Which External IRB to Use
Single Institutional Review Board (sIRB)
Effective Date: January 25, 2018
sIRB is mandated by the NIH and the revised Common Rule for the following types of non-exempt research:
The NIH Single IRB Policy for Multi-Site Research
Applies to: NIH funded studies in which two or more sites are using the same research protocol to conduct the same human subject research activities at each site. These will typically be clinical trials, but can include observational studies.
Exceptions to the Requirement: VA sites, international sites, or sites involving tribal nations.
Details: Single IRB Policy for Multi-site Research
The NIH single IRB policy does not apply to studies conducted under career development, research training or fellowship awards.
The Common Rule’s Cooperative Research Provision
Effective Date: January 20, 2020
Applies to: Federally funded cooperative research projects receiving initial IRB approval on or after January 20, 2020. That is, studies that involve more than one institution conducting research with human subjects (regardless if each institution is not carrying out the same human subject research activities).
Reviewing IRB: will be identified by the Federal department or agency supporting or conducting the research OR proposed by the lead institution (subject to the acceptance of the Federal department or agency supporting the research).
Exceptions to the Requirement: International sites, sites involving tribal nations, or studies that received initial IRB approval prior to January 20, 2020.
Details: The Revised Common Rule’s Cooperative Research Provision
Investigators should contact the Reliance Administrator in the Office of Research Compliance early in the multi-site grant/contract process to discuss possible sIRB options.
External Commercial IRBs
SBU has a Master Reliance Agreement in place with the following external commercial IRBs:
- Advarra
- SBU investigators wishing to conduct industry-funded, industry-initiated biomedical research studies must use the IRB services provided by our associate, Advarra. All other studies (e.g. investigator-initiated, etc.) must be reviewed by the SBU local IRB.
Exception: Review will need to be conducted by our SBU local IRB when the industry sponsor will not accept direct invoicing from Advarra and/or allow direct payments to Advarra.
- WIRB
- SBU investigators wishing to conduct industry funded, industry initiated biomedical research studies where WIRB is the central Institutional Review Board (cIRB) may utilize their services.
Exception: Review will need to be conducted by our SBU local IRB when the industry sponsor will not accept direct invoicing from WIRB and/or allow direct payments to WIRB.
National Cancer Institute’s Central IRB (NCI-CIRB) Adult and Pediatrics Initiative
SBU is a participant in the National Cancer Institute’s Central Institutional Review Board (CIRB) Initiative. SBU investigators who wish to enroll patients onto CIRB-approved protocols are encouraged to utilize this service.
Smart IRB is the National IRB Reliance Initiative: SBU is a participating institution in this Initiative. All participating sites that have signed the SMART IRB agreement are able to accept each other's IRB as the IRB of record for a multi-site study through a simple cede review process. Investigators are encouraged to review http://smartirb.org to see if their collaborating sites are participating too.
General Information
Other reliance arrangements will be considered on a case by case basis. All requests should be submitted on the Reliance Request Form.
A local submission through myRESEARCH is required for administrative review for all studies that are reviewed by an external IRB.
Note:
- SBU will only cede IRB review to an external entity if that entity is AAHRPP accredited.
- SBU uses myRESEARCH for submission of studies reviewed locally and external IRBs.