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New York State Stem Cell Science

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ESSC Board Statute

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Public Health Law Article 2, Title 5-A

Section 265. Definition.
265-a. Empire State Stem Cell Board.
265-b. Funding Committee.
265-c. Ethics Committee.
265-d. Members.
265-e. Public and Financial Accountability Standards.
265-f. Severability.

 

§ 265.Definition.

As used or referred to in this title, unless a different meaning clearly appears from the context "stem cell” means stem or progenitor cells that divide and are capable of generating one or more different types of progeny. Stem cells and their progeny can potentially repair or replace specific tissues or be used to develop disease models.

§ 265-a.Empire State Stem Cell Board.

  1. The empire state stem cell board ("board"), comprised of a funding committee and an ethics committee, both of which shall be chaired by the commissioner, is hereby created within the department for the purpose of administering the empire state stem cell trust fund ("fund"), created pursuant to section
    ninety-nine-p of the state finance law. The board is hereby empowered, subject to annual appropriations and other funding authorized or made available, to make grants to basic, applied, translational or other research and development activities that will advance scientific discoveries in fields related to stem cell biology.
  2. No grants made available in the fund from any source shall be directly or indirectly utilized for research involving human reproductive cloning.
  3. Notwithstanding any other provision of law, the board shall have the authority to adopt by laws to govern its proceedings including but not limited to rules respecting quorums and the number of votes needed to require the award of grants. No grants may be awarded by the board prior to the establishment of bylaws that must include merit based peer review application guidelines. Such bylaws must be approved by the funding committee.
  4. Grants may be made for one or more years, provided, however, that no grant shall be made for which the annual commitment is more than fifteen percent of the total funds available in any year. However, no single institution shall be awarded more than twenty-five percent of the total amount appropriated. This limitation shall be considered separately for each new proposal without aggregating any prior year approvals that may fund research activities. This requirement shall be determinative, unless two-thirds of the funding committee approves a higher limit for a particular grantee.
  5. The existence of the empire state stem cell board shall continue until there are no longer any assets or money available for distribution.

§ 265-b.Funding Committee.

  1. There shall be a funding committee which shall have thirteen members appointed by the governor, except for the commissioner who shall serve as an ex officio member. Six members shall be appointed directly by the governor; two shall be appointed on the nomination of the temporary president of the senate; two shall be appointed on the nomination of the speaker of the assembly; one shall be appointed on the nomination the senate minority leader and one shall be appointed on the nomination of the assembly minority leader. A member of the funding committee shall also serve on the ethics committee.
  2. The funding committee shall perform the following functions:
    1. 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 make recommendations to the funding committee for the award of grants;
    2. develop criteria including an appropriate competitive scoring method, standards, and requirements for considering funding applications and for awarding research grants, including but not limited to recommendations for the overhead/indirect component of such grants for the development and submission of funding applications by New York state
      based consortia;
    3. recommend standards for the scientific and medical oversight of awards;
    4. solicit through requests for proposals and otherwise, and to accept proposals for research projects including grant applications;
    5. review grant applications based on the criteria, requirements, and standards adopted by the funding 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;
    6. make recommendations to the commissioner for the award of research therapy development and clinical trial grants; and
    7. recommend standards for the evaluation of grantees to ensure that they comply with all applicable requirements, including, but not limited to, conducting peer group progress oversight reviews of grantees to ensure compliance with the terms of the award and report to the commissioner any recommendations or subsequent action. Such standards shall mandate periodic reporting by grantees.
  3. With the exception of the ex officio member, the funding committee shall be divided into three classes. Of the three classes, the first class appointed shall include three of the governor's appointees, one appointee nominated by the temporary president of the senate, and one appointee nominated by the speaker of the assembly and shall serve for a term ending one year from the effective date of this title. The second class shall include two of the governor’s appointees, one appointee nominated by the minority leader of the senate, and one appointee nominated by the minority leader of the assembly and shall serve for a term ending two years from the effective date of this title. The third class shall include the final governor’s appointee, one appointee nominated by the temporary president of the senate, and one appointee nominated by the speaker of the assembly; and shall serve for a term ending three years from the effective date of this title. Subsequently, each member appointed shall serve a term of three years and no more than two terms of three years each. A vacancy in the membership of the board shall be filled for the unexpired portion of the term in the same manner as the original appointment.

