Constitution

The GA4GH aims to accelerate progress in genomic science and human health by developing standards and framing policy for responsible genomic and health-related data sharing.

The GA4GH is founded on the following principles:

• respect for the data sharing and privacy preferences of participants;
• transparency of governance and operations;
• accountability to best practices in technology, ethics, and public outreach;
• inclusivity by partnering and building trust among stakeholders;
• collaboration to share data and information to advance human health;
• innovation in order to develop an ecosystem that accelerates progress;
• agility to ensure swift action to benefit those suffering with disease;
• independence through structures and governance.

The GA4GH is guided by its Framework for responsible sharing of genomic and health-related data, which seeks to activate the right of everyone to share in scientific advancement and its benefits as outlined under Article 27 of the 1948 Universal Declaration of Human Rights.

Below are goals and desired activities of the GA4GH:

• collaborate with the international genomics community to identify and create the standards, tools, and policy frameworks most needed to share data;
• innovate on new and existing standards and approaches for data sharing;
• accelerate progress in genomic science and human health by lowering the barriers to collaboration and data sharing.

4.1 Independence

The GA4GH is an independent, non-governmental, not-for-profit, international association. It is not controlled by any individual healthcare provider, research institution, research funder, disease advocacy organisation, life science or information technology company, or other single entity.

4.2 Structure

The GA4GH is an unincorporated association among entities interested in pursuing the GA4GH’s goals. The work of the GA4GH is supported by GA4GH Inc., Host Institutions, and Funders, and carried out by Organisational Members, Driver Projects, and Individual Contributors. The roles and criteria for these entities are further defined below.

4.3 GA4GH Inc.

GA4GH Inc. is a not-for-profit corporation incorporated in Canada to support the mission of GA4GH and is an Organisational Member.

4.3.1 Function of GA4GH Inc.

As an incorporated legal entity, GA4GH Inc. acts on behalf of GA4GH to hold intellectual property and other assets, enter into binding contractual agreements, and accept sponsorship funding from private sector entities and disburse funds in pursuit of GA4GH’s mission.

4.3.2 Governance of GA4GH Inc.

GA4GH Inc. is governed by a Board of Directors. The majority of the nominations for Directors will be recommended by the Core Funders, with the remaining nominations recommended by the Standards Steering Committee and other advisory bodies.

4.4 Host Institutions

The GA4GH is administered and hosted by a small number of organisations (the “Host Institutions”), each of which must be an Organisational Member in good standing of the GA4GH.

4.4.1 Function of Host Institutions

The Host Institutions will provide services and administrative support (e.g. space, grants management, and human resources) on behalf of the GA4GH. Commitments and principles on collaboration and data sharing will be set forth in a broad agreement. Specific commitments will be addressed through delineated agreements or grant contracts with individual Host Institutions, either with GA4GH Inc. or specific Funders. No Host Institution will be required to provide services, space, or staff support for the GA4GH beyond that to which it has committed and for which sufficient funding has been provided at the Host Institution’s sole discretion.

4.4.2 Selection of Hosts

Current Host Institutions are independent, non-profit organisations. New Host Institutions may be approved, and existing Host Institutions removed, by the Executive Committee. The GA4GH will endeavour to promote stability by ensuring long-term relationships with Host Institutions.

4.5 Funders

Funders are organisations that provide financial support to the GA4GH.

4.5.1 Core Funders

“Core Funders” of the GA4GH are defined as those Funders that provide a funding commitment of more than US$200,000 per year for a minimum of three years for projects that relate to developing standards and framing policy for responsible genomic and health-related data sharing. The Core Funders will engage in a consultative process with the board of GA4GH Inc. and will recommend for nomination a majority of Directors of GA4GH Inc. Representatives of Core Funders may be invited to attend meetings of the Standards Steering Committee or Executive Committee.

4.5.2 Funders Forum

Funders will be invited to meet periodically with the Executive Committee in a consultative Funders Forum to receive updates from and provide input to the Executive Committee.

