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Bylaws of the Empire State Stem Cell Board

I. Officers
II. Officer Duties
III. Executive Secretary
IV. Office of the Board
V. Meetings of the Board
VI. Committees of the Board
VII. Independent Scientific Peer Review Panel and Merit Based Peer Review Application Guidelines
VIII. Code of Ethics and Conflict of Interest
IX. Board Reports and Accountability
X. Adoption and Amendment of Bylaws

I. Officers

1. The officers of the Empire State Stem Cell Board ("Board") shall be the Chair and Vice-Chair. The Chair shall be the Commissioner of Health or his or her designee. The Chair shall select a Board member to serve as Vice-Chair. The Vice-Chair shall serve for one year or until his or her successor has been selected.

2. The Chair may appoint a Board member to preside during the absence of the Chair and Vice-Chair from any meeting.

II. Officer Duties

1. The Chair shall be responsible for the general supervision of the work of the Board. The Chair shall represent the Board before the Governor, committees of the Legislature, or other public authorities, and may request any member or members to appear with him or her, or in his or her stead.

2. The Chair shall preside at meetings of the Funding Committee, the Ethics Committee, and the full Board.

3. The Vice-Chair, in the absence of the Chair or his or her designee, shall perform the duties of the Chair.

III. Executive Secretary

1. The Board shall ask the Department of Health to designate a Department employee to serve as the Board's Executive Secretary ("Secretary").

2. The Secretary shall prepare and send official notices of actions of the Ethics Committee, the Funding Committee, and the full Board, and shall administer the daily business of the Board and its committees under the general direction of the Chair. The Secretary shall send a copy of the minutes of each meeting of the Board and its committees to each member of the respective body ten calendar days prior to the next meeting of such committee or Board. The minutes, as approved or corrected, shall serve as the official record of the meetings of the Board and its committees. The Secretary shall make approved minutes available to the public and provide access to records requested pursuant to the Freedom of Information Law. The Secretary shall make announcements to the media and public of scheduled meetings as required by the Open Meetings Law.

IV. Office of the Board

1. The official headquarters of the Board shall be at the offices of the Department of Health, Albany, New York.

2. The Secretary shall be responsible for the safekeeping of all minutes, records, documents, correspondence and other items belonging to the Board and its committees at the official headquarters of the Board.

3. Every member of the Board and its committees shall have access during the ordinary office hours of the Department of Health to all such minutes, records, documents, correspondence and other items belonging to the Board and its committees. Members of the Board and its committees shall provide the Secretary with reasonable notice of any documents and other items to be accessed.

4. The Secretary shall designate a person to be in charge of all such minutes, records, documents, correspondence and other items belonging to the Board during his or her absence from the office.

V. Meetings of the Board

1. Meetings.

The Chair of the Board may call a meeting of the full Board as frequently as deemed necessary to coordinate the activities of the Ethics Committee, Funding Committee and any other committees, or for any other purpose relating to stem cell research or the work of the Board.

2. Meeting Notification.

The Secretary shall notify each Board member of Board meetings and shall send an agenda and related materials to his or her usual address not less than ten calendar days before the meeting.

3. Quorum.

A majority (thirteen members) of the members of the full Board (twenty-four members) shall constitute a quorum for the transaction of any business or the exercise of any power or function of the Board and all matters requiring action shall be passed by a vote of a majority of the voting members of the full Board. For the purposes of these by-laws "full Board" shall mean the total number which the Board would have, as established in statute, were there no vacancies or disqualifications.

4. Open Meetings.

All Board meetings shall be noticed and conducted in accordance with the requirements of Article 7 (Open Meetings Law) of the Public Officers Law. Such meetings shall be open to the public except when otherwise provided by law. Guidelines for observers shall be adopted by Board and shall apply to all Board and committee meetings.

