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Constitution and Bylaws |
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As proposed by the HSG Governance Committee |
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and as modified and adopted by the members of the Huntington Study Group on September 13, 1996 and amended on November 21, 1998, November 4, 2001, and November 15, 2003 Address inquires to: Ira Shoulson, Chair This organization shall be known as the Huntington Study Group (HSG), representing a consortium of scientific investigators from academic and research centers who are committed to the cooperative planning, implementation, analysis and reporting of controlled clinical trials and of other research studies aimed at improving the treatment of Huntington’s disease and related disorders. To this end, the HSG aims to advance knowledge about the cause(s), pathogenesis and clinical impact of Huntington’s disease and related disorders and to develop and implement scientific strategies to examine promising therapeutic interventions. The HSG is committed to the principles of open and full scientific communication, peer review, full and open disclosure of potential conflicts-of-interest, and democratic governance of its organization and activities. The HSG is also interested in educating professionals and the public by providing scientific and medical information about Huntington’s disease. The HSG will work with other professional and family organizations and with government and industry sponsors to develop substantive treatments for patients and families affected by Huntington’s disease. ARTICLE II - ORGANIZATION The HSG, founded in 1993, is organized as an independent, nonprofit consortium of scientific investigators who conduct research at the institutions with which the investigators are affiliated. The views of the HSG do not necessarily represent the views of the institutions with which the investigators are affiliated or of the agencies or companies that may support the research and educational activities of the HSG. ARTICLE III - INCOME AND EXPENSES Any income or property of the HSG shall be applied solely towards the promotion of the objectives of the HSG as set forth in Article I, and no portion shall be paid or transferred to any officer, member or employee of the HSG, except for reasonable and proper remuneration including repayment of out-of-pocket expenses in return for any services rendered to the HSG. True and auditable accounting shall be kept of the sums of money received and expended by the HSG and presented to the HSG membership at least annually. ARTICLE IV - HSG HEADQUARTERS The office of the HSG shall be located at the institution of the chair of the Executive Committee where all income and expenses of the HSG shall be recorded and transacted in a discrete, designated account for which there are no administrative or overhead charges. Voting Members will include investigators, coordinators and steering committee members who are participating in an active HSG trial and the members of the HSG Executive Committee. The eligibility of investigators and coordinators as voting members shall be determined by the steering committee of each active HSG trial. The eligibility of steering committee members as voting members shall be determined by the Executive Committee. Voting members will have voting rights in approximate proportion to their active participation in active HSG trials. For each active HSG trial, one vote will be accorded to each participating site’s “administrative investigator” who is responsible for the overall conduct of work and administrative obligations for the study, and one vote will be accorded to the “enrolling investigator” (defined as the person with a professional degree and demonstrated commitment to Huntington’s disease) who is responsible for the enrollment, clinical evaluation and follow-up of subjects. In instances when the administrative and enrolling investigators are one and the same person, this person will be accorded two votes. One vote will be accorded to the site coordinator for each active HSG trial. Each member of an active steering committee and of the Executive Committee, including ex officio members, will be accorded two votes. Voting members may be accorded up to a maximum of 10 votes on the basis of their active participation as an investigator, coordinator, member of an active steering committee for an HSG clinical trial, or member of the Executive Committee. Voting members who have more than one vote must cast these votes in total for a particular voting issue or for purposes of elections. Votes are not transferable to other persons and cannot be cast as a proxy in instances when the presence of the voting member is required. The HSG Executive Director will adjudicate the voting process. Associate Members shall include: 1) HSG investigators who are not actively participating in an active HSG trial but who have been investigators in an active HSG trial in the past 3 years, 2) investigators and coordinators at sites who actively contributed to the HSG natural history database (UHDRS) within the most recent calendar year, 3) consultants who are actively serving on standing, advisory, organizing or monitoring committees, 4) professional staff members of the Coordination and Biostatistics Centers who are supporting an active HSG trial and 5) professional staff at participating sites who are supporting an active HSG trial. Associate members do not have voting rights. ARTICLE VI - OFFICERS The HSG shall be governed primarily by an eight-member Executive Committee consisting of a chair, co-chair, three investigator members and one coordinator member who are