The Nuts and Bolts of Single IRB and External IRB Review

The Clinical Research Podcast Series at NYU Langone Health

With a growing number of multisite human research studies requiring the use of the NYU Langone Health IRB as the single IRB (sIRB) of record, in addition to studies that require institutional clearance when using an External IRB, a new unit, the External Review Unit has emerged into the Human Research Protection area to manage the work related to these 2 work flows. Ms. Nadia Johnson, MS, CIP, Assistant Director of the External Review Unit, explains study eligibility, process and institutional requirements for both single IRB and external IRB submissions.

Discussion Questions:

Use of an External IRB

1:04 - When can an investigator use an IRB other than the NYU Langone Health IRB?

1:44 - Is use of an external IRB a matter of preference?

2:13 - What should the study team do once they receive confirmation of eligibility?

2:43 - What does institutional clearance entail?

3:39 - How long should the investigators expect reliance agreement execution and institutional clearance to take?

Single IRB

4:11 - What does “single IRB” mean? How is it different from external IRB?

4:49 - How can investigators request use of the NYU Langone Health IRB for single IRB review?

5:39 - What happens once the study team receives a “Just In Time” communication or “Notice of Grant Award?”

6:00 - What does the sirb/xirb unit do to facilitate SIRB review? Are the study teams responsible for reliance agreement set up or does this unit handle that?

6:43 - How long should the investigators expect reliance agreement execution and site approval to take?

General

7:12 - Can you go over how the sIRB and xIRB unit has changed over your time here?

8:01 - What is the future of the unit? What big projects are you working on?

9:10 - Final Thoughts