Adopted by: All Campus IRB
Adoption Date: December 4, 2004
Revised: March 6, 2008
Revised: November 6, 2008
Revised: December 4, 2008
Under federal law, any institution that engages in human subject research that is either conducted or supported by the Department of Health and Human Services or various other federal agencies, must comply with 45 CFR Part 46, known as the “Common Rule.” The Common Rule requires institutions engaged in human subject research to file an assurance; most commonly this is in the form of a “Federal Wide Assurance” (FWA). The Common Rule defines “institution” as “any public or private entity or Agency (including Federal, State, and other agencies)." An FWA is a statement of principles governing the institution in discharging its responsibilities for protecting the rights and welfare of human subjects. An FWA also requires an institution to designate one or more institutional review boards (IRBs) to review human subjects protocols for compliance with the IRB’s polices and procedures and with federal regulations, where appropriate.
Not all institutions engaged in human subject research have their own IRBs to review human subject protocols. Guidance by the Office for Human Research Protections (OHRP) states that an entity that does not have its own IRB may designate another established IRB for its use, so long as that IRB agrees to the arrangement and satisfies the guidelines for knowledge of the local research context (such guidelines may be found at the following OHRP link: http://www.hhs.gov/ohrp/humansubjects/guidance/local.htm). Additionally, an institution may defer review of a protocol to another institution’s IRB to avoid duplication of effort.
In most cases, a UW-Madison IRB will agree to act as IRB of record or agree to defer review to another institution’s IRB on a protocol-by-protocol basis only. In both cases, an IRB Authorization Agreement (IAA) must be signed by institutional officials from both institutions.
Before submitting the IAA to the UW-Madison Institutional Official for signature:
Ÿ The IRB director or director’s designee will review and authorize the IAA, and
Ÿ The Human Research Protection Program (HRPP) Manager will review the IAA for completeness and accuracy.
In the case of federally funded studies, if a UW-Madison IRB decides to defer review to another institution’s IRB, the UW-Madison Federalwide Assurance (FWA) must be updated to add the other institution’s IRB. The addition of the other institution’s IRB to UW-Madison’s FWA should occur only after the IAA is fully executed by representatives from both institutions. Once the IAA has been executed by the institutional official from both institutions, the IRB office director or director’s designee should request the update of the FWA by sending a copy of the signed IAA to the UW-Madison Human Research Protection Program Manager.
If a UW-Madison IRB agrees to act as IRB of record for another institution and the protocol is federally funded or the other institution has agreed to apply the Common Rule to non-federally funded research, the UW-Madison IRB must be added to the other institution’s FWA. Generally, the addition of the UW-Madison IRB to the other institution’s FWA should occur only after the IAA is fully executed by representatives from both institutions. However, the UW-Madison will not require a fully executed IAA prior to the addition of its IRB to another institution’s FWA when the other institution:
Ÿ is applying for its first FWA, and
Ÿ has received express written permission from a UW-Madison IRB director or director’s designee to designate a UW-Madison IRB as IRB of record on its FWA.
The UW-Madison Human Research Protection Program Manager will be notified when a UW-Madison IRB director or director’s designee grants express written permission to another institution to designate a UW-Madison IRB as IRB of record on its new FWA by being copied on the email or other written correspondence.
See, UW-Madison’s Multisite Research Policy, Secs. I-IV, for a detailed explanation of the requirements for UW-Madison research studies involving non-UW-Madison institutions or personnel, including requirements relating to IAAs, Individual or Institutional Investigator Agreements and Collaborating Investigator Responsibilities Handouts.
The cases outlined below describe what actions must be taken when a UW-Madison IRB agrees to act as IRB record for another institution or defers review to another institution’s IRB.
Case 1: An outside institution without its own IRB needs to apply for an FWA and wishes to designate a UW-Madison IRB to serve as its IRB of record for review of its human subject protocols.
Required Action: The outside institution must first obtain express written permission from the UW-Madison IRB director or director’s designee to designate the UW-Madison IRB as its IRB of record in its new FWA. The UW-Madison IRB director or director’s designee must notify the Human Research Protection Program Manager when the director or director’s designee grants express written permission to another institution to designate a UW-Madison IRB as IRB of record on its FWA before the execution of an IAA. Immediately after receiving its new FWA, an IAA must be completed and signed. The UW-Madison IRB director or director’s designee must review and authorize the IAA before forwarding it to the HRPP Manager for review. The HRPP Manager will then forward the IAA to the UW-Madison institutional official for signature. Final IRB approval of activities involving human subjects that involve the institution or personnel at the institution relying on the UW-Madison IRB will be granted only after both the FWA and IAA are completed.