elected by the voting members, and the director of the HSG Biostatistics Center and the director of the HSG Coordination Center, who are appointed by the chair of the Executive Committee. Voted decisions will be made by a quorum as defined by a majority of the voting members of the Executive Committee. The chair and co-chair, as a team, are to be elected by the voting members to serve a term of 6 years, and may be elected to succeed themselves. Each investigator member of the Executive Committee shall be elected by the voting members to serve staggered terms of three consecutive years, not to succeed themselves. One investigator member is to be elected to the Executive Committee each year. The coordinator member shall be elected by the voting membership for a two-year term, not to be succeeded. The appointed directors of the Biostatistics and Coordination Centers shall each serve a term of 3 consecutive years, and if re-appointed by the chair, may succeed themselves for additional 3-year terms. The chair of the Executive Committee shall appoint ex officio non-voting members of the Executive Committee to include: the chairs of the HSG Scientific Advisory and Bioethics Advisory Committees (each to serve a term of 4 consecutive years and, if re-appointed by the chair, may succeed themselves for additional 4-year terms), an Executive Director of the HSG and a Head Study Coordinator of the HSG, each to serve a term of 3 consecutive years, and if re-appointed by the chair, may succeed themselves for additional 3-year terms. Ex officio members of the Executive Committee will not have voting rights for Executive Committee business but will each be accorded two votes as voting members for general HSG business and elections. ARTICLE VII - EXECUTIVE COMMITTEE The HSG Executive Committee shall be responsible for: 1. developing and supporting the scientific projects of the HSG, including but not limited to the review and approval of research protocols, principal investigators, co-principal investigators and steering committees for these research projects, 2. reviewing and approving the appointments of the directors of the Coordination and Biostatistics Centers and for overseeing the high-quality performance of these centers, 3. reviewing and approving the appointments of the Executive Director, the Head Study Coordinator, and the chair and members of the standing HSG committees as described under Article XI. 4. formulating and maintaining standards for the HSG regarding the conduct of trials, publication policies (Article XII), and conflict-of-interest guidelines (Article XIII), 5. overseeing the program and activities of the HSG including its annual meetings, scientific/educational programs and administrative activities, 6. formulating and maintaining current and accurate listings of voting and associate members and of other qualified investigators who request participation in HSG trials, databases and programs, 7. proposing and overseeing the assessment and collection of dues, fees or surcharges for the HSG as specified in Article XVI, 8. disciplining or expelling a member of the HSG as recommended by an HSG steering committee or the Standards Committee after having an opportunity to defend oneself and respond to allegations. The Executive Committee shall meet at least twice each calendar year and report through the chair of the Executive Committee to the membership at the annual HSG meeting. ARTICLE VIII - BUSINESS MEETINGS OF THE HSG The HSG shall hold a business meeting of its membership at least yearly at the time of its annual meeting. At least a majority of voting members shall constitute a quorum for the transaction of business of the HSG. ARTICLE IX - NOMINATIONS AND ELECTIONS Elections for the chair and co-chair of the Executive Committee shall take place every 6 years by mail ballot, with the majority of total votes received from voting members required for election. The chair and co-chair should represent different institutions but shall be considered for nomination and election as a team. Each year, the voting members shall elect by mail ballot one investigator member of the Executive Committee to serve a term of 3 years. Every other year, the voting members shall elect by mail ballot one coordinator member of the Executive Committee to serve a term of 2 years. Within 6 months prior to each election, the Nominating Committee (appointed by the chair of the Executive Committee) shall recommend a slate of officers/members for the Executive Committee from among voting members of the HSG. This Nominating Committee shall solicit and consider the opinions of the voting members prior to making their recommendation. The slate of candidates will be mailed by the Executive Director to all voting members of the HSG who shall have the opportunity to nominate other candidates from the voting membership by mailing their preference to the chair of the Nominating Committee. The chair of the Nominating Committee shall close the nominations two months after sending out the selection of the Nominating Committee. Voting members need to receive nominations from at least 7 voting members in order to be declared an official candidate. The Executive Director of the HSG will then mail the election ballot to all voting members of the HSG. The ballot will contain the slate presented by the Nominating Committee plus all official candidates nominated by mail. Votes, which shall be by secret ballot, must be received by the Executive Director within 30 days after mailing out the official ballot in order to be counted. The Executive Director and the Chair of the Nominating Committee will oversee the election, ensuring that voting members are accorded their