Project Specific Authorization Agreement

Project Specific Authorization Agreement or Other

A Project Specific Authorization Agreement applies to a specifically designated human research project. IRB authorization agreements may also designate a specific scope to cover a range of project types; for example, to cover projects supported by a designated federal grant.

Process To Request Project Specific Reliance

The process to request a IRB reliance for a specific project differs based on which IRB will serve as the IRB record.

• If another institution may rely upon MSU as the IRB of record

  Request

  To request that another institution rely on MSU's IRB review, provide an explanation within the MSU New Study submission. If the non-exempt project has already received initial approval, submit a modification to add an external site.

  To faciliate the process, please contact the external site to determine their requirements for requesting review by the MSU IRB before submission of the initial or revision application, if possible. For example, the external site may require a reliance application to determine if the site would be willing to rely upon the MSU IRB. Speaking with the external site and determining their requirements before submission to the MSU IRB can help to streamline the process.

  Please contact the reliance coordinator, Kim Hess, if you have questions about whether reliance may be appropriate for the project. We encourage individuals to consider reliance and contact the IRB office prior to submission of the initial application, as the reliance process can take time to complete.

  Review

  The other institution will be contacted to determine if the institution is willing to rely upon MSU as the IRB of record.

  *For most federally funded human research, the other institution must have an active Federalwide Assurance (FWA). If the institution does not have an FWA and the project is federally funded, the institution may need to request/ apply for an FWA through the Office for Human Research Protections (OHRP).

  Agreement and Acknowledgement

  A fully executed Institutional Authorization Agreement must be in place prior to the external sites engagement in the human research.

• If MSU may rely upon another institution as the IRB of record

  Request

  To request MSU rely on another institution's IRB review, please see the External IRB - What & How to Submit page.

  Please contact Kim Hess with any questions.

  Please note that MSU does not typically enter into reliance agreements for exempt research.

  Review

  MSU may choose to rely on another institution for IRB review and approval after a determination is made that it is appropriate under the particular circumstances.  If MSU is the primary awardee of a grant and MSU is a site for the research, typically the MSU IRB will need to conduct its own review of the project. In addition, the other institution must have an active Federalwide Assurance (FWA) and should be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

  Agreement and Acknowledgement

  A fully executed Institutional Authorization Agreement must be in place and the reviewing IRB must approve MSU's involvement in the research prior to MSU's engagement in the human research. The HRPP office will send the MSU Principal Investigator a reliance acknowledgement letter once the agreement has been signed by both institutions and approval for MSU's involvement has been received. Research and/or clinical investigations involving human subjects cannot begin until the MSU Principal Investigator receives the MSU HRPP acknowledgement letter.