Ceding or Obtaining WWU Oversight

Human Research Protections Program

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Exempt Studies and Ceding Oversight/Reliance Agreements

By definition, studies that receive an Exemption or Not Human Participant Research (NHPR) determination are exempt from HRPP/IRB review, approval, and oversight. Thus, because the WWU HRPP does not maintain or assume oversight for exempt studies, it cannot serve as the institution of record for a reliance agreement to provide oversight for non-WWU affiliates for studies determined as Exempt/NHPR.

If a non-WWU collaborator serves as primary investigator and you will go through their HRPP/IRB: If that institution does not have the same policy as stated above and will serve as the IRB of record for the Exempt study, the WWU HRPP can sign an agreement to rely on the other institution (that is, the other institution maintains oversight).

If you (WWU affiliate) will serve as primary investigator and are submitting to the WWU HRPP: If another institutional HRPP/IRB asks for documentation for your co-investigator to participate in a project that the WWU HRPP has determined as Exempt, you may provide them with the formal WWU HRPP exemption determination letter. You may also request that the WWU HRPP determination letter acknowledge your co-investigator as a partner in the project; however, that statement does not indicate oversight or approval for that individual to participate in the project.

Non-Exempt Research Collaborations and Transferring Protocols

If you are a WWU affiliate working with co-investigators at another institution or a new WWU affiliate, you may wonder how to navigate multiple HRPPs or IRBs. Some institutions might require their investigators to go through their HRPP or IRB, in which case, you'd ask the WWU HRPP to cede oversight to the other institution. If that institution does not have a strict policy about oversight, you and your co-investigator(s) should discuss which HRPP/IRB process would work best for your project. Or your co-investigator(s) might request that their institution cedes oversight to the WWU HRPP.

Different institutions might have different requirements for review with varying timelines, so plan ahead to ensure the smoothest process for starting or continuing your research. Remember: WWU affiliates may not join a research project under another institution's oversight without obtaining WWU HRPP authorization first.

NOTE: To this point, projects federally funded by Common Rule agencies/sponsors (e.g., NIH, NSF) have required Single IRB (sIRB) review, meaning that one IRB (or HRPP) of record conducts the ethical review for all sites participating in a multi-site, collaborative human participant research study. However, this federal guidance is no longer posted on the official websites.

Ceding Oversight to a Non-WWU Institution

IMPORTANT: You may not join any aspect of the project until you have received formal notification from the WWU HRPP that it will cede oversight to the other HRPP/IRB of record.

  1. Discuss the institutional HRPP/IRB requirements, timeframe, and other details with your co-investigator to fully understand that institutional review and approval process.
  2. After the other institution has issued final approval, submit all final protocol materials by email to the WWU HRPP for consideration:
    1. Institutional approval letter with protocol number
    2. Entire final, approved protocol application form
    3. All final, approved supplemental materials (as applicable): recruitment materials, screening forms, consent documents, instruments, etc.
  3. Find out and notify the WWU HRPP what documentation (e.g., email, letter, IRBAA) the other institution requires to acknowledge that WWU agrees to cede oversight.
  4. If it is the policy of the other institutional HRPP/IRB to provide oversight for Exempt studies, the WWU HRPP will cede oversight through a reliance agreement if requested. The WWU HRPP will not assume oversight in a reliance agreement for Exempt studies.

Your co-investigator(s) should consult with their HRPP/IRB to determine that institution's requirement or preference for documentation, then notify the WWU HRPP which of the following will be needed: 

  • Email permission notification: Email from the WWU HRPP/IRB office that an institution is aware that their affiliate will be participating in a research project for which another IRB/HRPP maintains oversight.
  • Formal letter: Letter signed by the WWU HRPP Administrator indicating permission for the WWU affiliate to participate in a research project for which that insititution's IRB/HRPP maintains oversight.
  • IRB Authorization Agreement (IRBAA): A formal agreement between the two institutions (the relying institution and the institution ceding oversight) outlining the nature of the agreement and signed by institutional officials or their authorized designees. You can see a sample IRBAA template on the Consent and Other Templates page.

Request for WWU HRPP to Assume Oversight: Non-Exempt studies only

  1. Discuss the WWU HRPP/IRB requirements, timeframe, and other details with your co-investigator to fully understand the review and approval process.
  2. Contact the other institution to determine their requirements and process for ceding oversight.
  3. Your co-investigator must wait to begin any aspect of the project until their institution has provided appropriate documentation to the WWU HRPP.
  4. Your co-investigator is obligated to follow all WWU and HRPP policies and procedures during the course of the study.

Non-WWU non-academic affiliate as study team member

If a co-investigator or study team member is an independent researcher or part of an organization without an HRPP/IRB, and if a funding sponsor requires HRPP/IRB documentation to include that individual, the WWU HRPP may agree to extend the Exempt determination to that non-affiliate. In such cases, the WWU investigator must submit a signed Non-Affiliated Research Personnel Attestation for Exempt Studies form. (Wet signatures are required.) Through this form, the non-affiliate agrees to comply with all  WWU HRPP policies and procedures in the conduct of the research study.

The WWU HRPP will accept an email or letter by authorized HRPP/IRB staff of the institution ceding oversight, unless that institution requires a formal IRBAA.

The letter should state that the institutional HRPP/IRB has read the approved protocol materials, cedes oversight to the WWU HRPP, and gives permission for the co-investigator to join the study.

New WWU Affiliates Transferring Protocol(s) to WWU HRPP Oversight

For new to the WWU faculty, staff, or student body—Welcome! We're glad you're joining us and look forward to supporting your research endeavors. These steps will help ensure you remain in compliance with your previous institution's and WWU's policies and procedures:

  • Determine whether your current/former institution has a policy for transferring oversight to another institution and follow all procedures.
  • For any open or ongoing studies currently under institutional oversight, pause all recruitment, data collection, or other research activities until the WWU HRPP can establish oversight over these projects. (If pausing the project could elevate risk to participants, contact the HRPP right away to discuss options.)
  • Submit the form to Transfer an Ongoing Protocol to WWU HRPP Oversight. You will need to include
    • Approved protocol application and approval letter
    • All supporting documentation (recruitment materials, consent forms, etc.)
    • Current (within the past 5 years) CITI training

The WWU HRPP Administrator will assess your project to ensure it meets WWU HRPP standards for ethical human participant research and issue a new protocol number and approval letter for the project. Be sure to review and follow all post-approval protocol management requirements.

If you have questions at any stage, we're happy to assist.

Departing WWU Affiliates Transferring a Protocol(s) to Another Institution

If you are a primary investigator who will be joining another institution, you will need to arrange to transfer oversight of any open, non-Exempt protocols. First determine whether your new institution has a process for assuming oversight of your projects. Then discuss any raw data transfer considerations with your department chair or dean (e.g., for example, whether any raw data needs to remain at WWU or whether any highly sensitive data require special handling).

If the new institution requires any communication or documentation from the WWU HRPP, please let us know as soon as possible, so that we can assist your transition. Otherwise, notify us of your timeline, so that we can close your WWU HRPP project file.