Human Embryo and Human Pluripotent Stem Cell Research

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Policy Number:
UW-4025
Responsible Office:
Office of Research Compliance

University Policy

Rationale/​Purpose:

To ensure adherence to the basic ethical and legal principles of informed consent and protection of confidentiality, human embryonic stem cells (hESCs) may be used by UW–Madison investigators only after documentation of their provenance has been provided to and approved by the UW–Madison Stem Cell Research Oversight Committee. Documentation of provenance only needs to be provided prior to the first use of the human embryonic stem cells in research falling within the Stem Cell Research Oversight Committee’s purview. Upon approval by the committee, the human embryonic stem cells will be listed on the UW–Madison hESC Registry.

Definitions:
Chimera
An organism composed of cells with different species origins. This includes any (non-human) animal into which human cells have been introduced. Human pluripotent stem cells (hPSCs) include human pluripotent stem cells from embryonic and non-embryonic sources.  
Human embryonic stem cells (hESCs)
Cells derived from very early in development, usually the inner cell mass of a developing blastocyst. These cells are self-renewing (can replace themselves) and pluripotent (can form all cell types found in the body.)
Human pluripotent stem cells (hPSCs)
Stem cells that can become all of the cell types that are found in implanted embryo, fetus, or developed organisms. Embryonic stem cells are pluripotent stem cells.
Induced pluripotent stem cells
Stem cells that were engineered (“induced”) from non-pluripotent cells to become pluripotent. In other words, a cell with a specialized function (for example, a skin cell) that has been “reprogrammed” to an unspecialized state similar to that of embryonic stem cells.
Repository
A facility designed to collect, store, and broadly distribute cells, and data or information about those cells, on an ongoing basis. It might also store and distribute DNA or other biomaterials.
Scope:

Applies to researchers using human embryos, human embryonic stem cells, or transplantation of human pluripotent stem cells into animals with possible CNS integration or germline transmission.

Policy:
  1. Stem Cell Research Oversight Committee Purview
    1. The Stem Cell Research Oversight Committee will provide oversight for all research on campus or involving campus faculty or staff that involves any of the following:
      1. The use of human embryonic stem cells or their derivatives.
      2. The introduction of human pluripotent stem cells or their derivatives into nonhuman animals at any embryonic, fetal, or postnatal stage, if an expected effect is that human cells will be integrated into the central nervous system, testes, or ovaries of the animal.
      3. Preimplantation stages of human development, human embryos, or embryo-derived cells.
      4. The production of human gametes in vitro when such gametes are tested by fertilization or used for the creation of embryos.
      5. The storage or disposition of human embryos or gametes obtained for the purposes of stem cell research.
      6. The storage and distribution of human embryonic stem cells through a repository.
    2. The university established the Stem Cell Research Oversight (SCRO) Committee, which includes representation of the public and may include persons with expertise in developmental biology, embryo development, stem cell research, molecular biology, and ethical and legal issues in human pluripotent stem cell research.
    3. The Stem Cell Research Oversight (SCRO) Committee must review all human stem cell research regardless of the source of funding. If a collaborating, non-UW–Madison site has its own Stem Cell Research Oversight Committee, then both UW–Madison’s committee and the other site’s committee must review and approve the research. 
  2. Human Embryonic Stem Cell Registries
    1. National Institutes of Health (NIH) Human Embryonic Stem Cell (hESC) Registry

      Human embryonic stem cell lines listed on the NIH hESC Registry are eligible for use on the UW–Madison campus with approval from the Stem Cell Research Oversight Committee. These lines do not need additional provenance review and are eligible for use with federal funding.

