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Human Research Activities Performed At Other Institutions

Background

All research activities performed by or under the direction of UCI personnel in the course and scope of University duties, or which use University resources, must comply with applicable UCI policies and procedures, regardless of funding and whether performed in UCI facilities or at offsite locations.

Requirements for Approval of Offsite Research

Any human subjects research conducted in whole or in part offsite, including research at UCI affiliated institutions, must be reviewed and approved/registered by all applicable UCI entities prior to initiation if it satisfies any of the following criteria.

  1. It is conducted by or under the direction of UCI personnel in connection with his or her UCI responsibilities.
  2. It uses UCI property, facilities, or resources to support or carry out the research.
  3. The name of the University of California, Irvine is used in applying for funds (intra or extramural).
  4. The name of the University of California, Irvine is used in explanations and/or representations to subjects.
  5. The investigator plans to use his/her University of California, Irvine association in any publication or public presentation resulting from the research.
  6. UCI's non-public information will be used to identify or contact human research subjects or prospective subjects.

The UCI IRB may approve/register human subjects research that is proposed to occur at or in collaboration with offsite locations when appropriate documentation demonstrating the support and collaboration of the offsite location(s) and compliance with federal requirements is provided.

The documentation necessary for UCI approval/registration of offsite human subjects research is dependent upon several factors, including but not limited to the degree of risk to subjects, UCI's relationship with the site, the source of funding for the research, and the degree of responsibility UCI personnel will assume. See the campus Offsite Research Activities policy for detailed information.

Relying on Other IRBs

Background

Current UCI policy requires that all faculty, staff, and students must have UCI IRB approval before they begin research with human subjects. This requirement applies regardless of the source of funding and even when no funds are involved, regardless of the site of the study activities.

To facilitate human research and in response to requests by investigators for a more streamlined IRB review process UCI has entered into agreements for multi-UC campus research, for research conducted at Children’s Hospital of Orange County, and for research reviewed by the NCI Central IRB.

The purpose of this guidance is to help UCI investigators determine in which cases they may rely on another IRB to review their human research.

Definitions

Reliance agreement is a formal, written document that provides a mechanism for an institution engaged in research to delegate IRB review to an IRB of another institution. Institutions may use different descriptive terms, (e.g., reliance agreement, cooperative agreement, IRB authorization agreement (IAA), or memorandum of understanding (MOU)). Agreements may cover single studies, categories of studies, or all human subjects research under an organization’s Federalwide Assurance (FWA).

Reviewing IRB is the IRB that conducts initial and continuing reviews, and will review modification to approved protocol and unanticipated problems or adverse events that may arise. The Reviewing IRB will have the authority to suspend the research for failure to comply with conditions of approval or regulatory requirements.

The Reviewing IRB will notify the federal or funding agencies of these events consistent with their policies and procedures and copy the Relying IRB on any such correspondence. The Reviewing IRB will serve as the IRB of record. The IRB may refuse, on a case-by-case basis, to serve as the IRB of record for another location.

Relying IRB will rely on the IRB review of the Reviewing IRB. The IRB may refuse, on a case-by-case basis, to rely on the review of another IRB.

IRB Reliance Agreements

UCI has developed several IRB Reliance Agreements that may allow UCI IRB to defer IRB review to another institution. 
Refer to the specific webpage for more detailed information about each IRB Reliance Agreement as found on IRB Partners and Affiliates.

UCI will also consider relying on another institution for IRB review on a protocol by protocol basis when a UCI investigator is engaged in human subjects research with a non-UC investigator and:

  • The non-UCI investigator is the prime recipient of the funding award, or
  • The PI of the study is affiliated with the Reviewing IRB’s institution, or
  • The research will primarily take place at the Reviewing IRB’s institution, or
  • The other institution’s reviewing IRB is more properly constituted to review a certain scope or topic of work, or may have knowledge of the local research context, and
  • The UCI investigators will conduct human research activities that involve no more than minimal risk to subjects, and
  • No UCI research team member has a disclosable financial interest that would require review by the UCI Conflict of Interest Oversight Committee (COIOC). 

UCI will establish an IRB Authorization Agreement with the Reviewing IRB’s institution. The UCI Investigator will need to register the human research study with UCI IRB prior to initiating the research. Also, accepting the review of another IRB does not eliminate the UCI investigator’s responsibility to seek approval from other applicable UCI regulatory entities (e.g., Institutional Biosafety Committee, Radiation Safety Committee, and Human Stem Cell Research Oversight Committee). Please contact the HRP staff for more information.

The investigator must fill out the IRB Reliance Registration Form and submit a copy of the IRB approved protocol, consent document, assent form, and recruitment material(s) (when applicable) and the IRB approval letter from the Reviewing IRB. The UCI IRB will then make a determination as to whether it is appropriate to defer to another IRB, and will notify the investigator of the decision.

Note: For submissions under the UC Campuses MOU only, the UCI IRB will obtain copies of the Reviewing IRB’s approved documents via the UC IRB Reliance Registry.

When Can the UCI IRB Serve as the IRB of Record for non-UC entity?

The UCI IRB primarily serves as the IRB for UCI. In general, UCI cannot be considered the IRB of record for non-affiliated institutions or investigators. However, there are a few exceptions and the conditions where the UCI IRB can as the IRB for institutions not affiliated with the University.

UCI is the prime awardee on the award/contract: The IRB will agree to be the IRB of record if and only if the scope of human research activities conducted at the collaborating site are considered minimal risk and discussed in the UCI IRB Application. If the risk is greater than minimal, the site engaged in human subject research must obtain its own Federalwide Assurance (FWA) and designate a registered IRB, or register its own IRB. For more information on securing a FWA go to OHRP Federalwide Assurance web page.

Non-Affiliated Institutions: UCI IRB can be the IRB of record if the institutions complete an IRB Authorization Agreement. The research may begin only after the Institutional Officials at the respective organizations have signed the IRB Authorization Agreement. Because these agreements are handled on a protocol-by-protocol basis, contact the HRP Staff to discuss the details of the proposed study.

Non-Affiliated Individual Investigators: UCI can be the IRB of record if the individual investigator signs an Individual Investigator Agreement. This document requires various assurances of the individual investigator, as well as the signature of the FWA Institutional Official. Because these agreements are handled on a protocol-by-protocol basis, contact the HRP Staff to discuss the details of the proposed study.

Research does not involve an award/contract: The IRB may agree to be the IRB of record if and only if the human research activities conducted at the collaborating site are considered minimal risk and discussed in the UCI IRB Application. Because this type of research is handled on a protocol-by-protocol basis, contact the HRP Staff to discuss the details of the proposed study.

IMPORTANT NOTE: If the risk is greater than minimal, the location engaged in human subject research must contract with a commercial IRB.

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