Collaborative Research: IRB-HSBS sIRB Process

The Common Rule (45 CFR 46.114) requires that a single IRB-of-Record (sIRB) be designated to review and ongoing oversight of federally sponsored non-exempt cooperative or multi-site human research studies.  If a U-M study team wishes the IRB-HSBS to serve as the sIRB for a proposed project, the Principal Investigator (PI) or a designated study team member must submit an sIRB request, prior to proposal submission, to confirm whether IRB-HSBS will agree to be the single IRB-of-Record.  

The sIRB requirement does not apply to international collaborations or where tribal or other laws require a separate IRB review for each collaborating site.

Establishing the sIRB for a project has two components:

1. IRB review, approval, and ongoing oversight for the conduct of the human research at U-M and at other participating institutions.


2. Establishing the required IRB Authorization Agreements (IAAs, also known as reliance agreements) between institutions and/or individuals engaged in the project.  These legal documents identify the reviewing IRB (i.e., the sIRB) and the relying sites (i.e., those ceding oversight to the sIRB) and outline the oversight roles and responsibilities of each. 

Research activities with human participants cannot begin until both the sIRB approves the conduct of the project at the site and the IAA for that site is finalized.  

The majority of research collaborations involving IRB-HSBS fall into two models:

• Cooperative Research 
  Cooperative studies involve investigators from two or more institutions working together to conduct a research project.  Typically, participants are not enrolled at each site; instead one institution conducts the research interaction/intervention with participants and the other investigators/sites are involved in data analysis. 


• Multi-site Research
  Multi-site studies use the same research procedures outlined in a single protocol that is carried out at multiple institutions (e.g., a clinical trial where participants will be enrolled at each participating site, or an educational intervention implemented at each participating site).

As multiple criteria are used to determine the qualifications of a potential sIRB and to establish the IAAs for oversight of the research activity, designation of an sIRB for a federally-sponsored project involves early preparatory action from the study team, starting with the grant applications for the research.  Project collaborators should discuss which institution (or commercial IRB) they will propose as the sIRB as part of developing the project proposal.

sIRB Request Process

Requesting IRB-HSBS To Be the sIRB

A study teams proposing to designate IRB-HSBS as the sIRB for a federally-funded human research project must submit an sIRB Request through the UMICH Single IRB Review Core ("sIRB Core") in MiCORES at least six to eight weeks prior to submitting the PAF/funding proposal to ORSP.

Do not designate IRB-HSBS as the sIRB on a federal grant application/PAF without first submitting an sIRB Request in MiCORES!  The best practice is to contact IRB-HSBS sIRB Coordinator at irbhsbs@umich.edu to determine which sIRB Request form is appropriate for your proposed study before initiating the request in the sIRB Core.

The sIRB Core offers three sIRB Request forms:

Request Form 1:  U-M IRB as the sIRB for multi-site studies (per the NIH definition/regulation)

This form supports sIRB activity for NIH-funded clinical trials and other studies where the same protocol is conducted at U-M and multiple external domestic research sites.

 

Request Form 2:  U-M IRB as the sIRB on cooperative studies (per the Common Rule definition/regulation)

The form supports the establishment of authorization agreements with collaborators from other institutions and will likely be used most often by units/studies under IRB-HSBS jurisdiction.

 

Contact Form:  Consultation with an IRB staff member

This optional email form with the sIRB Core may be used to questions of an sIRB Coordinator (e.g., sIRB options, assistance with request form questions, general requests for sIRB budget information).  Sending an email to IRB staff from outside the sIRB Core is still acceptable, too! 

For instructions and details on how to use the UMICH Single IRB Review Core in MiCORES, review the sIRB/MiCORES Overview guide.

The sIRB Request:

• Provides key study details to the U-M IRB;


• Accords the IRB the necessary time during the proposal development stage to validate U-M’s capacity for IRB review and ongoing oversight of the project, and to determine the resources that will be needed to serve as the sIRB; and


• Permits an assessment of whether the proposed research may qualify for exemption and not require designation of an sIRB, represents a project that would not be regulated by the IRB, or whether the sIRB request should be forwarded to IRBMED for their consideration.

The infomation required in the sIRB Request may also assist the PI to develop the sIRB plan required by some federal sponsors (e.g., NIH) prior to award activation.  An sIRB plan is a narrative that identifies the sIRB and describes the communication plan that outlines the responsibilities of each participating site.  

Requesting an External or Commercial IRB as the sIRB

Where the collaborative research team proposes the use of an external (e.g., other academic institution's IRB) or an independent commercial IRB as the sIRB for a federally-sponsored project, the study team must request that IRB-HSBS act as a “Relying IRB.”   Contact the IRB-HSBS sIRB Coordinator at irbhsbs@umich.edu to discuss the project at least 3 weeks prior to submitting the PAF/funding proposal to ORSP.  It may be necessary to include fees for commercial and some external IRB services as part of the proposal budget. You may be asked to complete the IRB Authorization Request - U-M Ceding Oversight to an External IRB (U-M Relying) form and submit it to the IRB-HSBS.

