Planning a Move to a New Institution?February 2015 IssueBy Thomas J. Moore, MD,
IntroductionWhen a researcher decides to move from one institution to another and take her research program along, there are a number of things that need to be done to allow this move to occur smoothly. A summary of Faculty Departure Procedures can be found on the BUSM Faculty Central 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:
Typically, a researcher might need to move grant funding, IRB-approved research, and 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 BUMC and at her new institution at least four months before the move date.
I. Transferring Research FundingGrant 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, she 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 PI (with funding agency approval), to terminate the grant, or to “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 Procedures document. 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 ProtocolsA departing investigator has three options for dealing with active, IRB-approved protocols:
An investigator must choose one of these options for each active protocol. To transfer a protocol to a new institution requires IRB-approval at that institution, so this transfer process should also be begun as soon as possible. A. Closing protocols If the departing PI has open IRB-approved protocols for which the research has been completed, the PI should formally close those protocols (submit a Final Report in INSPIR) before departing. A protocol can be closed when there is no longer any interaction with research subjects or analysis using their personally-identifiable data. This means that, if the data analysis is the only task left in a protocol and if the analysis can be accomplished using de-identified data, then the PI can de-identify the data and close the protocol with the BUMC IRB. She can then get permission to take the de-identified data to the new institution where she can complete the analysis. Analysis of de-identified data is not considered human research, so the investigator may not need approval from the new IRB to complete the analysis. But, she should discuss this with her new IRB in case they have an institutional policy requiring IRB review of “not human subjects research.” B. Transferring a protocol to a new principal investigator here at BU or BMC: If for some reason a departing PI’s active research protocol must be continued at BUMC, the departing PI can transfer the principal investigator role to another qualified researcher here. First, the change in principal investigator should be approved by the study sponsor and the departing PI’s department chair. Second, the departing PI can name the new protocol PI using the Internal Study Personnel Change Request in INSPIR. After the new PI has been named, that new PI should submit an amendment to the protocol, making any necessary modifications to the consent form such as whom research subjects should call if they have questions about the research. Those changes are made through a formal amendment in INSPIR. But if the departing PI would like to remain part of the research, can she maintain some research role in her new institution? The answer is yes. For example, the departing PI would 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 her 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 she would be considered “engaged in research.” Since the departing PI would be engaged in research at her new institution, she would need IRB approval at her new institution. However, working with de-identified data is not considered “engaged in research.” So if the departing PI can do her analyses on de-identified data, she might not need IRB approval at her new institution. But she should check with her new IRB to be sure of their local policy for this situation. Whether the data that would be transferred to the new institution are identifiable or de-identified, the 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 her new location. See section III below for more details. C. Moving an approved protocol to the new institution: This requires getting IRB approval for the protocol at the new institution, getting permission to take BUMC data to the new institution, and closing the protocol here at 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. In the meantime, it may be necessary to keep the protocol open here at BUMC (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 BUMC IRB as soon as all research here has ended.
III. Moving Research Data and SamplesAs mentioned above, data and biological samples that are generated as part of a research study belong to the responsible institution. Here at BUMC, the “responsible institution” is either BU or BMC, whichever institution was the awardee of the research grant for the study. If the research was unfunded, the responsible institution is whichever would manage the PI’s research grants, if there were any. To move research data or biological samples to a new institution, the PI needs the permission of the BUMC responsible institution. A. Research data: The BUMC IRB must review the request to move data and for what purpose. The IRB will also assure that the consent form and HIPAA authorization that the research subjects agreed to and under which the data were collected, allow the data to be moved to a new institution (most often, consent and HIPAA authorizations do not mention this possibility). The IRB has the authority to require that the research subjects whose data would be moved should be re-consented and grant new HIPAA authorization before their data can be moved. Assuming the consent form does not preclude moving the data, there are several ways of meeting the HIPAA requirements:
The original data themselves, in whatever form (paper notebooks, spreadsheets, medical records, etc.), are the property of the “responsible institution.” Once permission to transfer the data is obtained, the departing PI and the BUMC institution need to agree on whether the original files or copies of those files can be moved. Typically, the BUMC institution will retain the original data so it can comply with the data retention commitment it made to the research sponsor, FDA, or other agency. It is the departing PI’s responsibility to copy the files and to leave the originals, in good order, with the BUMC institution. B. Transfer of human biological samples: A material transfer agreement (MTA) is the legal agreement that covers the transfer of samples to the new institution. The MTA establishes that the samples and intellectual property rights are still “owned” by the BUMC responsible institution. A typical MTA establishes exactly what samples are being transferred, the type of research the samples can be used for, who can use them, liability and indemnification language, and that the new institution will make no effort to identify the subjects who provided the samples. Both the MTA and an agreement about the transfer of any accompanying subject data must be completed before the samples can be moved. See Pat Bass’s June, 2013 article in the Clinical Research Times for more information about limited data sets, data use agreements, and MTAs.
ConclusionMoving to a new institution is a big decision. There are so many things that need to be done. Medical licensure in your new state? Hospital credentialing? Finding a place to live? But, if you want to minimize disruptions and down-time for your research 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! Acknowledgements: I would like to express thanks to Patricia Bass, Ellen Jamieson,Diane Baldwin, and John Ennever for their advice and guidance in the preparation of this article.
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