Relates to the duties of the ethics committee of the empire state stem cell board.
BILL NUMBER: S1502
TITLE OF BILL : An act to amend the public health law, in relation to the duties of the ethics committee of the empire state stem cell board
PURPOSE : To amend New York State Public Health Law, Article 2, Title 5-A, establishing the Empire State Stem Cell Board, to ensure that the ethics committee established in the statute is given authority to establish ethical standards for grant awards and for all medical, socioeconomic, and financial aspects of clinical trials and therapy delivery to patients, and to exercise oversight of the funded stem cell research projects across the state.
SUMMARY OF PROVISIONS : Amends subdivision 2 of section 265-c of the public health law by providing clarification of the responsibilities of the New York State Stem Cell Ethics Committee.
JUSTIFICATION : The ethics committee of the Empire State Stem Cell Bond is statutorily changed with making "recommendations to the funding committee regarding scientific, medical, and ethical standards" for stem cell research projects to be funded by the state. Created in the state budget in 2007, the ethics committee first met to deliberate in late fall of the same year (November 30, 2007), only after the funding committee had already approved a request for applications for research projects.
The ethics committee unanimously recommended a 6-month moratorium on funding controversial research - the creation of new human embryonic stem cell lines, the creation of human-animal hybrids, human cloning for research, etc. - so that the committee could discuss, debate and decide the ethics as they were charged to do. Two weeks later, in mid-December, the funding committee rejected this call for a temporary moratorium, and in the first week of January 2008, the first round of stem cell research grants were awarded.
The Empire State Stem Cell Board, in haste to move research forward, has ignored the advice of its own ethics committee and given that body little to no time to do the serious contemplative work it has the responsibility to do under law. Ethics committee members, like New York's citizens, hold diverse views on controversial aspects of stem cell research. The citizenry deserves careful, detailed, honest ethical review of how $600 million in taxpayer money will be spent in the field of regenerative medicine.
The role of the ethics committee should not be merely advisory. Each and every application for funding must adhere to the ethical standards established by the ethics committee and the ethics committee must be given oversight authority to ensure compliance. This legislation would accomplish that objective.
LEGISLATIVE HISTORY : S.8401/A.11611 of 2008
FISCAL IMPLICATIONS : None.
EFFECTIVE DATE : Immediately.
STATE OF NEW YORK ________________________________________________________________________ 1502 2009-2010 Regular Sessions IN SENATE February 2, 2009 ___________Introduced by Sens. DeFRANCISCO, GOLDEN, LARKIN, LAVALLE, MORAHAN, VOLK- ER -- read twice and ordered printed, and when printed to be committed to the Committee on Health AN ACT to amend the public health law, in relation to the duties of the ethics committee of the empire state stem cell board THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS: Section 1. Paragraphs (a) and (e) of subdivision 2 of section 265-b of the public health law, as added by section 1 of part H of chapter 58 of the laws of 2007, are amended to read as follows: (a) provide for an independent scientific peer review committee composed of individuals with expertise in the field of biomedical research who shall review grant applications based on the criteria requirements and standards adopted by the funding committee AND THE ETHICS COMMITTEE, and make recommendations to the funding committee for the award of grants; (e) review grant applications based on the criteria, requirements, and standards adopted by the funding committee AND THE ETHICS COMMITTEE utilizing a process that gives due consideration to the amount of nonpublic funds contributed by the project sponsor, including cash, in-kind personnel, equipment or materials, donations, the opportunity to leverage funds, including federal, private and not-for-profit funds reasonably anticipated to be received by the project sponsors; provided, however, that nonpublic funds shall only be considered as a factor by the funding committee when reviewing applications of equivalent merit as determined by the independent scientific peer review committee; S 2. Subdivision 2 of section 265-c of the public health law, as added by section 1 of part H of chapter 58 of the laws of 2007, is amended to read as follows: 2. The ethics committee shall
[make recommendations to the funding committee regarding]:EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD04782-01-9 S. 1502 2
[scientific, medical, and]ESTABLISH ethical standards FOR GRANT APPLICATIONS REVIEWED BY THE FUNDING COMMITTEE; (b) ESTABLISH ETHICAL standards for all medical, socioeconomic, and financial aspects of clinical trials and therapy delivery to patients, including, but not limited to standards for safe and ethical procedures for: obtaining materials and cells for research; clinical efforts for the appropriate treatment of human subjects in medical research; and ensuring compliance with patient privacy laws; (c) EXERCISE oversight of funded research to ensure compliance with the standards described in paragraphs (a) and (b) of this subdivision; [and](d) ADVISE THE FUNDING COMMITTEE REGARDING relevant ethical and regu- latory issues; AND (E) ESTABLISH STANDARDS BY WHICH GRANT APPLICANTS SHALL CERTIFY THAT: (I) ALL RESEARCH TO BE FUNDED BY THE GRANT SHALL BE CONDUCTED IN COMPLIANCE WITH THE ETHICAL STANDARDS FOR RESEARCH SET FORTH BY THE ETHICS COMMITTEE; AND (II) STANDARDS AND PROCEDURES HAVE BEEN ESTABLISHED BY THE GRANT RECIPIENT TO REVIEW ALL RESEARCH CONDUCTED PURSUANT TO THE GRANT, TO ENSURE THAT THE ETHICAL STANDARDS ESTABLISHED BY THE ETHICS COMMITTEE ARE FOLLOWED. S 3. This act shall take effect immediately.