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Institutional Review Board Operations Institutional Review Board News

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.

Clinical Research Submission Update

The Office of Science and Research would like to thank everyone for your recent 2019 coronavirus disease (COVID-19) research submissions to the Scientific Review Committee (SRC). Going forward, there will be a change in the review process as described below.

Observational and non-interventional research no longer require SRC review. Please submit directly to the IRB through Research Navigator. You may use the COVID-19–specific template for observational research or Protocol Builder® (access requires a Kerberos ID and password). Observational research includes studies such as chart reviews, surveys, biospecimen collection, and data analysis.

Interventional research submissions for SRC review must now be submitted through Research Navigator. Interventional research includes drug research, device research, behavioral research, as well as surgical or other medical interventions. Please submit your protocol as you would a normal IRB submission for review by both the SRC and IRB. The study will have to clear SRC review before the study will be fully submitted in Research Navigator. You will receive a notification when your study is reviewed by SRC and will be advised on the next steps for your submission.

Submissions should no longer be made to COVID-19-research@nyulangone.org.

If you have a potential interventional project without a protocol but you wish to obtain clearance from the SRC before further development, please complete and submit the interventional research intake form.

If you have any questions, please email COVID-19-research@nyulangone.org or irb-info@nyulangone.org.

New Guidance on Electronic Informed Consent

IRB Operations is releasing new guidance on electronic informed consent (e-Consent). This guidance provides information about using electronic methods to obtain informed consent, whether the subject is on-site or remote.

e-Consent provides researchers with additional tools in the consenting processes, such as the following:

  • on-site consenting with an electronic device such as a tablet
  • providing consent materials to remote subjects through services such as SendSafe and REDCap
  • screening subjects through WebEx

For more information, please see our guidance on e-Consent document and our utilizing SendSafe and REDCap for e-Consent intranet page (Kerberos ID and password is required to access the intranet).

Inclusion of e-Consent materials and processes require IRB approval prior to their use. Questions pertaining to e-Consent should be directed to irb-info@nyulangone.org.

2019 Institutional Review Board Metrics

IRB operations is releasing metrics pertaining to review and approval times for calendar year 2019. Metrics include a drop from 49 to 41calendar days in total duration from submission to approval for full board studies.

Review our 2019 metrics to see how the IRB is continuing to reduce review time. We also provide tips and resources for optimizing submissions and engagement with the IRB Operations team.

Clinical Research Operations and Regulatory Affairs Update

We want you to know that the Clinical Research Operations and Regulatory Affairs team is here to support you. Please see below for a new opportunity to connect with us.

Call Into a Virtual Session With Your Clinical Research Support Unit and IRB Colleagues

The IRB and Clinical Research Support Unit are partnering to bring you virtual meetings three times per week. Topics will cover the following:

  • IRB review of your human subjects research
  • how to handle your new or existing submissions at this time
  • budget and payment negotiations
  • coverage analysis or post-award management

These sessions also give us an opportunity to hear what is on your mind. Call into one of these live sessions and members of the IRB Operations team and Clinical Research Support Unit will be on the line to provide live support in an open forum. These sessions will be offered 3 times per week for next 30 days.

Complete and submit our virtual sessions signup form to let us know when you plan to call in. You will receive login information upon completion of registration.

IRB Operations Team is Operating at Normal Capacity

NYU Langone’s IRB operations are fully functional and operating at our normal capacity at both NYU Grossman School of Medicine and NYU Long Island School of Medicine. All fully convened IRB meetings will be held remotely for the foreseeable future.

We are still offering training and education sessions via WebEx, including those listed below.

Attend Training Sessions and Research Community Events

All of our regularly scheduled training sessions and research community events are being offered via WebEx. Please do not hesitate to sign up today. All registrants will receive a Microsoft Outlook invitation with WebEx login information.

Fundamentals of the IRB

Register for upcoming New Submissions sessions.

Register for upcoming Reportable New Information sessions.

Register for upcoming Continuations, Modifications, and Closures sessions.

Advanced Topics of the IRB

Register for upcoming How to Write a Protocol sessions

Register for upcoming Writing an Informed Consent that Informs sessions

Register for upcoming Informed Consent Process sessions

Register for upcoming Use of NYU Grossman School of Medicine IRB as a Single IRB for your multisite research sessions

Community Events

Register for an upcoming Food For Thought—Focus Group session. We will be holding this session via WebEx and inviting you back for lunch when our daily in-person work activities resume.