4.6 Industry Forum

Commercial enterprises that collaborate with GA4GH will be invited to meet periodically with the Executive Committee in a consultative Industry Forum to receive updates from and provide input to the Executive Committee.

4.7 Executive Committee

The Executive Committee is responsible and accountable for the direction, values, progress, and work products of the GA4GH. The Executive Committee has the ability to: appoint or remove Standards Steering Committee Members, Work Stream Leads, or Work Stream Contributors; approve or discontinue Work Streams, Driver Projects, or work products; and to communicate with and on behalf of Organisational Members.

4.7.1 Executive Committee function

The Executive Committee will provide regular and direct updates to the Standards Steering Committee (SSC) and Organisational Members, and will solicit and take into account the views of the SSC, Funders Forum, Organisational Membership, and other strategic advisory bodies.

4.7.2 Executive Committee membership

The membership of the Executive Committee of the GA4GH Standards Steering Committee (SSC) mirrors that of the Management Committee of the GA4GH Inc. Board of Directors (which is distinct from the GA4GH SSC). Because the Management Committee is appointed by the Board, so too is the Executive Committee of the SSC. Both are comprised of the chairperson and Vice-Chairs of the Board (who also serve as the Chair and Vice-Chair of the SSC of the Alliance) and the President of the corporation. The Executive Committee meets regularly to advance the strategic direction of and provide leadership coordination to the Alliance.

4.7.3 Executive Committee meetings and voting

Committee meetings shall be presided over by the Chair, or in his/her absence, a Vice-Chair, and may be held in person or by teleconference. Regular meetings will be scheduled by the Chief Executive Officer, who is also responsible for setting the agenda. A majority vote of all active members of the Executive Committee shall constitute the act of the Executive Committee. Votes can be registered via email or other electronic means. In the event of a tie, the Chair will have a deciding vote.

4.7.4 Chief Executive Officer

The Chair and Vice-Chair(s) are responsible for the performance management of the Chief Executive Officer. The Chief Executive Officer may be appointed or removed by majority vote of the Chair and Vice-Chair(s) at a duly constituted meeting.

4.8 Standards Steering Committee (SSC)

The SSC is a voluntary body responsible for driving and overseeing the delivery of the GA4GH work products. The SSC advises the Executive Committee on the direction, values, and progress of the GA4GH. SSC responsibilities include peer-reviewing work products, promoting the GA4GH at international fora, acting as ambassadors for the GA4GH, supporting fundraising efforts, and participating in the nomination of directors of GA4GH Inc.

4.8.1 SSC membership

The membership of the SSC will be made up of the Executive Committee, up to four representatives nominated by each Driver Project and approved by the Executive Committee, and the Work Stream Leads. The Executive Committee will ensure all necessary competencies and a diversity of perspectives, backgrounds, and geography are represented to reflect the participants in GA4GH. The Executive Committee may invite additional representatives to attend SSC meetings as non-voting participants.

4.8.2 SSC meetings and voting

SSC meetings shall be presided over by the GA4GH Chair, or in his/her absence, a GA4GH Vice Chair, and may be held in person or by teleconference. Regular meetings will be called at the direction of the Executive Committee, ideally four times a year (twice in person, and twice by teleconference). The GA4GH Chair is responsible for setting the agenda of the SSC. Special meetings may be called at the request of any three or more members of the SSC and with five days’ notice to the GA4GH Chair. Except where otherwise specified in this Constitution, decisions are made by a majority vote of all active members of the SSC. Each Driver Project is allotted one vote, regardless of the number of Champions appointed by the Driver Project. Votes can be registered via email or other electronic means. In the event of a tie, the GA4GH Chair will have a deciding vote.

4.9 Work Streams

Work Streams will be established to produce work products. The Executive Committee can discontinue or establish additional Work Streams. Work Streams may, individually or jointly, set up task teams to undertake specific work under their direction. Work Streams will have open dialogue and transparent communication with GA4GH participants and the interested general public, and will coordinate with the Standards Steering Committee and Executive Committee.

