Research with human stem cells offers significant potential to further our understanding of fundamental biology and to develop cell-based therapies to treat disease.  Northwestern University supports the responsible pursuit of research involving the use of human embryonic stem cells.

Human stem cell research at Northwestern is evaluated by the Northwestern University Committee on Human Stem Cell Research (NUCHSR), chaired by Lewis J. Smith, MD, Associate Vice President for Research, and is governed by Northwestern's Policy on Human Stem Cell Research.

Research involving non-approved stem cell lines under current federal guidelines requires special administrative provisions to ensure that the federal government does not financially support the research activities.  Northwestern researchers cannot conduct research using non-approved human stem cell lines without ensuring an appropriate administrative structure to support the research.

The Office for Research and the Office of the Controller have developed a mechanism to gather appropriate information to help you meet the administrative requirements for this research.  Prior to beginning any work with human stem cell lines, please contact:

Lewis Smith, MD, Associate Vice President for Research
312.503.2615

or

Tim Fournier, Associate Vice President for Research Integrity
312.503.0054

If you have questions regarding NUCHSR and/or the submission process, please contact Lisa Linn in OPRS by email at l-linn@northwestern.edu, or by telephone at (312) 503-5368.

POLICY ON HUMAN STEM CELL RESEARCH AT NORTHWESTERN UNIVERSITY (Click here for PDF version)

Research with human stem cells, including human embryonic stem (hES) cells, offers significant potential to further our understanding of fundamental biology and to develop cell-based therapies to treat disease.  Advances in our understanding of processes for cellular development, repair, and replacement in living organisms provide the basis for developing promising clinical treatments to nullify or counteract the effects of devastating illness.  Northwestern University supports the responsible pursuit of research involving the use of human embryonic stem cells.

Ethical concerns surround a variety of research activities, including human stem cell research.  Northwestern’s research programs are guided by and conducted within the context of a variety of ethical and regulatory considerations.  Accordingly, Northwestern University has determined that the University will not support research involving the use of human stem cells conducted with the objective of human reproductive cloning or that utilizes methodologies allowing for nuclear transfer from human cells into animal tissues or vice versa.  The purpose of this policy is to ensure that research involving the use of human stem cells at Northwestern University is conducted in an appropriate manner and within the guidelines established by State and Federal regulations and by other University policies. 

General Principles

Northwestern University has adopted the major recommendations outlined in the Guidelines for Human Embryonic Stem Cell Research prepared by the National Research Council with the Institute of Medicine.  These guidelines, intended to “ensure that the highest ethical, legal, and scientific standards are met in the derivation, storage, and use of [human embryonic stem cells] in research,” govern research utilizing human embryonic stem cells derived from human blastocysts initially intended for use in reproductive or research-related in vitro fertilization techniques as well as somatic cell nuclear transfer into oocytes.  Northwestern has also chosen to adapt these recommendations with respect to all research using human stem cells.

The guidelines recommend the adoption of an oversight committee for research using human stem cells.  Similar to the institutional review board (IRB), this committee should not replace the IRB but rather provide a level of review of the complex issues surrounding human embryonic stem cell research not possible or, in some cases, not required for the IRB to conduct.  The guidelines also recommend that the IRB should not waive the requirement for obtaining informed consent from any person whose somatic cells, gametes, or blastocysts are used in the research, and ensure that no financial or avoidable non-financial incentives exist that may be perceived to influence the donor decision. 

Definitions

• Northwestern University Committee on Human Stem Cell Research (NUCHSR): This Committee, appointed by the Vice President for Research, develops guidelines for the conduct of research involving the use of human stem cells.  In addition, this Committee reviews research protocols utilizing human stem cells and provides its recommendations to the IRB.
  
• Institutional Review Board (IRB): A committee designated by the University under Federal direction to review, approve the initiation of, and periodically review research involving human subjects or materials obtained from human subjects.
  
• Human Embryonic Stem Cells: Pluripotent cells from the human embryo that have the potential to become a wide variety of specialized cell types.
  
• Human embryonic germ cells: Cells found in a specific part of the human embryo/fetus called the gonadal ridge that normally develop into mature gametes.
  
• Human Adult Stem Cells: Undifferentiated cells found in fetal, neonatal, and adult human tissues that can renew themselves and, with certain limitations, differentiate to yield all the specialized cell types of the tissue from which the cells originated.
  
• NIH Human Embryonic Stem Cell Registry: A list of derivations of stem cells which are eligible for federal funding. The purpose of the Registry is to provide investigators with a unique NIH code for each cell line that must be used when applying for NIH funding and contact information to facilitate investigators' acquisition of stem cells.
  
