1. USING A SINGLE IRB (sIRB) MECHANISM
12/6/2018
Michelle LeMenager, CIP Allison Gerger MPH, CIP
Reliance Specialist, HRPO Reliance Specialist, HRPO

2. Disclaimer sIRB is a new and evolving process, locally and nationally
Check Pitt “Single IRB Review” webpage often
Join our mailing list to receive notices of future sIRB education sessions

4. Presentation Agenda Common Definitions When is reliance necessary?
NIH policy
DHHS regulation
Collaborative research
Types of Reliance Agreements
Process of requesting reliance
Building an sIRB protocol
Pitt cedes
Pitt IRB of Record
Other Institutional Requirements

5. Terms you might hear
Single IRB Review – a legal arrangement that allows one IRB to review the research on behalf of other engaged institutions
Also commonly referred to as “Central IRB”
Reliance Agreement – an agreement that outlines the responsibilities of each party when using reliance
IRB Authorization Agreement (IAA), IRB Agreement, Reciprocal Agreement, Master IRB Agreement, SmartIRB Master Reciprocal agreement

6. Reviewing IRB – the IRB that reviews and makes required regulatory determinations
Also commonly referred to as “IRB of Record,” “Single IRB” or “Lead IRB
Relying Institution – the institution that cedes IRB responsibilities to the reviewing IRB
Ceding site, Relying site

7. A Note of Caution Reliance only covers the IRB review piece
Study Initiation
Conflict of Interest (COI)
Institutional Biosafety Committee (IBC)
Institutional Review Board (IRB)
Office for Investigator Initiated IND/IDE Support (O3IS)
Radioactive Drug Research Committee/Human Use Subcommittee (RDRC/HUSC)
Education and Compliance Office (ECO)
Stem Cell Research Oversight Committee (SCRO)

8. When is reliance necessary?
Reliance using an sIRB:
Required by NIH
Required by DHHS
Required by research consortium or network
Reliance not using an sIRB:
Required because engaged collaborator(s) does not have access to an IRB or is completing a subset of the
procedures and dual IRB is not practical.

9. NIH sIRB policy – Historical Perspective
Historically, in multi-site studies, each site has its own IRB which conducts an independent review of studies involving human research participants. The use of a single IRB of record for multi-site studies that are conducting the same protocol will help streamline the IRB review process by eliminating the unnecessary repetition of those reviews across sites.
Pitt HRPO has been executing reliance agreements for a long time for various reasons.

10. NIH sIRB Policy - Goals
The goal of this policy is to enhance and streamline the IRB review process for multi-site research so that research can proceed as quickly as possible without compromising ethical principles and protections for human research participants.

11. NIH sIRB Policy NIH funded or supported
Competing grant applications (new, renewal, revision, or resubmission)
Receipt date on or after January 25, 2018
Non-exempt research
Conducted at U.S. domestic sites
Multi-site research

12. The NIH policy only applies to studies where the same research protocol is being conducted at more than one site; it does not apply to studies that involve more than one site but, the sites have different roles in carrying out the research.

13. Multi site vs. Collaboration
Multi-site research refers to two or more research sites executing the same research procedures. Slight variations in procedures, based on local context, are permitted.
NIH policy applies
Collaborative research involves researchers, at different sites, working on the same project but, the investigators are implementing different research activities.
NIH policy does not apply
E.g. Data collection occurs at one site, analysis of identifiable data occurs at a different site
CC/DCC only – not a data collection site

14. If it is not clear whether your NIH-funded project falls under the NIH sIRB mandate, contact your NIH Program Officer for confirmation.

15. DHHS Regulation Supported by any Federal Department or Agency
Non-exempt, cooperative research
Conducted at domestic sites
IRB determined by Federal Agency
Exclusions:
Required by law
Determined by Federal department or agency
Effective date: January 20, 2020
45 CFR

16. Non-sIRB Reliance: Collaborative Research
An investigator changes institutions mid-project
Engaged collaborators have access to their own IRB but subset of procedures they are engaged in do not warrant multiple IRB approvals.
Engaged collaborators do not have access to their own IRB
*May not have to complete all related reliance request steps. Contact for guidance.

17. Types of Reliance Agreements
IRB Authorization Agreement (IAA) -a written agreement between two or more institutions that is used to document the delegation of IRB review responsibilities. This can also be referred to as a Reliance Agreement or Cede Review Agreement.

18. SmartIRB Agreement
SMART Master Reciprocal Agreement a type of IAA that was developed under an NIH grant and is responsive to new NIH policy requiring the use of a single IRB for multi-site research funded by the agency.
The University of Pittsburgh, UPMC, and Magee Women’s Research Institute have all executed the SMART Master Reciprocal Agreement.

