Investigator Offboarding and Transition of IRB-Approved Research

When a Principal Investigator (PI) leaves the University of Utah, any active human subjects research under their oversight must be appropriately concluded, transferred, or restructured before their departure. Early planning is critical to help ensure participant protections, regulatory compliance, continuity of study activities, and proper management of research data.

The appropriate path forward depends on several factors, including:

Whether research activities at the University of Utah will continue
Whether participants remain actively enrolled or being followed
Whether the departing PI will maintain a University of Utah appointment
Whether a qualified University of Utah investigator can assume PI responsibilities
Whether research activities will continue at the PI's new institution
Whether identifiable data or specimens will be transferred
Whether single IRB (SIRB) requirements apply

Investigators should contact the IRB as early as possible, ideally several months before their anticipated departure date, to discuss transition plans and required submissions.

Key Questions to Consider

Before developing a transition plan, investigators should consider the following:

Examples include:
- Participant recruitment continues
- Ongoing interventions continue
- Follow-up visits remain ongoing
- Identifiable private information continues to be collected
- Data analysis involving identifiable information is ongoing
If research activities will continue, a qualified University of Utah PI will generally need to assume responsibility for the study.
Some investigators retain:
- Adjunct appointments
- Emeritus appointments
- Other approved affiliations
In these situations, the investigator may be eligible to remain involved in research activities, depending upon institutional requirements and the nature of their appointment.

However, operational responsibility for the study may still need to be transferred to an on-site faculty investigator if required by departmental, sponsor, or institutional policy.
If research activities will continue after the investigator relocates, important questions include:
- Will participants be enrolled at the new institution?
- Will identifiable data be shared?
- Will specimens be transferred?
- Will study interventions occur at both institutions?
In some situations, the project may effectively become a multisite study.
The transition plan should clearly identify:
- De-identified data only
- Identifiable data
- Coded data
- Human biospecimens
- Study records
Additional agreements and approvals may be required before transfers occur.

If you plan to share data or biospecimens outside the University of Utah, consult the Technology Licensing Office (TLO) or the Office of Sponsored Projects (OSP) early in the process to determine whether a Data Transfer Agreement (DTA) or Material Transfer Agreement (MTA) is needed.

While the IRB does not assist with establishing these agreements, it does verify that the proposed sharing is consistent with the consent and/or authorization provided by participants. If sharing is not covered under your current IRB approval, an amendment may be required. Depending on the circumstances, participants may also need to be re-consented before their information or specimens can be shared.
Additional review may be necessary if the project involves:
- Federal funding
- Industry sponsorship
- FDA-regulated research
- Certificates of Confidentiality
- Data Use Agreements
- Material Transfer Agreements
- Reliance agreements
Investigators should coordinate with the appropriate University offices before transferring any study materials.

This option may be appropriate when:
- Enrollment is complete
- No further participant interaction will occur
- Study activities at Utah have ended
Required actions may include:
- Completing all participant activities
- Finalizing recordkeeping
- Submitting a study closure request to the IRB
- Addressing sponsor closeout requirements
- Retaining records according to applicable requirements
This is often the preferred approach when research activities will remain active at Utah.

A new qualified investigator assumes responsibility for:
- Regulatory compliance
- Participant safety oversight
- Study conduct
- Continuing communications with the IRB
Required actions typically include:
- Identifying a successor PI
- Obtaining departmental approval
- Updating study personnel records
- Submitting an IRB modification identifying the new PI
- Updating sponsor and regulatory records, as applicable
The departing investigator may remain involved in the study if permitted by institutional policies and their ongoing affiliation status.
In some cases, the study remains based at the University of Utah, but the departing PI wishes to stay involved after moving to another institution.

Possible approaches include:
- Serving as a co-investigator
- Serving as an external investigator
- Serving as a consultant
- Participating in data analysis activities
Additional requirements may include:
- Updating study personnel listings
- Identifying the investigator's new institutional affiliation
- Establishing reliance or collaboration agreements if needed
- Ensuring completion of required human subjects protections training
If active research will occur at both institutions, the project may become a multisite study.

Examples include:
- Participant enrollment occurring at both sites
- Follow-up activities occurring at both sites
- Data collection occurring at multiple institutions
Additional considerations may include:
- Determining whether single IRB requirements apply
- Establishing reliance agreements when appropriate
- Clarifying local responsibilities for each site
- Updating grant and sponsor documentation
Investigators should work with both institutions and the reviewing IRB as early as possible to determine the appropriate oversight structure.
Sometimes the departing investigator plans to continue scholarly activities at the new institution but does not intend to continue human subjects research interactions there.

Examples include:
- Statistical analysis
- Manuscript preparation
- Secondary research activities
In these situations:
- A new Utah PI may continue oversight of the active study.
- The departing investigator may receive only de-identified data, when appropriate.
- Data sharing requirements and institutional approvals must be addressed before transfer.
The transfer of identifiable information typically requires additional review and approvals.

Federal single IRB requirements may become relevant when:

More than one institution is engaged in human subjects research
Federally funded research involves multiple participating sites
New research activities are initiated at the investigator's new institution

Questions to evaluate include:

Is the new institution engaged in the research?
Will participants be recruited or consented there?
Will interventions or interactions occur there?
Is identifiable data being received for research purposes?

Not all collaborations create a multisite study, but investigators should consult with the IRB to determine whether reliance agreements or sIRB arrangements are needed.

Institutional Review Board

Investigator Offboarding and Transition of IRB-Approved Research

Key Questions to Consider

Common Transition Scenarios

Single IRB Considerations

Checklist for Investigators Prior to Leaving the University

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