Reliance Agreements - External IRB Requests
A reliance agreement (or IRB Authorization Agreement) is a formal, written document indicating a collaborative arrangement between institutions that allows one or more institutions to cede human subjects research review to another Institutional Review Board (IRB). A reliance agreement describes the responsibilities of the relying institution and researcher as well as the responsibilities of the reviewing IRB and its institution. WSU IRB would be either the reviewing IRB (IRB of Record) or the relying IRB (ceding review). Reliance agreements can be used to avoid having duplicate IRB reviews at multiple sites, and they are also needed for meeting the NIH Single IRB policy for multi-center studies. Reliance agreements may be for a specific study, or for specific classes or categories of research.
There are two types of initial submissions:
(Type 1) Reliance agreement is already in place (ex. SMART IRB, University of Utah, Henry Ford Health System, or commercial IRB such as Advarra or Quorum IRB). The reliance agreement should be referenced with your request submission. For SMART IRB agreement use, please provide an acknowledgement form as explained below. If the Reviewing IRB is one of the >500 sites on SMART IRB and they are willing to use the SMART IRB master agreement, that will expedite the process.
(Type 2) Reliance agreement is not yet in place. Creation or negotiation of the reliance agreement, review by IRB Staff and Office of General Counsel, and signatures of the Institutional Officials at both institutions will be needed. If there is not an existing agreement, please note that this process of establishing one takes additional time.
For either situation described above, please submit the following by hard copy to the IRB Administration Office and also email to firstname.lastname@example.org:
- WSU-External IRB Request Cover Sheet and Review Authorization Form (.doc)
- Consent document with HIPAA Authorization (Reviewing IRB's consent template, with WSU local context language and WSU HIPAA Authorization inserted or as an appendix)
- HIPAA Summary Form http://research.wayne.edu/irb/04_2015_forms/hipaa_summary_04_2015.doc
- Reliance agreement document or SMART IRB Acknowledgement
- Local Context Worksheet required by Reviewing IRB (if applicable). Please fill out study specific information to the best of your ability, and the IRB Staff will fill in the rest.
Changes to local research arrangements (i.e. key personnel & HIPAA) should be submitted to the IRB Administration Office for review. Change requests should be submitted via email to email@example.com. Please submit highlighted revisions and indicate in the e-mail the modifications that are being requested along with the WSU External IRB Requests Modifications & Event Reporting Form.
Questions & Additional Information
Questions regarding External IRB Requests other than WIRB and NCI CIRB please email: firstname.lastname@example.org
WSU External IRB Policy (.doc)
WSU is a SMART IRB participating institution. To submit an External IRB Request using SMART IRB please submit the documents indicated above along with the SMART IRB Acknowledgement of Site Agreement to CEDE IRB Review letter (.doc)
For a listing of SMART IRB participating institutions see https://smartirb.org/participating-institutions/
Reliance Agreements FAQs
What WSU studies are eligible for submission to an external IRB (other than WIRB or CIRB)?
Studies may be considered for submission to an external IRB if they are multi-site studies, particularly NIH-funded studies to which the NIH Single IRB policy applies. Please see the policy link to determine whether this policy applies to your study. https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm
If an external IRB will be the IRB for my study, why must I go through the WSU Research Compliance Office?
- The external IRB will provide ethical review, which is only one part of research oversight. Certain regulatory responsibilities still remain the responsibility of WSU. These responsibilities include:
- Ensuring adequate personnel training in Protection of Human Subjects and Good Clinical Practice.
- Maintaining a compliance oversight role locally.
- Ensuring that site specific requirements are in place and that a reliance agreement is in place.
- Ensuring that required local ancillary reivews (i.e. Radiation Safety Committee, Institutional Biosafety Committee, etc) have been completed.
Is there guidance regarding NIH Single IRB?
How much money should be budgeted for external IRB studies?
The WSU Administration Office is in the process of determining fair market value of a single IRB/reliance agreement fee schedule. Upon determination of the fee schdedule that information will made avialable on this site. Please make sure you include the external IRB's fees as direct charges in your budget, and plan enough funds to cover amendments, continuing reviews, and other actions during the life of the study.
What if DMC review is required for my study?
If DMC Review is required DMC Review Authorization can be submitted concurrently at the time of IRB submission. For more information regarding DMC Review: https://www.dmc.org/for-health-professionals/clinical-translation-research-office
If you have additional questions, please contact email@example.com.