Affiliated Researchers
Research projects often involve collaboration between UTEP researchers and those at other universities. These collaborations may or may not need to obtain IRB approval from each institution. Information detailing the research activities for each site and/or individual must be included in the study protocol.
Options
- Reliance on Commercial IRB
- Reliance on Non-Commercial IRB
- Institutional Authorization Agreement (IAA)
What is multisite research & When is a Single IRB (sIRB) used?
When research is conducted at multiple universities and/or institutions but only a single IRB reviews and approves the research for multiple sites. Some sponsors/studies may require sIRB review or researchers may request sIRB for other multisite studies. In order to help facilitate research, UTEP is willing to establish IRB reliance agreements, dependent on factors in the proposed project.
The HROC office will facilitate communication with the respective IRBs. Please contact us as soon as possible in your planning process by completing the Notice of Intent for Collaborative IRB Project (NICP).
Considerations
- Source of funding for the research
- Location and nature of research activities
- Personnel
- Risk level of study
- IRB’s expertise, policies, and procedures
Policies
Certain projects may REQUIRE that one participating institution serve as the IRB of record.
OHRP (Common Rule) sIRB
Effective Date: January 20, 2020
The U.S. Department of Health and Human Services (DHHS) will mandate the use of a single IRB for all multi-site research. This mandate applies to:
- All Multi-site research, supported by any Federal Department or Agency
- Non-exempt research
- Conducted at U.S. domestic sites
- Reviewing IRB determined by Federal Agency
NIH sIRB
Effective Date: January 15, 2018
The National Institutes of Health mandated the use of single IRBs as a contingency for funding of NIH multi-site studies. This mandate applies to studies in which the sites are all using the same protocol:
- NIH funded or supported projects
- Competing grant applications (new, renewal, revision or resubmission)
- Grant receipt date on or after January 15, 2018
- Non-exempt research
- Conducted at U.S. domestic sites
Notes
sIRB review does not eliminate many of the institutional administrative requirements for ensuring research compliance.
The UTEP IRB retains responsibility to ensure compliance with the protocol and that UTEP policies are adhered to.
ALL studies will need to be submitted to IRBNet. The record of the research study is created and tracked by utilizing UTEP forms/templates or by submitting the external reviewing IRB’s approved research documents.