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KUMC Human Stem Cell Research Oversight

Policy
Purpose: 

To set forth the requirements for research involving the use of human stem cells at the University of Kansas Medical Center.

Applies to: 

Anyone engaged in human stem cell research at KU Medical Center.

Campus: 
Medical Center, Kansas City
Wichita
Salina
Policy Statement: 
  1. Activities involving Human Stem Cell Research shall be conducted  in accordance with:
  • the applicable state and federal laws and regulations governing such research, including any restrictions on the use of state or federal funds for such research;
  • any conditions of approval required by the Human Stem Cell Research Oversight Committee (“HSCROC”), and
  • the applicable Institutional Review Board (“IRB”), Institutional Animal Care and Use Committee (“IACUC”), and Institutional Biosafety Committee (“IBC”).
  1. Individuals who intend to conduct Human Stem Cell Research must submit the documentation requested by the Human Stem Cell Research Oversight Committee (“HSCROC”), for review and approval by the HSCROC, prior to engaging in such research.
  1. Individuals who intend to conduct Human Stem Cell Research using cells or cell lines that are not included on the NIH Human Embryonic Stem Cell Registry must submit a protocol to the applicable IRB for review and approval prior to initiation of the study.  This must be done even if there are no plans to put such cells into human subjects.
  1. Human Stem Cell Research may require additional approvals by the applicable Institutional Review Board (“IRB”), Institutional Biosafety Committee (IBC) or Institutional Animal Care and Use Committee (IACUC), as indicated in the applicable IRB, IBC and IACUC Standard Operating Procedures.
  1. In the event that the HSCROC and IRB approves Human Stem Cell Research involving embryonic stem cells or embryonic cell lines that are not on the NIH Human Embryonic Stem Cell Registry, the Department and Principal Investigator shall be responsible for separating out in toto both the direct and indirect costs of that research and charge the costs to a non-federal funding source.  The University extends this same funding prohibition to the use of funds from the State of Kansas.
  1. The Vice Chancellor for Research at KUMC shall appoint the voting members of HSCROC committee.
  1. The HSCROC will review the scientific merit and ethical justification of the research proposals.  The HSCROC will determine which categories of proposed research require notification/minimal or designated member review versus full review, and which will not be permitted at this time. 
  1. The HSCROC will establish and maintain a registry of human embryonic and human stem cell research conducted at KUMC and human stem cell lines derived or obtained by KUMC researchers covered by this policy. 
  1. The HSCROC members will include scientists, an ethicist, and compliance personnel in ex officio positions.   The chair of the committee shall serve a term of three years, with the option of a second term.  The SCROC may include a community member.
  1. Administrative support for the HSCROC will be provided by the Office of Compliance
Exclusions or Special Circumstances: 

This policy does not apply to research utilizing animal stem cells.

Consequences: 

The HSCROC may recommend suspension or termination of activities that fall under its jurisdiction and that are not being performed in compliance with the terms of its approval, its policies, or applicable law or regulation.  Such recommendation shall be made in writing to the appropriate Vice Chancellor for Research, who will take appropriate action.

Contact: 

Office of Compliance 913-588-1206

Approved by: 
Vice Chancellor for Research
Approved on: 
Wednesday, October 11, 2017
Effective on: 
Wednesday, October 11, 2017
Review Cycle: 
Annual (As Needed)
Definitions: 

NIH Human Embryonic Stem Cell Registry: A list of stem cell lines approved for research with federal funds.

Human Stem Cell Research: The term “Human Stem Cell Research” includes research involving the use or derivation 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, use of stem cells derived from nuclear transfer and chimeric animals produced with human stem cells are also considered “Human Stem Cell Research.”

Keywords: 
stem cell, oversight
Review, Approval & Change History: 

New: approved by Human Stem Cell Oversight Committee 2017 10 11

Research and Sponsored Projects Category: 
Research and Sponsored Projects

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