rightful votes, and will declare the winners of the election. If no one has received the majority of the votes cast for an office, the two candidates with the greatest number of votes will face each other in a second election to take place immediately; this election will be supervised similarly to the first. In the event of the death, resignation or vacancy of an officer or member of the Executive Committee, the following provisions shall apply. In the event of the death, resignation or vacancy of the chair, the co-chair shall succeed the chair for the balance of his or her elected term. In the event of the death, resignation or vacancy of the co-chair (including his/her succession to chair as described above), the chair shall appoint a replacement from the current members of the Executive Committee. Such replacement shall be approved by majority vote of the voting members of the Executive Committee and shall be voted upon by the voting membership of the HSG at the next regularly scheduled election. In the event of the death, resignation or vacancy of an elected Executive Committee member, the position shall remain vacant until the next regularly scheduled election, at which time the voting membership of the HSG shall elect a replacement to complete the remaining term of the departing member. ARTICLE X - HSG TRIALS The HSG is committed to the conduct of clinical trials wherein the HSG manages and retains the database and has free and unrestricted right to publish the data. Any voting or associate member of the HSG may make application to the Executive Committee for authorization of an HSG trial by submitting a sufficiently detailed summary and outline of the proposed protocol. In its decision as to whether or not to authorize a trial, the Executive Committee shall comment on the aims, objectives, scientific and clinical adequacy of the protocol, qualifications and capabilities of the investigators, mechanism for funding, and sponsorship for the proposed trial. For each authorized HSG trial, a principal investigator (PI) and co-principal investigator (Co-PI) will be appointed by the Chair and approved by the Executive Committee. The PI and Co-PI, who may be members of the Executive Committee, should represent different institutions and be appointed as a team. The PI and Co-PI for each authorized HSG trial shall appoint a steering committee consisting of three or four investigators who preferably are not directly involved in the evaluation of subjects for that trial and not participating as investigators in competing, commercially sponsored trials. The steering committee will include a chief biostatistician for the trial, to be appointed by the director of the Biostatistics Center, and a coordinating director for the trial, to be appointed by the director of the Coordination Center. The director of the Biostatistics Center and the director of the Coordination Center may serve respectively as the chief biostatistician and coordinating director for the trial. All members of the steering committee, including the chief biostatistician and coordinating director, must be approved by the HSG Executive Committee. Subject to approval by the Executive Committee, the PI may also appoint a head study coordinator and Executive Director to serve as ex officio members of the steering committee. All HSG steering committees will make exclusive use of the services of the HSG Coordination Center and HSG Biostatistics Center under the supervision of their respective directors. All HSG steering committees will also ensure that trial policies governing confidentiality, human subjects, clinical practice, conflict-of-interest and publication are consistent with policies contained in the HSG Constitution and Bylaws. The PI for each HSG trial will be responsible for formulating the protocol, overseeing the implementation, and supervising the analysis and reporting for the trial. The PI will also be responsible for securing adequate sponsorship and support for the trial. Funding for the trial will be directed primarily through an account at the affiliated institution of the PI, under the rules and regulations of that institution and of the sponsor. The PI, through his or her institution, will be responsible for subcontractual arrangements with the participating investigators and their institutions. The PI will also be responsible for subcontractual arrangements with the Coordination Center and the Biostatistics Center of the HSG. The Co-PI will assist the PI in carrying out these responsibilities and assume the responsibilities of the PI in the event that the PI is absent or incapacitated. As appropriate, the PI will also appoint chairs and members of the working groups and study committees to assist in the planning and implementation of the trial. These committees may include: 1) a budget committee to include the HSG Executive Director, the director of the Biostatistics Center, the director of the Coordination Center, 2) an independent (safety) monitoring committee, and 3) chairs of working groups to oversee secondary analyses and their publication. Each steering committee will be responsible for the selection of site investigators for that study, and for assisting the PI and Co-PI in the implementation, analysis and reporting of the trial results. Participating site investigators (defined as persons with a professional degree and demonstrated commitment to Huntington’s disease) for the trial will be selected, on the basis of performance and qualifications, from the current HSG listing of voting and associate members and of other qualified investigators who request participation in HSG trials. Each steering committee will also be responsible for removing from