Senator Deborah Ortiz, Chair
Senator George Runner, Vice-Chair
Members, Senate Health Committee
State Capitol
Sacramento, California

RE: Support for SCA 13

Dear Senators Ortiz and Runner, and members of the Senate Health Committee,

As a person who has been a public participant in the proceedings of the Independent Citizens Oversight Committee since its first meeting, I commend you for your leadership in opening a dialogue between the legislature, the public, and the ICOC. It is a much-needed supplement to the ICOC process which, regrettably, leaves a very limited role for public participation and democratic oversight. Your proposed SCA 13 will go far to address some of the most serious deficiencies-in oversight and democratic participation-- in Prop. 71 as it was drafted and is being implemented.

A judicious mix of complementary legislation, periodic oversight hearings, and constitutional amendments is needed to protect vital public interests.

I support SCA 13, and I hope that the Committee's draft of the constitutional amendment will remain open for public discussion and amendment. At the present time I want to urge you to consider the following amendments to SCA 13:

1. Permit closed meetings of a Working Group when the Working Group is engaged in peer review of specific grant applications (Sec. 8(b)).

2. Regarding conflict-of-interest standards (Sec. 8(a)), all persons enumerated in this section should be subject to state law disclosure requirements, without modification. The word "commensurate" is unnecessary and could create confusion. With regard to NIH standards, CIRM personnel and Working Group members should be held to conflict-of-interest standards "commensurate with those that are applied to persons appointed to serve the NIH or employed by the NIH in comparable positions."

3. Section 6 should be clarified to assure that it does not affect the outcome of pending lawsuits.

In addition to the above amendments, I encourage you to hold hearings to consider additional provisions to address the following concerns:

1. Assure that the public is adequately informed about sensitive ethical matters that are involved in particular grant recommendations. Requiring the issuance of an Ethical Impact Statement on each grant would be a possible solution, with the process overseen by the bioethicists on the Standards Working Group. The EIS should specifically address any grants that involve chimerical research and cloning. In addition a Supplemental EIS should be required to report any funded research that leads to the injury or death of any research subjects.

2. Require effective limitations on the licensing of Prop. 71 funded discoveries so that they do not become available to reproductive cloning experiments outside the state. Every grantee should be required to include in its licensing agreements a commitment not to permit licensed technology to be used for reproductive cloning. In addition, any person trained or employed in funded laboratories should agree in advance not to use skills and knowledge acquired in the funded program to promote reproductive cloning for a ten-year period.

3. Consider whether the state needs a regulatory mechanism to oversee the entire field of biomedical research, similar to the British model. The CIRM's purpose is promotion of such research, and it is impossible to mix the promotional objective with an effective regulatory process. Moreover, it has no control over any activity that is conducted without Prop. 71 money, including the activity of some commercial ventures that may be operating free of oversight and with lower ethical standards. This Committee should hold hearings to consider an effective regulatory scheme.

This Committee has undertaken a critically important process which provides a necessary complement to the work of the ICOC. The long-term interests of the stem cell research field-- and related areas of biomedical research-- demand a well-informed engagement by the public's elected representatives in the implementation of the ambitious program funded under Prop. 71.

Respectfully submitted,

Charles Halpern