A regular meeting of the Stem Cell Advisory Committee was held on January 17, 2006, at the CT Economic Resource Center, 805 Brook St., Rocky Hill, Connecticut.
Call to Order: The meeting was called to order at 1:00 p.m. by Dr. Robert Galvin, Chair. Members present: Robert Galvin, M.D., M.P.H. (Chair), Ernesto Canalis, M.D., Myron Genel, M.D., Julius Landwirth, M.D., J.D., M. William Lensch, Ph.D., Milton B.Wallack, D.D.S., Xiangzhong (Jerry) Yang, Ph.D, Charles Jennings, Ph.D, Kevin Rakin.
Introductions/Opening Remarks by Chair: Dr. Galvin introduced Henry Salton of the Attorney General’s Office and welcomed new Advisory Committee members Charles Jennings and Kevin Rakin.
Members were informed that the meetings were held by statute, were open to the public and were being recorded and videotaped.
Review of Minutes – Stem Cell Research Advisory Committee Meeting – 11/29/05: Members were reminded by Dr. Galvin that only those members present at the past meeting could approve those minutes. Call for a motion to approve the minutes was made.
Dr. Wallack wished a correction in the date the awards were to be made from on or before July 1st to June 1st.
Dr. Yang wished a correction to reflect that the letter from Commissioner Galvin should also go to for profit industries.
MOTION: The motion was made and seconded that the date the awards were to be made would be changed to June 1st. The motion was seconded and carried.
Dr. Genel made the comment that the minutes were more of an outline. He would like them to be verbatim. Dr. Galvin commented that the minutes were being recorded at today’s meeting and would be recorded in the future.
MOTION: The motion was made to accept the minutes with corrections with the understanding that timelines would be discussed later in this meeting. The motion was seconded and carried.
Recommendations: The Chair made the following recommendations regarding conduct of meetings:
Robert’s Rules of Order will be implemented for all meetings.
Telephonic attendance of members will be allowed
Meetings will be open to public.
MOTION: The motion was made that the recommendations regarding conduct of meetings be adopted. The motion was seconded and carried.
Summary of Statutory Principles – (Marianne Horn, DPH): Marianne Horn reviewed the handout entitled Summary of Statutory Principles with the Board members and explained that they were to provide Board member’s responsibilities and obligations all in one place. The Summary of Statutory Principles provides the following information:
Establishes the name of the Committee and its mission.
Establishes how members are appointed, duration of membership and what will be done in the event of an absence on the committee.
Establishes committee responsibilities to develop and approve an application for stem cell research grants, promote fundraising, monitor stem cell research and submit a report to the Governor of monies expended.
Establishes who will preside if Commissioner not present (Vice Chairman).
Establishes what constitutes a quorum and attendance requirements for board members
Establishes that Connecticut Innovations (CI) will be administrative support to the Committee.
Establishes that Robert’s Rules of Order will be guidelines for meetings and committee procedures.
The Chair advised that it would be more equitable to wait on discussion of election of a Vice Chairperson due to Charles Jennings and Kevin Rakin attending only their first meeting today.
Dr. Wallack raised the question as to the execution of documents as discussed in Article IX – Administrative Support. He questioned why this function would be done by Connecticut Innovations and not the Department of Public Health (DPH). Ms. Horn explained that Connecticut Innovations had been charged by statute with the executing and administration of documents.
Dr. Landwirth asked if Connecticut Innovations was charged with reviewing applications. Ms. Horn explained that Connecticut Innovations would be doing more of a procedural review of applications to ensure that they were complete.
Ms. Horn also explained that there would be another overlap of responsibilities with the Peer Review Committee and its input into decisions.
Mr. Wollschlager offered that the principles as written come directly from the law. They may be interpreted but the language can’t be changed. He explained that Section IV – Committee Responsibilities had been extracted from three sections of the law and are much broader than simply figuring out who gets the money, and include:
Mr. Wollschlager also offered that there had been a lot of discussion on marketing, branding and fundraising to promote stem cell research and that regarding those issues, the Advisory Committee members will want to plan how they want to fulfill the requirements of the law. He also advised the members that there is a lot of expertise available for marketing and promotion information.
