Studies conducted at offsite institutions may require approval by the offsite institution’s IRB. TWU requires that studies also be reviewed and approved by the TWU IRB (dual review). Regardless of the approval method, consent documents must meet TWU requirements. The goal in all circumstances is a single consent form that explains the roles of each institution and fairly and completely represents the decisions of each IRB involved.
Dual review procedure
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 in order develop a single consent document that meets the standards of both. This step is critical in minimizing delays and preventing resubmissions.
- All offsite approved protocols must be submitted 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 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.
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.
IRB Authorization Agreement
Under certain circumstances, TWU may enter into an agreement that authorizes an offsite IRB to serve as the IRB of record. Such agreements must be approved by the signatory officials of both institutions and the offsite IRB must be designated on TWU’s FWA for the duration of the study. Refer to the October 2010 Addendum to TWU IRB Policies & Procedures for complete information on the process of initating an authorization agreement.
page last updated 12/13/2013 12:38 PM