IRB Collaborative Research

Collaborative research is defined as research conducted in cooperation with an institution or organization that is not affiliated with WCU. Examples include conducting research with:

• Academic Institutions
• Hospitals
• Public Agencies
• Cultural Populations
• Businesses
• Schools

When conducting collaborative research projects, WCU acknowledges that each institution or agency is responsible for safeguarding the rights and welfare of human participants and for complying with applicable federal regulations. Permission or approval from the collaborating institution or agency is required, and these requirements may vary depending on the risk level of the research, the nature of the collaboration, and whether or not the organization has its own IRB. Investigators are encouraged to contact the IRB early in the process of establishing their collaboration.

 

IRB Authorization Agreements (Reliance Agreements)

When two or more institutions are engaged in a human subjects research study, options may be available to avoid duplicate IRB review. An IRB Authorization Agreement (IAA) can often be established to designate one IRB as the IRB of Record. If you are planning to collaborate with an institution that has an IRB, please contact us for information on whether an IAA is appropriate for your study.

• Mission Health System Reliance Agreement - In an effort to prevent duplicate review, Mission Health System (MHS) has agreed to be the IRB of record for most collaborative studies involving WCU faculty, staff, and students. If you've submitted an IRB application to MHS, a separate application to WCU's IRB may not be necessary. Please contact the WCU IRB if you are interested in adding your study to this standing agreement with MHS.

Individual Investigator Agreement

An Individual Investigator Agreement allows an institution to extend the applicability of its Federalwide Assurance (FWA) to collaborating individual investigators or investigators whose organizations do not have an IRB. If you are collaborating with an institution or organization that does not have an IRB, please submit an Individual Investigator Agreement Form for any non-WCU personnel.

Further information on agreements available to IRBs for collaborative studies can be found at: OHRP Guidance "Extending an FWA to Cover Collaborating Investigators"

Collaborative Research with the Eastern Band of Cherokee Indians (EBCI)

If your study will include tribal members from the Eastern Band of Cherokee Indians (EBCI) or will occur on Cherokee lands (e.g. the Qualla Boundary or Snowbird community), approval may also be required by the EBCI Cultural IRB and/or Health & Medical IRB.

The EBCI Cultural IRB has prepared the following information to consider before proposing research that includes EBCI tribal members:

Statement from EBCI Cultural IRB

For further information please contact the WCU IRB by emailing IRB@wcu.edu or calling 828-227-7212.