Single IRBs and IRB Authorization Agreements: FAQs

Both the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) permit an IRB the option to rely on the review of another IRB, and for multicenter research studies, the National Institutes of Health (NIH) and some funding agencies have increasingly encouraged that all participating sites rely on a single IRB. These FAQs provide detailed information on single IRBs and reliance arrangements at Penn State.

The Pennsylvania State University Institutional Review Board (IRB) 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.

The authorization agreement is negotiated and finalized by the 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.

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 PSU serve as a Reviewing or Relying IRB].

NOTE: 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.

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 PSU 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.

The Penn State IRB offices are making determinations on a case-by-case basis. Please contact your IRB office if you have questions.

Researchers at University Park and all other campus locations except Penn State’s College of Medicine and Penn State Health please contact:
Office for Research Protections (ORP) IRB
Email irb-orp@psu.edu and indicate "Single IRB" in the subject line.
 
Researchers at the Penn State College of Medicine and Penn State Health please contact
Human Subject Protection Office
Email hspo@pennstatehealth.psu.edu and indicate "Single IRB-NIH" in the subject line.

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 regarding whether to be a Reviewing IRB or a Relying IRB when Penn State is engaged in the study in question.

Please refer to the Investigator Manual (HRP-103) . Specifically, the section entitled, ‘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.

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 (SOPs) that describe with whom and how to communicate with the external IRB.

Please email the completed Reliance Request Form along with a copy of the grant proposal, if applicable, to your IRB Office via email. If needed for a grant proposal, please submit the request at least one (1) week before the grant submission deadline.

Researchers at University Park and all other campus locations except Penn State’s College of Medicine and Penn State Health please contact:
Office for Research Protections (ORP) IRB
Email irb-orp@psu.edu and indicate "Single IRB" in the subject line.
 
Researchers at the Penn State College of Medicine and Penn State Health please contact:
Human Subject Protection Office
Email hspo@pennstatehealth.psu.edu and indicate "Single IRB-NIH" in the subject line.
 
Once reviewed and the reliance determination made, your 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.

No. The list in CATS IRB on the ‘External IRB’ smart form page provides a drop-down menu to select the external IRB that will serve as the Reviewing IRB. Authorization agreements are generally executed on a study-by-study basis.

smart-irb-banner-234x60.png

SMART IRB is an initiative developed under an award from the National Center for Advancing Translational Science (NCATS) of the National Institutes of Health (NIH) to support single IRB review in facilitation of multi-site human subjects research. More information for investigators may be located at https://smartirb.org/go.

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 (SOPs) to guide implementation of the reliance relationship among Participating Institutions.
  • A 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.

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 except the Penn State College of Medicine and Penn State Health]
Researchers at University Park and all other campus locations except Penn State’s College of Medicine and Penn State Health please contact:
Office for Research Protections (ORP) IRB
By phone at 814-865-1775
Or by email to irb-orp@psu.edu and indicate "Single IRB" in the subject line.
 
Researchers at the Penn State College of Medicine and Penn State Health please contact:
Human Subject Protection Office
By phone at 737-531-5687
Or by email hspo@pennstatehealth.psu.edu and indicate "Single IRB-NIH" in the subject line.