4.9.1 Work Stream leadership

Two Leads are appointed for each Work Stream by the Executive Committee. Leads should both be technically competent and have the time to ensure delivery at the expected rate. These Leads will serve a renewable two-year term.

4.9.2 Process for developing work products

Work Streams will be responsible for developing work products (e.g. standards, methods, and recommendations) based on their own research and internal discussions, and in consultation with the Standards Steering Committee (SSC). Before their release, work products must be peer-reviewed by the SSC and approved by the Executive Committee.

Driver Projects are leading real-world research and clinical projects that process genomic and health-related data according to GA4GH standards. Driver Projects will initially be selected from key theme areas such as cancer, rare disease, complex traits, and basic biology. GA4GH standards and tools will be developed to meet the specific needs of Driver Projects, and will support those projects in the implementation of technical and regulatory standards to improve genomic data-sharing practices. Driver Projects must themselves be GA4GH Organisational Members in good standing, or else be led or owned by an Organisational Member in good standing.

5.1 Driver Project roles

Driver Projects will implement GA4GH policies and standards into immediate, real-world use to demonstrate the impact and benefit of genomic data sharing. Driver Projects will also provide input on the key policy and standards needs of the genomics community in the area of data sharing. They may nominate up to four representatives with domain knowledge and a deep understanding of the needed deliverables to serve as Driver Project Champions (DPCs). All DPCs are invited to participate on the Standards Steering Committee (SSC), with the expectation that at least one will attend each meeting. Each Driver Project is allotted one vote for all decisions presented to the SSC. They should also be connected with at least one technical Work Stream, and may also nominate Individual Contributors to join Work Streams in developing deliverables. Each Driver Project will have the right to designate individuals from its organisation who will represent the organisation in GA4GH-related work, meetings, and governance matters.

5.2 Driver Project criteria

The Executive Committee will determine criteria for the selection of Driver Projects, and may update these criteria at its discretion. The list of Driver Project criteria will be made available in a transparent manner to Organisational Members and prospective Driver Projects.

5.3 Executive Committee discretion

The Executive Committee may approve or reject Driver Project applications, and may discontinue Driver Projects. In particular, Driver Projects that do not adhere to the mission and founding principles of the GA4GH, or that act in such a way as to damage the interests or reputation of the GA4GH, may be removed by the Executive Committee. Driver Projects that are removed will be provided a written communication of this action, including a description of the reasons leading to the removal.

Organisational Members will be entities, either not-for-profit or for-profit, in fields such as healthcare, public health, biomedical and other research, information technology and life sciences, and disease and patient advocacy that subscribe to the mission, founding principles, and goals of the GA4GH outlined in this Constitution, sections 1 to 3. Individual Contributors from Organisational Members may play various roles, including members of Work Streams (at invitation of a Work Stream Lead), the Standards Steering Committee, or other committees. Each Organisational Member will have the right to designate individuals from its organisation who will represent the organisation in GA4GH-related work, meetings, and governance matters.

6.1 Existing Organisational Members

Existing Organisational Members will be informed of this revised Constitution and will continue to be Organisational Members of the GA4GH as described in this Constitution.

6.2 Executive Committee discretion

Organisations may apply to be an Organisational Member, and such applications will be considered for approval by the Executive Committee. Organisational Members that do not adhere to the mission and founding principles of the GA4GH, or that act in such a way as to damage the interests or reputation of the GA4GH, may be removed by the Executive Committee. Organisations that are removed as Organisational Members will be provided a written communication of this action, including a description of the reasons leading to the removal.

6.3 Plenary and other meetings

Much of the work of the GA4GH will be conducted by email and teleconference, but Plenary meetings will be held approximately annually. Additional meetings may be held, with invitations directed to relevant Organisational Members at the discretion of the Executive Committee.

6.4 Organisational Member criteria

6.4.1 Commitment to mission and principle of data sharing

Each Organisational Member will show significant commitment to the shared mission and values of the GA4GH and support the principle of promoting and enabling responsible and voluntary sharing of genomic and clinical data.