IRB-HSBS sIRB Request Actions

IRB-HSBS will contact the requestor to confirm the sIRB option to designate on the PAF and/or in proposal applications.

If requested, IRB-HSBS will provide a letter of support to the study team that indicates its agreement to be the Reviewing IRB (sIRB) or a Relying IRB, as applicable.  This letter may be included with the sIRB plan as supporting documentation required by the sponsor (e.g., NIH, NSF) for “just-in-time” processes prior to award activation.  

The letter of support only indicates the willingness of an IRB to be the Reviewing or Relying IRB for the project.  This letter is not equivalent to, nor does it indicate, IRB approval of the project. 

Approval for the human research from the sIRB must be obtained prior to the release of the sponsored award and the start of research.  As finalized authorization agreements are required for the sIRB to approve the human research, submitting the sIRB Request to IRB-HSBS early in the proposal development process is vital.

IRB Application Process

Before beginning the IRB application for a cooperative or multi-site site study, contact the IRB-HSBS sIRB Coordinator for assistance in identifying the appropriate application type and authorization (reliance) agreement type for your project.

IRB-HSBS as the sIRB (U-M is the reviewing IRB)

Use the Interaction/Intervention or Secondary Use application type, as applicable, for projects involving:

1. Cooperative studies where engaged external collaborators are contributing to U-M's research project but are not implementing the same protocol at each site or
2. Multi-site studies involving only one or two engaged external institutions conducting the interaction/intervention using the same protocol; or
3. Multi-site studies that are not federally sponsored, where the engaged external institutions may conduct an IRB review or may cede oversight to U-M.

Use the Multi-Site Application for projects involving three or more engaged external institutions.  Do not submit this application type without first consulting IRB-HSBS!  sIRB approval and continuing oversight for these projects requires action by the participating (relying) sites through the U-M Participating Sites application process as U-M will need to provide approved study documents to Participating Sites through eResearch and the relying sites will be responsible for submitting reports, such as continuing reviews or incident reports to the U-M IRB.  External sites/collaborators may not begin work on these studies until they have received sIRB approval.  In addition, a Communication Plan outlining the responsibilities of each participating site is required as part of the sIRB process.

IRB-HSBS ceding to an external IRB (U-M is a relying IRB) 

Use the Requesting Review by a non-UM IRB application (i.e., "ceding application").  This application type provides the local context and other site-specific information required for IRB-HSBS as the relying IRB and for the administration of the research at the U-M performance site by the study team.

Authorization/Reliance Agreement (IAA) Process

Once a grant is awarded, the sIRB coordinator and your IRB-HSBS staff liaison works with the U-M study team and IRB reliance coordinators at the other institutions to establish the appropriate IAAs, whether through each institution's process or through the SMART IRB process. 

The U-M study team is expected to be an active partner in working with the sIRB, IRB-HSBS, and the relying sites' study teams to obtain the information necessary to establish the agreement.  

IAAs are officially signed (i.e., executed) by the U-M HRPP Director and the appropriate institutional official for the relying institution.  Study teams do not have the authority to enter into a reliance agreement with other institutions.

Key Responsibilities 

Whether U-M is the sIRB or ceding authority to an external IRB, the U-M study team has the responsibility to conduct the research in accordance with the approved protocol.  As such, they should be aware of the key oversight responsibilities for the study teams and of the reviewing IRB and relying IRBs.

For projects where U-M serves as the sIRB (Reviewing IRB), the U-M PI is considered the Lead Investigator for the study and is responsible for overseeing the conduct of the research at all participating institutions.  Download the Lead PI/Study Team Guidance and Checklist for details.

Reviewing IRB responsibilities

Lead investigator responsibilities

Relying study team/institution responsibilities

Other Types of Collaborative Agreements

Individual Investigator Agreement (IIA)

An IIA is an agreement between U-M and an individual collaborator who is not affiliated with an FWA-holding institution (e.g., former student working after graduation with their faculty mentor, professional in the community with specific expertise, community partners).  This agreement type outlines the responsibilities of the individual investigator for the protection of human subjects.  The IIA is signed by the:

• Individual investigator
• U-M Principal Investigator (PI)
• U-M Institutional Official (federally-sponsored projects)

Collaborating Institution Agreement (CIA)

A CIA is an agreement between U-M and an institution/organization that does not have an FWA.  This agreement type is typically used for non-federally sponsored research projects involving multiple collaborators who are affiliated with the organization (e.g., research assistants affiliated with a non-profit agency, teachers offering educational interventions in a public school).  It outlines the responsibilities of the collaborating institution for the protection of human subjects.  A CIA is signed by a representative who has the authority to make commitments on behalf of the organization and by the U-M Institutional Official.

Contact the IRB-HSBS Single IRB Coordinator for assistance in obtaining an IIA or CIA.