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Single IRB FAQs
What is a Single IRB?
A single IRB (sIRB) is the IRB of record that oversees all clinical trial sites participating in a multi-site study.
When is the use of an sIRB required?
Effective January 25, 2018, the NIH will require the use of a sIRB for the review of non-exempt, multi-site, domestic, human subjects research protocols funded by the NIH.
Additionally, under the new Final Rule governing human subjects protections approved by the DHHS in January, 2017, most U.S. government funded cooperative studies that meet the criteria for non-exempt “human subjects research”, and involve more than one site, will also require sIRB review. This requirement goes into effect January 20, 2020.
Some other networks, companies and foundations may also require sIRB review.
Will my NIH grant application be subjected to the new sIRB policy?
The NIH sIRB requirement applies to all competing grant applications, including new, renewal, revision or resubmission, submitted on or after the January 25, 2018 effective date.
What is the SMART IRB Master Reliance Agreement and can I use it?
The SMART IRB Master Reliance Agreement is a national reliance agreement that is designed to harmonize and streamline the IRB review process for multisite studies, while ensuring a high level of protection for research participants. SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS) and is intended to serve as a roadmap for institutions to implement the NIH sIRB policy. Although not yet a requirement, many institutions will use the SMART IRB Master Reliance Agreement as a basis for reliance. When possible, Johns Hopkins will use the SMART IRB agreement as the basis for reliance when serving as the sIRB.
To learn more about the SMART IRB reliance agreement and confirm whether your collaborators have signed on, please visit: www.smartirb.org.
How is Johns Hopkins handling requests to serve as a sIRB?
When Johns Hopkins agrees to serve as the sIRB, the School of Medicine IRB (JHM IRB) will serve as the sIRB for all JHU divisions (e.g., School of Public Health, Homewood).
How do I submit a request to have JHM IRB serve as the sIRB for my grant proposal or study?
JHM IRB has created a reliance request tool [survey] that is available on the JHM IRB website at http://www.hopkinsmedicine.org/institutional_review_board/about/reliance_agreement.html. You must submit your request before making any commitment in your grant application that JHM is willing to serve as the sIRB. JHM IRB is required to review and approve your request before providing you with a letter of support and additional instructions for your grant application.
Once you have received confirmation from JHM IRB, the next steps are available on the JHM IRB website at http://www.hopkinsmedicine.org/institutional_review_board/about/reliance_agreement.html
Is there anything special that I need to put into my grant application when asking JHM to serve as the sIRB for my study?
Once you have completed the reliance request survey, and you have been notified that JHM IRB agrees to enter into a reliance agreement, you will be provided a letter of support as well as template language to include in your grant application. The template language will describe how JHM IRB is prepared to serve as a sIRB.
The NIH policy requires that a “communication plan” be included in your grant application/proposal. The applicant/offeror is expected to submit a communication plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites. The plan should include a statement confirming that participating sites will adhere to the sIRB Policy and describe how communications between sites and sIRB will be handled.
In addition, a budget for sIRB fees will be required as part for the grant application. Study teams should consult the JHM IRB in advance to develop this budget.
What do I have to submit in eIRB2 when JHM agrees to serve as the sIRB for my study?
Once you have received confirmation from JHM IRB, the next steps are available on the JHM IRB website at http://www.hopkinsmedicine.org/institutional_review_board/about/reliance_agreement.html. An eIRB2 application is required, and will be reviewed by normal process.
How do I request Johns Hopkins to permit an external IRB to be the sIRB for my study?
All requests for reliance must first be submitted through the reliance request survey that is available on the JHM IRB website at http://www.hopkinsmedicine.org/institutional_review_board/about/reliance_agreement.html.
What are my responsibilities as a PI when relying on an external sIRB?
You, as PI, will need to make sure that all study personnel receive appropriate training and are qualified to perform their duties, and that the study is conducted in accordance with the sIRB approved protocol and IRB policies. These requirements are outlined in the “Statement of PI Responsibilities when Relying on an External IRB”, which must be signed and submitted with your reliance request.
What do I have to submit in eIRB2 when relying on an external sIRB?
A local context review is still required so that we can address any local concerns, perform ancillary reviews, etc. The eIRB2 application is abbreviated in comparison to our full board and expedited applications and is typically reviewed during an expedited review session.
Are there fees involved in using JHM IRB as a sIRB?
The sIRB fee schedule will be available online in August 2017 but investigators seeking sIRB fees will need to incorporate sIRB fees as direct costs in their grant budget and should consult the IRB office for assistance with grant development.
See also: NIH Single IRB Policy