Multi-site research refers to human research conducted at more than one site that is external to the University or affiliate institutions (e.g. Banner-University Medicine Tucson, South and Phoenix campuses). A multi-site study can be from any discipline. Examples include other academic institutions, public elementary schools, nursing homes, independent health care facilities, etc.
The Human Subjects Protection Program determines whether or not the site is engaged in the human research as defined in federal guidance . If a site is engaged in human research, then IRB approval is required.
Forms below are to be used for each addition site where we are the IRB of record.
Appendix C: Multi-Site Research (Word)
A multi-site study is a study that involves multiple institutions engaged in the research project. This form should be used when the University of Arizona IRB will review research activities for an investigator or research staff who are not affiliated with the University. This form is not needed if each research site will obtain their own IRB approval.
F213b: Amending Research for a Multi-Site (Word)
This form is used to request approval to an amendment that is site specific for a site where we are the IRB of record. If the change being made will affect all sites, the submit the F213: Amending Approved Human Research.
F107b: Multi-Site List of Personnel (Word)
Site specific list of Senior/Key personnel, as defined by the National Institutes of Health, must be included on the F107b and have current CITI training before they may conduct any activities related to the human research.
Each additional site will need to have its own F107b.
F212c: Multi-Site Renewal Progress Report (Word)
This document should be completed by EACH site for which the UA IRB is the IRB of record. It will need to be attached with the F212 that is submitted.
For multi-site research with external sites engaged in the research activity, arrangements may be made for institutions to rely on one another for IRB review utilizing a formal Institutional Agreement (IA). The IA is signed by either the Director or the Institutional Official (IO) who is the Senior Vice President for Research. The Human Subjects Protection Program will route the IA to the appropriate person for signature when a request is submitted for review.
Individual Agreement (Word)
The Individual Agreement (IA) should be used when an independent person not affiliated with a specific institution will be engaged in the human research.
IRB Reliance Agreement – UA Reviewing IRB (Word)
The IRB Reliance Agreement (UA Reviewing IRB) should be used when the UA IRB will be the IRB of Record for the external site conducting human research.
IRB Reliance Agreement – Ceding Review (Word)
The IRB Reliance Agreement (Ceding Review) should be used when the UA IRB will be ceding its review to another IRB of Record.