a process approved by an IRB and that meticulous records are maintained about all aspects of cell culture. Uniform tracking systems and common guidelines for distribution of cells should be established.

5.2 Any facility engaged in obtaining and storing hES cell lines should consider the following standards:

  1. Creation of a committee for policy and oversight purposes and creation of clear and standardized protocols for banking and withdrawals.

  2. Documentation requirements for investigators and sites that deposit cell lines, including

    1. A copy of the donor consent form.

    2. Proof of Institutional Review Board approval of the procurement process.

    3. Available medical information on the donors, including results of infectious-disease screening.

    4. Available clinical, observational, or diagnostic information about the donor(s).

    5. Critical information about culture conditions (such as media, cell passage, and safety information).

    6. Available cell line characterization (such as karyotype and genetic markers).

A repository has the right of refusal if prior culture conditions or other items do not meet its standards.

  1. A secure system for protecting the privacy of donors when materials retain codes or identifiable information, including but not limited to

    1. A schema for maintaining confidentiality (such as a coding system).

    2. A system for a secure audit trail from primary cell lines to those submitted to the repository.

    3. A policy governing whether and how to deliver clinically significant information back to donors.

  1. The following standard practices:

    1. Assignment of a unique identifier to each sample.

    2. A process for characterizing cell lines.

    3. A process for expanding, maintaining, and storing cell lines.

    4. A system for quality assurance and control.

    5. A website that contains scientific descriptions and data related to the cell lines available.

    6. A procedure for reviewing applications for cell lines.

    7. A process for tracking disbursed cell lines and recording their status when shipped (such as number of passages).

    8. A system for auditing compliance.

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