Humans: Institutional Review Board (IRB)
sIRB for Federally Supported Research
Effective January 20, 2020, reliance on a single IRB (sIRB) is required for non-exempt, federally supported cooperative research projects (those that involve more than one institution) that are:
- conducted in the United States and
- funded or supported by a federal agency that has adopted the Common Rule regulations. Most federal agencies have adopted the Common Rule. Notable exceptions include The Department of Justice (National Institute of Justice) and Consumer Product Safety Commission.
Reliance on an sIRB is NOT required when:
- more than sIRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe), or
- the federal agency supporting the research determines and documents that use of an sIRB is not appropriate for the particular context.
Currently, little federal guidance is available regarding specific implementation expectations and procedures. Funding agencies may adopt sIRB-related processes currently in use by the NIH, but that is unknown at this time. When information becomes available, we will update this website to inform the campus community.
In the interim, we advise the following steps:
Prior to Funding Proposal Submission
Step 1:: Work with external collaborators across all sites to identify the IRB that will serve as the sIRB. Contact the chosen IRB office to verify they are willing to assume responsibility as sIRB.
|IMPORTANT: The Iowa State University IRB will not serve as sIRB for multi-site studies subject to the federal sIRB mandate. When Iowa State is the lead site on a funding proposal or award, the principal investigator may:Identify a qualified IRB at a collaborating site that is willing to serve as sIRB; OR|
sIRB responsibilities may be handled by an independent IRB. ISU has established an 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 may be included in the funding proposal budget.
Step 2: Work with the selected sIRB to obtain information about any review fees for inclusion in the grant budget.
Step 3: Ascertain the willingness of all participating sites to rely on the sIRB. If you need a letter of support from the Iowa State IRB, send the following information along with a very brief description of your project to IRB@iastate.edu:
- The Iowa State PI Name
- The name of the funding agency
- The exact title of the grant proposal/application
- Whether Iowa State is the lead/prime
- The name of the lead PI and lead/prime site (if not Iowa State)
- The name of the sIRB
- The grant submission deadline (or deadline for providing information to the lead site)
- The name(s) of the participating sites and Site PIs, if known
- Any additional relevant information (such as any prior contact with the sIRB, sIRB contact person information, etc.)
- A brief description of your project.
Step 4: Develop a communication plan outlining roles and responsibilities associated with IRB review. Devise processes for communication and notifications between researchers at collaborating sites and the sIRB. Note: Some funding agencies may require submission of a communication plan with the proposal.
Upon Notification of an Award
Step 1: Complete an IRB Application xForm for a new study in IRBManager. After starting the form, select “Request to Rely on an External IRB” as the application type.
Step 2: Work with the sIRB, following their established processes, to seek IRB approval.
NOTE: Local Context Information: The sIRB 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.
Step 3: Share the outcome of initial and subsequent sIRB review with the Iowa State IRB office (IRB@iastate.edu). If Advarra IRB is the selected sIRB, Advarra will handle this process.
Step 4: Conduct the study following the sIRB-approved protocol and all policies and procedures of the sIRB.
NOTE: sIRB review addresses only one aspect of responsible research – the Iowa State PI is also responsible for ensuring compliance with all applicable federal, state, and local regulations and laws as well as with Iowa State institutional requirements and policies related to the research. See the Office of the Vice President for Research website for guidance regarding a variety of aspects of responsible research.