Procedures

University of Pittsburgh IRB Reliance on Another IRB

Investigators considering requesting reliance on another IRB should contact the HRPO office early in the research proposal process.  Decisions about whether to permit reliance on another IRB shall be determined by the IO, after review and recommendation by the HRPO.  The University of Pittsburgh may rely on another appropriately constituted IRB for the review of cooperative research projects under the conditions set forth below.

In deciding whether or not to rely on another IRB, the IO will consider the following criteria:

  • Whether the use of a Central IRB mechanism has been mandated by the study sponsor.
  • The number of proposed studies involved in the collaboration.
  • The anticipated level of risk associated with proposed studies.
  • The terms and conditions of the proposed IIA or RA.
  • Whether the reviewing IRB’s policies and procedures meet University of Pittsburgh standards. If the other IRB is AAHRPP accredited, then it will be presumed that the University of Pittsburgh standards are being met; however, accredited status does not in itself necessarily suffice as a basis for the IO’s decision.
  • The location where the interventional human research activities will take place.
  • The capacity of the other institution and its IRB to sufficiently be informed about the University of Pittsburgh local research context and applicable laws and regulations.
  • Approval of UPMC for any cases where the requesting IRB will be serving as the HIPAA Privacy Board.

In order to initiate discussions with the institution requesting the reliance agreement, the UOP investigator must provide the HRPO with: 1) contact information for the collaborating institution’s IRB, 2) a draft version of the agreement and standard operating procedures, and 3) a copy of the local context form.

The Director of Regulatory Affairs or his/her designee will ensure that the finalized agreement is appropriately signed by the IOs for the involved institutions. Copies of all agreements will be maintained in the Regulatory Division of the HRPO.

In order to maintain an accurate record of studies being done at the institution, as well as to manage required ancillary reviews, investigators are required to create an OSIRIS application utilizing the external pathway for studies that are reviewed by another IRB. A member of the Regulatory Division will acknowledge receipt of the information and activate the study to begin at UOP. Updates to the OSIRIS application are only required 1) at the time of continuing review,2) if there is a change in PI, or 3) if there is a change that affects any of the required ancillary reviews (except fiscal).

Another Institution’s Reliance on the University of Pittsburgh IRB

The University of Pittsburgh may serve as the IRB of record for review of human participant research for another institution with appropriately executed IRB Authorization or Reliance Agreements.

In deciding whether to provide IRB review for another institution, the IO will consult with the Office of General Counsel and HRPO, and make a determination based on the following criteria:

  • The number of studies being proposed under the agreement.
  • The number of sites engaged in the research.
  • 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.
  • Whether the use of a Central IRB has been mandated by the sponsor.
  • Whether adequate funding is provided to cover the additional costs associated with managing the approval and necessary IRB oversight at the other sites.
  • The University of Pittsburgh’s capacity to be sufficiently informed about the other institution’s local research context and local applicable laws and rules.

In order to initiate discussions with the institution requesting the RA, the UOP investigator must provide the IRB with: 1) contact information for the collaborating institutions’ IRBs; and 2) a copy of the proposed protocol and/or consent document (as soon as available).

Members of the Regulatory Affairs Division will work with the Office of General counsel in drafting an appropriate form of RA which will be provided to the IRB representatives at each collaborating institution for review and comment. All comments will be considered and a final version of the agreement will be forwarded for signature along with a local context form. All finalized agreements will be maintained in the Regulatory Affairs Division.

The UOP investigator is required to create an OSIRIS application for review and approval by the UOP IRB. Upon approval, member of the Regulatory Affairs Division will provide all sites with 1) the finalized protocol and applicable attachments, 2) the consent template with unlocked fields for local language to be inserted, 3) the IRB approval letter, and 4) IRB minutes (if requested).

The University of Pittsburgh will facilitate communication with the relying institution about IRB actions on the human subject research that is the subject of the Agreement, in accordance with its specific provisions of the Reliance Agreement.

Serving as IRB of Record for an Entity Without an IRB

The University of Pittsburgh IRB may serve as the IRB of record for an entity that does not have its own IRB if (a) the University of Pittsburgh is directly involved in the conduct of or funding of the human subjects research at the entity; (b) the IO approves of the arrangement in advance; c) there are no unresolved conflict of interest issues; (d) the scope of the reliance is limited to the human subject research project in which the University is directly involved, and (e) the entity enters into an appropriate form of RA or IIA with the University. Agreements will be maintained by the Regulatory Affairs Division.

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

When a non-affiliated individual investigator (whether an independent investigator or an institutional investigator) is engaged in human participant research, the University of Pittsburgh IRB may choose to extend its FWA to cover that individual’s activities. In such cases, an Individual Investigator Agreement (IIA) outlining the terms and conditions of this arrangement must be executed by the IO of University of Pittsburgh as well as the individual investigator. The executed IIAs will be maintained by the Regulatory Division of the HRPO.

 

version 12.2.2015