active trial participation any steering committee member, investigator (administrative or enrolling) or coordinator who does not fulfill his/her obligations to the trial or who does not maintain the standards of the HSG with respect to confidentiality, professional conduct, rights of research subjects, conflict-of-interest, disclosure or publication policies. After solicitation and consideration of the opinions of voting members, the chair of the Executive Committee shall appoint chairs and members of the following standing committees: 1) Nominating, 2) Standards, 3) Publications, 4) Symposia, 5) Scientific Advisory, 6) Credentials, and 7) Bioethics Advisory. The Nominating Committee shall be responsible for nominations and elections as set forth in Article IX. The Nominating Committee will consist of a chair and four other members to be appointed by the chair of the Executive Committee for a one-year term (between annual HSG meetings). Members of the Nominating Committee are ineligible for nomination as an officer of the HSG during their term of committee service. The Standards Committee shall be responsible for professional standards including the annual review of conflict-of-interest guidelines of the HSG, as set forth in Article XIII, and for making recommendations, if any, to the Executive Committee for additions or revisions of these policies. The committee will also assist the Executive Committee in the oversight and adjudication, as necessary, of problems or conflicts arising in the maintenance of professional standards and the implementation of these guidelines. The committee will establish mechanisms of due diligence and due process in considering and making recommendations to the Executive Committee for disciplining or expelling a voting or associate member of the HSG. At the request of the Executive Committee, the Standards Committee may be asked to investigate and recommend action upon charges or allegations of scientific or professional misconduct, including issues or incidents of conflict-of-interest, relevant to participation in HSG studies. The procedures for investigating such allegations and consequent recommendations for disciplinary action will be in the sole discretion of the HSG, provided, however, that, in general, such procedures and recommendations will be consistent with those taken by academic institutions, employing organizations, Federal or State granting or regulatory agencies, and/or professional organizations, and will be communicated in advance to the involved and affected parties. The Standards Committee will consist of a chair and three other members to be appointed by the chair of the Executive Committee for a term of four years and will rotate off one-half of its members every two years. The Publications Committee will be responsible for an annual review of HSG publication policies and for making recommendations, if any, to the Executive Committee for additions or revisions to these policies. The committee will also assist the Executive Committee, as necessary, in the adjudication of problems or conflicts arising out of implementation of the HSG publication policy. The Publications Committee will consist of a chair and three other members to be appointed by the chair of the Executive Committee, to serve a term of four years and will rotate off one-half of its members every two years. The Symposia Committee will be responsible for conducting HSG scientific and educational symposia as directed by the Executive Committee. The Symposia Committee will establish and implement appropriate peer-review standards for such symposia. The Symposia Committee will consist of a chair and three other members, each to serve a term of four years and will rotate off one-half of its members every two years. The Scientific Advisory Committee will be responsible for advising the Executive Committee, Steering Committees and HSG members about the scientific basis of HSG research activities including the development, conduct, analysis and publication of HSG trials. The Scientific Advisory Committee will consist of a chair and five members (at least one neuropsychologist and one laboratory scientist) to serve terms of four years and will rotate one-half of its members every two years. The Credentials Committee will be responsible for reviewing applications received from individuals interested in joining the HSG and evaluating the merits of submitted applications. The committee shall develop and implement a uniform set of standards which shall be used in evaluating applicants; including, but not limited to: the applicant’s education and training; academic experience, movement disorder experience; letters of reference; past clinical trial experience; clinical experience and number of patients currently followed and other factors as determined by the Committee. The Credentials Committee will consist of the co-chair of the Executive Committee, who shall act as chair of the Credentials Committee during his/her six year term, and six members who shall serve terms of three years, with one third of the members rotating off every years. The Bioethics Advisory Committee will be responsible for advising the Executive Committee, Steering Committees, and HSG members about the ethical bases of HSG research activities including the development, conduct, analysis, and publication of HSG studies. The Bioethics Advisory Committee will consist of a chair and three members, to serve terms of four years and will rotate one-half of its members every two years. The chair of the Executive Committee shall appoint the chairs and members of the standing committees, subject to the approval of the Executive Committee. The chairs and members of