4.6 Investigators must document how they will characterize, validate, store, and distribute any new hES cell lines and how they will maintain the confidentiality of any coded or identifiable information associated with the lines (see Section 5.0 below). Investigators are encouraged to apply the same procedures and standards for characterization, validation, storage, and distribution to hPS cell lines.
There are several models for the banking of human biological materials, including hES cells. The most relevant is the U.K. Stem Cell Bank. The guidelines developed by this and other groups generally adhere to key ethical principles that focus on the need for consent of donors and a system for monitoring adherence to ethical, legal, and scientific requirements. 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 engaged in hES research should seek mechanisms for establishing central repositories for hES cell lines—through partnerships or augmentation of existing quality research cell line repositories and should adhere to high ethical, legal, and scientific standards. At a minimum, an institutional registry of stem cell lines should be maintained. Institutions are encouraged to consider the use of the same procedures for banking and distribution of hPS cell lines.
5.1 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 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:
Creation of a committee for policy and oversight purposes and creation of clear and standardized protocols for banking and withdrawals.
Documentation requirements for investigators and sites that deposit cell lines, including