2.4 Derivation, Banking and Distribution of Human Stem Cell Lines
Recommendation 2.4.1: Proposals for derivations of new hESC lines should be scientifically justified and executed by scientists with appropriate expertise. A clear, detailed outline for banking new lines should be incorporated into derivation proposals. Whenever feasible, the distribution of new hESC lines to the research community is strongly encouraged following derivation and first publication.
Consistent with the policies of many funders and scientific journals, researchers should deposit lines into centralized repositories where the lines will be held for release and distribution upon publication. Researchers performing derivations should have a detailed, documented plan for characterization, storage, banking, and distribution of new lines. Researchers performing derivations should propose a plan to safeguard the privacy of donors and inform donors that, in this era of data-intensive research, complete privacy protection might be difficult or impossible to guarantee.
Although a specialized oversight process is not required for derivation of non-embryonic stem cell lines, the general principles and aspirational goals for banking and distribution apply widely to all classes of scientifically valuable stem cell lines. It is understood that cell lines (e.g. pluripotent stem cells, neural stem cells, hematopoietic stem cells) made for commercial purposes may not be available for general distribution. In addition, cell lines made for autologous applications may not be suitable or available for general distribution.
Repositories & Registries for Stem Cell Lines
Recommendation 2.4.2: National and international repositories should accept deposits of newly derived stem cell lines to preserve them, maintain them to a high standard, and ensure their authenticity. Repositories are encouraged to distribute them internationally to enable their dissemination. Researchers are encouraged to deposit data on stem cell lines into registries.
Repositories should strive to adhere to common methods and standards to facilitate the easy exchange and dissemination of stem cell lines (see also Section 5, Standards in Stem Cell Research). At a minimum, each repository must establish its own guidelines and must have a clear, easily accessible material transfer agreement. A sample material transfer agreement is available in Appendix 4. Each repository may have its own criteria for distribution. Repositories should also have clear, publicly available protocols for the deposit, storage, and distribution of pluripotent stem cell lines and related materials. The repository has the right of refusal if a cell line does not meet its standards.
Repositories must require written assurances from depositors that research materials were procured according to the ethical principles and compliant with the regulations and policies of the respective jurisdiction. Depositors should attest that they were subject to appropriate oversight (IRB or equivalent) for all human subjects work, obtained informed consent from research material donors, and maintain consent documentation for the distribution and use of the research material. Provider/depositors must also provide written assurances that the MTA provided for the transfer of materials contains all restrictions, regulations, and obligations consistent with the informed donor consent for the use of the materials. Repositories must receive and preserve the material transfer agreements for any material deposit and ensure its full execution prior to the transfer of materials to the requesting investigators.
Repositories should obtain all available technical information from the depositor, for example, methods used in the derivation of lines, culture conditions, infectious disease testing, passage number and characterization data. Repositories should make this information available to researchers. If the repository modifies the depositor’s protocols or obtains additional data, this information should also be made available.
Repositories should engage in, but are not limited to, the following:
- Reviewing and accepting deposit applications.
- Assigning unique identifiers (catalogue number) to deposits.
- Expansion, maintenance and storage of cell lines.
- Quality assurance and quality control of all procedures.
- Maintenance of website with pertinent characterization data, protocols and availability of cell lines.
- Maintaining databases to allow tracking and distribution of the cell lines to primary researchers.
- Posting a clear and fair cost schedule for distribution of materials. Repositories should endeavor to distribute internationally and charge only the necessary costs, which include shipping and handling.
- Preserve cell lines for future use.
Provenance of Stem Cell Lines
Recommendation 2.4.3: Documentation of the provenance of stem cell lines is critical if the cell lines are to be widely employed in the research community. Provenance must be easily verifiable by access to relevant material transfer agreements and data demonstrating the identity of the cell line and uses allowed under the original informed consent. If a cell line has the potential to be used clinically, researchers are encouraged to provide information on the materials used for derivation and expansion.
Appropriate safeguards should be used to protect the privacy of donors and donor information due to the nature of the materials involved in the generation of human stem cell lines. For stem cell lines to be as useful as possible and so as not to preclude future potential therapeutic applications, as much donor information as possible should be maintained along with the cell line (see Recommendation 220.127.116.11). Subject to local laws, donor samples and cell lines should be anonymized or de-identified as stipulated in the informed consent forms.
Material transfer agreements or their equivalents must be consistent with the informed consent, and include all limitations, restrictions and obligations set forth by the material provider. These MTAs must be presented to the repository previous to or at the time of the material deposit and must be maintained by the repository while it holds the materials. Material providers must maintain documentation regarding consent and inform the receiving parties about relevant regulations thereof, including whatever reimbursement of direct expenses or financial or valuable considerations of any kind were provided in the course of the procurement.
Access to Research Materials
Recommendation 2.4.4: Institutions engaged in human stem cell research performed with public funding are encouraged to develop procedures whereby researchers are granted access to research materials for scientifically and ethically appropriate purposes, as determined under these guidelines and applicable laws.
Researchers are encouraged to make the materials readily accessible to the biomedical research community for non-commercial research. When arranging for the disposition of material rights generated with public funding to commercial entities, institutions are encouraged to preserve non-exclusive access for the research community. If materials are made available as a researcher-to-researcher transfer from a repository or bank, the costs of cell line expansion, handling, and shipping should be borne by the receiving party so as not to pose an undue financial burden on the entity or researcher providing the cells.