Dr. Genel asked about Article VII – Workgroups. Mr. Wollschlager said that the Department of Public Health and CI have been working on specific issues. These include:
Marketing – specific tasks would include development of a web page and how to market Connecticut stem cell research
Funding – need to identify alternative sources of funding besides public dollars
Economic committee – to attract companies to Connecticut
Dr. Genel asked about the formation of an Ethics subcommittee to deal with ethical issues. Mr. Wollschlager said that there was no working group at this time: However, the DPH has been working with the State Ethics Commission through Stacy Owens.
Mr. Rakin asked what roles Connecticut Innovations and the Department of Public Health played.
Mr. Wollschlager explained that the DPH was involved because of the Commissioner’s involvement as outlined in the statute. He further explained that weekly meetings with Connecticut Innovations had commenced in August of 2005 to begin preparations.
Mr. Rakin asked who would be responsible for the application. Mr. Wollschlager said that Connecticut Innovations would develop the application and that it would be reviewed by DPH.
Dr. Wallack explained that he is aware of the content of the Bill as far as establishing, administering and monitoring but felt that the execution of the documents should be with DPH. He felt that CI’s role should be assisting with agreements but not in fact signing or preparing documents.
Ms. Horn explained that CI would do the actual execution of the documents after review by the Advisory Committee and DPH.
Dr. Galvin explained that his interpretation of the role was that DPH would be to keep the projects going and complementing skill sets of people at CI.
Dr. Genel summarized that administration of procedures resides at CI but establishing policy and procedures resided at DPH. Commissioner Galvin further summarized that the evaluation of projects for scientific and technology appropriateness and decisions regarding these would be done by the Advisory Committee with review by the Peer Review Committee. Financial and administrative functions, a watchdog for funding, would be done by CI.
Dr. Yang asked if any entity that conducts stem cell research is eligible. Mr. Wollschlager explained that the responsibility of the Advisory Committee is promoting stem cell research in both the for profit and not for profit sectors.
Mr. Rakin asked how does the Advisory Committee get a web site, branding, etc. Is there a budget? Commissioner Galvin said that there is no budget and Mr. Wollschlager explained that the development of the web site would be discussed further in the meeting.
MOTION: A motion to adopt the Summary of Statutory Principles was made. The Motion was seconded and carried.
Dr. Jennings asked if subcommittees could include people outside of Advisory Committee. Mr. Wollschlager stated yes.
The Commissioner asked if subcommittees could be called workgroups instead.
Dr. Landwirth asked what the appointment procedure would be for workgroups.
Dr. Genel said that 3-5 members of the workgroups should be Advisory Committee members and they should be given the ability to add members. This would eliminate a cumbersome approval process.
The Commissioner stated that someone on a workgroup may not share the same values as the members of the Advisory Committee and recommended that the discussion be tabled until there is more time. He also recommended that the number of Advisory Committee members in a workgroup be changed to two.
Dr. Canalis stated that it would not be agreeable to asking consultants to serve without being paid. He also recommended that the number of Advisory Committee members in a workgroup not be changed to two.
Dr. Lensch recommended that the workgroups not make decisions but bring recommendations to the Advisory Committee.
Commissioner Galvin agreed that it would be hard to approach people and expect them to act pro bono. He also recommended that the discussion be tabled until a later time.
Ms. Horn stated that clarification on the issue of payment for eggs had been requested from the Attorney General’s Office and that a formal opinion would be issued in the near future.
Dr. Yang asked if paying the medical expenses of ova donors is direct or indirect.
Ms. Horn stated that under National Academies Guidelines (NAS) , the recommendation is that direct costs for medical expenses be picked up.
Dr. Landwirth wished clarification as to when consent is obtained when donating.
Code of Ethics – Stacy Owens, DPH
Ms. Owens updated the Board members on progress on the State Code of Ethics issues discussed at the previous meeting. She explained that board members are deemed public officials, that they need to comply with the State Code of Ethics, and that a written request has been sent to the Office of State Ethics regarding the issues outlined previously. She is waiting for their opinion and it should be issued prior to the February meeting.
Dr. Jennings asked if there was any indemnity by the state for members serving on the Advisory Committee. Mr. Salton explained that the indemnity clause for the state covers any “public officials” and as Advisory Committee members they were deemed to be public officials.