19. SmartIRB…is not an IRB
SmartIRB is a platform designed to ease common challenges associated with initiating multisite research and to provide a roadmap for institutions to implement the NIH Single IRB Review policy.
Freely available for institutions and investigators.
Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board

20. A master agreement to support collaboration across the nation
8 CTSAs came together to develop a national IRB reliance agreement
Public & private universities
Academic healthcare centers
Shared with 72 Institutions
25 CTSAs in 19 states
Community hospitals
Independent/commercial IRBs
Shared with 115+ Institutions
64 CTSAs in 33 states
NIH agencies
What the agreement/joinder is: language from website: 
Single IRB Authorization Agreement: The SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement needs to be signed just once. Institutions that have joined SMART IRB can then choose to use the SMART IRB Agreement on a study-by-study basis, streamlining the IRB review process and eliminating the time and effort typically required to negotiate an IRB authorization agreement for each new study
Institutions can participate in SMART IRB if they meet the eligibility criteria described within the SMART IRB Agreement, as follows:
FWA or IRB Organization: Unless it is an IRB organization, your institution must maintain a Federalwide Assurance (FWA) approved by the Office for Human Research Protections (OHRP).
Quality Assessment: If your institution has an IRB or is an IRB organization, it must have undergone or initiated an assessment of the quality of its human research protection program (HRPP) within five years prior to joining SMART IRB (through accreditation from an external organization, participation in OHRP's Quality Assessment Program, or equivalent approach).
Point of Contact: Your institution must establish a Point of Contact (POC) who will be responsible for, and communicate on behalf of, your institution regarding the initial and ongoing implementation of the SMART IRB Agreement.
Institutions join by completing the Joinder process at smartirb.org. Regional Ambassadors are available to answer questions and assist in the joinder process. 
Collaboratively developed with broad stakeholder input 20

21. Commercial Master Service Agreement (MSA) – a contract between parties, in which the parties agree to most of the terms that will govern future projects involving both parties. Helps streamline future dealings between the two parties.
Pitt/UPMC has MSAs in place with WIRB and Advarra
NIH funded – definitely permitted to use a commercial IRB
Non-NIH funded – HRPO must take additional step of
getting Institutional Official’s permission.

22. Individual Investigator Agreement (IIA) – a formal agreement, executed between an IRB and an external individual, describing the expectations and responsibilities of the individual in relation to the research project.
Used when the individual does not have access to an IRB at their own institution
If you need execute a PSA or CSA through Purchasing, also contact the Pitt IRB to determine if an IIA is also necessary.
Professional Service Agreement and Contracted Services Agreement

23. Preparing an NIH sIRB Grant Submission
The NIH sIRB mandates requires that investigators now begin communication with the IRB much earlier in the process.
The IRB must now be involved while the NIH grant application is being drafted.

24. sIRB Plan Grant application requires a sIRB plan that includes:
Name of the sIRB of record
Indication that all sites, including any added after award, agree to rely on sIRB
Sites will sign reliance agreement that will include a communication plan
Indicate who will maintain records of this agreement

25. NIH Grant – Letter of Support
The Pitt IRB provides a letter of support for inclusion with grant applications.
To request a letter of support, use the Qulatrics Reliance Request system. After you have entered the Pitt/UPMC PI & Coordinator contact information, select “Letter of Support for Grant Submission” and follow the prompts.

26. Grant budget – sIRB Review Costs
The IRB of Record is permitted to charge Relying sites for IRB Review.
Inquire with the IRB of Record regarding fee structure when constructing grant budget
Contact when formulating a budget where Pitt will act as IRB of Record

27. Budgetary Considerations - Staffing
When Pitt will act as the Reviewing IRB, the Pitt study team has additional responsibilities for managing the project on a national level.
Large scale, complex projects should budget to hire both a Reliance Program Manager and a Project Coordinator.
Reliance Program Manager -coordinates the project on a national level
Project Coordinator is needed to execute the daily needs of Pitt/UPMC acting as a data collection site.

28. Reliance Request Process

29. Requesting Use of a Single IRB
This is indeed a request, not a demand.
The Pitt HRPO reserves the right to determine if sIRB for a specific project is appropriate for our institution.
Never commit to using an sIRB mechanism without first communicating with the Pitt HRPO.
Any paperwork you receive from sponsor or others should be indicator you need to reach out to the Pitt IRB and begin a reliance request.

30. Requesting Use of a Single IRB
Contact us early in the process!
Complete reliance request via Qualtrics
Qualtrics Reliance Request link available on “Single IRB Review” webpage
Questions??
Review of paperwork handouts

31. Weekly sIRB meeting
sIRB requests are reviewed at a weekly sIRB meeting
Determinations to use sIRB made on case-by-case basis
Funding source
Site accreditation/expertise
Number of sites
Research activities
Level of risk

32. NIH Mandate - Priority
Given that the NIH sIRB mandate is currently the only enforceable requirement for use of an sIRB, the Pitt HRPO is currently giving reliance priority to these projects.

33. sIRB Decision – NIH studies
If the Pitt HRPO determines sIRB is not appropriate for a project that falls under the NIH sIRB mandate, the study cannot be conducted at our institution.

34. sIRB Decision: non-NIH studies
Prior to January 20, 2020 if the Pitt HRPO determines sIRB is not appropriate for a project that does not fall under the NIH sIRB mandate, reliance will not be executed and the Pitt researcher must submit directly to the Pitt IRB for oversight.
On or after January 20, 2020 if the Pitt HRPO determines sIRB is not appropriate for a project that falls under the DHHS sIRB mandate, the study cannot be conducted at our site.

