The Proposal Approval Process

The purpose of the UC Berkeley SCRO Committee is to insure that human stem cell research undertaken at the University is performed according to the highest ethical and scientific standards, in conformance with the campus Human Stem Cell Research Policy, and all applicable regulations and guidelines.

SCRO Committee Approval for Human Stem Cell Research

Principal investigators must submit an Application to Perform Human Stem Cell Research and obtain SCRO Committee approval prior to initiating any human embryonic or adult stem cell research. SCRO Committee approval must be renewed annually. Principal investigators seeking to make changes or additions to an approved human stem cell research protocol must request a protocol amendment from the SCRO Committee.

Stem cell research in the following categories will be evaluated administratively and approved by the Chair of the SCRO Committee:

  1. Applications to perform in vitro research using human embryonic stem cell lines listed on the NIH stem cell registry;
  2. Applications to perform in vitro research using existing human embryonic stem cell lines that have been deposited in the United Kingdom Stem Cell Bank, have been derived by or approved for use by a licensee of the United Kingdom Human Fertilization and Embryology Authority, or have been derived under an application approved by the Canadian National Stem Cell Oversight Committee;
  3. Applications to perform research using human adult stem cells, accompanied by documentation of IRB approval for the donation and research use of these materials.

Stem cell research that is purely in vitro utilizing previously derived pluripotent stem cell lines obtained outside the sources listed in 1-3 above, may be reviewed by the full SCRO Committee or a subcommittee of at least three SCRO Committee members, at the discretion of the Chair.

Proposals to perform research involving any of the following require full SCRO Committee review and approval:

  1. Procurement of human oocytes
  2. Use of fertilized human oocytes or blastocysts
  3. Derivation of a human pluripotent stem cell line
  4. Introduction of a human pluripotent stem cell line into a non-human animal
  5. Introduction of human neural progenitor cells into the brain of a non-human animal 
  6. Introduction of human pluripotent stem cells into a human

Appeals of SCRO Committee Decisions

If a principal investigator disagrees with the decision of the SCRO Committee, s/he can request an opportunity to present her/his case before the entire membership of the Committee. To initiate the appeals process, the principal investigator should submit a written request to the SCRO Committee Chair.

Additional Campus Approvals Required for Human Stem Cell Research

Human stem cell research protocols must also be approved by campus oversight committees as described below. Protocols may be concurrently considered by these committees and by the SCRO Committee, however, protocol approval numbers from the relevant committees must be provided on the Application to Perform Human Stem Cell Research before final SCRO Committee approval will be granted.

  1. Committee on Laboratory and Environmental Biosafety
    All uses of human tissue and human cell lines are considered Biosafety Level 2. Principal investigators using human embryonic or adult cell lines must maintain a current Biohazard Use Authorization. It is the principal investigator's responsibility to insure that all personnel working with human stem cells complete the EH&S training course "Biosafety for Human, Animal and Plant Pathogens" before they start BUA work and every five years thereafter.
  2. Radiation Use Authorization
    Proposals that include use of radioactive materials with human stem cells must list the principal investigator's Radiation Use Authorization number.
  3. Animal Care and Use Committee
    Proposals for human stem cell research that include the use of vertebrate animals must demonstrate current Animal Care and Use Committee approval. The approved ACUC protocol must include all proposed uses of vertebrate animals described in the Application to Perform Human Stem Cell Research.
  4. Committee for the Protection of Human Subjects
    All human stem cell research protocols involving interaction or intervention with living individuals, or including private identifiable information about living individuals, must be approved by the CPHS. CPHS will have primary responsibility for approving all aspects of these protocols directly related to human subjects. The SCRO Committee will work closely with the CPHS to evaluate the scientific merit and experimental design of the proposed human stem cell research.