1.5
Acceptability of research using hES cell lines imported from other institutions or jurisdictions

1.5(a) Before approving use of hES and hPS cell lines imported from other institutions or jurisdictions, ESCRO committees should consider whether such cell lines have been “acceptably derived.”


1.5(b) “Acceptably derived” means that the cell lines were derived from gametes or embryos for which

  1. the donation protocol was reviewed and approved by an IRB or, in the case of donations taking place outside the United States, a substantially equivalent oversight body;

  2. consent to donate was voluntary and informed;

  3. donation was made with reimbursement policies consistent with these Guidelines; and

  4. donation and derivation complied with the extant legal requirements of the relevant jurisdiction.

1.5(c) ESCRO committees should include on their registry a list of cell lines that have been imported from other institutions or jurisdictions and information on the specific guidelines, regulations, or statutes under which the derivation of the imported cell lines was conducted. This is in accord with the requirement in section 2.0 of the Guidelines that calls for ESCRO committees to maintain registries listing the cell lines in use at their institutions.

2.0
ESTABLISHMENT OF AN INSTITUTIONAL EMBRYONIC STEM CELL RESEARCH OVERSIGHT COMMITTEE

To provide oversight of all issues related to derivation and use of hES cell lines and to facilitate education of investigators involved in hES cell research, each many institutions currently require that research should have activities involving hES cells should be overseen by an Embryonic Stem Cell Research Oversight (ESCRO) committee. Although not required under the NIH Guidelines on Human Stem Cell Research, institutions conducting federally funded stem cell research are nevertheless likely to decide to maintain their ESCRO committees and use them for consultation, training, and any other functions appropriate to assist the institution and its researchers in evaluating and managing hES cell research. Institutions that conduct both federally funded and non-federally funded hES cell research, particularly if



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement