News

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...

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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...

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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...

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New Certificates of Confidentiality System for Non-NIH Funded Research

March 6, 2020

From the NIH Press Release (March 3, 2020):

Certificates of Confidentiality protect identifiable, sensitive research information from disclosure. While Certificates of Confidentiality are issued automatically for NIH-funded research, non-NIH funded research that collects identifiable, sensitive information can request a certificate.

NIH has updated its Certificate of Confidentiality request process for non-NIH funded research through a new online system. The new system simplifies the request process by using self-certification statements and shortened text fields,...

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NEW! Harvard IRBs Master Agreement

January 10, 2020

Are you a Harvard University Area researcher who is collaborating with a Harvard Medical School researcher?  Have you ever wondered why a reliance agreement is needed when you work with another Harvard researcher?  It’s almost like we are two separate institutions!  Well, we are, or at least in regard to how the Harvard IRBs are set up. Since the Harvard IRBs work independently of each other, if a Harvard University Area researcher (Cambridge and Allston campus) is working with a Harvard Longwood Campus Area researcher, it is like being at separate...

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Single IRB Requirement for All Federally Funded Studies in Effect January 20, 2020

January 10, 2020

The Revised Rule (aka “2018 Requirements”) that took effect on January 21, 2019 requires that all federally funded research that involves multiple institutions must have only one IRB provide review.  Also known as “Single IRB” (or “sIRB” – a cool new IRB word, by the way), this requirement follows the NIH’s implementation of a similar policy way back in 2018. With the NIH policy, only those studies...

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IRB Office Closed - Dec. 24th through Jan. 1st

December 24, 2019
The IRB Office will be closed during the Harvard Winter Recess - December 24th at noon through January 1st.  The IRB Office will re-open on Thursday, January 2nd.  No IRB submissions will be reviewed during this time. Thank you for your understanding and Happy Holidays!