Look Out for IRB Updates

This news page will be updated weekly to reflect communications that have gone out so that you don’t miss anything related to IRB operations.

Contact the IRB

If you have questions regarding 2019 coronavirus disease (COVID-19) and your research, email us at irb-info@nyulangone.org. You can also leave a voice message using the “0” option on our main line: 212-263-4110. We check our voicemail often.

For general questions, you can always contact contact a member of the IRB Operations team.

New Advanced Topics of the IRB Course for Multisite Research

The IRB Operations team is pleased to announce a new Advanced Topics of the IRB Course titled Use of NYU Grossman School of Medicine IRB as the Single IRB (sIRB) for Multisite Research.

This course will provide a detailed overview of the requirements and review process for federally-funded multisite research.

Classes will take place on March 30 and May 18 at One Park Avenue in Manhattan. NYU Winthrop Hospital employees are encouraged to email IRB Education at irb-education@nyulangone.org to learn more about attending remotely.

NYU Langone members can enroll online.

Recap: IRB 2020 Quarterly Information Session

The winter IRB 2020: The Road Ahead information session covered important updates that may impact the way you conduct human subjects research.

Our discussion included the following topics:

  • requirements for sIRB review of all federally-sponsored multisite research, not just the National Institutes of Health (NIH)
  • updates to the IRB approval timeline
  • new events, educational offerings, and resources
  • how the new electronic financial disclosure system impacts IRB review
  • IRB consistency efforts

For a full recap of the event, please email IRB Education at irb-education@nyulangone.org.

You spoke, We listened: Updated IRB Operations Webpage is Now Live

We are pleased to announce that our revamped IRB Operations website is now live.

With essential feedback from the NYU Langone research community, we have implemented changes that will make it easier for researchers at all levels to learn about IRB processes and find relevant information quickly.

Focus group sessions to review the new webpage are coming soon.

Single IRB for Federally-Sponsored Multisite Research Effective January 20, 2020

As of Monday, January 20, 2020, the federal Office for Human Research Protections will require an sIRB for all federally-funded multisite human subjects research. This will apply to all new studies submitted to the NYU Grossman School of Medicine IRB and the NYU Winthrop Hospital IRB on and after January 20. Previously, the sIRB policy only applied to NIH-funded research.

For more information about using the NYU Grossman School of Medicine IRB as the sIRB of your study, please email irb-single@nyulangone.org or read our single IRB information page (Kerberos ID and password required).

Learn more about the U.S. Health and Human Services (HHS) revised common rule's cooperative research provision regarding using an sIRB.

Spotlight On Ikoa Jeschke Lopez, MD

Thank you to all who sent in nomination letters for our first Office of Science and Research "Spotlight On." We are so excited to present you with our very first feature, Spotlight On Ikoa Jeschke Lopez, MD.

In one of the nomination letters, a colleague wrote, “Ikoa has a unique way of really motivating her team of employees and pushing everyone to be their best and perform at a high level. She does this with empathy, understanding, and the perfect balance of listening and providing guidance. She is not only a stellar colleague from a professional standpoint, but she is also a genuinely kind and wonderful person to everyone.” Another added, “She always goes above and beyond for all of us here at the Office of Science and Research.”

Ikoa started at NYU Langone in 2015 in the Leon H. Charney Division of Cardiology, part of the Department of Medicine, working for Stuart D. Katz, MD, and then moved over to the Office of Science and Research to work for Research Regulatory Services. She is now the senior scientific manager for the IRB Operations Expedited Team. “The best advice I was ever given, was just keep going. It might not always be easy, there might be times you feel like quitting, but perseverance is key,” says Ikoa. This mentality is exactly what you would expect from a duathlon competitor. A duathlon has both biking and running components but not swimming. “I am NOT a swimmer," Ikoa says. "I could swim for survival, but that is it.”

Using the NYU Grossman School of Medicine IRB as the Single IRB for Federally-Funded Research

The sIRB policy is an NIH policy that applies to grants and contracts submitted to NIH on or after January 25, 2018. The policy requires the use of one IRB to provide reviews and approval for research that is funded by the NIH, involves multiple domestic sites operating under the same protocol, and is non-exempt human subjects research.