the standing committees may be voting or associate members of the HSG or otherwise qualified persons who are not members of the HSG. Chairs and members of the standing committees may not be re-appointed for successive terms to the particular committees they are serving, but they may be appointed to other standing committees or re-appointed to previously served committees if the terms are not successive. For standing committees with terms of more than one year of service, appointments will be staggered to help ensure continuity and turnover of committee membership. Appointments are encouraged from a broad representation of HSG sites; standing committees should not have more than one member from the same affiliated institution. Other standing committees of the HSG may be established upon recommendation of the Executive Committee and approval by the HSG membership is outlined in Article XVIII. ARTICLE XII - HSG PUBLICATION POLICIES Publication of HSG research data by HSG members is strongly encouraged for several reasons. Publications indicate the generation and dissemination of new knowledge to the public. They are a measure of the success of HSG studies and are good for the morale of the HSG (investigators, coordinators, consultants). Authorship of peer-reviewed publications is encouraged in a variety of formats. The reason for a publication policy is both to encourage publications and to avoid potential conflicts about publication priorities and details before they arise. The authorship and acknowledgements of various types of articles should be formulated according to the following guidelines: 1. All articles utilizing data on patients recruited as part of a study must acknowledge support from the study sponsor(s), unless advised by the sponsor that an acknowledgement is not necessary. 2. Peer-reviewed articles on the major objectives and general demographic descriptions of the study populations should have as authors either the Huntington Study Group (HSG) with membership listed in a footnote, or the members of the HSG in the following order: the primary author, the Principal Investigator and Co-Principal Investigator if not the primary authors, the primary biostatistician, the coordinating director, HSG investigators in order of the number of their patients enrolled in the study, HSG site coordinators in order of their investigators, HSG members who are participating in the study who do not have responsibility for subjects. 3. Authorship on reports of ancillary studies should be decided by those who proposed the ancillary study to the steering committee. 4. Authorship on publications that come out of the working groups must be decided before any data are released for analysis, and should include all those who have intellectual input into the work, including biostatisticians, coordinators and consultants. “And the HSG” should be last author on these papers. 5. Authorship on invited reviews and chapters should be decided by the invitee. The steering committee will need to approve the release of any data that is not already in press or published in a peer review journal. 6. For the consistency of data reporting, raw study data should not be released for individuals or working groups to analyze. An individual’s or a working group's request for data from the steering committee should eventually consist of a hypothesis together with a description of the items from the database to by analyzed and the method of analysis in order to test the hypothesis. 7. Individuals are encouraged to attach themselves to working groups. An individual can be a working group of one, but the steering committee will only release data sets to an individual if his/her hypothesis does not overlap or interfere with the publication activity of an existing working group. Within a working group there can be subgroups interested in different aspects of a problem. Two subgroups cannot have the same set of data analyzed. They will have to combine into a single larger group. Individuals can belong to more than one working group or subgroup. ARTICLE XIII - ETHICAL AND CONFLICT-OF-INTEREST GUIDELINES Members of the HSG should maintain the highest personal and professional standards in conducting clinical trials and research. Real and perceived conflict-of-interest must be avoided. To these ends, we agree that: 1. HSG members shall not in any way or manner benefit financially from the information obtained as a result of their participation or knowledge of HSG studies. In particular, HSG members agree not to own or trade in the equity of a company whose drugs or products are being investigated by the HSG (“involved company”). HSG members further agree not to inform or influence relatives, friends or others in financial transactions regarding the “involved company”. 2. HSG members have an obligation to act in the public interest and should be willing to educate the scientific and lay communities. HSG members agree that such practices are permitted provided there is no disclosure of confidential information or any potential for jeopardizing the successful outcome of any clinical trial which is in progress. 3. HSG members agree not to serve as paid consultants to an “involved company” in relation to the study drug or related drugs or products of the company during the period of the clinical trial, except as requested by the “involved company” as an activity or consultation under the auspices of the HSG. Prior approval for such consultation must be made by the Executive Committee. Payment for such consultation shall be made through the HSG under the guidelines established in Subsection 4 (below). Scientific consultation to the “involved company” on issues not related to drugs undergoing clinical trial by the HSG is permitted. Such consulting services, however, must be disclosed to the Steering Committee on an annual basis. 