Single IRBs and IRB Authorization Agreements

 

Effective January 25, 2018, the NIH has 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 January 20, 2020, OHRP 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).

Authorization Agreements

An authorization agreement refers 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.

Researchers seeking to rely on the IRB of another institution or have Penn State's IRB serve as the reviewing IRB for another institution must have an IRB authorization agreement. These agreements are executed between a Reviewing IRB and one or more Relying Institutions and delineate the roles and responsibilities of the involved parties. The agreements can be for a single research study or for multiple studies (e.g., a master reliance agreement). The authorization agreement is negotiated and finalized by the Penn State IRB and reviewed by Penn State’s legal counsel, as needed. 

Authorizations agreements do not replace the need for IRB approval. Even with an authorization agreement, researchers must still obtain IRB approval from the reviewing IRB 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.

Requesting an Authorization Agreement

To request an authorization agreement, email the completed Reliance Request Form along with a copy of the grant proposal, if applicable, to the appropriate contact listed below. Indicate “Single IRB” in the subject line.

If needed for a grant proposal, please submit the request at least one (1) week before the grant submission deadline.

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, there is still a need to request an authorization agreement. Determinations are made on a case-by-case basis. Penn State will not do authorization agreements for research determined to be exempt.

 

Note:  It is not uncommon for new authorization agreements 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].

sIRB Review Process

sIRB review is more than just an IRB review. It includes other components, such as those depicted in the image below.

sIRB Review 1.png

sIRB vs Local Review

The image below depicts the different responsibilities of the sIRB compared to the local institution. 

sIRB vs local 1.png

Multi-Site Research

Multi-site studies use the same research procedures (i.e., protocol) outlined in a single protocol that is carried out at multiple institutions.

Examples of Multi-site Research

  • Protocols implemented at multiple locations that address the same research questions, involve the same methodologies, and evaluate the same outcomes, such as clinical trials
  • Sites that are accruing research participants for studies that are identical except for variations due to local context consideration

Cooperative Research

Cooperative or collaborative research is where two or more institutions coordinate to complete a portion of the research outlined in a protocol at their respective locations.

Examples of Cooperative Research

  • A study where one institution gathers the data and another institution analyzes the data
  • Protocols that are split between institutions, where one institution may collect a portion of the data, and another institution collects a different portion of the data

Relying on Other Institutions

Policies regarding willingness to serve as a Reviewing IRB are specific to each institution. To request that an institution’s IRB serve in this capacity, work with the IRB at that institution (and the principal investigator at that institution, if applicable) to confirm their policy before proceeding. 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 human subject research study in question.

The section entitled, ‘Reliance on an External IRB for Review of Human Subject Research Studies’ in the  Investigator Manual (HRP-103) provides the 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. Visit the CATS IRB Help Center to review the "External IRB Subissions" job aid for more information about who Penn State will rely on. 

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

SMART IRB

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.

Both IRB Offices at Penn State are signed on to the SMART IRB Agreement as Participating Institutions. 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]