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Single IRBs and Reliance Requests

Effective Jan. 25, 2018, NIH policy mandated that all domestic sites participating in a non-exempt, multi-site research study (where study activities outlined in a single protocol are carried out at multiple institutions) use a single IRB (sIRB).

Effective Jan. 20, 2020, the 2018 Common Rule will require a sIRB for all domestic sites participating in a non-exempt, cooperative research study (two or more institutions coordinate to complete a portion of the research outlined in a specific protocol).

Requesting a Reliance Determination

Investigators requesting a reliance determination should email the completed Reliance A form, along with a copy of the grant proposal, if applicable, to their IRB Office. If needed for a grant proposal, please submit the request at least one week before the grant submission deadline.

Penn State College of Medicine and Penn State Health researchers: Email the Human Subject Protection Office at hspo@pennstatehealth.psu.edu.

Penn State University Park and other non-College of Medicine/Penn State Health researchers: Email the Office for Research Protections IRB at irb-orp@psu.edu.

Once reviewed and the reliance determination made, the IRB office will provide you with a letter of support that describes the selected sIRB and Penn State’s willingness to rely on this IRB or serve as the reviewing IRB.

Note: Penn State’s IRB offices cannot guarantee their willingness to support the use of the sIRB that has been selected without prior consultation and agreement documented in a letter of support.

Contact Us

With questions about authorization agreements, use the following contact information:

Researchers at Penn State College of Medicine and Penn State Health: Contact the Human Subjects Protection Office at 717-531-5687 or hspo@pennstatehealth.psu.edu.

Researchers at Penn State University Park and other non-College of Medicine/Penn State Health researchers: Contact the Office for Research Protections IRB at 814-865-1775 or irb-orp@psu.edu.

You can also find more information below on the Single IRB process.

Submit a Single IRB Reliance Request Form

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Learn more about Single IRB

What is an authorization agreement? Expand answer

Penn State’s Institutional Review Board uses this term to refer collectively to the formal written agreement that documents respective authorities, roles, responsibilities and communication between an institution/organization serving as the IRB of Record (Reviewing IRB) and the institution relying on that IRB (Relying IRB).

This term includes: reliance agreement, cooperative agreement, master services agreement (MSA), master joint agreement (MJA) or umbrella agreement.

Who negotiates the terms of the authorization agreement and signs the agreement? Expand answer

The authorization agreement is negotiated and finalized by Penn State IRB. The IRB office will also coordinate review by Penn State’s legal counsel, as needed. The Institutional Official from each participating institution signs the authorization agreement. The IRB office coordinates the signature process and will provide a copy of the agreement to the Penn State principal investigator with the notice of approval.

Is an authorization agreement always faster than going through the Penn State IRB? Expand answer

No. The process for establishing a new authorization agreement can be lengthy. Sometimes it goes quickly, but it is not uncommon for it to take months. Researchers are advised to keep this in mind when considering a reliance request (either requesting Penn State serve as a Reviewing or Relying IRB).

Note that regardless of whether Penn State is the reviewing or relying IRB, researchers must submit to Penn State’s IRB and the type of submission will depend on the role that Penn State’s IRB will have for a given study.

Is executing an authorization agreement the same thing as having IRB approval? Expand answer

No. When Penn State’s IRB executes an authorization agreement, researchers must still obtain IRB approval from the IRB of record before beginning any study activities and before funds can be released. The Penn State principal investigator remains responsible for ensuring all of Penn State’s institutional requirements are met before beginning the research and throughout the course of the research activities.

What is SMART IRB? Expand answer

SMART IRB is an initiative developed under an award from the National Center for Advancing Translational Science of the National Institutes of Health to support single IRB review in facilitation of multi-site human subjects research. Investigators can learn more here.

