Procedures for IRB Reliance Mechanisms

University of Pittsburgh IRB Reliance on an External IRB

Investigators considering requesting reliance on an external IRB should contact the Pitt HRP early in the research proposal process and submit a reliance request.  Decisions about whether to permit reliance on an external IRB shall be determined by the Pitt HRP Reliance Team. If the reliance request is not within the Reliance SOP guidelines, the review of the request will be elevated to the Pitt HRP Director and, if necessary, the IO.  The University of Pittsburgh may rely on an appropriately constituted external IRB for the review of cooperative research projects under the conditions set forth below.

In deciding whether to rely on an external IRB, the Pitt HRP Reliance Team will consider the following criteria:

  • Whether the Pitt/UPMC site is engaged in human subject research
  • Whether the use of a single IRB mechanism has been mandated by the study sponsor and/or research consortium or network.
  • Whether there is a potential institutional conflict of interest that must be managed.
  • The number of proposed human subject research projects involved in the collaboration.
  • The scope of work to be completed at the Pitt/UPMC site(s)
  • The anticipated level of risk associated with proposed studies.
  • The terms and conditions of the proposed IAA or RA.
  •  Whether the reviewing IRB’s policies and procedures meet University of Pittsburgh standards. If the external IRB is AAHRPP accredited or utilizes the OHRP QA Self Assessment Tool (https://www.hhs.gov/ohrp/education-and-outreach/human-research-protectio...), then it will be presumed that the University of Pittsburgh’s standards are being met; however, accreditation status does not in itself necessarily suffice as a basis for the  decision to permit reliance.
  • The location where the interventional human research activities will take place.
  • The capacity of the external institution and its IRB to sufficiently be informed about the University of Pittsburgh’s local research context and applicable state laws and regulations.

In order to initiate discussions with the institution requesting the reliance agreement, the Pitt/UPMC investigator must complete a reliance request and provide the Pitt HRP with: 1) contact information for the collaborating institution’s IRB; 2) a draft version of the agreement and standard operating procedures to be utilized for the project; 3) a copy of the local context form; and 4) the consent template(s) for Pitt HRP review.

The Pitt HRP Reliance Team will finalize the agreement or ensure that the finalized agreement is appropriately signed by the IO(s) for the engaged institutions. Copies of all agreements will be maintained by the Pitt HRP Reliance Team.

In order to maintain an accurate record of studies being done at the institution, as well as to manage required ancillary reviews, Pitt/UPMC investigators are required to create and submit an IRB registration application for studies that are reviewed by an external IRB. A member of the Pitt HRP Reliance Team will acknowledge receipt of the information and activate the study to begin at Pitt/UPMC. Updates to the PittPRO application are only required 1) at the time of continuing review (if applicable), 2) if there is a change to Pitt/UPMC study team and/or research site, 3) if there is a change that affects any of the required ancillary reviews (except Fiscal review), and4) In the case that IRB determinations are made of serious/continuing non-compliance, unanticipated problem involving risk to subject other others, and/or study suspension/termination.

External Institution’s Reliance on the University of Pittsburgh IRB

Investigators considering requesting reliance for the Pitt IRB to serve as IRB of Record for external institutions should contact the Pitt HRP early in the research proposal process and submit a reliance request.  Decisions about whether to permit the Pitt IRB to serve as IRB of Record shall be determined by the Pitt HRP Reliance Team. If the reliance request is not within the Reliance SOP guidelines, the review of the request will be elevated to the Pitt HRP Director and, if necessary, the IO.  The Pitt IRB may serve as IRB of Record for the review of cooperative research projects under the conditions set forth below.

In deciding whether to serve as IRB of Record, the Pitt HRP Reliance team will consider the following criteria:

  • Whether the relying site is engaged in human subject research.
  • Whether the use of a single IRB mechanism has been mandated by the study sponsor and/or consortium.
  • The number of human research projects being proposed under the agreement.
  • The number of sites that will on the Pitt IRB for regulatory oversight
  • The scope of work to be completed at the external institution(s)
  • The risk level of the study.
  • Whether the study is being conducted under an investigator-initiated IND or IDE.
  • The location where the interventional human research activities will take place.
  • If the human subject research project has Federal funding, whether the external entity obtains and/or maintains an active Federal Wide Assurance (FWA).
  • Whether adequate funding is provided to cover the additional administrative costs associated with acting as the IRB of Record for external sites.
  • The University of Pittsburgh’s capacity to be sufficiently informed about the external institution’s local research context and applicable state laws and regulations.

In order to initiate discussions with the institution(s)s that will rely upon the Pitt IRB, the Pitt/UPMC investigator must complete a reliance request and provide the Pitt HRP with: 1) contact information for the external collaborating institutions’ IRBs; and 2) the scope of work to be completed at the external site(s) and 3) a copy of the proposed protocol and/or consent document (as soon as available).

