Expert Report

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Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research. Given limited federal involvement, privately funded hES cell research has thus far been carried out under a patchwork of existing regulations, many of which were not designed with this research specifically in mind. In addition, hES cell research touches on many ethical, legal, scientific, and policy issues that are of concern to the public. This report provides guidelines for the conduct of hES cell research to address both ethical and scientific concerns. The guidelines are intended to enhance the integrity of privately funded hES cell research by encouraging responsible practices in the conduct of that research.

Key Messages

  • A primary activity of ESCRO committees will be to ensure that inappropriate research is not conducted and that sensitive research is well justified and subject to appropriate additional oversight. Oversight will in many instances conform to a higher standard than required by existing laws or regulations.
  • As hES cell research advances, it will be increasingly important for institutions that obtain, store, and use cell lines to have confidence in the value of stored cells.
  • Because of the complexity and novelty of many of the issues involved in hES cell research, the committee believes that all research institutions conducting hES cell research should create special review bodies to oversee this emerging field of research.
  • FDA's Good Laboratory Practice regulations pertain to the management of laboratories that are developing products that might eventually be introduced into humans (for example, in a clinical trial). Those regulations do not cover basic exploratory studies conducted to determine whether a test article has any potential utility or to determine its physical or chemical characteristics, but they do encompass in vivo or in vitro experiments to determine their safety an activity that would be characteristic of the preclinical phase of hES cell research.
  • Laboratory research that uses hES cells is generally not subject to federal regulations governing research with human subjects unless it involves personally identifiable information about the cell line's progenitors.
  • One particularly important aspect of regulatory compliance for hES cell research deals with protection of donors of blastocysts and gametes.
  • Research institutions are likely already to have rules in place for research involving other biological tissues, and hES cell research, like any other form of biological or biomedical research, would be covered by these rules and in many cases will not require further review.
  • Research involving hES cells will require access to human oocytes and embryos, necessitating some interaction between oocyte and blastocyst donors and people or institutions seeking to procure these materials for use in hES cell research.
  • Research using hES cells offers great promise for future improvements in health care. To realize those benefits, further research will be required, including derivation of additional hES cell lines and testing of their potential.
  • Such research is already in progress in many institutions and there is a need for a common set of standards.
  • The donors of sperm, oocytes, or somatic cells used to make blastocysts for research are themselves rarely the subject of the research. Nevertheless, the physical interaction needed to obtain the materials brings them under the purview of the human subjects protections system, and IRB review is required.
  • The ethical and legal concerns involved in hES cell research make increased local oversight by research institutions appropriate.