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Stem Cell Research

Welcome to the website of WesternU’s Stem Cell Research Oversight (SCRO) Committee, established in accordance with Section 125119 of the California Code of Regulations to ensure that stem cell research at WesternU meets the highest scientific and ethical standards. It is WesternU’s policy that the information contained on these pages is applicable to the use of human embryonic stem cells or human pluripotent stem cells, induced or otherwise, in any research or teaching activity conducted at any facility owned or operated by WesternU.

The application form for the use of human pluripotent stem cells in teaching or research may be obtained by clicking here.

The SCRO Committee meets on an ad hoc basis, but not less than once per year, to review newly submitted protocols and previously approved projects to ensure that the research continues to meet the standards set forth in the Guidelines developed by the State Department of Public Health pursuant to Section 125118 of the California Health and Safety Code. A complete copy of the Guidelines may be viewed by clicking here.

Committee membership conforms to Section 4(a) of the Guidelines with members being appointed to two-year renewable terms.  The membership reflects the scientific, medical and ethical expertise required to review human embryonic or induced pluripotent stem cell (iPSC) research applications.  The Committee serves as an advisor to the Vice President (VP) for Research and Biotechnology with the Chair of the Committee reporting directly to the VP.  The Committee works in conjunction with the Institutional Review Board (IRB) and, when appropriate, the Institutional Animal Care and Use Committee (IACUC) and other compliance committees to ensure adequate review of research and teaching involving pluripotent stem cells and to ensure the protection of human and animal subjects.

Regulations require that “All research projects involving the derivation or use of human embryonic stem cells shall be reviewed and approved by a stem cell research oversight committee prior to being undertaken”, and that the Guidelines be applied when reviewing proposed human embryonic stem cell research projects.  However, the following are exempt from SCRO review:

  • Adult precursor cells that differentiate into cells of a single tissue type;
  • Use of human cord blood;
  • Transplantation of stem cells as part of recognized and accepted medical treatment for a disease or condition.

Definitions as Used in the Guidelines

Covered cells refers to cells from covered stem cell lines or cells differentiated from cells that are from covered stem cell lines

Covered stem cell line refers to a culture-derived, human pluripotent stem cell population derived from an embryo or product of somatic cell nuclear transfer (SCNT) that is capable of: (1) sustained propagation in culture; and (2) self-renewal to produce daughter cells with equivalent developmental potential. Title 17, Section 100020, of the California Code of Regulations includes in this definition “…embryonic and non-embryonic human stem cell lines regardless of the tissue of origin”.

Pluripotent refers to stem cells that are capable of differentiation into mesoderm, ectoderm, and endoderm. These guidelines also apply to “…introducing human pluripotent cells or cells differentiated from human pluripotent stem cell lines into non-human animals, or introducing neural-progenitor cells into the brain of non-human animals at any state of embryonic, fetal, or postnatal development”.

Prohibited Activities

The following activities involving stem cell research are prohibited at any facility owned or operated by WesternU:

  • Human reproductive cloning;
  • In vitro culture of an intact human embryo for more than 12 days of development or until formation of the primitive streak, whichever occurs first;
  • Payment to a donor solely for the purpose of creating a human embryo to be used in human embryonic stem cell research;
  • Implanting a chimeric embryo containing non-human cells, including ESC, into the uterus of a human;
  • Implanting a chimeric embryo containing human embryonic stem cells into the uterus of a nonhuman primate and allowing the resulting pregnancy to progress to the point of independent viability;
  • Breeding of a chimeric animal having human embryonic stem cells that were introduced during any stage of the animal’s embryonic or fetal development;
  • Breeding of a chimeric animal having human embryonic stem cells where there is a reasonable possibility that human genetic material could be incorporated into the animal’s germ cells;
  • Using federal funds to engage in ineligible human embryonic stem cells research; or
  • Engaging in human embryonic stem cells research in a manner that is contrary to any applicable local, state or federal laws, rules or regulations.

Review Requirements

Activities involving covered human embryonic or pluripotent stem cells, as defined above, shall be conducted, regardless of source of funding, in accordance with applicable state and federal regulations, including any restrictions on the use of federal funds, and any other relevant WesternU policies and procedures.

  • All submissions must come from the Principal Investigator (PI).
  • Projects involving the derivation of stem cell lines cannot be combined on the same protocol application with projects involving the subsequent use of those lines.
  • Research with human pluripotent stem cells involving animal subjects must also be reviewed and approved by WesternU’s IACUC prior to initiation of the study;
  • Research involving human subjects that seek to derive pluripotent cell lines must also be reviewed and approved by WesternU’s IRB prior to initiation of the study;

            NOTE:  Regardless of IRB review requirements, all human embryonic stem cell research   must still be reviewed and overseen by the SCRO Committee and any other applicable compliance committees (CCR Section 125119(a)(1)).

  • Receipt, use, and disposal of human pluripotent Stem Cells must be in compliance with Environmental, Health and Safety requirements;
  • Research that intends to introduce human neural progenitor cells into the brain of non-human animals at any state of embryonic, fetal, or postnatal development must be reviewed and approved by WesternU’s SCRO and IACUC committees prior to initiation of the study.

Acquisition and Transfer of Material

Receipt or transfer of human embryonic or pluripotent stem cell materials must comply with any Material Transfer Agreement (MTA) requirements that the University may have or any other written acknowledgements. Any WesternU-generated or WesternU-modified human embryonic stem cell material to be transferred off campus for use by others must comply with the requirements of WesternU’s Office of Technology Transfer and Intellectual Property requirements.  Offices handling such transactions will also be responsible for compliance with SCRO requirements for assuring prior approval and providing information for campus tracking of such transactions, as appropriate.

Derivation of new human pluripotent Stem Cell lines or human gametes, zygotes, embryos, stem cell, or pluripotent lines for the purpose of publication or external sharing will require SCRO Committee review. However, the IRB shall be responsible for reviewing requests to establish banking of human gametes, zygotes, embryos, stem cells or pluripotent lines for the purpose of external sharing and usage.

Responsibilities and Authority of the SCRO Committee

Click on the navigation bar on the left side of this page for a comprehensive list of the responsibilities and authority of the SCRO Committee.

Review Process

Investigators are responsible for submitting applications to the SCRO Committee and to the IRB, IACUC and other compliance committees as necessary. Although there is no specific requirement regarding the order of submission, SCRO Committee approval must be obtained prior to or concurrent with approval by any other committee and prior to initiation of any research or teaching activities involving human embryonic or pluripotent stem cells.

The Committee may take one of the following actions regardless of the type of submission or method of review:

  • Approval: Revisions or additional paperwork are not required.
  • Deferred Pending Clarification: Revisions or additional paperwork are required to obtain approval.
  • Tabling: A protocol may be tabled if the Committee runs out of time or loses a quorum.
  • Disapproval: The proposal does not meet requisite standards.
  • Closure: If an investigator does not respond to repeated concerns about an approved protocol, the Committee may close the protocol and all work covered by the protocol must stop.
  • Withdrawal: If an investigator does not respond to repeated concerns about a submission that has not yet been approved, the Committee may withdraw the protocol from further consideration and the PI must resubmit anew.

The PI shall be informed in writing of the action taken. SCRO Committee approvals are contingent on approval from any other applicable compliance committees such as the IRB, IACUC and IBC. Approvals shall be for a period of one year from the date of the meeting at which the project was approved regardless of when any other committee approval is obtained.  Continuation of work beyond the expiration date will require review and approval by the Committee.  Renewal requests must be submitted well in advance of the project expiration date to avoid a lapse in the research.    However, if a protocol expires, all activities covered by the approval must stop until the protocol has been reapproved. If the proposal is disapproved, the PI shall be informed in writing of the reason(s) and shall be given an opportunity to rebut the decision in writing or before a convened meeting of the Committee.

Amendments to a project, including adding additional cell lines or proposing additional testing, must be received, reviewed and approved by the SCRO Committee and other committees as appropriate before they are initiated except when necessary to eliminate the apparent immediate hazard to subjects.  Requests for approval of modifications/changes may be submitted at any time by the Principal Investigator (PI) during the approved period of a study.

No member may participate in the initial or continuing review of any project or vote on any project in which the member has a conflict of interest other than to provide information requested by the committee. Members with a conflict of interest must recuse themselves from the voting. Recused members may not contribute to a quorum.

Ethics Training

WesternU requires that investigators working with human embryonic or pluripotent stem cells complete ethics training in the responsible conduct of research. Documentation of training must be provided to the SCRO Committee at the time of submission of a proposed project for review and approval.  This requirement may be fulfilled in any one of the following ways:

  • Submission of a Certificate of Completion, or equivalent, from a training course on the Responsible Conduct of Research;
  • Documentation of attendance at the stem cell ethics component of a local, state or national stem cell meeting;
  • Any other equivalent experience (subject to approval by the SCRO Committee).

Adverse Events

Any adverse event involving the use of human embryonic or pluripotent stem cells that would be reported to the IRB, IBC or Environmental Health & Safety must also be reported to the SCRO Committee.

Frequently Asked Questions (FAQs)

Click on the navigation bar on the left side of this page for a list of FAQs.

References

Title 45, Code of Federal Regulations, Part 46,