When appropriate, creation of a clear Material Transfer Agreement or user agreement.
A liability statement.
A system for disposal of material.
Clear criteria for distribution of cell lines, including but not limited to evidence of approval of the research by an ESCRO committee or equivalent body at the recipient institution.
Once hES cell lines have been derived, investigators and institutions, through ESCRO committees and other relevant committees (such as an IACUC, an IBC, or a radiation safety committee) should monitor their use in research.
6.1 Institutions should require documentation of the provenance of all hES cell lines, whether the cells were imported into the institution or generated locally. Notice to the institution should include evidence of IRB approval of the procurement process and of adherence to basic ethical and legal principles of procurement. In the case of lines imported from another institution, documentation that these criteria were met at the time of derivation will suffice.
6.2 In vitro experiments involving the use of already derived and coded hES cell lines will not need review beyond the notification required in Section 6.1.
6.3 Each institution should maintain a registry of its investigators who are conducting hES cell research and ensure that all registered users are kept up to date with changes in guidelines and regulations regarding the use of hES cells.
6.4 All protocols involving the combination of hES cells with nonhuman embryos, fetuses, or adult animals must be submitted to the local IACUC for review of animal welfare issues and to the ESCRO committee for consideration of the consequences of the human contributions to the resulting chimeras. (See also Section 1.2(c)(3) concerning breeding of chimeras.)