Research Data Security Policy (HRDSP), which will be effective as of July 15, 2020. The updated HRDSP better reflects current roles and practices, and importantly, requires use of the existing applications (e.g. ESTR-IRB, Agreements-DUA, and Data Safety and Security) to...

Read more about Revised Harvard Research Data Security Policy Effective July 15, 2020

ESTR-IRB Upgrade-Friday, May 29 at 2:00 pm until Monday, June 1 at 8:00 am

May 26, 2020

The ESTR support team announces its spring release for May 29. This release incorporates significant suite-wide updates and enhancements.

ESTR-IRB will be unavailable from Friday, May 29 at 2:00 pm until Monday, June 1 at 8:00 am  to allow for system updates.

Highlights of the release include:

  • Integration with Office365 for easier viewing and editing of submission-related documents in Word, Excel, and PowerPoint.
  • Modernized SmartForm design with updated navigation and reviewer options; and
  • ...
Read more about ESTR-IRB Upgrade-Friday, May 29 at 2:00 pm until Monday, June 1 at 8:00 am

New Data Security Review Process Coming on May 15, 2020

May 8, 2020

Starting May 15th, 2020, the University will be implementing a partial rollout of the updated Research Data Security Policy Guidance!
 

What is meant by partial?

Only certain requirements from the updated HRDSP Guidance will be effective starting May 15th, specifically:
 
  • As part of their review, IRB’s will begin assigning non-Sensitive/Sensitive determinations, as opposed to a...

Read more about New Data Security Review Process Coming on May 15, 2020
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