sIRB for Federally-Funded Research

Applicability:

Effective January 20, 2020, reliance on a single IRB (sIRB) is required for non-exempt 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 a single IRB (sIRB) is NOT required when:

  • more than single IRB 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 a single IRB is not appropriate for the particular context.

Implementation Plans

Currently, no Federal guidance is available regarding specific implementation expectations and procedures.  Funding agencies may adopt sIRB-related processes currently in use by NIH, but that is unknown at this time.  When information becomes available, we will update this website to inform the campus community.

In preparation for the January 20, 2020 effective date, we advise the following steps:

Prior to Funding Proposal Submission

Step 1:  Work with collaborators across all sites to identify the IRB that will serve as the sIRB at the time of proposal development/submission.  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 sIRB mandate.  When ISU 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.  To obtain a letter of support from the ISU IRB, send the following information along with a very brief description of your project to IRB@iastate.edu:

  1. ISU PI Name

  2. Whether ISU is the lead/prime or is a participating site

  3. Name of the lead PI and lead site (if not ISU)

  4. Name of the sIRB

  5. The exact title of the grant proposal/application

  6. The grant submission deadline (or deadline for providing information to the lead site)

  7. The name(s) of the participating sites and Site PIs, if known

  8. Any additional relevant information (such as any prior contact with the sIRB, sIRB contact person information, etc.)

  9. 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:  Send a formal request for ISU to rely on an external IRB by completing an IRB Application xForm in IRBManager.  This is the same form used to obtain IRB approval for a new study, however the xForm is conditioned to ask questions only pertinent to the reliance arrangements when you indicate that researchers at other institutions will be involved and you wish for the ISU IRB to rely on another institution’s IRB for oversight.   

NOTE:  The IRBs at each collaborating site will need to establish a reliance agreement (also called an IRB Authorization Agreement (IAA) or Deferral Agreement) with the sIRB.  Reliance agreements are reviewed and signed by institutional officials at each participating site and at the site of the sIRB.  Investigators DO NOT have the authority to sign reliance agreements on behalf of ISU.

Step 2:  Work with the sIRB, following their established processes, to seek IRB approval.
 

Working with Advarra IRB
         
          Submit a Study to Advarra IRB
          Investigator FAQ’s

NOTE:  Local Context Information:  The SIRB may require ISU-specific local context information, such as contact information for the ISU IRB, ISU-specific policies such as child-abuse reporting, etc.  

Child-abuse reporting:   ISU 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 your reporting obligations when applicable.

Contact information for the ISU 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:  Research subjects that receive compensation from ISU sources must complete ISU’s Research Participant Receipt Form to meet ISU recordkeeping requirements.  Participants should be informed if they must complete the Research Participant Receipt Form, especially if the form requires disclosure of their social security number.

Step 3:  Communicate the outcome of initial and subsequent sIRB review with the ISU IRB office (IRB@iastate.edu).  If Advarra IRB is the selected sIRB, Advarra will handle this process.  

Step 4:  Conduct the study in a manner that ensures compliance with the sIRB approved protocol and all policies and procedures of the sIRB. 

NOTE:  sIRB review addresses only one aspect of responsible research —the ISU PI is also responsible for ensuring compliance with all applicable federal, state, and local regulations and laws as well as with ISU institutional requirements and policies related to research.  See the Office of the Vice President for Research website for guidance regarding a variety of aspects of responsible research.