Subcontracting for Human Subjects Research

Mississippi State has a Federalwide Assurance (FWA) with the federal government that allows us to receive federal funding to conduct human subjects research.  One provision of that assurance says, "The Institution is responsible for ensuring that all institutions and investigators engaged in its U.S. federally-supported human subject research operate under an appropriate OHRP or other federally-approved Assurance for the protection of human subjects."  This means that anyone Mississippi State University subcontracts with for human subjects research activities must have an assurance with the federal government. 

This is addressed during the subcontracting process.  Your SPA Administrator can guide you through this process.

Generally, if the entity has an IRB or has access to an IRB, they must provide proof of IRB approval for the project.  Discussing these requirements with any potential subcontractor is advised.  Discovering that a subcontractor is not eligible to receive federal funds for human subjects research during the subcontracting process is not pleasant for anyone involved.

However, if the subcontract is issued to an individual who has no organization/university/center affiliation, and therefore, no means of access to an IRB, the MSU IRB may be petitioned to act as the IRB for that individual.  However, in some cases, such an arrangement is not advisable and will not be undertaken.  If the IRB agrees to serve as an individual’s IRB, the researcher must complete human subjects training, execute an unaffiliated investigator agreement and obtain IRB approval at MSU.