Transfers of IRB Oversight and PI Institutional Affiliation Changes
Transfers between the UW IRB and a non-UW IRB
In most cases, one IRB will have oversight of a research project throughout the life of the study. However, in some circumstances, it becomes necessary to transfer oversight of the research to a different IRB. This transfer from one institution’s IRB to another’s can happen for a variety of reasons, for example when:
- The ongoing activities become subject to a single IRB requirement and a different IRB will assume the role of the single IRB.
- The institutional affiliation of the PI changes and the IRB of their new institution will assume oversight.
- The organization that runs the IRB is acquired by another organization whose IRB will assume oversight of the research.
It is important to ensure that ongoing activities with human subjects have the appropriate IRB oversight throughout the transfer process and after the receiving IRB assumes oversight. Issues that should be addressed can vary depending on the research, but typically include:
- Ensuring the availability and retention of IRB review records,
- Establishing an effective date for transfer of oversight,
- Determining what kind of review the receiving IRB will perform before it accepts responsibility for the research,
- Identifying any IRB reliance agreements that need to be put in place,
- Determining whether information about the transfer should be given to current or former subjects,
- Notifying the key parties such as funding agencies or FDA sponsors.
HSD’s Reliance Team manages the transfer process between the UW IRB and non-UW IRBs, as well as the reliance process when a UW research project is transferred between two non-UW IRBs. HSD strongly recommends consulting with the Reliance Team at email@example.com prior to submitting any materials in Zipline or modifying applications when an investigator becomes aware of a potential transfer of IRB oversight.
Transfers between UW IRBs
UW operates four IRBs each with their own DHHS registration number. The overwhelming majority of studies reviewed by UW IRBs are reviewed by the same IRB throughout the life of the study, however, on occasion, due to one IRB having greater capacity or expertise or a change in the departmental affiliation of the PI, a study may be temporarily or permanently transferred to another IRB or one or more submissions (e.g. a modification or continuing review) will be reviewed by another IRB. The decision to transfer between UW IRBs is made exclusively by HSD staff and leadership. There is no role for study teams in this decision or in accomplishing this transfer. Temporary transfers are documented by indicating the letter designation of the IRB that reviewed the submission. The assigned IRB/HSD team designation in Zipline does not change. Permanent transfers are documented in Zipline by a change to the assigned IRB/HSD team designation in Zipline, and research teams are typically informed in advance or at the time of the permanent transfer. Research teams are responsible for notifying other offices or organizations (e.g. the funding agency, the FDA, the FDA sponsor, etc.) of the change in IRB oversight and registration information if required by those organizations. To reduce the need for updating IRB registration information, HSD recommends that research teams list all four UW IRB registration numbers in documents related to IRB registration that are required by other organizations.
PI Affiliation Changes
Investigators may be employed by different institutions throughout their career. When investigators with active human subjects research change employment status or other institutional affiliations, that change often has implications for the continued IRB oversight of the research. When activities with human subjects are ongoing, it is important to ensure that the activities have the appropriate IRB oversight throughout the course of the study. Many investigators may retain an unpaid affiliate appointment at UW after becoming employed at another institution, however affiliate status does not automatically qualify an investigator to continue to use of the UW IRB or to serve as the PI for activities conducted by UW employees. As investigators move between institutions, the IRB oversight requirements change as activities and funding start at new institutions and/or end at other institutions.
- Whether the change in employment will lead to changes in how the research will be conducted or who will serve as PI, either temporarily or permanently. Many investigators may retain an unpaid affiliate appointment at UW after becoming employed at another institution, however affiliate status is typically insufficient to continue to serve as PI.
- Which IRB will review the research after the change of employment and if oversight will need to be transferred. It should not be assumed that the IRB that initially reviewed the research will continue to review the research after the investigator’s affiliation changes.
- Which institutions are engaged in the research and must obtain oversight for their activities. It is important to identify which institutions need IRB review and when that IRB review should start in relation to transferred funding or new subawards.
- Whether reliance agreements should be established between institutions, either temporarily or permanently. When the move of a research project creates a situation where two or more institutions are engaged, the IRBs at each institution may decide to review their involvement individually or may request that a reliance agreement be used to ensure that oversight is provided for all institutions. A reliance agreement allows one IRB to provide review for activities done by personnel at multiple institutions. These agreements can take some time to negotiate so they are not appropriate for every situation and require advance consultation to ensure no lapses in IRB oversight.
- Whether new determinations (e.g. exemption, not human subjects research) will need to be issued by any institution. Institutions do not typically enact reliance agreements or accept the determinations of other institutions. New determinations are often required when activities with human subjects will continue.
- Whether the transition will necessitate changes to other regulatory considerations such as registration in clinicaltrials.gov. HSD manages some aspects of compliance with federal clinicaltrials.gov registration and reporting requirements on behalf of UW. A change of affiliation may change whether HSD should continue to manage this, whether the new institution should take this over, and who the responsible party will be.
- How to accomplish the transfer with minimal disruptions to the research.
HSD strongly recommends that investigators consult with the Reliance Team at firstname.lastname@example.org as soon as they are aware that an institutional affiliation change will occur in order to prevent lapses of IRB approval and a halt of the research. The process to transfer research and/or establish reliance agreements can often take several months. If appropriate, representatives from other IRBs may be invited to consultations. Please have the following information prepared for each research project that may be affected:
- Zipline number or a brief description of the overall project,
- Current funding status and whether or not the funding structure will change (e.g. will the funding be transferred to a new institution),
- The current activities with subjects and/or identifiable data about subjects,
- Which activities will be done by UW employees or agents,
- Which activities will be done by non-UW employees or agents,
- What level of review the non-UW IRB may have reviewed the research under (e.g. exempt, expedited, full board).