4. Certain activities with “involved companies” are not considered to be a conflict-of-interest. But no personal compensation shall accrue to the HSG member for these activities, although the intended compensation can be directed to a public charity, scientific society, or to the member’s department, university or hospital, including an academic account administered by the HSG member. These activities must be disclosed annually by December 31st to the appropriate Steering Committee. These activities include: (a) serving as an educator, e.g. giving a lecture or speaking in a panel discussion at a forum sponsored by an “involved company”’ (b) participating in research activities unrelated to the study drug or product, and supported by the “involved company”. 5. These ETHICAL AND CONFLICT-OF-INTEREST GUIDELINES will apply from the time of recruitment of subjects into a study until one month following public disclosure of the results of the study. This will be binding for all members including those who might leave the study, for any reason, prior to its completion. 6. In these GUIDELINES a HSG member is defined as an investigator, coordinator, data processor, statistician, consultant, or any other person involved with or privy to information regarding HSG studies. 7. Members of the HSG should insist on full and meaningful disclosure of financial support for educational events to which they are invited to participate. 8. Members of the HSG should fully disclose their research support and any significant financial interest with manufacturer(s) of commercial products related to the topic of their presentation for education events in which they participate. ARTICLE XIV - ANNUAL HSG MEETING The Executive Committee with the assistance of the Executive Director will organize an annual meeting of the HSG to conduct its business and provide an opportunity for scientific review and meetings of HSG steering committees, standing committees, investigators and coordinators. ARTICLE XV - SCIENTIFIC SYMPOSIA The HSG through its Symposia Committee shall help sponsor and organize scientific and educational programs as directed by the Executive Committee. ARTICLE XVI - CONSORTIUM, MATERIALS TRANSFER The affiliated institutions of the HSG shall be bound by a consortium agreement that affirms the existence of the HSG, the cooperative mission of its members, and adherence to this Constitution and Bylaws. Materials and specimens obtained by the HSG shall be shared with other parties, within and outside the HSG, according to the HSG Materials Transfer Agreement (based on NIH's Uniform Biologic Material Transfer Agreement) for non-profit institutions and the HSG License Agreement for profit entities (attached). ARTICLE XVII - DUES, FEES AND SURCHARGES The Executive Committee may propose annual dues for HSG members and fees or surcharges for participation in HSG trials in order to support HSG activities, including but not limited to the planning and implementation of HSG trials, scientific and educational symposia, and its annual meeting. Proposals of the Executive Committee for dues, fees or surcharges will require approval by a majority of votes received from HSG members who respond. ARTICLE XVIII - DATE OF ACTIVATION OF CONSTITUTION When approved by at least two-thirds of the votes cast by voting members who are present, these Constitution and Bylaws will become active and adopted at the time of the business meeting of the Eighth Planning Meeting of the HSG, on October 26, 1996. Upon adoption of this Constitution, the first election of the Chair, Co-chair and other members of the Executive Committee shall take place immediately thereafter by anonymous balloting under the procedures set forth by the HSG Nominating Committee. For this first election, the nominee for investigator member of the Executive Committee who receives the most votes will serve a three-year term, the one receiving the second highest number of votes will serve a two-year term, and the one receiving the third highest number of votes will serve a one-year term. The elected and appointment members of the HSG Executive Committee shall begin their terms of service at the time of the business meeting of the Eighth Planning Meeting of the HSG on October 25, 1996. ARTICLE XIX - AMENDMENTS Amendments to the Constitution and Bylaws may be proposed by any voting member, must be made in writing, must be signed by 6 other voting members, and must be submitted to the HSG Executive Director at least 2 months prior to a meeting of the HSG Executive Committee, at which time the proposed amendment will be considered and voted upon. If the proposed amendment is approved by a majority of the Executive Committee, it will be circulated to all voting HSG members for a mail ballot. Affirmation by at least two-thirds of votes received by the Executive Director, within one month after the proposed amendment was circulated, shall be required for the amendment to be adopted. At the request of the proposer, amendments not approved by the Executive Committee may be placed on the agenda at least one month prior to an annual HSG meeting where the proposal may be enacted by an affirmative vote by at least three-quarters of votes cast by voting members at the meeting. |
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HSG Overview | Huntington's Disease Overview | What is a Clinical Trial? Clinical Trials in Progress | New Clinical Trial Initiatives Completed Clinical TrialsWhat's New? | UHDRS | Contributions |
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