Humans: Institutional Review Board (IRB)
IRB Approval Requirements for Cooperative or Multi-Site Research Studies
Research projects often involve collaboration between researchers at Iowa State and those at other universities. Federal regulations and policy refer to these projects as cooperative or multi-site research. Human subjects research activities conducted by employees of an external site fall under the jurisdiction of that site’s Institutional Review Board (IRB). When researchers collaborate, that can mean that IRB approval by multiple IRBs is required.
In many cases, there is a way to avoid duplicate review. The IRBs at each site can enter into formal agreements called Reliance Agreements or IRB Authorization Agreements (IAA), designating one IRB to serve as Reviewing IRB for the work conducted by all collaborating sites.
Typical reliance options:
- Iowa State agrees to serve as serve as Reviewing IRB for the research activities conducted by Iowa State researchers and external collaborators.
- The Iowa State PI coordinates IRB review (including all future review activities) for the human subjects research activities of Iowa State researchers and external collaborators.
- Iowa State agrees to defer or cede IRB review responsibilities to the collaborating institution; the IRB at the collaborating institution serves as Reviewing IRB.
- The Iowa State PI works with the external PI to coordinate IRB review and is responsible for following the Reviewing IRB’s policies, procedures, submission requirements, etc.
Which option is best?
Research collaboration arrangements vary, and thus the “best” option for IRB oversight depends on the specific situation for each project, funding agency requirements, and whether a study qualifies for exempt review. Establishing these agreements can also take time. Principal Investigators are encouraged to contact IRB staff for guidance early in the process.
|Special circumstances for federally supported research: Nearly all federally supported non-exempt human subjects research is subject to a federal mandate that requires reliance on a single IRB (sIRB). The Iowa State University IRB will not serve as sIRB for research subject to the federal sIRB mandate. When Iowa State is the lead site on a federal award, the principal investigator mayIdentify a qualified IRB at a collaborating site that is willing to serve as sIRB, OR|
sIRB responsibilities may be handled by an independent IRB. Iowa State has established a reliance agreement with a pre-selected independent IRB – Advarra IRB – to serve in this capacity. Costs associated with independent IRB review are the responsibility of the PI and should be included in the funding proposal budget.
Do all research activities performed by external collaborators require a reliance agreement?
It depends on external collaborators’ role(s) on the project. In general, a reliance agreement is needed if the external collaborators are conducting human subjects research activities such as any of the following:
- actively recruiting participants (beyond forwarding/sharing IRB-approved recruitment materials);
- obtaining participants’ informed consent;
- collecting data or administering research interventions; or
- using, studying, or analyzing private and identifiable information about participants.
Reliance arrangements may be handled less formally for research eligible for exempt review
Determining when a reliance agreement is needed can be difficult, and Principal Investigators are encouraged to consult with IRB staff (IRB@iastate.edu).
Who can sign reliance agreements?
Reliance agreements are reviewed and signed by institutional officials (IO) at the sites of the Reviewing and Relying IRBs. Researchers DO NOT have the authority to sign reliance agreements on behalf of Iowa State.
Basic Information for IRB Authorization Agreements
Reliance agreements require basic information about the project(s) and institution. Project information will vary; relevant Iowa State institutional information is as follows:
Iowa State Federalwide Assurance Number: FWA00002678
Iowa State IRB Registration Numbers:
IRB #1: IRB00000473
IRB #2: IRB00005531 (Reviews research involving prisoners as subjects)
Iowa State Signatory Official: Kerry Agnitsch, Assistant Director, Office of Research Ethics (Reliance Agreement signatory designee for IO)
Local Context Information
The external Reviewing IRB may require Iowa State-specific local context information such as contact information for the Iowa State IRB, Iowa State-specific policies such as child-abuse reporting, etc.
Child-abuse reporting: Iowa State policy requires reporting by employees who in the course of employment receive information related to suspected physical or sexual abuse of children. Participants should be informed of researchers’ reporting obligations when applicable.
Contact information for the Iowa State IRB that may be included in consent forms: If you have any questions about the rights of research subjects or research-related injury, please contact the IRB Administrator, (515) 294-4566, IRB@iastate.edu, or the Director, Office of Research Ethics, Iowa State University at (515) 294-3115.
Records related to payment to research subjects: Iowa State has policies regarding documentation of payment from Iowa State sources to research participants. In many cases, participants must complete Iowa State’s Research Participant Receipt Form to receive compensation. Participants should be informed about this form, especially if compensation is $100 or more, as the form requires disclosure of their social security number. Wording is available in Iowa State’s Informed Consent Templates.