Planning a Move to a New Institution?

March 2023 Issue

(Note: this article is an update of an article published in February 2015)

Author(s):

  • Matthew Ogrodnik, MS, CIP, Director, Office of Human Research Affairs
  • Thomas J. Moore, MD

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Introduction

When a researcher decides to move from one institution to another and take their research program along, there are a number of things that need to be done in order to facilitate a smooth transition.  A summary of procedures for faculty who intend to move their research activities to another institution, (including staff, grants/contracts, basic and clinical research records, animals, materials and databases, equipment, etc.), or who intend to close their lab without relocation, can be found in the Faculty Departure Checklist on the BU Research Support website.  In this article, we will discuss departure tasks that are focused on investigators who do human subjects research:  both what needs to be done and how far in advance the tasks should be started.  Knowledge about these procedures is helpful not only for researchers who are departing, but also for: 

  • Someone whose manager is departing
  • A chairperson or chief whose department or section member is departing
  • A manager who is recruiting a new researcher from another institution

Typically, a researcher might need to move grant funding, IRB-approved research and exempt human subjects research*, and the associated research data and specimens to the new institution.  Moving grant funding, getting protocols approved by the new IRB, and getting the approvals to move data and specimens can take several months.  It is recommended that the departing investigator begin the process by contacting the grants offices and the IRBs at Boston Medical Center and BU Medical Campus and at their new institution at least four months before the move date.

*To keep things simple, in this article we will refer to all active human subjects research (both exempt and non-exempt) as “IRB-approved research”.

 

I. Transferring Research Funding

Grant funding is typically awarded to an investigator’s institution, not directly to the investigator.  When an investigator with an approved grant that is within an approved project period plans to move to a new institution, they can request that the remaining funds be transferred from the current to the new institution.  The current institution then can choose to keep the grant and name a new Principal Investigator (PI) (with funding agency approval), terminate the grant, or “relinquish” it back to the sponsor.  Any unencumbered funds remaining in the relinquished grant can then be transferred to the investigator’s new institution if the sponsor and the new institution agree.

The investigator should notify the program officer at the funding agency, the grants office that is managing the grant (either BU or BMC), and the grants office at the new institution.  Details regarding the several steps in the transfer process can be found in the Faculty Departure Checklist.

The transfer of funds from an industry-sponsored award or a foundation follow the same general pattern, and starts with notification of the sponsor, the current grants office, and the grants office of the new institution.

 

II. Managing IRB-approved Protocols

A departing investigator has three options for dealing with active, IRB-approved research:

  • the study can be closed, or
  • the study can be transferred to a new PI here at BMC/BU Medical Campus, or
  • the study can be continued at the new institution. 

The second and third options above can be combined; that is, the study can be transferred to a new PI here at BMC/BU Medical Campus *and* opened/continued at the new institution if human subjects research activities will continue at BMC/BU Medical Campus and will also begin at the new institution.

Note that transferring an active study to a new institution requires IRB oversight at that institution, so this transfer process should also be started as soon as possible.

A. Closing research studies

If the departing PI has open IRB-approved research but the human subjects activities have ended, then the PI must formally close those studies (submit a Final/Closure Report in INSPIR) *before departing*. PIs are required to submit a Final/Closure Report for all active studies prior to leaving the institution, rather than simply leaving and letting the study expire or miss its check-in due date. A protocol can be closed when there is no longer any interaction with research subjects and no further analysis using their individually-identifiable data.  This means that, if the data analysis is the only task left in a protocol and the analysis can be accomplished using non-identifiable data (such as data that has been coded with a unique ID, with all direct identifiers removed), then the PI can continue to analyze the non-identifiable data and close the study with the BMC/BUMC IRB. Please see the CR TIMES Feature Article Closing Time: The Dos and Don’ts of Study Closure - Jun/Jul 2022 for more information on when a study can be closed.

The PI could also then get permission to take the coded data to the new institution where they can complete the analysis.  Analysis of non-identifiable data is not considered human subjects research, so the investigator may not need approval from the new IRB to complete the analysis.  But, they should discuss this with their new IRB in case they have an institutional policy requiring IRB review of “not human subjects research.”

The PI also retains the responsibility for maintaining research records as described in Human Research Protection Program (HRPP) Policies and Procedures Section 6.6.7.  If the study is closed before the required record retention time period, then the PI must designate an individual remaining at BMC or BU Medical Campus who will have access to study records as needed for audits or other purposes.

B.  Transferring a research study to a new PI here at BMC or BU Medical Campus:

If for some reason a departing PI’s active research study needs to be continued at BMC/BUMC, the departing PI can transfer the Principal Investigator role to another qualified researcher here. 

First, the change in PI should be approved by the study sponsor and the departing PI’s department chair.  Second, the departing PI must obtain IRB approval for the change in PI by submitting an Internal Study Personnel Change Request form in INSPIR. As part of this form, any actively-used consent form(s) and other study materials must be modified to replace the departing PI’s name and contact information with this same information for the new PI. Please note that you may *only* change the PI name and contact information as part of this Internal Study Personnel Change form; any changes to the study procedures or the content of consent forms and other study materials would instead need to be requested by the submission of a Change Request and Amendments form.

It is very important that the Internal Study Personnel Change form to change the PI is submitted *before* the original PI leaves the institution. Once the departing PI is no longer affiliated with BMC or BU Medical Campus, then their INSPIR account will be deactivated, and the study team will be unable to submit the Internal Study Personnel Change form without assistance from the IRB.