Mr. Rakin asked if Ms. Owens could clarify sole proprietorships. She explained that all questions of that nature would be answered by the forthcoming opinion from the Office of State Ethics.
Dr. Yang stated that he understood that there was no payment for outside donors but asked whether state funds could be used for medical costs or if additional medical treatment was needed. Ms. Horn stated that this would be answered in the forthcoming opinion.
Mr. Wollschlager recommended that the information for the two new members be sent to the Ethics Commission.
Review of Application – Nancy Rion, CI: Ms. Rion explained that February 1st is a goal, but not a statutory deadline for the application to be completed. Members are encouraged to take all the time needed to review the application. The law states that the application needs to be published by July 1st and the current February 1st goal is aggressive.
Definition of Embryonic stem cells – proposed modification to take out the word “human”
Dr. Canalis asked if animal models are allowable or not allowable by the law. Ms. Rion explained that if it leads to human research, this would be the Advisory Committee’s call. Ms. Horn pointed out that the law is for human stem cell research, not animal, however if there is linkage between animal models and it leads quickly to human research, then it may be acceptable. One of the goals of the law was clearly to get funds to stem cell research for which there was no other source of funding.
Dr. Jennings stated that they would have an obligation to find out if this is in fact acceptable. Dr. Canalis also pointed out that this would have to be well defined.
Dr. Jennings also pointed out that the conduct of research is not the same as advancing research.
Dr. Lensch stated that in historical content, various models have been used. The field is founded on animal modeling and should continue to be part of project funding.
Dr. Genel stated that he agreed with Dr. Lensch and applicants should be asked as to human connection and advancement of research.
Dr. Yang stated that complementary research has to take place.
Institutional Review Committee – proposed modification to add that applications be reviewed by an ESCRO committee in keeping with NRC recommendations:
Dr. Jennings stated that it would take a long time to get members for an ESCRO committee approved but that a higher authority/institution should be required. Ms. Horn stated that applicants should be strongly encouraged to have an Embryonic Stem Cell Research Oversight (ESCRO) committee.
Dr. Lensch stated that the role of the ESCRO committee is meant to be independent from the universities’ role. The proposed change should be “ESCRO or similar committee”.
Dr. Canalis stated that he has difficulty with this and asked who will the ESCRO committee turn to with questions? He also felt that going against federal guidelines is unwise and that we need to ensure projects are following all federal guidelines.
Mr. Salton suggested that applicants be informed that since the NAS Guidleines may be adopted as regulations as provided under the statute, it would be prudent for all applications to be submitted in accordance with the NAS guidelines.
Dr. Landwirth asked how would the Advisory Committee deal with these issues if the guidelines are not addressed.
Dr. Yang stated that approval should be required for funding.
Ms. Rion stated that the recommended projects will get approval prior to the disbursement of funds.
Ms. Horn stated that she would be comfortable drafting language consistent with Mr. Salton’s suggestion.
Dr. Genel suggested that the least sentence be left off and a definition of an ESCRO committee be added with reference to the NAS guidelines.
Dr. Lensch stated that ESCRO committee should be defined separately.
Funding Amounts – specifically, specifying project grants, institutional grants (larger), limit to amount of money, and limit to amount of money to specific institutions:
Dr. Galvin stated that he feels money should not be disbursed as $100 million for a ten-year project or even $50 million for a two-year project.
Dr. Yang stated that funding should go to both program and individual projects.
Dr. Lensch stated that there is an incredible variety of grant types including individual, program research. The NIH model is very broad and it would be wise not to take all submission types off the table when no one is sure of the types of people or projects that will come in.
Dr. Jennings stated that he agreed and that if the program was made attractive, it would attract a wide variety of submissions.
Dr. Galvin stated that this discussion would have to be continued since it was time to review procedures for the informational meeting, scheduled to begin at 3:15 p.m.
MOTION: The motion to accept the procedures for the information meeting was made. The motion was seconded and carried.
MOTION: The motion to adjourn the business portion of the meeting and recess prior to the information meeting was made. The motion was seconded and carried.
The business portion of the Stem Cell Research Advisory Committee meeting was adjourned at 3:00 p.m.