• Human Stem Cell Research: Research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, human umbilical cord stem cells, and human adult stem cells from any source. Human somatic cell nuclear transplantation and use of stem cells derived from nuclear transfer are also considered “human stem cell research.”
  
• Human Reproductive Cloning: A procedure utilizing nuclear transfer from a human donor cell into an enucleated human egg cell and which implants the resulting blastocyst into a uterus with the intent of developing a fetus.  Human reproductive cloning is not permitted under this Northwestern University policy.
  
• Somatic Cell Nuclear Transplantation: A procedure utilizing nuclear transfer from a human donor cell into an enucleated human egg cell and which does not implant the resulting blastocyst but uses the blastocyst to develop stem cell lines for research.
  
• Human-Animal Xenogeneic Nuclear Transfer: A procedure utilizing nuclear transfer from a human cell into an enucleated egg of a non-human animal species or vice versa.  Human-animal xenogeneic nuclear transfer is not permitted at Northwestern University.

Responsibilities

• Research Personnel.  Researchers are responsible for maintaining the highest ethical standards in human stem cell research. Principal investigators are responsible for ensuring that this University policy is communicated to and maintained by all who work under their supervision, directly or indirectly, as appropriate.  Research support staff are responsible for ensuring that financial and administrative requirements established by this policy are appropriately applied and documented.  Principal investigators have primary responsibility for completing the Northwestern application for review of human stem cell research.
  
• The Northwestern University Committee on Human Stem Cell Research.  The Committee is responsible for reviewing requests for research using human stem cells and providing recommendations to the IRB and/or its decision to the principal investigator on a timely basis.  This review should focus on ethical concerns and consider the scientific basis of the proposed methodology only with respect to the notion that the investigator has formulated a significant hypothesis that can lead to generalizable knowledge.  In the absence of a required IRB review, the principal investigator will accept the Committee’s determination of the appropriateness of conducting the proposed research. 
  
• Institutional Review Board.  The IRB receives recommendations from NUCHSR related to the conduct of human stem cell research protocols and may consider the Committee’s recommendation in the IRB’s evaluation of risk and benefit.
  
• Office of the Controller/Cost Studies.  The Office of the Controller will review the portion of the application for review of human stem cell research that identifies the research location and other financial considerations to ensure that Northwestern is able to meet applicable Federal guidelines for the conduct of this research.

Administrative and Financial Documentation

Northwestern research utilizing human stem cells will be conducted in accordance with University policies for the conduct of research as well as applicable State and Federal regulations governing the research.  As a recipient of Federal research and development funding, Northwestern has accepted certain obligations and restrictions related to a wide variety of University research activities. 

To help ensure the University’s ability to meet the regulatory expectations of our funding and oversight agencies, members of Northwestern’s research community who plan to conduct human stem cell research must provide a protocol to NUCHSR for review and approval prior to beginning work on the protocol.  The application for NUCHSR review will include sufficient information for the Committee to complete its responsibilities as well as clarification of the source of funding and the Northwestern location in which the research will be conducted. 

Research using human pluripotent stem cells that are not included in the NIH Embryonic Stem Cell Registry must be clearly identified to ensure the University’s appropriate treatment of both direct and indirect costs.

All requests to conduct human stem cell research must be accompanied by the Northwestern University Human Stem Cell Research Application.  Federal regulations prohibit the use of federally-funded equipment, supplies, and personnel to support research using non-approved stem cell lines.  It is the responsibility of the principal investigator and all research personnel involved in human stem cell research to understand and adhere to these Federal restrictions.  The Human Stem Cell Research Application will help ensure that federal funds are not used to support the facilities and administrative infrastructure for research using non-approved human stem cell lines at Northwestern. 

As with all sponsored programs, direct costs such as supplies and salary costs must be separately monitored and charged to appropriate research accounts.  It is inappropriate to share resources among research projects without an accurate allocation of costs to the funding source.  Therefore, with respect to research using non-approved stem cell lines, it is essential that supplies and personnel supporting these projects are segregated from other research activities. 

Categories for Oversight of Human Stem Cell Research

NUCHSR will categorize human stem cell research into three categories as recommended by the Guidelines for Human Embryonic Stem Cell Research:

• Research that is permissible after notification of NUCHSR and completion of the reviews mandated by current requirements.  Purely in vitro hES research with pre-existing coded or anonymous human stem cell lines in general is permissible provided that the notice of the research, documentation of the provenance of the cell lines, and evidence of compliance with any required Institutional Review Board, Institutional Animal Care and Use Committee, Institutional Biosafety Committee, or other mandated reviews, is provided to NUCHSR.  For research included in Category A, a review similar to the IRB expedited review will be conducted and the investigator notified.
  
