Multi-Site Studies

If a study will be conducted at multiple sites, the IRB-HSR requires a common protocol that is used by all sites. A common protocol is required even if the overall PI is not from UVA. If a common protocol does not exist, templates for a common protocol found on the IRB-HSR Website may be used. Templates exist for different types of studies such as a minimal risk study requiring expedited review, a study with more than minimal risk requiring full board review. Templates are also available for studies involving an investigational drug, device or biologic. 

In addition, if the protocol requires full board review, the protocol must also be submitted to the School of Medicine Research Office (SOM CRO) for their review.

Non-Engaged in Human Subject Research

If you are planning to work peripherally on a project and you think that the level of involvement is so low that it does not qualify as engaged in human subject research, then you should check the criteria for non-engaged in human subject research as provided by DHHS.  If the study is regulated by the FDA, these criteria may not be applied. 

If the study is not regulated by the FDA, the DHHS criteria for non-engaged may be found here. If, after reviewing the guidance, you have determined you are not engaged in human subject research you must go to Protocol Builder and submit a Non-Engaged application to the IRB-HSR.

Research Performed with Other Institutions

Requirements for Approval of research at Non-UVA Facilities

Any human subjects research conducted in whole or in part outside of UVA facilities must be reviewed and approved by a UVA IRB prior to initiation if it satisfies any of the following criteria unless an IRB Reliance Agreement is in place documenting reliance on a non-UVA IRB of Record. For additional information see IRB Reliance Agreements below. 

  • It is conducted by or under the direction of UVA personnel in connection with his or her UVA responsibilities. 
  • It uses UVA property, facilities, or resources to support or carry out the research. 
  • The name of the University of Virginia is used in applying for funds (intra or extramural). 
  • The name of the University of Virginia is used in explanations and/or representations to subjects. 
  • Non-public information from UVA will be used to identify or contact human research subjects or prospective subjects.

IRB Reliance Agreements