Please note: All new multisite, federally-funded research studies will require the use of one IRB to provide review and approval of that research as of January 21, 2020, in accordance with the new HHS revised common rule.

The NYU Grossman School of Medicine IRB will serve as the sIRB for any research that meets these criteria when NYU Langone is the main site recipient of the federal award. We encourage all researchers that plan to engage in this type of research to email the IRB Operations team at irb-single@nyulangone.org so that we may guide you through the sIRB process.

If you are applying for a federally-funded human research study with multiple sites where the main site/award recipient is not NYU Langone, please email the IRB External Review Unit at irb-external@nyulangone.org before completing your grant application submission. For more information regarding first steps towards using an sIRB, please email us or read our single IRB information page (Kerberos ID and password required).

NYU Langone’s IRB at the 2019 Advancing Ethical Research Conference

Public Responsibility in Medicine and Research, also called PRIM&R, a nonprofit with a focus on improving research administration and oversight, held their annual Advancing Ethical Research conference in Boston. NYU Langone’s IRB Operations staff presented two posters during the conference—the Single IRB Alliance and IRB Fast Track: Express Review of Industry Initiated Studies—which highlight innovative programs that demonstrate the successful work of our IRB. Professionals from public and private institutions, the federal government, industry, and academic institutions from across the country attended the conference. The 2019 PRIM&R conference featured the most posters displayed on-site in the history of the conference. The NYU Langone IRB Operations staff received great feedback from the greater IRB community on their work.

Access more information about using a Single IRB Alliance at NYU Langone or about IRB Fast Track on the Research Portal of NYU Langone’s Office of Science and Research (a Kerberos ID and password are required). For more information on our fast-track program, please contact Marina Godina, associate director of IRB Operations, at 646-754-4631.

NYU Grossman School of Medicine and NYU Winthrop Hospital IRB Integration

The full-asset merger between NYU Langone Health and NYU Winthrop Hospital was completed on August 1, 2019. Because the integration is impacting how clinical research is reviewed and conducted at both locations, the IRB Operations teams at both campuses have been working together to navigate upcoming changes. Please read below to learn more about how our integration efforts may impact your IRB submissions.

Changes to Electronic Submission Systems

As of September 1, 2019, researchers at NYU Winthrop Hospital must use Research Navigator for all initial and ongoing submissions (Kerberos ID and password required). IRBNet is no longer available for any submissions.

If your study was initially reviewed and approved by the NYU Winthrop IRB, you must begin to submit continuations and modifications to the NYU Winthrop IRB using Research Navigator. Please contact the NYU Winthrop IRB at the point of continuation or modification for further instructions.

All new submissions must be submitted through Research Navigator and will be reviewed by the NYU Winthrop IRB.

Changes to Policy

In the coming months, the human research policies at both sites will be updated to create a unified policy. Keep an eye out for announcements about policy changes and check with the IRB Operations office for updates at 212-263-4110 or irb.office@nyulangone.org.

IRB of Record

While there will be changes in submission systems for researchers at NYU Winthrop, the IRB office overseeing the review of your studies will remain the same. The following will apply:

  • NYU Langone faculty: New and ongoing studies will remain under the NYU Grossman School of Medicine IRB or an external IRB.
  • NYU Langone faculty who transitioned effective January 1, 2019: Studies beginning after January 1, 2019, will continue to be submitted to the NYU Grossman School of Medicine IRB or an external IRB. Ongoing studies that started before January 1, 2019, will remain with the original IRB.
  • Current faculty at NYU Winthrop: New and ongoing studies will remain under the NYU Winthrop IRB or Western IRB (WIRB) but will now be managed through Research Navigator, effective September 1, 2019.

Training Available for Upcoming Changes

Researchers and their staff should view the on-demand Research Navigator training modules for training refreshers.

If you are a research staff member managing human subjects research that will require NYU Grossman School of Medicine IRB review, you should plan to attend the “Fundamentals of the IRB” sessions. Review the session schedule (Kerberos ID and password required) and reserve a spot by contacting our education team at irb-education@nyumc.org. Sessions are held in person, but a WebEx option will also available.

In the upcoming months, look for announcements and an IRB informational session regarding policy changes. In the meantime, please contact the IRB Education team with any training-related questions at irb-education@nyumc.org. For more information regarding the integration and system changes, please contact NYU Grossman School of Medicine IRB Operations at irb-info@nyulangone.org or 212-263-4110.