If the SMART Master Reciprocal Agreement is not being utilized with an external site because they have not joined SmartIRB, members of the Pitt HRP Reliance Team may work with the Office of University Counsel in drafting an appropriate type of RA which will be provided to the IRB representatives at each external collaborating institution for review and comment  All comments from external institutions will be considered. If the Smart Master Reciprocal Agreement is being utilized, the Pitt HRP Reliance Team will sign the agreement. All other types of agreements will be forwarded to the IO for signature. All finalized agreements will be maintained by the Pitt HRP Reliance Team.

The Pitt/UPMC investigator is required to create and submit an PittPRO application for review and approval by the Pitt IRB. Upon approval, a member of the  Pitt HRP Reliance Team will provide all sites with 1) the initial IRB approval letter for the project and IRB minutes (if requested); 2) IRB-approved materials including  the multi-site protocol and consent template(s)with highlighted fields for local language to be inserted; 3) the reliance agreement for execution; and 4) the Local Context Survey for Relying Sites.

The Pitt HRP will facilitate communication with the relying institution(s) about IRB actions on the human subject research that is the subject of the Agreement, in accordance with the specific provisions of the Reliance Agreement.

Serving as IRB of Record for an Entity Without an IRB

Pitt/UPMC Investigators considering requesting reliance for the Pitt IRB to serve as IRB of Record for an entity without an IRB should contact the Pitt HRP early in the research proposal process and submit a reliance request.  Decisions about whether to permit the Pitt IRB to serve as IRB of Record for an entity without an IRB shall be determined by the Pitt HRP Reliance Team. If the reliance request is not within the Reliance SOP guidelines, the review of the request will be elevated to the Pitt HRP Director and , if necessary, the IO.  The Pitt IRB may serve as IRB of Record for an entity without an IRB under the conditions set forth below.

In deciding whether to serve as IRB of Record, the Pitt HRP Reliance team will consider the following criteria:

  • Whether the relying site is engaged in human subject research.
  • Whether the use of a single IRB mechanism has been mandated by the study sponsor and/or research consortium or network.
  • The scope of work to be completed at the external institution(s)
  • Whether the University of Pittsburgh is directly involved in the conduct or funding of the proposed human subject research project.
  • Whether the scope of reliance is limited to the human subject research project in which the University is directly involved.
  • The IO approves the arrangement in advance.
  • There is no unresolved conflict of interest issues.
  • If the human subject research project has Federal funding, whether the external entity obtains and/or maintains an active Federal Wide Assurance (FWA).The entity enters into an appropriate form of RA or IAA with the University.

In order to initiate discussions with the institution(s) that will rely upon the Pitt IRB, the Pitt/UPMC investigator must complete a reliance request and provide the Pitt HRP with: 1) contact information for the external collaborating institutions(s) 2) the scope of work to be completed by the external entity and 3) a copy of the proposed protocol and/or consent document (as soon as available).

Members of the Pitt HRP Reliance Team may work with the Office of University Counsel in drafting an appropriate form of RA which will be provided to the entity for review and comment. All comments will be considered, and a final version of the agreement will be forwarded to the IO for signature. All finalized agreements will be maintained by the HRP Reliance Team.

Serving as IRB of Record for a Non-Affiliated Individual Investigator

Pitt/UPMC Investigators considering requesting reliance for the Pitt IRB to serve as IRB of Record for a non-affiliated individual investigator should contact the Pitt HRP early in the research proposal process and submit a reliance request.  Decisions about whether to permit the Pitt IRB to serve as IRB of Record for a non-affiliated individual investigator shall be determined by the Pitt HRP Reliance Team. If the reliance request is not within the Reliance SOP guidelines, review of the request will be elevated to the Pitt HRP Director and, if necessary, the IO.  The Pitt IRB may serve as IRB of Record for a non-affiliated individual investigator under the conditions set forth below.

In deciding whether to serve as IRB of Record for a non-affiliated individual investigator, the Pitt HRP Reliance team will consider the following criteria:

  • Whether the non-affiliated individual investigator is engaged in human subject research.
  • Whether the use of a single IRB mechanism has been mandated by the study sponsor and/or research consortium or network.
  • The scope of work to be completed by the individual investigator
  • There is no unresolved conflict of interest issues.
  • The individual investigator enters into an appropriate IIA with the University.

In order to initiate discussions with the non-affiliated individual investigator requesting the RA, the Pitt/UPMC investigator must complete a reliance request and provide the HRP with: 1) contact information for the individual investigator 2) a copy of the Scope of Work or Scope of Services document, and 3) a copy of the Community Partner Research Ethics Training (CPRET) certificate of completion  or evidence of having completed CITI training modules.

Members of the Pitt HRP Reliance Team will draft an appropriate form of IIA which will be provided to the non-affiliated individual investigator for review and signature.  All finalized agreements will be maintained by the HRP Reliance Team.

5/14/2021