Summarize the purpose and objectives of the tissue bank in this section.

This section should specify who is eligible to participate in the Tissue Bank. If there are plans to collect residual tissue, (for example left over blood samples from a blood draw or tissue biopsy for diagnosis or medical evaluation unrelated to collection for the tissue bank), which would not involve tissue donor informed consent, that should be noted here as well.  In that instance, it will be necessary to obtain IRB approval for such actions, and to collect and store the samples as de-identified tissue samples (consistent with HIPAA regulatory procedures for de-identification) � and that requirement should be noted here. 

For tissue samples collected specifically for research, written informed consent should be obtained from each tissue donor in accordance with HHS regulations noted in 45  CFR 46.116. Included among the basic elements of informed consent should be a clear description of the:

• operation of the cell repository
• length of time the specimen will  be stored
• specific types of research to be conducted (if the tissue bank is set up for to service a wide variety of research interests, that can be so stated rather than noting a specific research type)
• conditions under which data and specimens  will be released to recipient-investigators
• procedures for protecting the privacy  of subjects and maintaining the confidentiality  of data

This section should describe the procedure for obtaining donor informed consent, i.e. who may sign the consent, location of the original informed consent form, etc.  The Tissue Bank informed consent form should be referenced here and added to this Tissue Bank Protocol as an attachment.

This section should specify how collection procedures are to be accomplished. If there are tissue-type specific collection requirements, that should be captured as a subsection.  The subsections below are listed as typical examples.  Add, modify or delete the example subsections as appropriate.

Typically tissue must be transported to the Tissue Bank within a specified period of time after collection from the donor in order to remain viable.  Such requirements and any tissue transport requirements (e.g. whether or not the tissue must be transported on dry ice, etc.) should be included in this section or the associated subsections.

NOTE :  all personnel involved in the handling and transportation of human tissue are required to successfully complete the applicable training offered by the Office of Environmental Health and Radiations Safety (EHRS).  For further information about this training requirement and course offerings, please contact the ERHS at: 215.898.4453 or ehrs@ehrs.upenn.edu .

This section should overview the requirements for tissue processing and length of storage as noted in the following subsections.

Note the length of time samples will be stored in this section.   There is no regulatory or legal requirement for a limit on the duration of storage, though if there clear plans for a limit on the length of storage in your tissue bank, that should be noted here.  For example, some Tissue Banks have plans to store certain types of tissue, such as blood serum, indefinitely, while limiting the planned storage time of other types of tissue, such as soft tissue or bone.

This section should discuss the process for labeling of Tissue Bank samples including the information to be included on the label.

The section should overview the tissue/cell separation and storage procedures.  The following gives some example subsections and associated language:

As an example of language that might be used in this section:

When a donor blood sample is received, an attempt is made to isolate, collect and store peripheral blood mononuclear cells (PBMC), granulocytes and serum. Theses samples are stored in liquid nitrogen and/or �80°C freezer according to the tissue bank standard operating procedures.

[Add further description of processing as appropriate.]

This section should describe how the identity of the tissue donor is protected and should include a statement to the effect that only personnel authorized by the Principle Investigator (owner) of Tissue Bank will have direct access to the tissue storage facilities and samples. 

According to the above section describing eligibility for storage in the Tissue Bank, in some cases tissue samples will arrive without donor identifiers, in other cases there will be specific donor identifiers.  This section must describe the process for handling and managing tissue samples, with a detailed description of the procedures to be followed when receiving samples that arrive with tissue donor identifiers.