SMART IRB includes:

  • An IRB reliance agreement that permits eligible institutions that join it (“Participating Institutions”) to rely on the IRB review and oversight of human subjects research by another Participating Institutions’ IRBs.
  • A set of standard operating procedures to guide implementation of the reliance relationship among Participating Institutions.
  • Centralized online system to support institutional sign-on and reliance determinations.
    • Participating Institutions agreeing which institution will serve as the Reviewing IRB and whether the other Participating Institutions are willing to rely on review by that IRB.
Is Penn State signed on to use the SMART IRB Agreement, and what does that mean? Expand answer

Yes, both IRB offices at Penn State are signed on to the SMART IRB Agreement as Participating Institutions. Using the SMART IRB Agreement means that the institutions collaborating on a project and seeking to utilize single IRB review do not have to establish and execute a separate authorization agreement. Using the SMART IRB Agreement as the “Reliance Agreement” is an option if the other Participating Institutions have signed on and also agree to use the SMART IRB Agreement for a given study. A decision to use the SMART IRB agreement is made on a study-by-study basis by each Participating Institution.

Using SMART IRB does not replace or negate the internal submission process at Penn State regardless of whether Penn State is the Reviewing IRB or relying on an external IRB. Investigators should never assume that the agreement can or will be used for a given study or convey to others, including a funding agency, that the agreement will be used, without explicit documented agreement from each Participating Institution.

Note: There are three listings for Penn State as participating institutions signed onto SMART IRB; please be sure to select the appropriate institution:

  • Penn State College of Medicine
  • Penn State Milton S. Hershey Medical Center
  • The Pennsylvania State University (covers University Park and all other campus locations)
When will Penn State serve as the Reviewing IRB? Expand answer

These determinations are being made on a case-by-case basis.

If you work with the Office for Research Protections IRB and have questions about your project, email irb-orp@psu.edu and include “Single IRB” in the subject line.

If you work with the Penn State College of Medicine IRB and have questions about your project, email hspo@pennstatehealth.psu.edu and include “Single IRB – NIH” in the subject line.

Will all IRBs agree to serve as the Reviewing IRB? Expand answer

No. Policies regarding willingness to serve as a Reviewing IRB are specific to each institution. If you wish to request that an institution’s IRB serve in this capacity, please work with the IRB at that institution (and the principal investigator at that institution, if applicable) to confirm their policy before proceeding.

Note: The Penn State IRB makes the final determination to regarding whether to be a Reviewing IRB or a Relying IRB when Penn State is engaged in the study in question.

When will Penn State consider relying on an external IRB? Expand answer

Please refer to the Investigator Manual (HRP-103) located in the CATS IRB Help Center.

Specifically, the section titled “Reliance on an External IRB for Review of Human Subject Research Studies” provides three overall criteria that Penn State’s IRB considers when deciding to cede review to an external IRB.

One of the three criteria must be true for Penn State to consider ceding review to an external IRB.

Once the reliance agreement is executed for relying on an external IRB, who do I contact for questions about how to submit my study to the Reviewing IRB? Expand answer

Questions about how to submit your study to the external (Reviewing) IRB should be directed to the external (Reviewing) IRB. Your reliance arrangement may involve standard operating procedures that describe with whom and how to communicate with the external IRB.

How do I make a reliance request (whether Penn State could be the Reviewing IRB or the Relying IRB)? Expand answer

Investigators requesting a reliance determination should complete a Single IRB Reliance Request form. If needed for a grant proposal, please submit the request at least one week before the grant submission deadline.

Penn State College of Medicine and Penn State Health researchers: Email the Human Subject Protection Office at hspo@pennstatehealth.psu.edu.

Penn State University Park and other non-College of Medicine/Penn State Health researchers: Email the Office for Research Protections IRB at irb-orp@psu.edu.

Once reviewed and the reliance determination made, the IRB office will provide you with a letter of support that describes the selected sIRB and Penn State’s willingness to rely on this IRB or serve as the reviewing IRB.

Note: Penn State’s IRB offices cannot guarantee their willingness to support the use of the sIRB that has been selected without prior consultation and agreement documented in a letter of support.

If an institution is listed under the "External IRB" list in CATS IRB, does that mean Penn State has an authorization agreement in place that would cover my study? Expand answer

No. The list in CATS IRB on the “External IRB” smartform page provides a dropdown menu to select the external IRB that will serve as the Reviewing IRB. Authorization agreements are generally executed on a study-by-study basis.