5. Conduct of Meetings and Order of Business.

Except as provided below, all meetings shall be conducted in accordance with Robert's Rules of Order Newly Revised, and a record of each vote shall be maintained. The normal method of voting shall be by roll call. A roll call vote on any question shall be taken by ayes and nays, abstentions noted, and a record of how each member voted entered in the Minutes. The order of business may be altered at the Chair's discretion or upon the request of a Board member.

VI. Committees of the Board

1. The primary work of the Board shall be performed by its two standing committees: the Funding Committee and the Ethics Committee.

a. The Funding Committee shall be composed of thirteen members who shall be appointed in accordance with Title 5-A of Article 2 of the Public Health Law. The Commissioner of Health or his or her designee shall serve as the Chair of the Funding Committee. The Funding Committee shall be responsible for performing the following functions:

1) provide for an independent scientific peer review panel 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 and 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 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 panel;

6) make recommendations to the Commissioner of Health for the award of grants from the Empire State Stem Cell Trust Fund for basic, applied, translational and other research, including clinical trials and therapy, and development activities that will advance scientific discoveries in the fields related to stem cell biology;

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; and

8) ensure that the recommendations of the Funding Committee are consistent with the restrictions contained within Public Health Law Article 2, Title 5-A, including, but not limited to:

i. No grants shall be made available directly or indirectly for use in research involving human reproductive cloning;

ii. Unless two-thirds of the Funding Committee approves a higher limit for a particular grantee:

a. No grant shall be made for which the annual commitment is more than fifteen percent of the total funds available in any year;

b. No single institution shall be awarded more than twenty-five percent of the total amount appropriated, provided, however, that prior year approvals shall not be aggregated when applying such limitation.

b. The Ethics Committee shall be composed of thirteen members who shall be appointed in accordance with Title 5-A of Article 2 of the Public Health Law. The Commissioner of Health or his or her designee shall serve as the Chair of the Ethics Committee. The Ethics Committee shall be responsible for making 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 (1) and (2) of this subdivision; and

4) relevant ethical and regulatory issues.

2. Ad hoc Committees.

The Board may, at any time, appoint a special committee on any subject within the purview of the Board. Each such committee shall consist of one or more Board members and may include non-Board members. All such special committees not previously discharged by the Board shall be considered discharged one year following their appointment, unless the Board shall move to continue them. For the purposes of these by-laws, the Independent Scientific Peer Review Panel shall not be considered to be a "committee" of the Board.

3. Regular Meetings.

The meetings of the Funding Committee, the Ethics Committee and any ad hoc committees shall be held as frequently as deemed necessary by the Chair to accomplish the work of such committees.

4. Meeting Notification.

The Secretary shall notify each committee member of committee meetings and shall send an agenda and related materials to his or her usual address not less than ten calendar days before the meeting.

5. Quorum.

a. A majority (seven members) of the members of the full Ethics Committee (thirteen members) shall constitute a quorum for the transaction of any business or the exercise of any power or function of the Ethics Committee and all matters requiring action shall be passed by a vote of a majority of the members of the full committee. For the purposes of these by-laws, "full committee" shall mean the total number which the committee would have, as established in statute, were there no vacancies or disqualifications.

b. A majority (seven members) of the members of the full Funding Committee (thirteen members) shall constitute a quorum for the transaction of any business or the exercise of any power or function of the Funding Committee and all matters requiring action shall be passed by a vote of a majority of the members of the full committee. For the purposes of these by-laws, "full committee" shall mean the total number which the committee would have, as established in statute, were there no vacancies or disqualifications.

c. A majority of the members appointed to any ad hoc committee shall constitute a quorum for the transaction of any business or the exercise of any power or function assigned to it by another committee or the full Board. All matters requiring action shall be passed by a vote of a majority of the members of the committee.

6. Open Meetings.

All committee meetings shall be noticed and conducted in accordance with the requirements of Article 7 (Open Meetings Law) of the Public Officers Law. Such meetings shall be open to the public except when otherwise provided by law. Guidelines for observers adopted by the Board shall apply to all committee meetings.

