博彩网站 as the Relying IRB or the Reviewing IRB

In most cases, the 博彩网站 IRB will waive oversight to an External IRB; however, we will generally NOT agree to be reviewing IRB (i.e., the single or central IRB) for multi-site studies. The 博彩网站 IRB can help researchers determine whether an External IRB can be used, and which type(s) of agreement will be needed between 博彩网站 and the other institution.

See the Working with Other IRBs section of the IRB FAQs page for further information.

Note: The 博彩网站 PI and study team still have responsibilities to the 博彩网站 IRB even when 博彩网站 relies on an external IRB. These include submitting and maintaining the study in the 博彩网站 eIRB, ensuring 博彩网站 consent and ancillary review requirements are met, and completing 博彩网站 training. Before the study may start both the external IRB and the 博彩网站 IRB office must sign off on the study.

When 博彩网站 is the relying IRB

In most cases, the 博彩网站 IRB will waive oversight to an External IRB. The final decision to waive oversight occurs during the review of the 博彩网站 eIRB submission. When 博彩网站 is acting as the relying IRB, there must are two kinds of reliance agreements that can be used:

  • IRB Authorization Agreement (IAA)
  • Memorandum of Understanding (MOU, e.g., the SMART IRB Agreement)

For more information on these reliance agreements, see IAAs, IIAs, and MOUs and SMART IRB.

博彩网站 PI and study team responsibilities: When 博彩网站 is the Relying IRB, the responsibilities of the 博彩网站 PI and study team include:

  • Submitting the study in the 博彩网站 eIRB in addition to submitting to the external IRB
  • Promptly providing the lead PI, lead study team, or external IRB with any required information, such as the names and roles of local study personnel, local context information affecting conduct of the study at 博彩网站, and information needed for continuing review
  • Providing Conflict of Interest Management plans for any 博彩网站 study team members to the external IRB
  • Following all determinations of the external IRB
  • Following the external IRB's policies including those for reporting unanticipated problems, noncompliance, and subject complaints
  • Notifying the lead PI of any local reportable events (per the External IRB's policies)
  • Notifying the lead PI of any changes, such as changes in personnel, funding, or Conflict of Interest Management plans

When 博彩网站 is the reviewing IRB

The 博彩网站 IRB will only agree to act as the reviewing IRB under specific circumstances. Research where 博彩网站 may agree to be the reviewing IRB includes:

  • Research involving a single collaborator with limited study activities at another institution, for example:
    • Collaborators are receiving identifiable data or specimens
    • A former 博彩网站 faculty member that would like to continue data analysis while working at their new institution
  • Local/regional collaborations, including research under the respective MOUs with Kaiser, Portland State University, or Oregon State University
    • Whether 博彩网站 will be the reviewing IRB (vs. one of the collaborators) will be decided during the review process
    • The reviewing IRB will be chosen based on multiple factors, such as where the lead PI is and where the bulk of research is occurring
  • Research where 博彩网站 personnel will be conducting the study procedures at another institution

If you are not sure that your research clearly falls into the above categories, contact us at IRBReliance@ohsu.edu to ask whether the 博彩网站 IRB can be the reviewing IRB for your study. These requests will be reviewed by the IRB Chair.

When 博彩网站 is acting as the reviewing IRB, the following reliance agreements can be used:

  • Individual Investigator Agreement (IIA)
  • IAA
  • MOU

For more information on these reliance agreements, see Collaborations – Non-博彩网站 Researcher Decision Tree (Quick Guide) or IAAs, IIAs, and MOUs.

博彩网站 PI and study team responsibilities: When 博彩网站 is acting as the reviewing IRB, the responsibilities of the 博彩网站 PI and study team include:

  • Promptly responding to questions or requests for information about external collaborators
  • Collecting any information from external collaborators the 博彩网站 IRB requires for review
  • Providing the external collaborators with the 博彩网站 IRB policies (including policies for reporting unanticipated problems and noncompliance)
  • Providing the external collaborators with the 博彩网站 IRB approved versions of pertinent study documents
  • Notifying external collaborators of pertinent 博彩网站 IRB determinations for initial review, continuing review, modifications, and reportable events
  • Promptly reporting to the external collaborators any unanticipated problems involving risks to subjects or other issues that may affect subject participation