pansion of cell line; process control; packaging, labeling, and distribution; and documentation and data management. Those requirements, in addition to routine quality assurance and control, will be as critical in hES cell research as in any other field that uses human materials. As hES cell research advances, it will be increasingly important for institutions that are obtaining, storing, and using cell lines to have confidence in the value of stored cells—that is, that they were obtained ethically and with the informed consent of donors, that they are well characterized and screened for safety, and that the conditions under which they are maintained and stored meet the highest scientific standards.
Institutions that are banking or plan to bank hES cell lines should establish uniform guidelines to ensure that donors of material give informed consent through a process approved by an Institutional Review Board, 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.
Any facility engaged in obtaining and storing hES cell lines should consider the following standards:
(a) Creation of a committee for policy and oversight purposes and creation of clear and standardized protocols for banking and withdrawals.
(b) Documentation requirements for investigators and sites that deposit cell lines, including
A copy of the donor consent form.
Proof of Institutional Review Board approval of the procurement process.
Available medical information on the donors, including results of infectious-disease screening.
Available clinical, observational, or diagnostic information about the donor(s).
Critical information about culture conditions (such as media, cell passage, and safety information).
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.
(c) A secure system for protecting the privacy of donors when materials retain codes or identifiable information, including but not limited to