1.1(a) What These Guidelines Cover

These guidelines cover all derivation of hES cell lines and all research that uses hES cells derived from

  1. Blastocysts made for reproductive purposes and later obtained for research from in vitro fertilization (IVF) clinics.

  2. Blastocysts made specifically for research using IVF.

  3. Somatic cell nuclear transfer (NT) into oocytes.

The guidelines do not cover research that uses nonhuman stem cells.

Many, but not all, of the guidelines and concerns addressed in this report are common to other areas of human stem cell research, such as

  1. Research that uses human adult stem cells.

  2. Research that uses fetal stem cells or embryonic germ cells derived from fetal tissue; such research is covered by federal statutory restrictions at 42 U.S.C. 289g-2(a) and federal regulations at 45 CFR 46.210.

Institutions and investigators conducting research using such materials should consider which individual provisions of these guidelines are relevant to their research.

1.1(b) Reproductive Uses of NT

These guidelines also do not apply to reproductive uses of nuclear transfer (NT), which are addressed in the 2002 report Scientific and Medical Aspects of Human Reproductive Cloning, in which the National Academies recommended that “Human reproductive cloning should not now be practiced. It is dangerous and likely to fail.” Although these guidelines do not specifically address human reproductive cloning, it continues to be the view of the National Academies that research aimed at the reproductive cloning of a human being should not be conducted at this time.

1.2 Categories of hES Cell Research

These guidelines specify categories of research that:

  1. Are permissible after currently mandated reviews and proper notification of the relevant research institution.

  2. Are permissible after additional review by an Embryonic Stem Cell Research Oversight (ESCRO) committee, as described in Section 2.0 of the guidelines.

  3. Should not be conducted at this time.

    Because of the sensitive nature of some aspects of hES cell research, these guidelines in many instances set a higher standard than is required by laws or regulations with which institutions and individuals already must comply.

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