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Guidelines for Human Embryonic Stem Cell Research 

The National Research Council

The Institute of Medicine

of The National Academies

 
 

Committee on Guidelines for Human Embryonic Stem Cell Research 

Richard Hynes, Daniel K. Ludwig Professor of Cancer Research; Investigator, Howard Hughes Medical Institute; Massachusetts Institute of Technology (Co-Chair) 

Jonathan Moreno, Emily Davie and Joseph S. Kornfeld Professor of Biomedical Ethics; Director, Center for Biomedical Ethics; University of Virginia (Co-Chair) 

Marcia Imbrescia, Trustee, Arthritis Foundation 

 
 

Committee on Guidelines for Human Embryonic Stem Cell Research 

Elizabeth Price Foley, Professor of Law; Florida International University College of Law

Norman C. Fost, Professor of Pediatrics; Director of the Program in Medical Ethics; University of Wisconsin

H. Robert Horvitz, Professor of Biology; Investigator, Howard Hughes Medical School, Massachusetts Institute of Technology

Terry Magnuson, Sarah Graham Kenan Professor and Chair of Genetics; Director, Carolina Center for Genome Sciences; University of North Carolina

Cheryl Mwaria, Associate Professor of Anthropology; Hofstra University

Janet Rossant, Joint Head; Program in Development and Fetal Health; Samuel Lunenfeld Research Institute; Mount Sinai Hospital, Toronto, Canada

Janet Rowley, Blum-Riese Distinguished Service Professor of Medicine; Section of Haematology/Oncology; University of Chicago Medical Center

Alta Charo, Elizabeth S. Wilson-Bascom Professor of Law and Bioethics, University of Wisconsin (Liaison to Board of Life Sciences)

 
 

The Need for Guidelines 

hES cell research already actively underway with both federal and non-federal funding - several states are initiating major research efforts Significant public support for hES cell research A patchwork of regulations Limited federal support / little federal regulation No federal regulations governing hES cell research funded from other sources Disparate state regulations No system for oversight of hES cell research Uncertainty about appropriate procedures Public concerns Uncertain scientific environment  

Guidelines for Human Embryonic Stem Cell Research

 
 

Statement of Task 

Develop guidelines to encourage responsible practices in hES  cell research, regardless of source of funding

    including the use and derivation of new stem cell lines

  i)   derived from surplus blastocysts from IVF clinics

          ii)  from blastocysts  produced with donated gametes

          iii) from blastocysts produced using nuclear transfer. 

The guidelines should take ethical and legal concerns into account and encompass the basic science and health science policy issues related to the development and use of hES cells for research and eventual therapeutic purposes  
 

Guidelines for Human Embryonic Stem Cell Research

 
 

Issues Considered 

Recruitment of donors of blastocysts, gametes, or somatic cells

   informed consent

   financial incentives

   conflicts of interest

   donor confidentiality

   risks associated with oocyte retrieval

   handling of genetic information arising from the research

2)  Characterization and standardization of stem cells

Safe handling and storage of blastocysts and stem cell material Conditions for transfer of such material among laboratories Appropriate uses of hES cells in research or therapy Limitations on the use of hES cells

7)  Safeguards against misuse 

Guidelines for Human Embryonic Stem Cell Research

 
 

NATIONAL ACADEMIES GUIDELINES FOR RESEARCH ON HUMAN EMBRYONIC STEM CELLS 

1.0  Introduction 2.0  Establishment of an Institutional Embryonic  Stem Cell Research Oversight Committee 3.0 Procurement of Gametes, Blastocysts or Cells  for hES Generation 4.0 Derivation of hES Cell Lines 5.0 Banking and Distribution of hES Cell Lines 6.0 Research Use of hES Cell Lines 7.0 International Collaboration 8.0 Conclusion and Need for a National Panel  

Guidelines for Human Embryonic Stem Cell Research

 
 

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. 
 

Guidelines for Human Embryonic Stem Cell Research 

1.1(a) What The Guidelines Cover 

Many, but not all, of the guidelines and concerns are common to other areas

      of human stem cell research, such as

      (a) Research that uses human adult stem cells.

      (b) Research that uses fetal stem cells or

                  embryonic germ cells derived from fetal tissue

 
 

1.1(b) Reproductive Uses of Nuclear Transfer  

The guidelines do not address reproductive uses of nuclear transfer - those are addressed in the 2002 report Scientific and Medical Aspects of Human Reproductive Cloning, in which the National Academies recommended that 00uman reproductive cloning should not now be practiced. It is dangerous and likely to fail.00 

Although the 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. 