    2. UW–Madison Human Embryonic Stem Cell (hESC) Registry
      1. In addition, the Stem Cell Research Oversight Committee established and maintains the UW–Madison hESC Registry (which should not be confused with the NIH Human Embryonic Stem Cell Registry). This registry includes human embryonic stem cells with provenance already approved by the committee. Lines on this registry cannot be used with federal funding.
      2. Human embryonic stem cell lines not currently listed on this registry must go through review of the documentation of provenance. Once the review is completed and approval is granted, the human embryonic stem cell line will be listed on the UW–Madison hESC Registry and will be eligible for use by UW–Madison investigators.
  3. Provenance Approval Process
    1. To ensure adherence to the basic ethical and legal principles of informed consent and protection of confidentiality, human embryonic stem cells may be used by UW–Madison investigators only after documentation of their provenance has been provided to and approved by the Stem Cell Research Oversight Committee. Documentation of provenance only needs to be provided prior to the first use of the stem cells in research falling within the committee’s purview. Upon approval by the committee, the human embryonic stem cells will be listed on the UW–Madison hESC Registry
    2. Documentation of Provenance: The Stem Cell Research Oversight Committee reviews documentation of the provenance of human embryonic stem cell lines before such lines may be added to the UW–Madison hESC Registry and used by university investigators. In determining which human embryonic stem cell lines may be used by university researchers, the committee will consider whether the proper consent and additional criteria have been met, but may approve human embryonic stem cell lines for inclusion on the UW–Madison’s hESC Registry where procurement processes differ slightly from that specified. For a list of the criteria, please see UW–Madison Guidance for Documentation of Provenance. Consent documentation requirements are as follows:
      1. Embryos Created for Reproductive Purposes: For human embryonic stem cell lines derived from embryos originally created for reproductive purposes, but which are now in excess of clinical need, the Stem Cell Research Oversight Committee must receive documentation that the embryo procurement process was approved by an Institutional Review Board (IRB) or appropriate institutional ethics committee and must receive a copy of the IRB-approved consent form(s) used during the embryo procurement process. If sperm or oocyte donors were used in this process, documentation of their consent to donate these excess embryos for research is not required (as outlined in 2009 NIH Guidelines II., A., 2.).
      2. Embryos Created for Research Purposes: For human embryonic stem cell lines derived from embryos created for research purposes through conventional (standard or intracytoplasmic sperm injection [ICSI] insemination) in vitro fertilization (IVF), the Stem Cell Research Oversight Committee must receive documentation that the sperm and oocyte procurement processes were approved by an IRB or appropriate institutional ethics committee and must receive a copy of the IRB69 approved consent form(s) used during the sperm and oocyte procurement processes.
      3. Embryos Created by Somatic Cell Nuclear Transfer (SCNT): For human embryonic stem cell lines derived from embryos created for research purposes through SCNT, the Stem Cell Research Oversight Committee must receive documentation that the oocyte and somatic cell procurement processes were approved by an IRB or appropriate institutional ethics committee and must receive a copy of the IRB-approved consent form(s) used during the oocyte and somatic cell procurement processes.
  4. Oversight for Introduction of hPSCs into Non-Human Animals (Chimeras)
    1. UW–Madison Chimera Review
      1. This Human Embryo and Human Pluripotent Stem Cell Research policy requires the Stem Cell Research Oversight Committee to review research involving the creation of chimeras when the chimeras are created in either of two ways:
        1. By introducing human embryonic stem cells, or cells derived from human embryonic stem cells, into an animal; or
        2. By introducing human pluripotent stem cells obtained from non-embryonic sources, or cells derived from such human pluripotent stem cells, into an animal, when one expected effect of the introduction is that human cells will be integrated into the central nervous system, testes, or ovaries of the animal.
      2. Particular attention must be paid to at least three factors: the extent to which the implanted cells colonize and integrate into the animal tissue; the degree of differentiation of the implanted cells; and the possible effects of the implanted cells on the function of the animal tissue (in accordance with NAS Guidelines 2016 section 2.1).
      3. Standard teratoma formation assays used to test whether cells are pluripotent must be reviewed by the Institutional Animal Care and Use Committee (IACUC).
    2. Human Pluripotent Stem Cell Line Limitations
      1. The committee will not approve the introduction of any cell lines with consent limitations, or cells derived from them, into animals during their embryonic stages of development.
      2. Consent documents prohibit the following research utilizing human embryonic stem cells: WA01, WA07, WA09, WA13, WA14 (the original five Wisconsin lines):
        1. Mixing WA01, WA07, WA09, WA13, WA14 or their modifications with an intact embryo, either human or non-human.
        2. Implanting WA01, WA07, WA09, WA13, WA14, their modifications, or their products in a uterus.
        3. Attempting to make whole embryos with WA01, WA07, WA09, WA13, WA14 or their modifications with any method.
        4. Using WA01, WA07, WA09, WA13, WA14 or their modifications for therapeutic or commercial purposes, including the performance of services (including diagnostic services), for consideration or the production or manufacture of products for sale or distribution.
    3. Carnegie Stages of Development and Human Pluripotent Stem Cell Limitations
      1. The Stem Cell Research Oversight Committee uses the definition of the embryonic stage to extend through Carnegie Stage 23. In mice, this extends through E16, in rats through E17.5, in chicks through E10, and in pigs through E32.5. (See Carnegie Stages for information about other species.)
      2. For researchers requesting to introduce pluripotent stem cells during the embryonic stages of development, researchers must provide a rationale for introducing cells at the embryonic stage. In evaluating the application, the committee will consider the following:
        1. The possibility the human material could affect the cognitive abilities of the animal research subject in ways that would be morally relevant.
        2. The possibility the that human gametes could form within animal research subjects, the breeding of which could then produce a human conceptus.
    4. Prohibitions
      1. The breeding of animals into which human pluripotent stem cells have been introduced.
