UW–Madison Stem Cell Research Oversight (SCRO) Multisite Research

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Policy Number:

UW-4029

Responsible Office:

Office of Research Compliance

University Policy

Rationale/​Purpose:

The National Academies’ Guidelines for Human Embryonic Stem Cell Research, which guided UW–Madison’s own policy on human pluripotent stem cell research, encourages all institutions to create a Stem Cell Research Oversight Committee to provide oversight of all issues related to derivation and use of human embryonic stem cell lines and to facilitate the education of investigators involved in human embryonic stem cell research. The guidelines further suggest that the Stem Cell Research Oversight Committee could be internal to a single institution or established jointly with one or more other institutions. Alternatively, an institution may have its proposals reviewed by the Stem Cell Research Oversight Committee of another institution, or by an independent Stem Cell Research Oversight Committee.

Not all institutions have established a Stem Cell Research Oversight Committee in response to the guidelines. In recognition of the fact that UW–Madison faculty and staff may collaborate on human pluripotent stem cell research with investigators at other institutions that do not have such a  committee, and that UW–Madison believes it is important for all activities of investigators who collaborate with UW–Madison faculty and staff on such research to be fully vetted by such a committee, the UW–Madison Stem Cell Research Oversight Committee adopts the following policy.

Definitions:

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.

Scope:

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.

Policy:

When UW–Madison faculty and staff engage in research as described in Section 1 of the UW–Madison human pluripotent stem cell research policy which involves multiple sites, the following applies:

1. If a 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.
   1. Collaborating investigators who submit a stem cell research protocol application to their own institution’s Stem Cell Research Oversight Committee should not be listed as project personnel on the UW–Madison Application for Initial Review of Research Projects Involving Human Pluripotent Stem Cells.
   2. A copy of the collaborating investigator’s final notice of approval from their institution’s Stem Cell Research Oversight Committee should be submitted to UW–Madison's committee when it is obtained.
2.  If a non-UW–Madison site does not have its own Stem Cell Research Oversight Committee, then all project personnel engaged in the research should be listed on the UW–Madison Application for Initial Review of Research Projects Involving Human Pluripotent Stem Cells.
   1. All investigators and project personnel listed on the UW–Madison Application for Initial Review of Research Projects Involving Human Pluripotent Stem Cells must complete the UW–Madison online Stem Cell Ethics and Policy Training (Stem Cell Research Oversight: Training). Collaborating investigators may alternatively take stem cell training from their own institution. In this case, a certification of training must be submitted to the UW–Madison Stem Cell Research Oversight Committee.
   2. Additionally, the UW–Madison committee will require proof that the collaborating site’s Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), and/or Institutional Animal Care and Use Committee (IACUC) has reviewed the protocol, when applicable, on behalf of the collaborating investigator.
   3. The UW–Madison principal investigator is expected to communicate with collaborators regarding the need to follow UW–Madison stem cell research oversight policies, including those requiring changes of protocol to be reviewed by the Stem Cell Research Oversight Committee before implementation and requiring the submission of a continuing review application every three years until the conclusion of the study.

Related UW-Madison Policies:

UW-4025 UW–Madison Policy for Human Embryo and Human Pluripotent Stem Cell Research

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

Stem Cell Research Oversight: Training

Policy Administration

Approval Authority:

OVCRGE Offices: Research Compliance; Policy and Integrity

Policy Manager:

OVCRGE Offices: Research Compliance; Policy and Integrity

Contact:

OVCRGE Offices: Research Compliance; Policy and Integrity -- Heather McFadden, heather.mcfadden@wisc.edu, (608) 890-2468

Effective Date:

05-27-2009

Retrieved:

04-25-2024 05:05:04