  
• Research that is permissible only after additional review and approval by NUCHSR, such as:
1. NUCHSR will evaluate all requests for permission to attempt derivation of new hES lines from donated blastocysts, from in vitro fertilized oocytes, or by nuclear transfer.  The scientific rationale for the need to generate new hES lines, by whatever means, should be clearly presented, and the basis for the numbers of blastocysts or oocytes needed should be justified.  Such requests should be accompanied by evidence of Institutional Review Board approval of the procurement process.
2. All research involving the introduction of hES lines into nonhuman animals at any stage of embryonic, fetal, or postnatal development should be reviewed by NUCHSR.  Particular attention should be paid to the probably pattern and effects of differentiation and integration of the human cells into the nonhuman animal tissues.
3. Research in which personally identifiable information about the donors of the blastocysts, gametes, or somatic cells from which the hES line was developed is readily ascertainable by the investigator also requires NUCHSR review and approval.

• Research that should not be permitted at this time, for example:
  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 comes first.
  2. Research in which human embryonic stem cells are introduced into nonhuman primate blastocysts or in which any embryonic stem cells are introduced into human blastocysts.
  3. No animal into which human embryonic stem cells have been introduced at any stage of development should be allowed to breed.

Submission to NUCHSR, IRB, ACUC and IBC

Investigators may make an application for NUCHSR approval of Category B research at any time.  The research may not begin until both NUCHSR and other relevant review committees have approved the research application.  NUCHSR will follow a procedure in which the application for NUCHSR review is provided to a primary reviewer along with appropriate application forms, an appropriate description of the research, and a copy of the relevant funding proposal.  The primary reviewer will review the submitted material, gather additional information from the investigator as necessary, and present the protocol application to the full NUCHSR for discussion. 

Bibliography

Chapman, Audrey R., Mark S. Frankel, and Michele S. Garfinkel. Stem Cell Research and Applications: Monitoring the Frontiers of Biomedical Research. American Association for the Advancement of Science and Institute for Civil Society, 1999.

Commission on Life Sciences. Stem Cells and the Future of Regenerative Medicine. The National Academies Press, 2002.

Committee on Guidelines for Human Embryonic Stem Cell Research, National Research Council (2005). Guidelines for Human Embryonic Stem Cell Research, Prepublication Copy. The National Academies Press, 2005.

Harvard University. Treatment of Human Embryonic Stem Cell (hESC) Research Activities for Indirect Cost Recovery Purposes at Harvard University [online]. Cambridge, MA [cited 26 December 2004]. Available from World Wide Web: http://vpf-web.harvard.edu/osr/managing/man_pos_stem.shtml.

Holden, Constance, and Gretchen Vogel. "A Technical Fix for an Ethical Bind?" Science, December 24, 2004, 2174-76.

National Institutes of Health. Guidelines for Research Using Human Pluripotent Stem Cells. Federal Register Vol. 65, No. 166. August 25, 2000.

National Institutes of Health. Guidelines for Research Using Human Pluripotent Stem Cells; Correction. Federal Register Vol. 65, No. 225. November 21, 2000.

National Institutes of Health. Guidelines for Research Using Human Pluripotent Stem Cells (Withdrawal notice). Federal Register Vol. 66, No. 220. November 14, 2001.

National Institutes of Health.  NIH Human Embryonic Stem Cell Registry [online]. Bethesda, MD: National Institutes of Health [cited 29 December 2004].  Available from World Wide Web: http://stemcells.nih.gov/research/registry/.

National Institutes of Health. Stem Cell Information [online]. Bethesda, MD: National Institutes of Health [cited 29 December 2004].  Available from World Wide Web: http://stemcells.nih.gov/info/basics/basics1.asp.

The University of California, San Francisco. Human Stem Cell Research Policy [online]. San Francisco, CA [cited 27 December 2004]. Available from World Wide Web: http://www.research.ucsf.edu/SC/Policy/scPolicy.asp

The University of California, San Francisco. Human Stem Cell Research Policy: Frequently Asked Questions [online]. San Francisco, CA [cited 27 December 2004]. Available from World Wide Web: http://www.research.ucsf.edu/SC/FAQ/scFAQ.asp.

Washington University in St. Louis. Statement on Stem Cell Research and Somatic Cell Nuclear Transfer [online]. St. Louis, MO [cited 27 December 2004]. Available from World Wide Web: http://www.wustl.edu/policies/cloningstatement.hml.

Washington University in St. Louis. Human Embryonic Stem Cells Policy [online]. St. Louis, MO [cited 26 December 2004]. Available from World Wide Web: http://www.wustl.edu/policies/humanembryonicstemcell.hml.

The White House. Fact Sheet: Embryonic Stem Cell Research [online]. Washington, DC [cited 27 December 2004]. Available from World Wide Web: http://www.whitehouse.gov/news/releases/ 2001/08/print/20010809-1.html.