In this chapter we collect all the recommendations made throughout the report and translate them into a series of formal guidelines. These guidelines focus on the derivation, procurement, banking, and use of human embryonic stem (hES) cell lines. They provide an oversight process that will help to ensure that research with hES cells is conducted in a responsible and ethically sensitive manner and in compliance with all regulatory requirements pertaining to biomedical research in general. The National Academies are issuing these guidelines for the use of the scientific community, including researchers in university, industry, or other private-sector research organizations.
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
(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:
(a) Are permissible after currently mandated reviews and proper notification of the relevant research institution.
(b) Are permissible after additional review by an Embryonic Stem Cell Research Oversight (ESCRO) committee, as described in Section 2.0 of the guidelines.
(c) 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.
1.2(a) hES Cell Research Permissible after Currently Mandated Reviews
Purely in vitro hES cell research that uses previously derived hES cell lines is permissible provided that the ESCRO committee or equivalent body designated by the investigator's institution (see Section 2.0), receives documentation of: i) the provenance of the cell lines; ii) appropriate informed consent in their derivation; and iii) evidence of compliance with any required review by an Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), or Institutional Biosafety Committee (IBC), or other mandated review.
1.2(b) hES Cell Research Permissible Only after Additional Review and Approval
(1) Generation of new lines of hES cells by whatever means.
(2) Research involving the introduction of hES cells into nonhuman animals at any stage of embryonic, fetal, or postnatal development; particular attention should be paid to the probable pattern and effects of differentiation and integration of the human cells into the nonhuman animal tissues.
(3) Research in which the identity of the donors of blastocysts, gametes, or somatic cells from which the hES cells were derived is readily ascertainable or might become known to the investigator.
1.2(c) hES Cell Research That Should Not Be Permitted at This Time
The following types of research should not be conducted at this time:
(1) Research involving in vitro culture of any intact human embryo, regardless of derivation method, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first.
(2) Research in which hES cells are introduced into nonhuman primate blasto-cysts or in which any embryonic stem cells are introduced into human blastocysts.
(3) No animal into which hES cells have been introduced at any stage of devel opment should be allowed to breed.
All scientific investigators and their institutions, regardless of their field, bear the ultimate responsibility for ensuring that they conduct themselves in accordance with professional standards and with integrity. In particular, people whose research involves hES cells should work closely with oversight bodies, demonstrate respect for
1oo the autonomy and privacy of those who donate gametes, blastocysts, or somatic cells and be sensitive to public concerns about research that involves human embryos.
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