Stem Cell Research Oversight (SCRO) Full and Expedited Review

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Policy Number:
UW-4028
Responsible Office:
Office of Research Compliance

University Policy

Definitions:
Full Stem Cell Research Oversight Committee review
The application is reviewed at a Stem Cell Research Oversight Committee meeting with a quorum, defined as half the committee plus one member present, and any action taken on the application is done via a majority vote of members present.
Expedited panel review
The review is carried out by the Stem Cell Research Oversight Committee chair or by one or more committee members designated by the chair. In reviewing the research, the expedited reviewer(s) may exercise all of the authorities of the committee except that the reviewer(s) may not disapprove the research. The expedited reviewer(s) may also bring the application to the full committee for review when they determine that full committee review is appropriate.
Scope:

All research on campus involving campus faculty or staff that involves the following must be submitted to the Stem Cell Research Oversight Committee for review and approval:

  • The use of human embryonic stem cells or their derivatives.
  • The introduction of human pluripotent stem cells or their derivatives, obtained from a non-embryonic source, into non-human 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.
  • All research that:
    • Involves pre-implantation stages of human development, human embryos, or embryo-derived cells; or
    • Entails the production of human gametes in vitro when such gametes are tested by fertilization or used for the creation of embryos.
  • The storage or disposition of human embryos or gametes obtained for the purposes of stem cell research.

  • The storage and distribution of human embryonic stem cells through a repository.

Policy:

  1. Review by the Full Stem Cell Research Oversight Committee

    1. Per UW–Madison's Human Embryo and Human Pluripotent Stem Cell Research policy, all research on campus involving campus faculty or staff that involves the following must be submitted to the Stem Cell Research Oversight Committee for review and approval:
      1. The use of human embryonic stem cells or their derivatives.
      2. The introduction of human pluripotent stem cells or their derivatives, obtained from a non-embryonic source, into non-human 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. All research that:
        1. Involves pre-implantation stages of human development, human embryos, or embryo-derived cells; or
        2. Entails the production of human gametes in vitro when such gametes are tested by fertilization or used for the creation of embryos;
      4. The storage or disposition of human embryos or gametes obtained for the purposes of stem cell research.
      5. The storage and distribution of human embryonic stem cells through a repository.
    2. All applications submitted to the Stem Cell Research Oversight Committee for initial or continuing review of research involving human embryo and or human pluripotent stem cells will be reviewed by the full committee, except for those applications that qualify for expedited review. See III.A. below.
    3. Applications for changes of protocol will be reviewed by the full committee, except for those applications that qualify for expedited review. See III.B. below.
    4. The Stem Cell Research Oversight Committee uses a primary reviewer system for all reviews by the full committee. At least two primary reviewers, who are committee members, are assigned to each application for review.
    5. The assignments are made by the Stem Cell Research Oversight Committee staff and reflect the expertise of the primary reviewers. The staff also check for conflicts of interest between primary reviewers and research protocols. See SCRO Committee Conflict of Interest Policy.
    6. The assigned primary reviewers conduct the in-depth review of the protocol application and all provided materials, and lead the discussion of the application at the full Stem Cell Research Oversight Committee meeting. All other committee members, including any alternate members substituting for a committee member, are expected to review the provided materials in enough depth to be familiar with them and be prepared to discuss them at the convened meeting.

  2. Transplantation of hPSCs into Non-Human Animals

    1. The full committee will review transplantation research that involves the integration of human pluripotent stem cells or their derivatives into non-human animals at any embryonic, fetal, or postnatal stage into the central nervous system, testes, or ovaries of the animal.
    2. New protocols that involve transplantation will be initially reviewed by the Stem Cell Research Oversight Committee chair or by one or more committee members designated by the chair. In reviewing the research, these reviewer(s) may deem that the research does not meet the criteria for full review and review may be expedited.
    3. Teratoma experiments to test pluripotency of human pluripotent stem cells may qualify for expedited review.

  3. Expedited Review

    1. Those initial and continuing review applications that qualify for expedited review include:
      1. In vitro studies using National Institutes of Health (NIH) approved cell line(s); and
      2. In vitro studies using a cell line(s) previously approved by the Stem Cell Research Oversight Committee and listed on UW–Madison's hESC Registry.
      3. Teratoma assay transplantation research. Teratoma experiments to test pluripotency of human pluripotent stem cells may qualify for expedited review.
    2. Those changes of protocol that qualify for expedited review include:
      1. Changes in personnel.
      2. Changes in funding source.
      3. Other changes that do not affect the research type, research design or research question.
Related UW-Madison Policies:
Related UW–Madison Documents, Web Pages, or Other Resources:

Policy Administration

Approval Authority:
Compliance Manager, Responsible Conduct of Research and Stem Cell Research Oversight
Policy Manager:
Compliance Manager, Responsible Conduct of Research and Stem Cell Research Oversight
Contact:
Compliance Manager, Responsible Conduct of Research and Stem Cell Research Oversight -- Heather McFadden, heather.mcfadden@wisc.edu, (608) 890-2468
Effective Date:
10-27-2010
Revised Dates:

05-10-2017, 05-26-2021, 10-06-2021

Retrieved:
04-27-2024 07:16:18