      2. The introduction of human pluripotent stem cells, or cells derived from such human pluripotent stem cells, into non-human primate preimplantation embryos.
      3. The introduction of pluripotent stem cells from any species into human preimplantation embryos.
  5. Embryo Research Oversight
    1. Research requiring comprehensive review by a stem cell research oversight process includes the following activities:
      1. Use of IVF embryos for research.
      2. Research that generates human gametes when such research entails performing studies of fertilization that produce human embryos.
      3. Research involving the genetic manipulation of human embryos or gametes used to make embryos in vitro.
      4. Derivation of new pluripotent cell lines from human embryos.
        1. The scientific rationale for the need to generate new human embryonic stem cell lines, by whatever means, must be clearly presented, and the basis for the numbers of preimplantation embryos and oocytes needed should be justified. Evidence of IRB or appropriate institutional ethics committee approval of the procurement process and a copy of the consent form used during the embryo procurement process should accompany such requests.
        2. Human embryos in existence at UW as of the date of the approval of this policy may be used for the derivation of new stem cell lines so long as the consent process for such use utilized a consent form approved by the university's Health Sciences IRB. Any request for the generation of new human embryonic stem cell lines from these embryos and the protocol for research using the derived lines are still subject to Stem Cell Research Oversight Committee review.
        3. The procurement processes for gametes or embryos used in the derivation of human embryonic stem cell lines in existence prior to the date of the approval of the original policy are not required to fully comply with this policy. However, the provenance of pre-existing human embryonic stem cell lines must still be documented in accordance with the Human Embryonic Stem Cell Registry and Provenance Approval Process sections of this policy.
      5. Research aimed at generating human totipotent cells that have the potential to sustain embryonic or later development.
      6. Research involving the in vitro culture of embryos or experimental generation of embryo-like structures that might manifest human organismal potential, to ensure minimal periods of in vitro culture, as justified by compelling scientific rationale but not beyond 14 days or formation of the primitive streak, whichever occurs first.
      7. Research in which human totipotent cells or pluripotent stem cells derived by any means are mixed with human embryos.
    2. Research that is prohibited:
      1. In vitro culture of any intact human preimplantation embryo or organized embryo-like cellular structure with human organismal potential, regardless of derivation method, beyond 14 days or formation of the primitive streak, whichever occurs first.
      2. Experiments whereby human embryos or organized cellular structures that might manifest human organismal potential are gestated in any non-human animal uterus.
      3. Research in which human embryos produced by reprogramming of nuclei from somatic cells by nuclear transfer or comparable techniques are gestated in a human or animal uterus. Given current scientific, medical safety, and ethical concerns, attempts at human reproductive cloning are prohibited.
      4. Research in which human embryos that have undergone modification of their nuclear genome are gestated in a human or animal uterus. Genome-modified human embryos include human embryos with engineered alterations to their nuclear DNA and/or embryos generated from a human gamete that has had its nuclear DNA modified, when such modifications will be inherited through the germline. Given current scientific, medical safety, and ethical concerns, attempts at germline editing are prohibited.
      5. Research in which animal chimeras incorporating human cells with the potential to form human gametes are bred to each other.
  6. Human Embryonic Stem Cell Storage and Distribution
    1. When members of a laboratory store cells for their own use, or share cells derived or engineered in that laboratory with other researchers in compliance with funder policies (e.g., NIH Grants Policy Statement, Section 8.2.3: Sharing Research Resources) the laboratory does not become a repository for purposes of this policy. However, if a laboratory under the Stem Cell Research Oversight Committee’s jurisdiction derives or obtains cells and stores them with the intent to broadly distribute them on an ongoing basis, it becomes a repository.
    2. Any repository under the jurisdiction of the Stem Cell Research Oversight Committee that obtains, stores, and distributes human embryonic stem cell lines must have and follow policies and procedures to ensure that the human embryonic stem cell lines were derived ethically and in accordance with relevant laws and policies. It must have evidence-based, standardized methods and protocols in place to conduct biosafety screening; to characterize, maintain, store, and distribute cells; and to assess cell quality. It must document its activities. In particular, the repository’s policies must include:
      1. A secure system for protecting the privacy and confidentiality of donors and their medical information when materials retain codes or are accompanied by other identifiable information.
      2. A policy governing whether and how to return clinically significant information back to donors.
      3. A policy and system for disposal of cellular material, and documentation of that policy.
    3. Any investigator under the jurisdiction of the Stem Cell Research Oversight Committee who derives new human embryonic stem cell lines is encouraged to deposit the lines in a repository from which they could be distributed. The deposit should occur no later than the end date of the investigator’s Stem Cell Research Oversight protocol.
    4. The Stem Cell Research Oversight Committee has authority to review policies and protocols for any repository under its jurisdiction.
    5. The university or any repository under the jurisdiction of the Stem Cell Research Oversight Committee may refuse to accept human embryonic stem cell lines if they do not comply with this policy.
  7. Amendments to Policy

    This policy may be amended by action of the Stem Cell Research Oversight Committee subject to the written approval of the amendment by the vice chancellor for research.

Related UW-Madison Policies:

UW-4026 Human Embryo and Human Pluripotent Stem Cell Research

Related UW–Madison Documents, Web Pages, or Other Resources:
External References:

Policy Administration

Approval Authority:
Senior Associate Vice Chancellor
Policy Manager:
Office of Research Compliance
Contact:
Office of Research Compliance -- Heather Mc Fadden, HEATHER.MCFADDEN@WISC.EDU, (608) 890-2468
Effective Date:
05-15-2007
Date Issued:
05-15-2007
Revised Dates:

09-25-2013, 01-28-2017, 12-20-2017, 04-24-2019, 09-25-2019, 05-26-2021, 06-21-2024

Retrieved:
01-17-2025 01:56:22