§ 265-c.Ethics Committee.

  1. There shall be an ethics committee which shall have thirteen members appointed by the governor, except for the commissioner who shall serve as an ex officio member. Six members shall be appointed directly by the governor; two shall be appointed on the nomination of the temporary president of the senate; two shall be appointed on the nomination of the speaker of the assembly; one shall be appointed on the nomination of the senate minority leader; and one shall be appointed on the nomination of the assembly minority leader. A member of the ethics committee shall also serve on the funding committee.
  2. The ethics committee shall make recommendations to the funding committee regarding:
    1. scientific, medical, and ethical standards;
    2. 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;
    3. oversight of funded research to ensure compliance with the standards described in paragraphs (a) and (b) of this subdivision; and
    4. relevant ethical and regulatory issues.
  3. With the exception of the ex officio member, the ethics committee shall be divided into three classes. Of the three classes, the first class appointed shall include three of the governor’s appointees, one appointee nominated by the temporary president of the senate, and one appointee nominated by the speaker of the assembly; and shall serve for a term ending one year from the effective date of this title. The second class shall include two of the governor's appointees, one appointee nominated by the minority leader of the senate, and one appointee nominated by the minority leader of the assembly; and shall serve for a term ending two years from the effective date of this title. The third class shall include the final governor’s appointee, one appointee nominated by the temporary president of the senate, and one appointee nominated by the speaker of the assembly; and shall serve for a term ending three years from the effective date of this title. Subsequently, each member appointed shall serve a term of three years and no more than two terms of three years each. A vacancy in the membership of the board shall be filled for the unexpired portion of the term in the same manner as the original appointment.

§ 265-d.Members.

  1. The members of the funding and ethics committees shall serve without compensation, but shall be entitled to reimbursement for actual and necessary expenses incurred in the performance of their official duties. Such members, except as otherwise provided by law, may engage in private employment, or in a profession or business.
  2. The provisions of section seventeen of the public officers law shall apply to members of the committees.
  3. The provisions of article seven of the public officers law shall apply to meetings of the funding and ethics committees.

§ 265-e.Public and Financial Accountability Standards.

  1. Report. The board shall issue an annual report to the public, which sets forth its activities, grants awarded, grants in progress, research accomplishments, and future program directions. Each annual report shall include, but not be limited to the following:
    1. number and dollar amounts of research and facilities grants;
    2. grantees for the prior year;
    3. board's administrative expenses;
    4. summary of research findings, including promising new research areas; and
    5. strategic plan of the board.
  2. Conflicts of interest. No employee of the board or member of the funding or ethics committees shall make, participate in making, or in any way attempt to use his or her position to influence a decision to approve or award a grant, loan, or contract to:
    1. his or her employer or relative, or any entity in which the employee, member of the board, or member of the advisory counsel or the relative of any such individual has a financial interest; or
    2. an organization in which such employee, member of the board, member of the advisory counsel, or any relative of any such individual is an officer, director or partner of such organization.
  3. Patent royalties and license revenues. The board shall establish standards that require that all grants be subject to intellectual property agreements that establish the scope, if any, of the state's ownership or other financial interest in the commercialization and other benefits of the results, products, inventions and discoveries of state-funded stem cell research, and shall also include consideration in such agreement for amounts of funding from sources other than the state.
  4. Contributions to the board. Notwithstanding any other provisions of the law to the contrary, the board is authorized to receive contributions from any governmental entity, for profit and not-for-profit corporation, association or person.

§ 235-f.Severability.

If any clause, sentence, paragraph, section or part of this title shall be adjudged by any court of competent jurisdiction to be invalid, such judgment shall not affect, impair or invalidate the remainder thereof, but shall be confined in its operation to the clause, sentence, paragraph, section or part thereof, directly involved in the controversy in which such judgment shall have been rendered.