News

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.

Undergraduate Research Ethics Training (URTP)

March 8, 2019

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:

Spring 2019 Training Dates

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New Alternative to NIH Online Training Now Available!

October 12, 2018

The National Institutes of Health (NIH) discontinued their very popular online ethics training, “Protecting Human Research Participants” on September 26, 2018. Historically, for study team members that are not affiliated with Harvard University or do not have a Harvard Key, the Harvard University Area (HUA) IRB offered this training as an alternative to completion of the CITI ethics training, as the CITI training is only available to Harvard affiliates. With the discontinuation of the NIH training, non-Harvard affiliates were left with few-to-no options.... Read more about New Alternative to NIH Online Training Now Available!

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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