7. Conduct of Meetings and Order of Business.

Except as provided below, all committee meetings shall be conducted in accordance with Robert's Rules of Order Newly Revised, and a record of each vote shall be maintained. The normal method of voting shall be by roll call. A roll call vote on any question shall be taken by ayes and noes, abstentions noted, and a record of how each member voted entered in the Minutes. The order of business may be altered at the Chair's discretion or upon the request of a committee member. A portion of each committee meeting shall be set aside for the development of an agenda for the next committee meeting.

8. Committee Minutes and Reports.

Minutes of the committee and any report should, in addition to reporting any recommendations of the majority of the committee, summarize any significant deliberations leading to such recommendations as well as opinions or recommendations of committee members who did not support the majority recommendations.

9. Absences.

Any member who fails to attend three consecutive meetings of a committee shall, unless excused by a formal vote of the committee, be deemed to have vacated his or her position.

VII. Independent Scientific Peer Review Panel and Merit Based Peer Review Application Guidelines

1. Establishment of Independent Scientific Peer Review Panel.

The Funding Committee shall provide for the establishment of one or more Independent Scientific Peer Review Panels (ISPRP) as needed to review applications submitted to the committee. An ISPRP shall be composed of individuals with expertise in biomedical research. Members of the ISPRP shall be individuals who have demonstrated scientific excellence through their own research and publications, are respected in the scientific community, have a breadth of expertise in biomedical research or expertise in an area relevant to the applications submitted, demonstrate an ability to perform reviews fairly, present ideas and comments clearly, and are willing to commit to performing the work required by the ISPRP. To reduce the potential for conflicts of interests by members of the ISPRP, members of the panel shall not live or work in New York State and shall provide sufficient information, in the time and manner prescribed by the convener of the panel, to enable the convener to identify any potential conflicts of interest.

2. Responsibilities of the Independent Scientific Peer Review Panel

The ISPRP shall perform the following functions:

a. review and rank applications based upon criteria, requirements and standards adopted by the Funding Committee for the specified requests for proposals or requests for applications; and
b. make recommendations to the Funding Committee for the award of grants and contracts.

3. Merit Based Peer Review Guidelines

The following guidelines shall be followed for the review of grant applications:

a. each application shall be reviewed by at least two reviewers, at least one of whom shall be responsible for preparing a written evaluation of the application prior to the meeting of the ISPRP, using the criteria, requirements and standards established by the Funding Committee;

b. applications shall be assigned to members of the ISPRP based upon their expertise and the absence of any conflicts of interest;

c. reviewers shall not review an application when:

1) the funding decision may benefit the reviewer, his or her employer, a relative, a close associate, or any organization in which the reviewer, relative or close associate is an officer, director or partner;

2) the reviewer has a professional relationship or a shared financial interest with another reviewer or the applicant; or

3) the reviewer is aware of any circumstances that could create the perception of a conflict of interest.

d. if a reviewer concludes that he or she should not review an assigned application because of an actual or potential conflict of interest, insufficient expertise to review the application, or any other reason, he or she should advise the convener of the panel or other designee of the Board of such incapacity immediately;

e. members of the ISPRP shall keep the contents of each application confidential and shall not misappropriate or plagiarize the intellectual property of the applicant;

f. members of the ISPRP shall keep the discussions of the review and merit of the application confidential and shall not discuss the review or communicate to investigators, their organizations, or any unauthorized person, the panel's deliberations and evaluations;

g. members of the ISPRP shall recuse themselves from any discussions when there is a real or apparent conflict of interest that would have precluded the member from reviewing the application initially; and

h. prior to making a recommendation to the Funding Committee, the reviewers shall discuss each application and its relative merits thoroughly within the ISPRP and prepare a summary of the discussion and its evaluation for the Funding Committee, provided, however, the ISPRP, consistent with the provisions of a specific request for applications, may establish procedures for a streamlined review of the submitted applications based upon the evaluations and scores of the initial reviewers identifying the weakest applications, which may remain undiscussed and unscored.

