For tissue samples arriving with identifiers, this section must clearly state whether any link is being maintained between the sample and the donor. For example, it is common to assign samples a unique serial number, from which it is not possible to identify the tissue donor unless linked by an identifier key to the actual donor. This section should describe the process of assigning such unique serial numbers and also the procedures for maintaining the identification key in a secure (locked) location with limited access, who will be responsible for ensuring security of the linking key, and who will be able to access the key.
Additionally, if the sample is going to be obtained in a vial that does contain patient identifying information, but the sample will be transferred into a vial that does not have identifiers, such a process should be discussed in this section as well, including plans to destroy the original vials that contain donor identifiers.
For additional privacy, the Tissue Bank owner can request a Certificate of Confidentiality from the National Institutes of Health (NIH). Such protections will prevent legal subpoena of information identifying the donor. The NIH Certificates of Confidentiality can be requested regardless of whether the tissue bank or associated tissue research is government funded.
As an example the following language could be included in this section:
All records pertaining to the identity of participants in the Research Repository will be maintained as private and confidential. Personal identifying information will only be released with the express written permission of the tissue donor or by IRB approval.
Blood samples and all records associated with blood samples will be labeled only with a numeric code that contains no donor personal identifiers. A link does exist between the participant’s name and the numeric code. This link is not available to staff managing samples at the Research Tissue Bank, or any investigative personnel requesting samples.
[go on to describe the procedures and safeguards for protection the numeric code]
This section should discuss who will have direct access to the tissue samples and tissue bank records (including electronic data systems that store tissue information and tracking) for any purpose, for example, those in charge of the Tissue Bank and/or involved with the operation of the Bank, etc. You can note the role of the individual rather than the specific name of the individual to avoid the need for amending the protocol when there is personnel turnover. In such an instance, it should be noted that actual names of the personnel performing the roles described in this section of the Tissue Bank Protocol are be kept on file with the owner or manager of the tissue bank (i.e. the Principle Investigator named on the face page of this Tissue Bank Protocol or his/her designee). Investigators or other personnel not involved with the management or operations of the tissue bank are most typically not permitted direct access to the tissue bank storage facilities or samples, rather must obtain samples from the Tissue Bank management/operations personnel. Such a restriction to direct access should be noted in this section.
This section should overview the process for requesting samples from the Tissue Bank.
If there is a specific form that must be completed to request samples, that form should be referenced here and included as an attachment to this Tissue Bank Protocol.
This section should describe the process for reviewing and approving sample requests. Note any criteria that must be met in order for approval to be granted for use of tissue bank samples, for example the tissue bank may require a review of the proposed research protocol for scientific merit, or samples may only be supplied for a specific type of research, etc.
This section should note issues related to the use of samples for research such as whether the tissue bank is to support only the owner’s research or the owner’s departmental research, or if it will permit samples to be used by other investigators outside of the department, School, or even outside of Penn. IF the Tissue Bank is planning to supply tissue preferentially to Penn researchers vs other entities (e.g. other academic institutions, pharmaceutical companies, etc.), or planning other similar special restrictions for research, that should be noted in this section.
NOTE: If the Tissue Bank plans to service researchers outside of the School of Medicine, a tissue transfer agreement is required, and therefore such plans for the tissue bank along with the requirement for a tissue transfer agreement should be clearly noted in this section as well. Contact the Office of General Council (215-746-5200, generalcounsel@ogc.upenn.edu) for assistance in developing and receiving approval for any needed tissue transfer agreements.
Include any other special requirements affecting the use of samples for research, for example note if the tissue bank plans to charge for samples or other services associated with releasing samples.
Tissue is considered identifiable when there is a mechanism by the investigator receiving the sample (recipient investigator) that can trace data or samples back to the identity of the research subject. This section should describe the procedure for managing studies requiring tissue sample information that includes HIPAA-defined identifiers, including he requirement that the proposed research study must be submitted to the IRB for review and approval prior to the release of donor-identifying information.
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