Sponsors: Representatives Schual-Berke, Wood, Ruderman, Chase, Sullivan, McIntire, Hunt, Hankins, Cody, Kagi and Sommers.

Brief Summary of Substitute Bill

• Expresses that it is state policy to permit research using human embryonic stem cells, human embryonic germ cells, and human adult stem cells upon appropriate review.

• Directs the Department of Health to develop guidelines regarding human embryonic stem cell research and to create a registry of such embryos available for research purposes.

• Requires health care providers to inform fertility treatment patients of their options regarding the disposal of unused embryos. Requires patients to provide written consent before donating unused embryos for research.

• Permits the donation of human embryonic tissue or human cadaveric fetal tissue for research, and contains criminal provisions for the sale of any such tissue.

• Prohibits reproductive cloning or attempted reproductive cloning of a human being.

Majority Report: The substitute bill be substituted therefor and the substitute bill do pass. Signed by 7 members: Representatives Cody, Chair; Morrell, Vice Chair; Clibborn, Darneille, Edwards, Moeller and Schual-Berke.

Minority Report: Do not pass. Signed by 6 members: Representatives Bailey, Ranking Minority Member; Alexander, Benson, Campbell, Rodne and Skinner.

Stem cells can be distinguished from other types of cells in three ways. First, they are capable of dividing and replicating (renewing) themselves indefinitely. Second, stem cells are unspecialized. This means that they do not perform any specific function, as do heart muscle cells, red blood cells, or nerve cells. Lastly, stem cells can create specialized cells. While they do not perform a particular function, they can give rise to specialized cells while remaining unspecialized themselves.

Stem cells can be classified as embryonic stem cells, embryonic germ cells, and adult stem cells according to the stage of development of the organism. The key difference between embryonic stem cells and adult stem cells is that an embryonic stem cell can become any type of cell in the body, while adult stem cells can only vary between the different types of cells within the organ in which they are found. Recent research, however, suggests that adult bone marrow stem cells may have similar characteristics. Another significant difference is that embryonic stem cell replication can generate large numbers of new cells, while adult stem cells do not replicate as easily (under current technology).

Scientists obtain human embryonic stem cells from embryos that are not used after in vitro fertilization treatment. In 1998 scientists first isolated and cultured human embryonic stem cells, a process that destroys the embryo. Current research using stem cells pertains to diabetes, Parkinson's disease, heart disease, cancer, and spinal cord injury.

Cloning is the process where scientists make a genetic copy of another animal by asexual reproduction. By transplanting the nucleus from a specialized cell into an unfertilized egg that has had its nucleus removed, a genetically identical animal is made. Sheep, mice, goats, pigs, and cows have all been cloned. The determination of whether or not one animal is a clone of another is made by comparing the DNA of both creatures.

In August 2001, the President announced that federal funding of embryonic stem cell research would be permitted for research on the embryonic stem cell lines in existence at that time, but the funding would not be available for any subsequently created embryonic stem cell lines. The limitation does not apply to privately funded research. At the same time, the President announced the creation of the President's Council on Bioethics to study the ethical and moral implications of developments in biomedical and behavioral science and technology.

Recently, California and New Jersey have declared that it is their policy to permit research regarding human embryonic stem cells, human embryonic germ cells, and human adult stem cells.

The policy of Washington State is declared to be that research involving the use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells is permitted upon review by an institutional review board.

The Department of Health (Department) must develop guidelines for research using human embryonic stem cells. In addition, the Department must provide annual reports to the Legislature regarding human embryonic stem cell research activity. A human stem cell research advisory committee is established consisting of 13 members who are scientists with experience in biomedical research; medical ethicists; individuals with legal expertise in embryonic stem cell research, in vitro fertilization, or family law; and representatives of the public.

All research projects involving human embryonic stem cells must be reviewed and approved by an institutional review board that has considered the Department's guidelines.

The Department shall create an anonymous registry of embryos that are available for research purposes. The Department may contract with the University of Washington or private or public entities to establish and administer the registry.

Health care providers that deliver fertility treatment to patients must provide them with adequate information to make an informed choice regarding the disposition of unused human embryos after treatment. Patients must be presented with four options for disposing of unused embryos including storing them, discarding them, donating them to another person, or donating them for research. Patients must also receive a form that details the patients' preferred disposition of any unused embryos in the event of the death of a patient, the separation or divorce of the partners, or the abandonment of the embryos due to failure to pay the storage fee. Before donating the unused embryos for research, the patient must provide written consent. Elements of what constitutes informed consent are established.

The donation of human embryonic tissue or human cadaveric fetal tissue for research purposes is permitted. The sale of such tissues is a felony. Reasonable payments to cover certain expenses are allowed.

Reproductive cloning or attempted reproductive cloning of a human being is prohibited and carries a civil penalty of $100,000 for each violation.

Cloning is categorized into either therapeutic cloning or reproductive cloning. Therapeutic cloning is defined as cloning for the purpose of curing disease and not involving transplantation in a uterus. Reproductive cloning is defined as cloning for the purpose of creating a human being and it involves transplantation into the uterus. It is specified that reproductive cloning is prohibited.

The two committee representatives of religious organizations are replaced with members of the public. Reporting requirements for institutional review boards are eliminated. Provisions related to unprofessional conduct for not informing fertility treatment patients of the options for disposing of unused embryos are removed.

Effective Date of Substitute Bill: The bill takes effect 90 days after adjournment of session in which bill is passed.

Testimony For: Unused embryos should be used for productive purposes rather than discarded. Embryonic stem cell research holds promise for curing several diseases. Researchers will leave the state if there is not an environment that promotes this type of research.

Testimony Against: The ban on cloning is unenforceable. Embryonic stem cell research is unsafe, unethical, and unnecessary. Human life begins with one-celled embryos and this will destroy them.

Persons Testifying: (In support) Representative Schual-Berke, prime sponsor; Judy Baker and Carey Christensen, Parkinsons Action Network; Dennis Wright, Northwest Parkinsons Foundation; Dan and Elaine Kovach; Diana Price, Parkinsons Support Group; Melanie Roberts; Jared Ragland; Pat Kessler, Juvenile Diabetes Research Foundation; and Hans Wold, Northwest Hereditary Disease Foundation.

(Opposed) Sharon Quick, American Academy of Medical Ethics; Bob Higley, Washington Evangelicals for Responsible Government; and Sister Sharon Park, Washington State Catholic Conference.