Guidelines for Human Embryonic Stem Cell Research

 
 
Should always be reviewed by an Institutional Review Board Should be governed by informed consent of all donors Separation of decision to donate from all clinical decisions No payments to donors beyond reimbursement

of direct expenses

No purchase or sale of donated materials Protection of donor privacy  
 

Guidelines for Human Embryonic Stem Cell Research 

Donations of blastocysts, oocytes, sperm and somatic cells

 
 

Recommendations for Oversight of Human  
Embryonic Stem (hES) Cell Research 

1. Local oversight - each institution should establish an Embryonic Stem Cell Research Oversight (ESCRO) committee to review and monitor all proposals to conduct hES cell research.  

   The committee should include representatives of the public and  persons with expertise in developmental biology, stem cell  research, molecular biology, assisted reproduction, and ethical  and legal issues in hES cell research.  

Guidelines for Human Embryonic Stem Cell Research 

2. A national panel should be established to assess periodically the

          adequacy of the guidelines and to provide a forum for a

          continuing discussion of issues involved in hES cell research.

politically independent and without conflicts of interest respected in the lay and scientific communities able to call on suitable expertise to support this effort.  
 

Functions of Embryonic Stem Cell Research Oversight  
(ESCRO) Committees - #1 

To provide local oversight over all issues related to derivation  and research use of hES cell lines To ensure adherence to the basic ethical and legal principles of  informed consent and protection of donor confidentiality. To review compliance of all hES cell research with all relevant  regulations and guidelines. To maintain registries of hES cell research conducted at the   institution and of all hES cell lines To facilitate education of investigators involved in hES cell   research The ESCRO committee will not substitute for an Institutional  Review Board (IRB) but rather will provide an additional   level of review and scrutiny warranted for hES cell   research and review proposals not requiring IRB review.  

Guidelines for Human Embryonic Stem Cell Research

 
 

Functions of Embryonic Stem Cell Research Oversight  
(ESCRO) Committees - #2 

To review and approve the scientific merit of research proposals and divide into three categories in setting limits on research and determining the requisite level of oversight:  
Research that is permissible after notification of the ESCRO committee and completion of all reviews mandated by current requirements;

        e.g., all purely in vitro hES cell research with pre-existing

              coded or anonymous hES cell lines. 

(b) Research that is permissible only after additional review and approval by the ESCRO committee

  (i) all derivations of new hES cell lines from donated blastocysts, from  in vitro fertilized oocytes, or by nuclear transfer.

  (ii) all research involving the introduction of hES cells into nonhuman  animals at any stage of embryonic, fetal, or postnatal development.

  (iii) all research in which identifiable information about donors is   readily ascertainable or could become known by the investigator  
 
 

Guidelines for Human Embryonic Stem Cell Research

 
 
 

    (i) 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. 

    (ii) Research in which hES cells are introduced into nonhuman   primate blastocysts or in which any ES cells are introduced  into human blastocysts. 

    (iii) No animal into which hES cells have been introduced at any  stage of development should be allowed to breed. 

Guidelines for Human Embryonic Stem Cell Research 

(c) Research that should not be permitted at this time: 

 
 

          To help ensure that these guidelines are taken seriously, stakeholders in hES cell research00ponsors, funding sources, research institutions, relevant oversight committees, professional societies, and scientific journals, as well as investigators00hould develop policies and practices that are consistent with the principles inherent in these guidelines. Funding agencies, professional societies, journals, and institutional review panels can provide valuable community pressure and impose appropriate sanctions to ensure compliance.  

ESCROs and IRBs should require evidence of compliance when  protocols are reviewed for renewal

Funding agencies should assess compliance when reviewing  applications for support

Journals should require that evidence of compliance accompanies  publication of results  
 

Guidelines for Human Embryonic Stem Cell Research 

Mechanisms for Ensuring Compliance 

 
 

Committee on Guidelines for Human Embryonic Stem Cell Research 

Richard Hynes, Daniel K. Ludwig Professor of Cancer Research; Investigator, Howard Hughes Medical Institute; Massachusetts Institute of Technology (Co-Chair) 

Jonathan Moreno, Emily Davie and Joseph S. Kornfeld Professor of Biomedical Ethics; Director, Center for Biomedical Ethics; University of Virginia (Co-Chair) 

Marcia Imbrescia, Trustee, Arthritis Foundation 

Frances Sharples, Study Director

Kathi Hanna, Science Writer

Matthew McDonough, Program Assistant

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