Feature Article

You Just Can’t Take It With You!
May 2012 Issue

By Mary A. Banks
Director, BUMC IRB
Authors has nothing to disclose with regards to commercial support.

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Introduction

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.

Multiple Options

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:

  1. closing the study at this site
  2. keeping the study open at BUMC and transferring the study to another BUMC PI
  3.  moving the study in its entirety to the PI’s new institution
  4. transferring research data/samples to the investigator’s new institution for future use   

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.

Option #1 – Closing the Study

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:

  • The data and samples must be completely “de-identified” (all 18 HIPAA identifiers are removed, and the “master key” that links the study data to any identifiers is destroyed) if the data will not be destroyed.
  • If the identifiable data and/or samples need to be retained for future analysis, then the study should be transferred to another BUMC PI (as described in Option #2 below), or transferred to an existing BUMC repository. A protocol amendment to transfer the samples to a repository will be required BEFORE the IRB protocol is closed.
  • No data or samples (including “de-identified” or “coded” data/samples) may be removed from BUMC by anyone without approval of the BUMC IRB (as described in Options 3 or 4 below).
  • Federal regulations and institutional policies require that research data be retained for a minimum of three years.  If the study is closed before the required time period, the PI needs to designate someone to have access to the archived research data so that, if necessary, the research files can be retrieved for audits, etc.

Option #2 – Keeping the Study Open at BUMC with a New BUMC PI

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:

  • The “new” PI is accepting responsibility for the research study, including responsibility for stewardship of the research data /specimens.
  • If the primary analysis is still being conducted, then the study is still “active”:  The study will need to remain open at the BUMC site, and continued BUMC IRB approval is required.
  • The departing investigator cannot take any data/specimens to the new institution (unless processes under Options #3 or #4 have been followed).

 

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:

  • Departing investigators must inform the BUMC IRB that the research is being moved and the study is being closed at BUMC.  
  • A materials transfer agreement (MTA) between institutions will be needed to move samples, patents, etc.).  PIs should consult their BU/BMC grants office or legal departments about these agreements.
  • All related HIPAA requirements must be met and approved by the BUMC IRB.
  • If the departing PI will continue to need access to the INSPIR protocol, then, when he submits the INTERNAL STUDY PERSONNEL CHANGE FORM to name the “new” PI, he should move his name to the “Administrative Assistant” section of INSPIR (Section 3.6).  This will allow him to continue to access the INSPIR protocol.
  • If the PI is the “sponsor” of an IND or IDE, then the FDA will need to be notified about the change.  Also, if there is a Certificate of Confidentiality, then the NIH needs to be notified.  The departing PI can obtain regulatory assistance from the BUMC Clinical Research Resources Office.

 

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: 

  • the original intent of the research
  • any limitations in the consent regarding future use
  • all HIPAA considerations
  • any future plans for the research
  • the extent to which subjects will be able to be identified
  • whether genetic information or samples are involved  

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:

  1. Re-authorization: The departing PI can contact subjects and obtain their authorization to take their research materials to the new institution.  Depending on the authorization, this could allow the sharing/transfer of data with all subject identifiers.
  2. Limited Data Set (LDS) with Data Use Agreement:  The departing PI can request that the research data be released with certain “limited” identifiers.  This requires IRB approval and a Data Use Agreement (DUA) between BUMC and the new institution.
  3. De-identification:  Only data and specimens that have been stripped of all 18 HIPAA identifiers can be transferred. If the data is coded, then the master code cannot be shared with the departing investigator.  The “new” PI must take responsibility for ensuring that the data is fully de-identified before it is released, and the departing investigator must agree to never try to re-identify the subjects in the data set.
  4. Waiver of Authorization and Consent: Approval  by the IRB to release subjects’ identifiable data without the subjects’ consent and HIPAA authorization can be done if the IRB approves a HIPAA Waiver of Authorization and Waiver of Informed Consent.  However, waivers are frequently not an option for these situations because of the strict criteria that must be met for the IRB to approve the HIPAA Waiver of Authorization and Waiver of Informed Consent.   

Important considerations:

  • A Material Transfer Agreement (MTA) will be required to transfer human biological specimens (such as tissue, DNA, blood, serum, etc.).
  • Because the departing PI has had access to the study master code, the BUMC IRB will usually require that there is a plan to “re-code” the data prior to releasing it to the departing PI in order to ensure that identifiable data is not being released.
  • In most cases, the institution will require that the original data or a copy be retained at this institution.
  • The new BUMC PI is responsible for accounting for any Uses or Disclosures of research data under HIPAA waivers.

 

Other Requirements

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.

Summary

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.


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