News

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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Undergraduate Research Ethics Training now posted

February 21, 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.

Here are some upcoming dates:

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

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!

Starting June 1, Data Security Level 3 will require HUIT approval prior to IRB approval

June 4, 2019

Why is this change happening?

As you know, all research that receives a data security level (DSL) assignment of 3, 4, or 5 requires review by HUIT. While HUIT DSL 3 must be reviewed within a one-year time frame, HUIT review of DSL 4 and DSL 5 has been required prior to IRB approval. With the recent changes to the federal regulations governing human subject protections, many studies that received a DSL 3 used the continuing review timepoint as a “due date” for the DSL 3 HUIT review. As continuing review is no longer a requirement for many studies, a working group has been...

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ESTR will be unavailable from 4:00 PM ET on Friday, April 12 until 7:00 AM ET on Monday, April 15.

March 28, 2019

Highlights for this release include:

  • Simplified process for single IRB review and management of participating sites,
  • Improved reference and flagging items for reviewers, and 
  • Updated workspace views.

View the detailed release notes to learn about key changes expected with this update.

Read more about ESTR will be unavailable from 4:00 PM ET on Friday, April 12 until 7:00 AM ET on Monday, April 15.