35. Pitt Cedes Oversight

36. Pitt cedes - Outside institution is IRB of Record
The Pitt IRB will contact the IRB of Record to determine what type of agreement will be executed
Drafted from scratch
OHRP template
SmartIRB Master Reciprocal Agreement
Master Service Agreement
The agreement must be signed by the Institutional Official at both institutions

37. Pitt cedes – local context
Lead study site sends materials to collect information about local context
Institutional policies and procedures
State law
Purpose: used by the IRB of Record to review for the
Relying site
The Pitt study team will need to complete this in conjunction with the Pitt IRB
Discuss local context sample handout

38. Pitt cedes – local consent/assent form(s)
Lead study site sends a template consent form to insert local language
Pitt Study team inserts local language and s draft to for Pitt IRB to review
The Pitt study team provides the final version of the local consent form to the lead site for submission to the
IRB of Record

39. Pitt cedes – External Pathway (EXT) submission
AFTER the IRB of Record approves Pitt as a site
A registration application is submitted via “External Pathway” OSIRIS
Ensures completion of other institutional requirements (ancillary reviews)
Allows tracking of approved studies at institution
Research cannot begin until we activate this submission

41. External (EXT) Pathway submission
Materials that must be submitted in EXT application:
Approval letter from IRB of Record that states Pitt has been officially approved as a research site
IRB-approved protocol
IRB-approved local consent/assent form(s)
IRB-approved recruitment materials

42. After External Pathway Activation
Only limited information is submitted to Pitt IRB
Time of continuing review (Renewal)
If the Pitt PI or study staff changes
If any procedure related to an ancillary review changes (i.e. adding an x-ray)
If the Reviewing IRB makes a determination of serious or continuing non-compliance or unanticipated risk to
subjects or others at the Pitt site

43. PI/Research Team Responsibilities – ceded review
Complying with the IRB of Record’s policies and procedures
Registering through External Pathway
Maintaining a current and accurate study regulatory binder
Including correspondence from IRB of Record

44. Pitt IRB of Record

45. Pitt as IRB of Record – Agreement
Pitt IRB contacts the Relying Site IRBs to determine what type of agreement will be executed
Pitt IRB facilitates obtaining agreement signatures

46. Pitt as IRB of Record – IRB Submission
Normal submission through OSIRIS
Indicate “(sIRB)” after protocol title
First submit as if Pitt is the only research site
Do not list other sites in CS15.0
Upload Pitt-specific consent form in 4.9 of OSIRIS
Upload consent template in CS11.0
Do not list external personnel in OSIRIS

47. Consent template Areas of the consent template Relying Sites edit:
Institutional letterhead
Local staff and contact info
Compensation for injury language (if may cause physical injury)
HIPAA language
A separate authorization document can be used if required by external site policy
Data retention policy
Discuss consent template handout

48. Dissemination of materials
Pitt study team disseminates to Relying sites and collects completed materials:
Initial IRB approval letter
IRB-approved consent template
IRB-approved protocol
Communication Plan
sIRB Implementation Checklist
Local context form
Discuss Communication Plan & Checklist handouts

49. Onboarding conference call
If deemed necessary, an all-site phone conference can be scheduled
All study teams
All Relying Site IRB Representatives

50. Onboarding Relying Sites
AFTER the following steps have been completed, Pitt Study team submits a Modification to add site(s).
Agreement fully executed between sites
Local context form completed and returned
Local consent template vetted by Relying Site’s IRB

51. Rolling or Batched Onboarding
Pitt Study team can decide:
Submit Mods to onboard sites one at a time, as they are ready
Batch sites to onboard

52. PI/Research Team Responsibilities – Pitt IRB of Record
Primary contact for all Relying Sites & Pitt IRB
Disseminating and collecting all study materials to/from Relying Sites
Submitting study into OSIRIS
Following provisions of agreement

53. Other Institutional Requirements

54. Grants & Contracts - OOR Needs
Pitt Cedes Oversight
Pitt IRB of Record
Fully executed agreement or Letter of acknowledgement (if SmartIRB is used)
Initial IRB approval letter
External Pathway Activation letter
Modification approval letter that on-boarded the Relying Site(s)

55. Data Use Agreements - OOR
Reliance agreements do not include terms regarding data sharing between entities. In addition to a Reliance Agreement, you must still execute a Data Use Agreement (DUA) with the Office of Research. Phone:

56. “We are all keenly aware of the inefficiencies of our new efficiency.”
-Anonymous Reliance Specialist from an external site

57. COMING ATTRACTIONS

58. New System to replace OSIRIS
Currently accepting new Exempt/Expedited, non-sIRB submissions
January new Full Board studies
Date TBD – sIRB protocol submissions
Simplified submission system
Improved questions
Built with sIRB needs in mind

60. Common Rule
Did you know that the Federal policy for the protection of human subjects (The common rule, subpart A) has major changes coming?
policy/regulations/finalized-revisions-common- rule/index.html
HRPO will keep you posted on the revisions and policies

61. When in Doubt… Call us: 412-383-1480 Set up a consultation appointment
us: