Office of Research Integrity

UCR Stem Cell Oversight Committee (SCRO)

StemCells

About This Committee

The STEM CELL OVERSIGHT (SCRO) COMMITTEE has authority over and responsibility for the use of human pluripotent cells* at UCR. The Office of Research Integrity (ORI) administers and supports the functions of the SCRO Committee.

  • PLURIPOTENT CELLS: "Pluripotent Cells" includes any cell capable of differentiating into either ectoderm, mesoderm or endoderm (e.g. embryonic stem cells and cell lines induced to pluripotency).
  • HUMAN PLURIPOTENT CELLS: All activities with HUMAN PLURIPOTENT CELLS (receiving, storage, maintaining, teaching, and lab experiments) must be reviewed and approved by the Stem Cell Research Oversight Committee PRIOR to initiation of that activity.
  • HUMAN ECTODERMAL OR NEURAL STEM CELLS: The use of HUMAN ECTODERMAL OR NEURAL STEM CELLS requires SCRO Committee review only if they are to be incorporated into vertebrate animals.
  • The use of human pluripotent cells at UCR is regulated by the California Department of Public Health.

Information for Investigators

Activities that must be authorized by the SCRO Committee

  • Obtaining and storing human pluripotent cells.
  • The use of human pluripotent cells in in vitro studies.
  • The incorporation of human pluipotent cells into non-human animals.
  • The incorporation of ectodermal or neural stem cells into non-human animals.
  • The attempt to induce pluripotency in a human cell line.
  • The attempt to derive a new embryonic stem cell line.
  • The incorporation of human pluripotent cells or ectodermal/neural stem cells into a human being.

REQUIRED REGULATORY REVIEWS

The use of human pluripotent cells requires, at a minimum, review by the Stem Cell Research Oversight Committee AND the Institutional Biosafety Committee. Please review the information below to determine all the requirements necessary for your research.

Stem Cell Use: All uses of human pluripotent cells are reviewed via the Stem Cell Use Authorization. See below for details on the SCUA.

Biosafety: All uses of human derived materials must be approved by the IBC (via the Biosafety Use Authorization). Currently, protocols must be completed for both Committees (a joint database is under construction). Click IBC to obtain information regarding this committee. Click BUA to complete and submit an IBC protocol. Location - If you are using the Stem Cell Facility, that location needs to be included in (or added by amendment to) a BUA.

Vertebrate Animals: The use of vertebrate animals (e.g. harvesting of mouse embryonic fibroblasts or incorporation of stem cells into) must be approved by the IACUC (via an AUP). Note: IACUC review is not needed if you are obtaining mouse embryonic fibroblasts from the Stem Cell Facility (or another investigator).

Human Subjects: Human Research Review Board review of human protections in the original donation of materials is incorporated into the SCRO Committee review (there is no need for a separate Human Subjects protocol).

MTAs: Most human pluripotent cell lines cannot be obtained without a Material Transfer Agreement (MTA). The Research and Economic Development Office is required to review these contracts in accordance with UC mandated restrictions. It is recommended that you contact mta@ucr.edu as soon as you have determined you would like to obtain a particular cell line.

Stem Cell Use Authorization (SCUAs)

How to apply to use Human Pluripotent Cells: A procedure to apply for SCUAs over the internet is under development. Until that is established, the following forms should be used:

  • SCUA base forms (choose if activities do NOT include pluripotent cell incorporation into non-human animals)
  • SCUA with vertebrate animals forms (choose if activities DO include pluripotent or neural stem cell incorporation into non-human animals) Submit the forms to ibc@ucr.edu.

If your activities will involve the derivation of embryonic stem cell lines or incorporation into humans, contact ibc@ucr.edu (827-4809) as soon as possible.

Amendments to SCUAs

An amendment is required if:

  • A new pluripotent cell line is to be used.
  • There is a substantial change in the focus or research question.
  • Incorporation of human pluripotent cells OR NEURAL OR ECTODERMAL STEM CELLS into non-human animals are to be performed.
  • Derivation of a new embryonic stem cell line is planned.
  • Incorporation of human pluripotent cells into humans is planned.

To Submit an amendment:
A web-based SCUA system is under development. Until that is established, the following forms should be used:

  • SCRO Committee base amendment form (choose if activities do NOT include pluripotent cell incorporation into non-human animals)
  • SCRO Committee amendment forms with vertebrate animals (choose if activities DO include pluripotent or neural stem cell incorporation into non-human animals) Submit the forms to ibc@ucr.edu.

If your activities will involve the derivation of embryonic stem cell lines or incorporation into humans, contact ibc@ucr.edu (827-4809) as soon as possible.

SCUAs and Amendments Review Procedure

When submitted, SCUAs are reviewed to determine status according to California Department of Public Health regulations. Some activities require review by the Committee while other activities require only notification. If it is determined that only notification is necessary, you will be informed that your submission has been accepted. If Committee review is required, the SCUA will be distributed to the Committee. Committee members may choose to approve the SCUA, request a revision for further review, or request that the SCUA be reviewed at a Committee meeting. ORI will contact the investigator regarding the results and facilitate any necessary revisions.

SCRO Committee Meeting Schedule

SCRO Committee meetings are currently scheduled on an ad hoc basis.

Grants, Contracts and AUP Approval

UCR is legally obligated to confirm that all activities involving human pluripotent cells proposed in a funded grant or contract have been reviewed and approved by the SCRO Committee (some granting agencies require this confirmation at the time of submission). When a grant is funded, the Office of Research Integrity provides this confirmation by comparing the grant and protocol. If it is determined that elements in the grant or contract are not described within an approved protocol, the funds may be held until the investigator has submitted and received approval for these activities (via an amendment or new protocol). This applies to all grants, contracts and fellowships. Note: coverage of activities can be within the lead PI's SCUA or within a UCR collaborator's SCUA, and can exist on more than one protocol. PLEASE ENSURE THAT ALL PROPOSED ACTIVITIES WITH HUMAN PLURIPOTENT CELLS ARE COVERED BY AN SCUA OR SUBMIT AN AMENDMENT/PROTOCOL PRIOR TO THE RECIEPT OF FUNDS.

Verification of Approval

Investigators are often asked to provide a letter verifying approval when dealing with granting agencies or as a subcontractor to another institution. Contact the ibc@ucr.edu Office of Research Integrity to obtain this letter. Similarly, investigators sometime receive requests to provide a signed letter of approval. UCR letters of approval are not signed, and a letter verifying approval can be obtained instead.

Consequences of performing activities with human pluipotent cells without approval (non-compliance)

The UCR SCRO Committee considers potential non-compliant situations very seriously. The investigation into such situations is taken carefully, with full consideration of both regulatory requirements and the research program involved. It is understood that although non-compliance may involve willful action on the part of the investigator, it may also be due to a misunderstanding or inaccurate information on the part of the investigator. The primary goal of a non-compliance investigation is to ensure future compliance.

About the SCRO Committee

The University of California, Riverside (UCR), recognizes the scientific and ethical responsibility for the appropriate uses of human pluripotent cells used in research and education. UCR has established the SCRO Committee, which is qualified through the experience and expertise of its members to oversee the institution's use and handling of human pluripotent cells. The SCRO Committee, as agent for UCR's obligations for the appropriate use of human pluipotent cells, shall:

  • Be constituted according to state requirements. Members are appointed by the Vice Chancellor for Research.
  • Assure that all activities involving human pluripotent cells meet ethical and legal requirements.
  • Maintain and promote an open and cooperative relationship with investigators and faculty, and the greater university community.
  • Educate the UCR community concerning the ethical and regulatory standards for the use of human pluripotent cells.

Functions of the UCR SCRO Committee are:

  • Review proposed activities involving human pluripotent cells (via the SCUA).
  • Set university policy regarding the use of human pluipotent cells.
  • File all required reports with appropriate agencies, including CDPH.
  • Investigate all allegations of non-compliance, providing related reports and recommendations to the Vice Chancellor for Research.

Forms

Click here to view Research Integrity forms.

Links to Regulatory Agencies and Other Sources of Information

UCR Links:

Government Links:

Links to Other Sources of Information