1. Preparing for NIH’s sIRB Review Requirements
Megan Kasimatis Singleton, JD, MBE, CIP Assistant Dean for Human Research Protections

2. Overview Understanding the NIH sIRB Policy
Complying with the Policy at the Time of Grant Proposal
Tools & Resources

3. NIH policy Use of a single IRB for multi-site research
June 21, 2016: New policy requires single IRB (sIRB) review for multi-site NIH-funded research
Effective Date: January 25, 2018
What types of studies does this policy apply to?
NIH-funded multi-site studies that involve non- exempt research
Multi-site Studies: The same protocol is being conducted at more than one site and the study is being funded wholly or in part by NIH
New applications or competitive renewals submitted on or after the effective date
Policy: files/NOT-OD html
Exceptions:
Does not apply to Exempt research
International sites [Policy applies to Domestic Sites only]
Does not apply to studies conducted under career development, research training or fellowship awards
Exceptions to this policy will be made where sIRB review would be prohibited by a federal, tribal, or state law, regulation, or policy. 
Requests for exceptions that are not based on a legal, regulatory, or policy requirement may be
considered by NIH
Compelling justification required
sIRB is the selected IRB of record that conducts the ethical review for participating sites of the multi-site study.

4. Additional Regulatory Changes
Final rule: Published January 19, 2017
Effective Date: Delayed to July 19, 2018 [For most provisions]
Common Rule extends Single IRB review requirement to all “cooperative research” [Research involving one or more institutions]
Implementation date: January 20, 2020
Commentary about the Final Rule suggests that the FDA may revise its applicable regulations for human subjects protections to align with Common Rule changes [including provisions for single IRB review]

5. Key Decisions for JHU
Where JHU single IRB services are needed, only JHM IRB will serve as the single IRB.
JHU has three separate IRBs [JHM, Public Health, Homewood Schools]
Only JHM IRB is accredited
Mandatory Use of Online Reliance Request Tool:
Investigators may not indicate in a grant application that a JHU is willing to rely on an external IRB or JHM IRB is willing to serve as the IRB of Record without first securing a letter of support from the appropriate IRB.
Online Reliance Request Tool enables easy communication with the JHM IRB at the time of grant proposal

6. Preparing the Grant Application: Overview of the Requirements
Study teams must include their plan for adherence to the sIRB policy at the time of grant application
New PHS Human Subject and Clinical Trial Information Form “Forms E” is required for submissions on/after 1/25/18.
See:
Select "Yes" or "No" to indicate whether this is a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site.
Select "N/A" only if any of the following apply (do not select "N/A" if none of the following apply):
You answered "Yes" to "Question 1.2 Is this Study Exempt from Federal Regulations? (Yes/No)"
You are a career development applicant
You are a training applicant
You are a fellowship applicant

7. The Single IRB Plan
For applications subject to the sIRB policy an sIRB plan must be supplied that includes the following elements:
Describe how you will comply with the NIH Policy on the Use of sIRB for Multi-Site Research.
Provide the name of the IRB that will serve as the sIRB of record.
Indicate that all identified participating sites have agreed to rely on the proposed sIRB and that any sites added after award will rely on the sIRB.
Briefly describe how communication between sites and the sIRB will be handled.
Indicate that all participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.
Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.

8. The Single IRB Plan: Identifying the sIRB
Identify the sIRB
The applicant is expected to identify the sIRB of record for the study
The history and experience of the IRB, as well as its capacity to serve as the IRB of record for the particular protocol should be considered
The sIRB need not be the IRB at the lead site
Not every academic IRB will be willing to serve as the sIRB
JHM IRB serves as a Trial Innovation Center IRB as part of the Trial Innovation Network
Works collaboratively with other TIC CIRBs [University of Utah and Vanderbilt University] to develop innovative strategies for operationalizing CIRB review.
Recommend including a letter of support from the designated sIRB

9. The Single IRB Plan: Reliance
Applicants must:
Indicate that all identified participating sites have agreed to rely on the proposed sIRB and that any sites added after award will rely on the sIRB.
Can be done via a letter of support or via text in the application
Address Reliance Agreements and the Communication Plan between sites

10. SMART IRB Reliance Agreement
In anticipation of the release of the NIH policy, the National Center for Advancing Translational Sciences [NCATS] funded a multi-institutional collaborative initiative to develop a national IRB reliance agreement [SMART IRB]
As of September 2016, this agreement is now available:
FWA-holding Institutions sign on to use the agreement through a joinder process.
Once you are a signatory to SMART, you may use SMART as your reliance agreement for any specific study that also involves institutions that are SMART signatories
Johns Hopkins University School of Medicine and Johns Hopkins Hospital and Health System signed on in October 2016.
Key Facts:
Eliminates the need for study-specific reliance agreement negotiations
Institutions may have “addendums” to cover items not specified in the agreement such as indemnification – The JHM IRB will have an addendum
Where possible and appropriate JHM will use the SMART agreement to cover other CIRB activities
384
signatories 64
CTSA Hubs

11. Preparing the Grant Application: Key Considerations: Budgeting for sIRB Fees
 Budgeting for IRB Fees
sIRB fees will be included as direct costs in the budget [allowable per NIH policy]
Only secondary activities can be charged as direct costs
sIRB Fees are not standardized- Each IRB can set its own fee schedule
The total award amounts have not gone up to accommodate the inclusion of sIRB fees as direct costs
In cases where JH is engaged as a prime or sub-awardee, the sIRB fees should be included in the award to Hopkins
JHM IRB needs to be engaged in budget planning when agreeing to serve as an sIRB for a project – Contact us Early!
Scenarios for Costs:

12. Tools & Resources Contact: JHMIRBreliance@jhmi.edu
Online Reliance Request Tool
Template Letters of Support
Template text for grant applications
Standard communications to walk relying sites through the process needed to sign onto the SMART IRB agreement and cede review
Letter of Indemnification for the SMART IRB Agreement
Training Sessions [How to fill out a Reliance Request, Relying on an External IRB]
ts/reliance_agreement.html
Contact:
IRB Reliance Manager: Janelle Maddox-Regis