State Stem Cell Agency ICOC Agenda 12-07-06

INDEPENDENT CITIZENS’ OVERSIGHT COMMITTEE (“ICOC”)
TO THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE (CIRM)

Organized Pursuant To The
CALIFORNIA STEM CELL RESEARCH AND CURES ACT

Date: December 7, 2006

Time:  9 AM – 5 PM (Estimated)

Location:

OPEN SESSION

1. Call to Order.
2. Pledge of Allegiance.
3. Roll Call.

   [Members of the Public will be invited to provide testimony before or during consideration of each agenda item. Speakers are asked to limit their testimony to three (3) minutes.]

CONSENT ITEMS

4. Approval of minutes from October 11, 2006 ICOC meeting.

EXECUTIVE PRESENTATIONS

5. Chairman’s Report.
6. President’s Report.

ACTION ITEMS

7. Consideration of CIRM Scientific Strategic Plan
8. Consideration of interim CIRM Policy for For-Profit Organizations and submission to the Office of Administrative Law to begin Administrative Procedure Act review process.
9. Consideration of Intellectual Property Regulations for Non-Profit Organizations, including but not limited to permanent adoption of Proposed Regulations 100306 regarding “Licensing CIRM-Funded Inventions” and 100309 regarding “Press Releases.”
10. Consideration of permanent adoption of Grants Administration Policy for Academic and Non-Profit Institutions Regulations.
11. Consideration of recommendations for CIRM Medical and Ethical Standards regulations:
      a. Consideration of final Standards Working Group recommended language for section 100085 – use of human tissue in CIRM-funded research. For this regulation to be submitted to the OAL to begin the adoptions process, the ICOC must approve regulatory language.
      b. Consideration of final Standards Working Group recommended language for section 100120 – record keeping requirements. Recommended language has been drafted to address comments from OAL. For this regulation to be submitted to OAL for final adoption, the ICOC must approve regulatory language.
      c. Consider Standards Working Group recommended withdrawal of section 100130 – materials sharing. Materials sharing is addressed in the CIRM intellectual property regulations. For this regulation to be withdrawn, the ICOC must approve deletion.

CLOSED SESSION

   12.
            a. Pending Litigation (Government Code section 11126, subdivision (e)): (1) People’s Advocate v.
                Independent Citizens’ Oversight Committee, First District Court of Appeal, Case No. A114282 and
                California Family Bioethics Council v. California Institute for Regenerative Medicine, First District Court of
                Appeal, Case No. A114195; (2) Mary Scott Doe v. Robert Klein, et al., U.S. Court of Appeals for the Ninth
                Circuit, Case No. 06-55387; and (3) National Tax Limitation Foundation v. Westly, Sacramento Court
                Superior Court, Case No. 06AS02700.
            b. Discussion of Personnel (Government Code section 11126, subdivision (a); Health & Safety Code section
                125290.30(d)(3)(D)).
 

OPEN SESSION

13. Public report of any action taken, if necessary, during closed session.

ACTION ITEMS

Consideration of recommendations from the Governance Subcommittee, including the following:

Consideration of confidentiality policy and conflict of interest forms for use as part of Facilities Working Group grant review process, and proposed amendments to regulation 100004 regarding Facilities Working Group Conflict of Interest policy.

Consideration of update from Facilities Working Group including but not limited to:

14. Consideration of Procedures for Conducting Review of Grant Applications by the Grants Review Working Group for Recommendation to the ICOC.
      a.Consideration of all proposed amendments to the Policy for Contracting and Services of Independent
          Consultants.
      b. Consideration of amendments to the 2006-07 CIRM Administrative Operating Budget.
      c. Consideration of proposed amendments to the Policy and Regulations Governing Travel for CIRM staff |
          and Working Group members.
      d. Consideration of modification of Governance Subcommittee Mission Statement to include delegation of
          authority for future CIRM travel policy amendments.
15. Consideration of any action necessary in connection with $150 million General Fund loan or $31 million second round BANs funds.
      a. FWG Confidentiality Form
      b. FWG Financial Disclosure Report
      c. FWG Post-Review COI
      d. FWG Pre-Review COI
      e. DRAFT Summary CIRM Policies for FWG
     
16. Consideration of CIRM providing part-time contract services for patient advocates on the ICOC in support of their execution on the mission.
      a. Consideration of the definition of “capital equipment” under Proposition 71. 

DISCUSSION ITEMS

20. Presentation on allocation of funds available for CIRM grant making.
21. Public comment. The Committee will accept public testimony on any matter under its jurisdiction that is not on the agenda, but the Committee cannot act on any such matter at this meeting.

THE ORDER OF BUSINESS MAY BE CHANGED WITHOUT NOTICE.
Notice is hereby given that the order of consideration of matters on this agenda may be changed without prior notice.

**NOTICE**

The California Institute for Regenerative Medicine and its Independent Citizens Oversight Committee, and any subcommittees thereof, comply with the Americans with Disabilities Act (ADA) by ensuring that the meeting facilities are accessible to persons with disabilities, and providing that this notice and information given to the Members of the Committee is available to the public in appropriate alternative formats when requested. If you need further assistance, including disability-related modifications or accommodations, you may contact Melissa King at the California Institute for Regenerative Medicine at 415-396-9100 no later than the day prior to the meeting.

Questions or requests for additional information prior to the Independent Citizens Oversight Committee meeting may be referred to Melissa King at the California Institute for Regenerative Medicine at mking@cirm.ca.gov or 415-396-9100.

This meeting agenda is also available on the website for the California Institute for Regenerative Medicine at https://www.cirm.ca.gov.