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West Virginia University Office of Human Research Protections
WVU Research Office

Reliance

Reliance Topics

Overview of IRB Reliance Agreements

In order to help facilitate human research by allowing investigators to avoid duplicative IRB review while at the same time protecting the rights and welfare of human research participants, WVU is willing to establish IRB reliance agreements for research involving collaborations between two or more institutions. IRB reliance agreements allow for a single IRB review for research procedures conducted by all collaborating personnel. Such agreements are limited to IRB review, and do not include ancillary committee reviews such as radiation safety, biosafety, etc. 

Reliance agreements will be processed on a case-by-case basis. Research that is not federally funded does not have a mandate for a single IRB of Record. In most cases, WVU will not serve as the Single IRB of Record for funded projects unless the WVU investigator is the prime recipient of funds. Please note: Data Use Agreements may be required whether WVU relies or serves as the single IRB of Record.

NOTE: Reliance agreements cannot be processed for the following types of projects:

  • Projects that do not meet the definition of human subjects research
  • Human subject research that qualifies as Exempt under 45 CFR 46.104
  • Projects that meet the criteria for Flex review under WVU OHRP policies. 

Reliance Agreements can include the following:

  • WVU IRB serves as the IRB of record for a study
  • WVU relies on another IRB for a study

Please note: whether a WVU PI is requesting to use WVU's IRB as the Single IRB of Record for multiple sites, or is requesting to rely on an external IRB, the PI should complete a Reliance Request Form before submitting a protocol to WVU+kc.

Please email reliance@mail.wvu.edu with any questions on this topic. 

Who approves WVU IRB Reliance Agreements?

The Institutional Official (IO) is vested with the authority to make the decision whether or not to review for or rely on another IRB. At WVU, the IO is the Vice President of Research. The IO is authorized to execute IRB reliance agreements on WVU’s behalf and may delegate this authority.

Factors that the Institutional Official (IO) will consider when deciding whether a proposed reliance agreement is appropriate:

  • Whether other IRB's policies and procedures meet WVU standards - If the other IRB is part of an AAHRPP-accredited HRPP, then it will be presumed that WVU standards are being met. However, accreditation status does not in itself necessarily suffice as a basis for the IO decision; nor does not being accredited necessarily mean WVU will not rely on another IRB.
  • Risk level of study - Can the study be reviewed using an expedited review procedure (minimal risk) or does the study require review at a convened meeting of the full committee?
  • Source of funding - Which institution is the prime awardee?
  • Location of human research activities - If research activities are not the same at both or all institutions, where will most of the contact with the research participants occur?
  • Personnel involved - Is the WVU PI able to provide appropriate coordination and oversight of the study activities? What is the expertise of the personnel? Where is the primary appointment of the PI?
  • IRB expertise - Which IRB has the most appropriate expertise to conduct the review?

How is an IRB reliance agreement documented?

  • The WVU OHRP will ensure that any required IRB reliance agreement is appropriately signed by the lOs/Delegates for both or all institutions involved and is kept on file for reference and review.
  • The WVU OHRP will facilitate communication with the relying or reviewing institution about WVU IRB actions on the Human Subjects Research that is subject to the IRB Authorization Agreement (IAA), in accordance with its specific provisions.
  • All relying WVU investigators must complete a reliance registration (CIRB) in WVU+kc for each study even though the WVU IRB won’t be conducting a standard review. This submission provides the mechanism for the WVU OHRP to collect and track administrative and compliance requirements. See "When WVU Relies on Another IRB" tab at the top of this page for additional details.
  • If a WVU investigator would like for WVU to serve as Single IRB of Record for another institution, a reliance request form and a standard IRB submission are required. Additional documentation will be needed depending upon the research roles of the other institution(s). See "When WVU IRB Reviews for Another Institution" tab at the top of this page for additional details.