Infection Management / Sepsis Collaborative Community Charter

Conditionally Approved by the Interim Steering Committee on April 25, 2022

Last updated July 6, 2023

Article 1: Background

Sepsis is the body’s overwhelming and life-threatening response to infection which can lead to tissue damage, organ failure, and death. Each year at least 1.7 million adults in the U.S. develop sepsis—one every 20 seconds—and more than 350,000 Americans die from sepsis—one every 90 seconds—more than from stroke, prostate cancer, breast cancer, and opioid overdose combined. It is the leading cause of death in U.S. hospitals and the most expensive inpatient condition—in-patient hospital and skilled nursing costs for sepsis care are approximately $62 billion per year.

Any infection can lead to sepsis, but it is difficult to predict or identify risk of infection, infection status, infection severity risk, and which patients are most at risk for sepsis or long-term complications. Sepsis is also difficult to treat because it can damage organ systems throughout the entire body, beyond the site of the original infection. In addition, to further complicate diagnosis and patient management, there is great heterogeneity amongst patients due to the pathogen involved, concomitant comorbidities and individual responses to disease. As the host responds to an infection and becomes dysregulated, traditional pathogen-targeted approaches may not be sufficient.

Many sepsis survivors also face amputations and other chronic health complications that require supportive care and management beyond the initial sepsis event.

Article 2: Challenges and Unmet Needs

The clinical complexity of infection management including early recognition of severe complications, such as sepsis, require interventions to identify and mitigate severe outcomes, including products that could aid in the prevention, detection, prediction, treatment and management of infection and its complications. This situation is compounded by the regulatory complexity associated with infection management and sepsis-relevant products, especially those that are based on the host response to infection, and not the pathogen. There is a desire to understand regulatory paths for innovative new diagnostic and digital technologies and apply guidance in development.

Collaboration of diverse stakeholders involved at each stage of a patient’s journey through survivorship is critical to identify and pursue opportunities to address these unmet needs and improve innovation and equity in infection management and sepsis care. To bridge these gaps, Sepsis Alliance is establishing IMSCC in partnership with the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and with support from the Biomedical Advanced Research and Development Authority (BARDA).

IMSCC will provide a venue to enhance the understanding of diverse stakeholders’ perspectives by fostering communication and knowledge sharing, including engagement with the U.S. Department of Food and Drug Administration (FDA) to better align on regulatory requirements and science.

Article 3: Mission

Infection Management/Sepsis Collaborative Community (IMSCC) was established to accelerate the development, availability, and adoption of safe and effective medical devices, digital health, and other medical technologies to prevent, diagnose, manage infection, treat sepsis, and support sepsis patients and survivors.

Article 4: Vision

The vision of IMSCC is to be a sustainable and inclusive community of diverse stakeholders dedicated to accelerating innovation in the medical device ecosystem to achieve a world where no one is harmed by sepsis.

Article 5: Objectives

IMSCC seeks to:

• Harmonize and optimize sepsis-related definitions, guidelines, and/or (surrogate) outcomes measures;
• Address equity, diversity, and improve outcomes in underserved communities and vulnerable populations;
• Merge and harmonize sepsis-relevant data;
• Support innovation and regulatory science around infection management tools;
• Identify and address unmet clinical needs identified by patients, their family members, and sepsis survivors;
• Accelerate novel product development; and
• Additional initiatives as may be identified.

Specific priority areas include, but are not limited to:

• Early detection of infections
• Prediction of infection severity
• Patient stratification for improved clinical management
• Long-term or chronic sequelae
• Understanding the regulatory pathway for novel diagnostics and digital health technologies
• Improved clinical endpoints
• Understanding risk /benefit around novel diagnostic and device technologies
• Development and deployment of patient-centered tools to inform regulatory decision-making
• Development of standards to collect, integrate, and analyze real-world data
• Enhanced use of patient-centered tools including patient-reported outcomes (PROs) for regulatory consideration
• Use of real-world evidence (RWE) for decision-making by regulators and payors

Article 6: Membership Composition

Member organizations may include but are not limited to patient organizations, health professional organizations, research organizations, foundations, life science companies, product developers, payors, and U.S. Government agencies.

