Studies Requiring Approval from More than One IRB
Research conducted at non-TWU sites (Offsite Institutions) that require approval by the non-TWU IRB
Studies conducted with offsite institutions may require approval by the offsite institution’s IRB. There are three ways to handle IRB approval for studies conducted with other institutions that require approval from more than one IRB: 1) follow the typical process for review by each institution; 2) utilize the dual review process; or 3) request that TWU and the other institution enter into an Institutional Authorization Agreement (IAA).
Generally, if the study is an exempt study, following the exemption process at each institution would be the most streamlined process. For expedited and full review studies, the dual review process would be used when at least a portion of the study is being conducted on the TWU campus. If all subject recruitment and data collection is conducted on the non-TWU campus, the IAA may be more efficient.
A dual review process means that the study will be reviewed by the IRB of both sites. Offsite approved protocols are reviewed by TWU with the standard purpose of protecting the rights and welfare of study subjects and in light of the fact that the study has been approved by another IRB.
- The researcher’s initial step after discerning that offsite IRB review is required is to review the requirements of both institutions to develop a single consent document that meets the standards of both. This step is critical in minimizing delays and preventing resubmissions.
- Once the IRB approval has been granted by the other institution, TWU's Dual Review Application Form may be completed and submitted.
- All offsite approved protocols must be submitted to the TWU IRB for review at the level approved by the offsite IRB and will be reviewed as follows:
Full Review Studies will be reviewed at a fully convened meeting. The TWU IRB Chair will designate a primary reviewer who possesses expertise in the study discipline as well as dual review procedures.
Expedited Studies will be reviewed by the TWU IRB Chair or one reviewer designated by the chair.
Exempt Studies will be reviewed by the IRB Chair or Co-Chair.
Dual review applications must include a completed IRB Dual Review Application Form, the completed offsite IRB application with all associated materials (including the consent form), the offsite IRB approval letter, and any additional administrative requirements as determined by TWU policy. All TWU research team members will be required to have current training certificates on file with the TWU IRB.
The Dual Review Application will include the researcher’s role in the study, name and role of the offsite PI, and offsite IRB contact information.
Dual review studies are subject to the same TWU IRB rules, reporting requirements, and deadlines as regular IRB applications. The TWU IRB is authorized to approve, disapprove, upgrade review levels, terminate, or suspend any study submitted for review regardless of the method of submission.
Institutional Authorization Agreement (IAA)
An IAA is a written agreement prescribed by the Office of Human Research Protections (OHRP) that describes the obligations of both institutions when one relies on the other for IRB review and continuing oversight of one or more human subject research projects. Typically, an IAA would be appropriate if subject recruitment and data collection are being conducted at a non-TWU site. IAAs must be approved by the signatory officials of both institutions. In order to request that TWU rely on another institutional IRB review and approval for a specific study, an investigator must complete the IRB IAA Request, obtain necessary signatures, and forward the signed form to Ms. Tracy Lindsay in the Office of Research & Sponsored Programs at firstname.lastname@example.org.
Detailed information regarding the IAA process can be found in the IRB Procedures.