4. Notwithstanding the foregoing, under exceptional circumstances, when soliciting applications, the Funding Committee may decide that the goals of a particular request for applications, the specific types of activities to be funded, and the committee's established objective criteria and/or possible reliance on previous similar independent peer reviews, have rendered the review of applications by a Board-established ISPRP unnecessary.

VIII. Code of Ethics and Conflict of Interest

1. Code of Ethics.

Members of the Board shall comply with Section 74 (Code of Ethics) and 78 of the Public Officers Law. No member of the Board should have any interest, financial or otherwise, direct or indirect, or engage in any business or transaction, or professional activity, or incur any obligation of any nature, which is in substantial conflict with the proper discharge of his or her duties as a Board member. Members should exercise their duties and responsibilities as Board members in the public interest of the inhabitants of the State, regardless of their affiliation with, or relationship to, any institution, organization, facility, agency, program, activity, category of provider, or interest group. The principles that should guide the conduct of Board members include, but are not limited to, the following:

a. A Board member should endeavor to pursue a course of conduct that shall not raise suspicion among the public that he or she is likely to be engaged in acts that are in violation of his or her trust as a Board member.

b. No Board member should accept other employment which will impair his or her independence of judgment in the exercise of his or her duties as a Board member.

c. No Board member should disclose confidential information acquired by him or her in the course of his or her duties as a Board member, or by reason of his or her position as a Board member, nor use such information to further his or her personal interests.

d. No Board member should accept other employment or engage in any business or professional activity which will require him or her to disclose confidential information which he or she has gained by reason of his or her position as a Board member.

e. No Board member should use, or attempt to use, his or her position as a Board member to secure unwarranted privileges or exemptions for himself or herself or others.

f. No Board member should engage in any transaction as a representative or agent of the State with any business entity in which he or she has a direct or indirect financial interest that might reasonably tend to conflict with the proper discharge of his or her duties as a Board member.

g. A Board member should not make personal investments in enterprises which he or she has reason to believe may be directly involved in decisions to be made by him or her as a Board member or which shall otherwise create substantial conflict between his or her duty as a Board member to act in the public interest and his or her private interest.

h. A Board member should not by his or her conduct give reasonable basis for the impression that any person can improperly influence him or her or unduly enjoy his or her favor in the performance of his or her duties as a Board member, or that he or she is affected by the kinship, rank, position or influence of any party or person.

i. To preserve the public trust, Board members are prohibited during the tenure of their appointment from applying for, or receiving support from, the Board and the Empire State Stem Cell Trust Fund created pursuant to Title 5-A of Article 2 of the Public Health Law and section 99-p of the State Finance Law, or from having any role (other than routine professional and collegial interest in the success of their institution or department) in proposals submitted for consideration by, or in research or proposals supported by, the Board and the Empire State Stem Cell Trust Fund.

2. Conflict of Interest - Applications and other Pending Matters.

This section applies both to activities of the full Board and its committees.

a. Absolute Disqualifications.

1) No member of the Board or of a committee of the Board 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:

i. His or her employer or relative, or any entity in which the member of the Board, or his or her relative, has a financial interest; or

ii. An organization in which such member of the Board, or his or her relative, is an officer, director or partner of such organization.

2) When a Board or committee member, or his or her family has an interest, financial or otherwise, whether as owner, officer, director, fiduciary, employee, colleague, consultant, or supplier of goods or services, in an entity, institution, organization, facility, agency or program (hereafter collectively referred to as "entity") whose application is before the Board or a committee of the Board for consideration or determination for a grant from the Empire State Stem Cell Trust Fund created pursuant to section 99-p of the State Finance Law, that member shall (i) identify such interest to the Board or committee at any meeting when the application or request is to be considered, (ii) absent himself or herself from any portion of any meeting when such application is considered, and (iii) not participate in any vote of the Board or committee on such application. For purposes of this Article, "family" shall include a spouse, children, sibling, and any relative living in the member's household.

b. Disclosure and Possible Disqualification.

