Registered and non-registered human embryonic stem cell lines
Development of human embryonic stem cell lines, including Somatic Cell Nuclear Transfer (SCNT), Induced Pluripotent Stem Cells (IPSC)
Human adult stem cells, including cancer, progenitor, mesenchymal, fetal-derived stem cells
Human embryos
Human gametes: oocytes, (parthenotes), sperm
Compliance and operational risks associated with the conduct of non-registered human embryonic stem cell (hESC) research

Requires of all hESC research:

identification of and training for involved researchers,
use of special operating procedures for laboratories where hESC research is conducted, and
compliance monitoring and reporting to ensure that established requirements and procedures are implemented as intended.

Also establishes a Stem Cell Research Oversight Panel to advise the Vice Provost and Dean of Research regarding issues related to the conduct of human stem cell research at Stanford.

This statement contains Stanford University's policy regarding the conduct of human stem cell research and applies to all who conduct such research at Stanford. The Vice Provost and Dean of Research is responsible for interpretation and overall coordination of the policy. Violation of any part of this Policy may cause a faculty member to be subject to sanctions as described in the Statement on Faculty Discipline. This policy will be modified as necessary to comply with all applicable regulations and statutes.

DEFINITIONS

“Human embryonic stem cells” (hESC) are derived from human embryos; “Induced Pluripotent Stem Cells” (IPSC) are derived from somatic cells. Both are pluripotent cells that are self-replicating, and capable of developing into cells and tissues of the three primary germ layers. Although human embryonic stem cells may be derived from embryos, such stem cells are not themselves embryos.

In this policy, those human embryonic stem cell lines that were in existence on August 9, 2001, that meet requirements established by the Presidential directive of that date, and that are registered with the National Institutes of Health are defined as "registered stem cell lines"; any human embryonic stem cell lines created after August 9, 2001 are defined as "non-registered stem cell lines."

GENERAL PRINCIPLES

In August 2001, the Federal government established a prohibition on use of Federal funds for any research involving non-registered human embryonic stem cell lines. The California law requires that all human stem cell research be reviewed and approved by a Stem Cell Research Oversight Panel. In addition, the State of California has mandated that all human embryonic stem cell research funded by the California Institute of Regenerative Medicine must be undertaken with "..full consideration of the ethical and medical implications of this research." (California Health and Safety Code Section 125300).

Similarly, the State of California has mandated that "research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells, including somatic cell nuclear transplantation, shall be reviewed by a stem cell research oversight committee." (California Health and Safety Code Section 125300)

In light of these considerations, Stanford University has established the following policy related to human stem cell research. All research on registered human embryonic stem cell lines must follow existing University policies, while research on non-registered human embryonic stem cell lines must follow the Special Operating Procedures discussed in this document. This policy is supplemental to, and in no way takes the place of, existing policies for all activities including the conduct of human subjects research.

The goals of this policy are to ensure that:

Stanford University is aware of all human stem cell research activities conducted by University faculty, staff, postdoctoral scholars, students and visiting scholars, including, to the maximum extent possible, the sources or derivation of any human embryonic stem cells planned for use or being used;
every person at Stanford working on such research is fully aware of the compliance requirements associated with the work including the requirement for annual review;
the Federal government’s current prohibitions against inappropriate direct or indirect use of Federal funds on non-registered human embryonic stem cell lines are fully observed;
Stanford complies with any special reporting requirements for such research imposed by all sponsors and donors;
existing SCRO protocol review procedures are followed, and
provisions exist to monitor compliance with this policy continuously and make changes in it as are deemed appropriate.

DISCUSSION AND DETAIL

Tracking all human embryonic stem cell research undertaken at the University or by University Principal Investigators

Due to the Federal government's current prohibition against the use of its funds for any purpose associated with non-registered human embryonic stem cell lines, it is necessary for University offices, including the offices of the cognizant Deans, to know at all times what research involving human embryonic stem cells has been proposed by and is being conducted by Stanford researchers. Investigators using human embryonic stem cells are required to provide the following detailed information on the Human Embryonic Stem Cell Research Tracking Form for all research, whether it is funded by externally sponsored projects, fellowships, gift, departmental, or other university funds:
1. source(s) of the human embryonic stem cells, including the original source(s) of derived cell lines,
2. source(s) of funding for the research work, and
3. equipment and location(s) on or off campus where the work will be or is being performed.
Training for all personnel who will be engaged in human embryonic stem cell research

Because of the complexity of rules and restrictions associated with such research, all University personnel, including faculty, staff, postdoctoral scholars, and students, as well as visiting scholars and other researchers, who plan to engage in its conduct are required to complete training before they begin work on any project involving human embryonic stem cells.
Special Operating Procedures

Stanford University has operating procedures that apply to the conduct of human embryonic stem cell research. These procedures, which must be observed by all persons at Stanford including faculty, staff, postdoctoral scholars, students and visiting scholars conducting such research, have been developed to ensure federal funds are not used directly or indirectly for research using non-registered human embryonic stem cells.
Monitoring compliance

Faculty investigators will be expected to participate in periodic reviews by the University’s Internal Audit Department to assure that all applicable regulations are being followed, and to evaluate the effectiveness of University policies and procedures related to the conduct of such research.
Responsibilities of the Dean of Research

The Vice Provost and Dean of Research is the University officer responsible for interpreting and overseeing implementation of and compliance with this Policy. Questions may be addressed to the Dean of Research or the Associate Vice President for Research Administration.

STEM CELL RESEARCH OVERSIGHT PANEL

The Vice Provost and Dean of Research will designate a Stem Cell Research Oversight Panel, comprised of qualified individuals, to advise regarding issues related to the conduct of human stem cell research at Stanford. This Panel will be expected to report on its activities at least annually to the Vice Provost and Dean of Research, and to other offices or entities within the University as directed.