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Institutional Review Board News

Stay up to date on the latest news regarding Institutional Review Board (IRB) policies and procedures at NYU Grossman School of Medicine.

Research COVID-19 Portal

For information regarding guidance, requirements, and tools for conducting human subjects research on COVID-19, please visit the Research Focused COVID-19 Information portal.

IRB 2021—The Road Ahead Info Session

When: Thursday, August 5, 2021, 11:00AM–12:00PM
Where: Zoom
Host: Royell Sullivan-Green, MA, CIP, IRB Education Manager

At our quarterly IRB Information Session, we discussed new initiatives to help you better manage your work and policy changes that may impact your studies.

This session covered the following topics:

  • system updates
  • IRB admin team updates
  • new IRB resources workgroup
  • guidance regarding the use of novel technology
  • updated CITI certification guidance and no more NYU Winthrop IRB
  • new waiver application
  • reminders regarding data and safety reports requirements
  • metrics and more

Updates Regarding Required Human Research Protection Training

The institution name referenced in the Collaborative IRB Training Initiative (CITI) program has been updated to NYU Langone Health. With this update, the “New York University School of Medicine/Medical Center” name has been revised. Please note the following:

  • The name that displays under the list of institutions on the CITI program website will now display “NYU Langone Health”.
  • All existing and future certificates of completion will now display “NYU Langone Health” as the affiliated institution.

Additionally, the guidance for required course access and institutional affiliation has been revised to reflect this name change and to provide updated instructions on the following:

  • first-time user account setup
  • linking existing CITI information from another institution to your NYU Langone account
  • locating CITI certification status in the Research Navigator system

The CITI program provides access to required training courses for all research investigators conducting studies that involve human participants at NYU Langone Health.

These changes require no action from CITI users. Should you have any questions or concerns related to this matter, you can contact us at irb-education@nyulangone.org.

New IRB OnDemand Training: Minimal Risk Research

A new IRB training module that covers the requirements and process of new minimal risk research is now available in FOCUS.

By taking this course, researchers learn to determine what activities meet the definition of “research,” understand what category of exempt or expedited review their research may fall under, and understand the submission requirements for each minimal risk review type.

Access the online courses below (Kerberos ID and password required):

IRB Education: IRB Requirements and Process of New Minimal Risk Research, Part 1
IRB Education: IRB Requirements and Process of New Minimal Risk Research, Part 2a
IRB Education: IRB Requirements and Process of New Minimal Risk Research, Part 2b

New Policy: Inclusion of Employees and Students in Research

The Human Subjects Research Protection Program and Institutional Review Board Policies and Procedures Manual’s section on the Inclusion of Employees and/or Students in Research has been updated to include additional information regarding the requirements for IRB review and the additional ancillary review process for research studies that include NYU Langone students and/or employees as research participants.

The MyStudies submission process has been updated to include automatic notifications to departments requiring review of employees or students as research participants. Depending on the population, an ancillary review by the appropriate NYU Langone department will take place concurrently with IRB review. The policy includes additional steps you will need to take to advertise your study.

The new policy went into effect on June 1, 2021. Please review the updated policy as well as the new accompanying guidance document.

Please call IRB Operations at 212-263-4100 or email irb-info@nyulangone.org with any questions.

2020 IRB Metrics

Check out the IRB’s metrics for 2020 (Kerberos ID and password required). This report includes the review time of external IRBs, the IRB Operations team’s productivity rates, and the COVID-19 review and approval times.

The 2020 highlights include significant improvement in submission-to-approval times with drops in median rates:

  • 35 days for full board initial study review (down from 40 days in 2019)
  • 17 days for expedited initial study review (down from 29 days in 2019)
  • 14 days for exempt study review (down from 15 days in 2019)

Review the full report to see how the IRB is continuing to reduce review times. The report also provides tips and resources for optimizing submissions to reduce your study’s submission-to-approval time.

IRB Announces Changes to Informed Consent Forms Following the 21st Century Cures Act

Since April 5, 2021, consistent with the requirements of the 21st Century Cures Act, NYU Langone provides our patients with immediate digital access to all new test results and clinical notes.

Research data and information that may be contained in a patient’s electronic medical record (EMR)/EPIC Chart are now available to them immediately. However, the 21st Century Cures Act allows for suppressing research-related information within the medical record, as well as delayed release of research-related information within the medical record. In order to ensure research participants are informed of this new information, the IRB has updated the standard informed consent language.

The specific required language to be included in consent forms along with instructions on when to use this new language is now available to researchers (Kerberos ID and password required).

If you have questions about consent form template language or whether you need to submit a modification, please call IRB Operations at 212-263-4110 or email irb-info@nyulangone.org.

Resource Highlight: IRB Policy on Incidental Findings in Research

The new IRB Guidance for Returning Incidental Findings from Research (see Section 17.10 of the policies and procedures manual), effective May 1, 2021, is available now. This policy addresses specific criteria for the disclosure of incidental findings to subjects involved in human subjects research at NYU Langone and the elements that must be included in plans for incidentals findings disclosures.

Points covered in the policy include the following:

  • what types of research are subject to this policy, such as genetic, genomic, and imaging human subjects research
  • what to include in a protocol and informed consent form when submitting to the IRB for research where incidental findings are expected
  • how principal investigators and their teams can disclose the discovery of incidental findings to research participants

The policy applies to all new studies submitted on or after May 1, 2021. Learn more by reading the guidance document on the return of incidental findings from research.

IRB Operations Virtual Drop-In Hours

We are here to help! Our new drop-in program offers you an opportunity to meet with the IRB team to discuss any questions you may have as you work with the IRB and IRB system.

You can join one of our video chats to have your questions addressed:

Wednesdays 2:30–3:00PM
Thursdays 10:00–10:30AM

If you are not available during those times, you can reach us via email:

General questions: irb-info@nyulangone.org
Education questions: irb-education@nyulangone.org