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Non-sponsored research (unfunded, internally-funded)
Use of an sIRB is not required for projects that are not sponsored by a federal agency. IRB-HSBS, however, encourages the use of the sIRB model for most collaborative research projects, except where the project involves international research partners or where each institution conducts a discreet component of the project.
External sIRB Recommendation
IRB-HSBS may recommend use of an external sIRB when:
- U-M is not the direct recipient of the funding, or
- The lead investigator/principal investigator on the study is not from U-M, or
- The multi-site project involves more than 10 collaborating institutions.
Use of an independent/commercial IRB may be appropriate for multi-site projects that involve more than 10 collaborating institutions.
U-M HRPP Reference
HRPP Operations Manual, Part 5 - IRB Jurisdiction, Cooperative Research, and Reliance Agreements
Prior to submitting funding proposals for federally sponsored collaborative, multi-site social/behavioral human subjects studies, contact the IRB-HSBS to discuss single IRB-of-Record (sIRB) requirements and options. Best practice is to contact IRB-HSBS four to six weeks before proposal submission if you want IRB-HSBS to serve as the sIRB.
Working with external research collaborators
The Common Rule (45 CFR 46.114) requires that a single IRB-of-Record (sIRB) be designated to review and approve federally sponsored non-exempt collaborative, multi-site human subjects studies. Establishing the sIRB for a project has two components:
- IRB review and approval for the conduct of the human subjects research at U-M and at other participating institutions.
- 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 subjects cannot begin at a participating site until both the sIRB approves the conduct of the project at the site and the IAA for that site is finalized.
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.
For projects that are not federally-funded, the agreement process typically occurs at the time of IRB submission. Work with your collaborators and the IRB-HSBS sIRB coordinator to identify the appropriate review process for your study.
Sponsored Grant Application Preparation
The National Institutes of Health (NIH) require that the sIRB be identified on their grant applications for non-exempt collaborative, multi-site human subjects research at the time of proposal submission. Other Common Rule agencies are expected to adopt this requirement as they formalize their sIRB processes.
Do not designate IRB-HSBS as the sIRB on any grant application without first consulting with the IRB-HSBS sIRB Coordinator! Contact IRB-HSBS at email@example.com no later than 4-6 weeks before the ORSP submission deadline to discuss sIRB options.
As part of the preparation, the principal investigator may be asked to complete and submit to the IRB-HSBS the applicable IRB Authorization Request form:
- IRB Authorization Request - Michigan IRB-HSBS as the Single IRB-of-Record (U-M Reviewing) [download]
- IRB Authorization Request - U-M Ceding Oversight to an External IRB (U-M Relying) [download]
These forms, completed prior to the IRB application, provide basic information about your project and collaborators, including local context information such as state or local laws that may affect the research, or special language for the informed consent document.
- The sIRB Coordinator uses this information to recommend the appropriate sIRB for the proposed project and to establish the IAAs once the project is awarded.
- The forms may also assist the investigator to provide required sIRB information to the sponsor, whether at the time of proposal in an sIRB Plan or (for NIH) in a statement identifying the sIRB in a just-in-time submission prior to award. An sIRB plan is a required narrative describing the communication plan that outlines the responsibilities of each participating site.
IRB-HSBS provides a letter of support to the study team indicating either its agreement to be the Reviewing IRB (sIRB) or a Relying IRB, as applicable. This letter should be uploaded to the PAF and/or, as required per the sponsor, included with the sIRB plan as part of the proposal submission. Similar support documentation from an external sIRB may be required by the sponsor when U-M will be a relying site for a project and is ceding oversight responsibility to another IRB.
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 subjects research from the sIRB& must be obtained prior to the release of the sponsored award and the start of research. Some federal sponsors may require documentation of the sIRB approval for the human subjects research and an IRB approved protocol to be included with the grant application, as opposed to at the time of award. As finalized IAAs are required for the sIRB to approve the human subjects research, submitting the IRB Authorization Request to IRB-HSBS early in the proposal process is vital.
IRB Application Process
Before beginning the IRB application for a collaborative, 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.
The majority of research collaborations involving IRB-HSBS fall into two models:
- Collaborative/Cooperative Research
Collaborative 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 study implemented at each participating site).
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:
- Collaborative studies where engaged external collaborators are contributing to U-M's research project but are not implementing the same protocol at each site or
- Multi-site studies involving only one or two engaged external institutions conducting the interaction/intervention using the same protocol; or
- Multi-site studies that are not federally sponsored, where the engaged external institution 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 they 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.
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.
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) or IRB Chair (all other sponsors)
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.