IMSCC is open to those working in the field who wish to join and are committed to innovation and the collaborative process to achieve common outcomes, solve shared challenges, and leverage collective opportunities. Members are expected to join teleconferences and in-person meetings and to provide input and feedback to inquiries from their colleagues and Sepsis Alliance staff. Members are free to leave IMSCC at any time. All members will comply with the Code of Conduct. A roster of members can be found on the IMSCC website here.

 Article 7: Meetings

IMSCC will hold general membership meetings on a quarterly basis. All IMSCC general membership meetings are open to observation (remotely) by the public. General membership meetings are intended to provide updates on recent activities and to coordinate the scope of collective efforts. An agenda will be developed and disseminated to all IMSCC members at least fourteen (14) calendar days in advance of the meeting to allow IMSCC members sufficient opportunity to ensure that their voting representative or a designated alternate is present for any discussion leading to a vote. All decisions made during general membership meetings are supported democratically through a simple majority vote with dispute adjudication exercised before the full IMSCC.

Article 8: Governance

The IMSCC governance structure is outlined below. Note that IMSCC is part of a larger entity, Sepsis Innovation Collaborative (SIC), an initiative of Sepsis Alliance.

Article 8.1: Convener

As the convening organization, Sepsis Alliance is responsible for coordinating and facilitating effective collaboration by:

• Providing administrative and operational support to IMSCC;
• Instituting and overseeing financial oversight of IMSCC-funded activities; and
• Promoting an open, diverse, and inclusive collaborative community.

Article 8.2: IMSCC Steering Committee

The IMSCC Steering Committee (Steering Committee) is the decision-making body of IMSCC, providing support, guidance, and oversight of progress towards the IMSCC mission and its objectives. The activities of IMSCC will initially be led by an interim Steering Committee selected by Sepsis Alliance and other stakeholders and in accordance with its Values and Guiding Principles. The interim Steering Committee shall serve until such time that the convening organization, in consultation with the interim Steering Committee and the membership, determine that a transition to a regular Steering Committee, duly elected in accordance with Article 8.2.5 of this Charter, is appropriate.

Article 8.2.1: Steering Committee Composition and Leadership

The Steering Committee is composed of volunteer members representing a diverse range of stakeholder organizations and perspectives including, but not limited to, sepsis survivors and family members, representatives of: patient organizations, provider and/or sub-specialty organizations, device manufacturers, digital health developers, regulators, health systems, and payers. The exact number and composition of the Steering Committee—with the exception of the two (2) seats reserved as described in the following paragraph—is not to be prescribed in this Charter but left to the discretion and determination of IMSCC with full and careful consideration of its Guiding Principles and the criteria set forth in the section of this Charter titled “Selection Criteria.”

A total of two (2) seats on the Steering Committee are reserved for the following:

• Sepsis Alliance—one (1) seat is reserved for a representative from Sepsis Alliance or their designee.
• Sepsis Survivor—one (1) seat is reserved for a sepsis survivor or surviving relative.

Each U.S. government agency, state agency, and/or international government agency participating in IMSCC is permitted one (1) permanent seat on the Steering Committee as a non-voting liaison. These seats are in addition to any regular seats on the Steering Committee and are not counted towards any maximum number as determined by IMSCC.

Leadership of the Steering Committee is the responsibility of the two (2) Co-Chairs, one of which will be the representative from Sepsis Alliance. The two Co-Chairs will work together to determine how their responsibilities will be divided.

Article 8.2.2: Steering Committee Responsibilities and Duties

Generally, the role of the Steering Committee is to provide support, guidance, and oversight of progress towards the IMSCC mission. Members of the Steering Committee do not implement projects themselves (unless as part of a working group). Rather, the Steering Committee focuses on the direction, scope, budget, timeline, and methods used by IMSCC to implement and deliver projects. It is the responsibility of the Steering Committee to:

1. Develop—in consultation with the Advisory Committee—and approve updates to the IMSCC action plan and any metrics used to evaluate the performance and effectiveness of IMSCC.
2. Consider issues identified by IMSCC members and evaluate and approve IMSCC member proposed projects.
3. Develop implementation and evaluation plans for approved projects.
4. Assign approved projects to the relevant working group(s) or create new working group(s) as needed.
5. Evaluate nominees and develop a slate of nominees for any vacancies on the IMSCC Steering Committee.