Case 2: An outside institution has its own FWA designating a non-UW-Madison IRB for review of its human subjects protocols, but wishes to rely solely on a UW-Madison IRB for review of a particular protocol to avoid duplication of efforts.
Required Action: Both institutions agree that the UW-Madison IRB may act as the sole IRB for purposes of review of the protocol, and an IAA must be completed and signed for the protocol. The IRB director or director’s designee must review and authorize the IAA before forwarding it to the HRPP Manager for review. The HRPP Manager will then forward the IAA to the UW-Madison institutional official for signature. If the protocol is federally funded, or if the other institution has agreed to apply the Common Rule to non-federally funded research, the UW-Madison IRB must be added to the other institution’s FWA. The addition of the UW-Madison IRB to the other institution’s FWA should occur only after the IAA is fully executed by representatives from both institutions.
Case 3: An outside institution has its own FWA designating a non-UW Madison IRB for review of its human subjects protocols, but an UW-Madison IRB decides that a separate review by the UW-Madison IRB is appropriate.
Required Action: Both the outside institution’s IRB and a UW-Madison IRB review and approve the protocol. An IAA is not required.
Case 4: A UW-Madison IRB wishes to defer review of a particular protocol or class of protocols to a non-UW-Madison institution’s IRB to avoid duplication of effort. The non-UW-Madison institution has its own FWA designating a non-UW Madison IRB for review of its human subjects protocols.
Required Action: Both institutions must agree that the non-UW-Madison IRB will act as the sole IRB for purposes of review of the protocol, and an IAA must be completed. The IRB director or director’s designee must review and authorize the IAA before forwarding it to the HRPP Manager for review. The HRPP Manager will then forward the IAA to the UW-Madison institutional official for signature. If the protocol is federally funded, the non-UW-Madison IRB must be added to the UW-Madison’s FWA. The addition of the non-UW-Madison IRB to the UW-Madison’s FWA should occur only after the IAA is fully executed by representatives from both institutions.
Case 5: A UW-Madison IRB wishes to rely on a centralized IRB review process in a multi-center trial. Centralized review involves an agreement under which multiple study sites rely in whole or in part on the review of an IRB other than the IRB affiliated with the research site.
Required Action: If a UW-Madison IRB agrees to participate in a centralized IRB review process, an IAA must be completed and signed by the UW-Madison institutional official and an official from the central IRB. If any of the protocols to be reviewed by the central IRB are federally funded, the central IRB must also be added to the UW-Madison FWA. If the agreement apportions IRB review responsibilities between the central IRB and the UW-Madison IRB, the agreement should delineate the specific responsibilities of the central IRB and the UW-Madison IRB for the initial and continuing review of the study. UW-Madison must also put in place written procedures for implementing the centralized IRB review process.
Case 6: A non-UW-Madison institution without its own FWA that does not routinely engage in federally funded research wishes to participate in a federally funded research study with the UW-Madison and defer review of the research to a UW-Madison IRB.
Required Action: Each person from the non-UW-Madison institution who is engaged in research on the protocol at the non-UW-Madison institution must take human subjects training and sign an Individual Investigator Agreement or an Institutional Investigator Agreement. The UW-Madison IRB director or director’s designee must review and authorize the Individual or Institutional Investigator Agreement, verify the individual or institutional investigator’s human subjects training and have the individual or institutional investigator sign the Individual or Institutional Investigator Agreement before forwarding it to the HRPP Manager for review. The HRPP Manager will review the Individual or Institutional Investigator Agreement and then forward the Agreement to the UW-Madison institutional official for signature. Final IRB approval of activities involving human subjects that involve personnel at the non-UW-Madison institution that is relying on the UW-Madison IRB will be granted only after the Individual or Institutional Investigator Agreement(s) are completed and signed by both parties and the individual or institutional investigator’s human subjects training is verified.
Case 7: A non-UW-Madison institution that does not have its own FWA and does not routinely engage in federally funded research wishes to participate in a non-federally funded research study with the UW-Madison and defer review of the research to a UW-Madison IRB.
Required Action: Each person from the non-UW-Madison institution who is engaged in research on the protocol at the non-UW-Madison institution must take human subjects training and receive from the Prinicipal Investigator a Collaborating Investigator Responsiblities Summary. The UW-Madison IRB director or director’s designee must verify that the collaborating investigator has taken human subjects training and has received the Summary. Final IRB approval of activities involving human subjects that involve personnel at the non-UW-Madison institution that is relying on the UW-Madison IRB will be granted only after this verification is completed.