If the departing PI would like to remain part of the research, can they maintain some research role at their new institution, even if the human subjects activities are not being opened there?  The answer is “yes.”  For example, the departing PI may like to participate in manuscript writing.  Human subjects regulations do not consider manuscript writing as being “engaged in research”, so the departing PI can participate in the writing process without IRB approval at their new institution.  What if the departing PI would like to participate in data analysis?  If the departing PI will have access to identifiable subject data, then they would be considered “engaged in research.”  Since the departing PI would be engaged in research at their new institution, they would need IRB approval at their new institution.  However, working with non-identified data is not considered “engagement in research.”  Therefore, if the departing PI can do the analyses on non-identified data, then they might not need IRB approval at their new institution.  As mentioned above, they should always be sure to check with their new IRB to comply with their local institutional policy for this situation. 

Whether the data that would be transferred to the new institution are identifiable or non-identifiable, the BMC/BUMC IRB and our local institutions (either BU or BMC, whichever is managing the grant for the study) must approve the transfer of the data to the PI at their new location. See section III below for more details. 

C.  Moving an active human subjects research study to the new institution:

This requires getting IRB approval (or an IRB exempt determination) for the study at the new institution, getting permission to take BMC or BU Medical Campus data to the new institution, and, if human subjects activities are not continuing at BMC or BU Medical Campus, closing the protocol here at BMC/BUMC.

The departing PI should contact the new IRB as far in advance of the move as possible. Often, the departing PI does not yet have a formal appointment at the new institution.  The new institution may have policies about whether a not-yet-appointed faculty member can obtain IRB approval. For example, at BMC and BU Medical Campus, the BMC/BU Medical Campus IRB will permit incoming investigators to start working on their IRB submission(s) in the electronic INSPIR system as soon as they have been given a BMC or BU Medical Campus email/username (as this is needed to access INSPIR). The BMC/BU Medical Campus IRB will not grant final approval until the incoming PI officially begins their appointment at BMC or BU Medical Campus, but in this interim period, they can start working on the submission. Or, if they have a trusted collaborator already here at BMC or BU Medical Campus, then that affiliated individual can be named as PI for the IRB review process. In this instance, IRB approval could be granted with the BMC or BU Medical Campus-affiliated collaborator as PI, and the incoming PI can then be changed to PI via the submission of the Internal Study Personnel Change form once their appointment at BMC or BU Medical Campus begins.

When the PI is departing BMC or BU Medical Campus, it may be necessary to keep the protocol open here at BMC or BU Medical Campus (transferring the PI role to a new PI as of the date the departing PI has left) to be sure there are no interruptions in the protocol for subjects who are still active.

Finally, either the departing PI, or the PI who was newly-assigned to manage the protocol for the departing PI, should close the protocol with the BMC/BUMC IRB as soon as all research here has ended.

 

III. Moving Research Data and Samples

As mentioned above, data and biological samples that are generated as part of a research study belong to the responsible institution.  Here at BMC and BU Medical Campus, the “responsible institution” is either BU or BMC, depending on which institution was the awardee of the research grant for the study (which is in nearly all cases the home institution of the PI).  If the research was unfunded, the responsible institution is similarly  the home institution of the PI.  To move research data or biological samples to a new institution, the PI needs the permission of the responsible institution. When BMC is the home institution, departing PIs must contact DUA.MTARequest@bmc.org to discuss requirements for moving data or samples to a new institution. When BU Medical Campus is the home institution, departing PIs must review the requirements for Data Use Agreements and Material Transfer Agreements, and complete those forms and/or contact those offices as needed.

Prior to leaving BMC or BU Medical Campus, PIs must also reach out to the IRB at medirb@bu.edu to open a discussion about whether the current IRB approval(s) covers moving research data and samples to the new institution. Release of data or specimens must either be consistent with the original consent form and HIPAA authorization, or a new consent and authorization must be obtained. Confidentiality protections must be adequate at the new institution, and the approval of the IRB from the new institution must be obtained according to its policies for review of research involving analysis of data or specimens.

 

IV. ClinicalTrials.gov Responsibilities

If the departing PI has one or more studies registered on ClinicalTrials.gov (CTgov), then the CTgov record(s) may need to be transferred to the PI’s new institution. If, for example, BU or BMC was the prime awardee of a federal grant that is funding a study registered on CTgov, and the grant is being transferred to the new institution, then the CTgov record will also need to be transferred, per CTgov policies.

Conversely, if the CTgov registration record will remain at BMC or BU Medical Campus, then the new PI who takes over the study will need to be informed of their responsibilities related to the CTgov record.

Departing PIs who have studies registered on CTgov must contact the BMC/BUMC PRS Administrator Karla Damus (damusk@bu.edu, 617-358-5337) to discuss how their move to a new institution will affect their existing CTgov record(s).

 

Conclusion

Changing institutions is a big decision, with many moving pieces. if you want to minimize disruptions and down-time for your human subjects research during and after the move, then remember what needs to be done to move grant funding, research protocols, research data, and specimens … and start the planning process as far in advance as possible! By following the steps above and carefully completing all steps on the Faculty Departure Checklist, you will be able to successfully navigate the move to a new institution, while simultaneously maintain compliance with local HRPP policies and procedures for leaving BMC or BU Medical Campus.