It is the responsibility of individual Steering Committee members to:

1. Have a broad understanding of project management issues.
2. Understand the aim, strategy, and intended outcomes of IMSCC projects.
3. Understand and be able to communicate the impact of IMSCC projects to their organizations, and act as a representative of IMSCC and secure input from their organization and larger communities on the work developed by IMSCC and its working groups.
4. Foster positive communication outside of IMSCC regarding projects’ progress and outcomes.
5. Actively promote the outputs of IMSCC projects.
6. Contribute to the evaluation of IMSCC projects, both the process of developing and implementing projects, and their actual impact on their intended audience(s).
7. Help balance conflicting priorities and resources.
8. Provide guidance to working groups and project staff.
9. Make every effort to attend 75% of Steering Committee meetings.
10. Participate in at least one IMSCC working group.
11. If requested to by one of the Steering Committee Co-Chairs (and able to perform in such a capacity) serve as a Chair or Co-Chair of an IMSCC working group.
12. Attend, at minimum, 75% of any working group meetings to which they have been appointed as a Chair or Co-Chair.
13. Respond, in a reasonably timely manner, to Sepsis Alliance staff requests for feedback, participation in working groups, and other IMSCC activities.
14. Agree to abide by all applicable SIC and IMSCC policies and procedures.

Article 8.2.3: Steering Committee Meetings

Regular meetings of the Steering Committee shall be held four (4) times per calendar year, in-person or remotely.

Special meetings, convened virtually, of the Steering Committee may be called at any time by the Steering Committee Co-Chairs. Notice of the time of each special meeting will be provided to each Steering Committee member at least fourteen (14) calendar days in advance of the meeting unless this requirement is waived by unanimous consent of the two (2) Co-Chairs.

Article 8.2.4: Steering Committee Estimated Time Commitment

The estimated time commitment to prepare for and attend Steering Committee meetings is four (4) hours per quarter on average.

In addition to Steering Committee meetings, it is expected and required that Steering Committee members respond, in a reasonably timely manner, to Sepsis Alliance staff requests for feedback. The time commitment to respond to such requests is estimated at approximately two (2) hours in total each month.

Article 8.2.5: Steering Committee Selection Process

Members are selected based on their individual knowledge and skills that they bring to the Steering Committee. Steering Committee members should be able and willing to make decisions that are in the best interests of IMSCC by promoting pre competitive collaboration. Steering Committee members’ first responsibility is to the achievement of IMSCC projects’ success, and secondly to their own respective stakeholder communities and/or organizations.

An open call for nominations to fill openings on the Steering Committee will go out to all members of IMSCC on August 1 of each year and remain open for a period of ten (10) business days. All IMSCC members, including current Steering Committee members, may put forward recommendations for Steering Committee members for approval. Each new Steering Committee nominee and each renominated incumbent Steering Committee member shall be evaluated or re-evaluated by the Steering Committee based on the selection criteria outlined in the following section. The Steering Committee shall have five (5) business days to evaluate and/or reevaluate nominees and develop a slate of nominees to fill any vacancies on the Steering Committee. The development of the slate of nominees shall be made based on the particular needs of IMSCC as determined by the Steering Committee—in consultation with the Advisory Committee—and take into careful consideration its mission, vision, objectives, priority areas, stakeholder needs, and the Values and Guiding Principles. The slate of nominees shall be shared electronically with IMSCC members, at which time IMSCC members shall have five (5) business days to either approve or reject the slate of nominees. A two-thirds (2/3) majority to approve the slate of nominees is required; any IMSCC member that does not explicitly approve or reject a slate of nominees advanced by the Steering Committee for consideration will be considered as a vote in the affirmative. In the event that the Steering Committee-approved slate of nominees fails to garner the necessary 2/3 majority approval, this process will be repeated.

Article 8.2.6: Steering Committee Selection Criteria

Nominees under consideration for appointment to the Steering Committee should at a minimum:

• Be an individual of the highest integrity and have an inquiring mind, a willingness to ask difficult questions, and the ability to work well with others.
• Commit to transparency regarding potential conflicts of interest that could violate an applicable law or regulation or interfere with the proper performance of the responsibilities of a Steering Committee member.
• Be willing and able to devote sufficient time to the affairs of IMSCC and be diligent in fulfilling the responsibilities of a Steering Committee member.
• Have the capacity and desire to represent the best interests of the stakeholders as a whole.
• Embody the Values and Guiding Principles in their professional and personal lives.

Article 8.2.7: Steering Committee Terms

Steering Committee members serve for a two (2) year term and may be nominated for one (1) additional term. Steering Committee members who serve two (2) consecutive terms must wait one (1) year before consideration as a nominee again.