6.4.2 Collaboration

Organisational Members will collaborate and engage on issues, share knowledge and best practices, and contribute to the development of interoperable tools and methods through Work Streams and other efforts. Organisational Members should possess and demonstrate the expertise, willingness, and ability to contribute to such a collaborative effort.

6.4.3 Catalysing data sharing

To the greatest extent possible and appropriate to their mission, existing commitments, and role in the GA4GH, Organisational Members should be leaders in the responsible sharing of data to advance human health — both through their own participation in data sharing activities, and by supporting the work of the GA4GH to enable and draw attention to positive examples of data sharing in biomedicine. Organisational Members should advocate for the use of GA4GH-developed harmonised approaches to share data responsibly.

6.4.4. Data sharing requirements

Recognizing that genomic and clinical data sharing is a relatively new and evolving ethos, Organisational Members are not required to commit to a particular threshold of data sharing as a condition of membership in the GA4GH. Organisational Members’ data sharing activities will be expected to conform to applicable GA4GH methods and approaches, such as those included in the Framework for responsible sharing of genomic and health-related data, with the understanding that not all data can be shared, that patient and research participant privacy must be respected, that certain commercial and intellectual property interests must be protected, and that policies and approaches will evolve and be expanded as knowledge and best practices develop. The Executive Committee retains the discretion to remove Organisational Members who do not adhere to the principles of the GA4GH.

6.4.5 Requirements for participation in specific projects, initiatives, or networks

Participation in specific data sharing projects, initiatives, or networks developed or catalysed by the GA4GH may carry additional data sharing requirements that go beyond those described in this Constitution. Such requirements might include active contribution of data, and specified approaches to data sharing, ethics, informed consent, or other matters. Each such project, initiative, or network will set requirements as appropriate to the project needs and Member involvement. Participation in such projects, initiatives, and networks will be at the sole discretion of each Organisational Member.

6.4.6 Uptake

The GA4GH will seek to encourage adoption of GA4GH technical standards and policy frameworks by Organisational Members through incentives, project opportunities, and highlighting of best practices. This may include, but is not limited to, benchmarking and publishing lists of those entities and projects that are compliant with developed approaches and/or best practices.

6.5 Evolution of Organisational Membership criteria

Criteria may be added or modified as generally accepted approaches to data sharing are developed and embraced. Any changes in criteria are at the discretion of the Executive Committee and all Organisational Members will be informed before such a transition.

It is a guiding principle of the GA4GH that work products developed as part of the GA4GH Standards Steering Committee and Work Stream processes will be openly shared for the benefit of humanity. Appropriate intellectual property policies will be developed and promulgated.

Early in the course of GA4GH efforts, the GA4GH will develop appropriate policies concerning its operations, including, without limitation, policies regarding conflict of interest, managing dissent, confidentiality, report development process, and reviews and appeals.

8.1 Conflict of Interests

Organisational Members, GA4GH Inc., Funders, Host Organisations, and Standards Steering Committee members may have existing or future business interests or other potential conflicts that will require disclosure and recusal from certain proceedings, projects, or votes. If an organisation or individual is subject to policies and requirements or has pre-existing relationships that create a fundamental conflict with the criteria of the GA4GH, the Executive Committee has the right to reject or remove the organisation or individual.

The GA4GH will seek financial support from various sources, including philanthropic, government, for-profit, and institutional sources, to fund its core operations. Where appropriate, funding will be accessed through Host Institutions or GA4GH Inc. As future circumstances warrant, the GA4GH may consider requesting a form of Organisational Member or Funder fee. To guard against disproportionate control, a single funder will not be permitted to dominate GA4GH funding. All funding raised by the GA4GH shall be exclusively applied to further the mission of the GA4GH.

This Constitution may be amended from time to time by vote of a two-thirds majority of the Executive Committee, with feedback requested from the Standards Steering Committee and other advisory bodies prior to a vote being held.