By Mary A. Banks
Promise me you'll never forget me because if I thought you would I'd never leave.” ~ A.A. Milne
It’s that time of year where many faculty, staff, and students who have participated in human subjects research are moving on to new and exciting opportunities beyond BUMC. An important question that arises related to their departure is, “What should we do about our IRB protocols, research data, and samples?” Some departing investigators simply want to close out their studies here at BUMC; but more frequently, departing investigators wish to transfer their research data and/or samples to their new institutions.The purpose of this article is to describe the regulations and institutional policies and procedures that must be followed when a researcher leaves the institution, as well as what steps are necessary for the transfer of research materials (data and samples) from BUMC to another institution.
This article will be written with the presumption that the investigator departing from BUMC is the Principal Investigator (PI) listed on the IRB protocol. There are four basic “options” for EACH human subjects research protocol. Although these options are not mutually exclusive, depending on the circumstances, a combination of these options will be necessary in order to facilitate the transfer. The options that will be described in detail in this article are:
The designated PI of the study is the primary steward of the research data. He/she has control and possession of the research data and can make the research data available to other researchers as allowed by the approved IRB protocol. As the steward of the research data, it is the PI’s responsibility to ensure that the data and samples are secure, and that sufficient protections are in place so that they are not removed from the institution by anyone (including other investigators) without appropriate IRB approvals and HIPAA approvals.
In many instances, the research that was conducted by the BUMC PI has been completed and the PI has no plans to continue the research. In this case, the study should be closed, the dataset and/or samples “de-identified” or destroyed, and a final report submitted to inform the IRB that the study has been closed. Investigators should not simply leave and let the study expire. Federal regulations and institutional policy require the PI to inform the IRB of any changes in status of the study (which includes study closure and/or the PI leaving the institution).
The January 2010 CR Times Feature Article provides additional information about submitting Final Reports to the IRB.
Important points to consider:
In some cases, the BUMC PI will be leaving to go to another institution before the research has been completed here at BUMC. The main consideration is the safety and well being of the research subjects. Under these circumstances, the research protocol will need to be transferred to another BUMC PI. The “new” BUMC PI must be a member of the BUMC faculty or staff whose primary appointment is at BUMC and who has the appropriate qualifications to oversee the research. The departing BUMC PI (who is transferring to another primary institution and retaining an “adjunct faculty” appointment at BUMC) cannot continue to serve as the PI of the BUMC research protocol.
If, after transferring to a new BUMC PI, the departing BUMC PI will no longer be involved with the research, then the process is simple. The “departing” BUMC PI submits an INTERNAL STUDY PERSONNEL CHANGE FORM via INSPIR. On this form, the departing PI indicates the name of the “new” PI and removes himself/herself from the research protocol. Once this PI change is approved by the IRB, then the “new” PI takes over and is responsible for all future protocol activities and IRB submissions.
Often the “new” PI will also need to submit an amendment using the CHANGE REQUEST AND AMENDMENT FORM via INSPIR to make changes to the IRB protocol and consent forms (e.g., changing the contact information for the PI in the ICF, etc.)
Important points to consider:
Option #3 – Departing PI Wishes to Move the Study in Its Entirety to the New Institution
The study cannot be transferred to the new institution until IRB approval has been obtained at the new institution. Since the departing BUMC investigator’s primary appointment will be at the new institution, the departing investigator will now be engaged in the research on behalf of the new institution; therefore, IRB approval on behalf of the new institution will be required. The new institution’s IRB may require that new informed consent and HIPAA authorization be obtained from the subjects being transferred.
Investigators must plan ahead and start early working on the transfer, as this process usually takes considerable time. In order to ensure appropriate oversight of the research during the transition, it may be necessary for the departing PI to internally “transfer” the study to a new BUMC PI (Option #2) temporarily until everything is in place to officially move the study to the new institution.
Important points to consider:
Option #4 – Departing PI Wants Access to Some or All of the Research Data/Specimens
In many instances, even when all research activities have been completed (including the primary analysis), the departing investigator wishes to transfer the research data and/or specimens to the new institution for future use and/or future secondary analysis.
In order for the BUMC to approve the transfer of research materials, it must consider such factors as:
BUMC IRB approval is required before any research data or specimens can be transferred to another institution or removed by departing investigators. IRB approval is requested by the PI submitting a CHANGE REQUEST AND AMENDMENT FORM via INSPIR. The form must provide detail regarding which specimens and which data (including any identifiers) will be released, to whom, etc. It is the responsibility of the “new” PI of the study, as the steward of the research materials, to ensure the security of the data/specimens. In most cases, IRB approval will also be needed from the departing PI’s new institution for the use and/or storage of the data/specimens.
If the person leaving the institution is a co-investigator (NOT the PI), then the requirements are the same as described above. In addition, the permission of the study PI is required.
Typically when a researcher is transferring to a new institution, the BUMC informed consent and HIPAA Authorization/HIPAA Waiver does NOT specifically cover the transfer of research materials to the new institution. There are three basic ways in which the departing PI can obtain BUMC IRB approval to transfer research data/specimens to his/her new institution:
This article specifically addresses the IRB and HIPAA concerns related to the transfer of research materials (data and specimens). There are numerous other considerations that are not addressed here, including but not limited to: transfer of funding and contracts, IBC approval to move specimens, patent concerns, budget, staff, etc. More information can be found in the BU Faculty Departure Procedures.
The most important point of this article is that all PIs and other investigators must understand that no human subjects research data or specimens may be removed from the institution or transferred to another institution until the necessary IRB approvals (which include HIPAA approvals) have been obtained. Failure to follow these procedures could result in a serious HIPAA violation involving fines and penalties.
This Quiz applies to the next recertification period from July 1, 2013 to June 30, 2015, but we recommend that you take this quiz now so you can stay up-to-date.