When a Board or committee member, or his or her family member has (i) any of the above-noted interests in an entity the status of which might reasonably be affected by another entity whose grant application is before the Board or a committee of the Board, or (ii) when a member has any other interest or association which might reasonably be construed as tending to embarrass the Board or elicit public suspicion that he or she might be engaged in acts in violation of his or her trust as a Board member, the member shall disclose such interest or association at the time the application or other matter is formally considered by the Board or committee, so that the Chair and, if necessary, the Board or committee can then determine whether the member's participation in the discussion or the vote on the application by the Board or by the committee or on the other matter would be proper.

c. Procedure.

Prior to the discussion of a grant application, the Chair of the Board or committee shall request that Board members and committee members disclose all actual or potential conflicts and, when appropriate, explain the conflicts. In the case of conflicts constituting Absolute Disqualifications, the members with such conflicts shall immediately leave the meeting and remain absent during the period when the application is under consideration. In the case of conflicts constituting possible disqualifications, the Chair of the Board or committee shall rule upon such conflicts subject to appeal by motion to the Board or committee that may override the Chair's decision by the affirmative vote of a majority of those present, excluding those members who are the subject of the vote.

d. Disclosure of Committee Interests to Board Meetings.

When the Chair of any committee reports the committee's deliberations and recommendations on a matter to the Board, the committee Chair shall indicate in the report all interests or associations disclosed by the committee members and state how such members voted with respect to the committee's recommendations.

e. Additional Restrictions.

The following conflicts of interest rules shall also apply to Board members:

1) No member shall receive, directly or indirectly, or enter into any agreement express or implied, for compensation, in whatever form, for the appearance or rendition of services by himself or another against the interest of the Board in relation to any case, proceeding, application or other matter before, or the transaction of business by himself or another with, the court of claims.

2) No member of the Board shall accept any gift or gratuity of more than nominal value where the circumstances would permit the inference that the gift was intended to influence him or her as a member of the Board, or that the gift constituted a tip, reward, or sign of appreciation for any act performed as a member of the Board.

f. Annual Disclosure Statement.

Members of the Board shall comply with the provisions of Public Officer Law § 73-a concerning financial disclosures and shall provide the Secretary of the Board with a statement of employment and other interests in sufficient detail to help the Executive Secretary and Chair assess potential conflicts of interests of Board members regarding matters pending before the Board.

g. Violation of Provisions.

If any member knowingly and intentionally violates these provisions, the Board or its Chair shall refer the matter to the Commissioner of Health for appropriate action.

IX. Board Reports and Accountability

1. 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:

a. Number and dollar amounts or research and facilities grants;

b. Grantees for the prior year;

c. Board's administrative expenses;

d. Summary of research findings, including promising new research areas;
and
e. Strategic plan of the Board.

2. 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.

X. Adoption and Amendment of Bylaws

1. These bylaws shall be adopted by an affirmative vote of a majority of the members of the Board, provided, however, that the merit based peer review application guidelines shall be first be approved by an affirmative vote of a majority of the members of the Funding Committee.

2. These bylaws may be amended upon the affirmative vote of a majority of the members of the Board at any regular or special meeting, provided that a copy of the proposed amendment and notice of the proposed action has been sent by the Secretary to each member of the Board at least thirty days prior to the vote.

3. Notwithstanding the foregoing, the Funding Committee may amend the provisions of these bylaws establishing the merit based peer review application guidelines upon the affirmative vote of a majority of the members of the Funding Committee, at any regular or special meeting of such committee, provided that a copy of the proposed amendment and notice of the proposed action has been sent by the Secretary to each member of the Board at least thirty days prior to the vote.

Adopted October 22, 2007