Steering Committee members that represent either Sepsis Alliance or any U.S. federal, U.S. state, or international government agency are exempt from term duration and term limits so long as they remain employed by and have the approval of their respective organizations.

Article 8.2.8: Steering Committee Quorum

The Steering Committee will seek to reach decisions in a collaborative manner. A quorum is achieved if at least 50% of Steering Committee members are present. If the Steering Committee is voting to change this Charter or alter the composition of the Steering Committee, a minimum of 75% of Steering Committee members must be present to meet the quorum threshold for such votes with a 75% majority required to approve any action(s) to change this Charter or alter the composition of the Steering Committee.

Article 8.2.9: Steering Committee Resignations

Steering Committee members may resign at any time by providing written notice to one of the Steering Committee Co-Chairs.

Article 8.2.10: Steering Committee Vacancies

Vacancies on the Steering Committee will be filled using the selection process established in this Charter. Steering Committee members who fill a vacant seat will serve out the remainder of that term and will then be automatically nominated for consideration to serve an additional term.

Article 8.2.11: Steering Committee Conflicts of Interest

All members of the Steering Committee must comply with the Conflicts of Interest Policy. Disclosure statements are to be completed by all Steering Committee members once a year and are available upon request. If a new conflict of interest arises during the time between annual disclosures, it is the obligation of the Steering Committee member to provide an update to their conflicts of interest statement.

Article 8.3: Advisory Committee

The Advisory Committee augments the knowledge and skills of the Steering Committee in order to more effectively guide IMSCC.

Article 8.3.1: Advisory Committee Composition and Leadership

The exact number and composition of the Advisory Committee is not to be prescribed in this Charter but left to the discretion of the Steering Committee with full and careful consideration of its Guiding Principles and the needs of IMSCC. Leadership of the Advisory Committee is the responsibility of the two (2) Steering Committee Co-Chairs.

 Article 8.3.2: Advisory Committee Responsibilities and Duties

The Advisory Committee does not have formal authority to govern IMSCC; that is, the Advisory Committee cannot issue directives. Rather, it is the responsibility of all Advisory Committee members to (at the direction of the Steering Committee):

1. Make recommendations and/or provide key information and materials to the Steering Committee and Sepsis Alliance staff.
2. Provide a unique perspective on strategic and programmatic issues by focusing narrowly on specific issues and programs in order to advise and/or support IMSCC.
3. Review, monitor, assess, and/or evaluate the performance of specific projects.
4. Gather and provide feedback to the Steering Committee from the broader stakeholder community.
5. Provide technical expertise.
6. Serve as an independent and unbiased sounding board.
7. Enhance the public standing of IMSCC.
8. Respond, in a reasonably timely manner, to Sepsis Alliance staff requests for feedback, participation in working groups, and other IMSCC activities.
9. Agree to abide by all IMSCC policies and procedures.

 Article 8.3.3: Advisory Committee Meetings

The Advisory Committee does not meet for regular meetings. Special meetings, convened virtually, of the Advisory Committee may be called at any time by the Steering Committee Co-Chairs. Notice of the time of each special meeting will be provided to each Advisory Committee member at least fourteen (14) calendar days in advance of the meeting.

 Article 8.3.4: Advisory Committee Estimated Time Commitment

The estimated time commitment for Advisory Committee members is four (4) hours per quarter on average inclusive of responding to Sepsis Alliance staff requests for feedback.

Article 8.3.5: Advisory Committee Selection Process

Members of the Advisory Committee are appointed by the Steering Committee

The exact number and composition of the Advisory Committee is not to be prescribed in this Charter but left to the discretion of the Steering Committee with full and careful consideration of its Guiding Principles and the needs of IMSCC.

Article 8.3.6: Advisory Committee Selection Criteria

Nominees under consideration for appointment to the Advisory Committee should at a minimum:

• Be an individual of the highest integrity and have an inquiring mind, a willingness to ask difficult questions, and the ability to work well with others.
• Commit to transparency regarding potential conflicts of interest that could violate an applicable law or regulation or interfere with the proper performance of the responsibilities of an Advisory Committee member.
• Be willing and able to devote sufficient time to the affairs of IMSCC and be diligent in fulfilling the responsibilities of an Advisory Committee member.
• Have the capacity and desire to represent the best interests of the stakeholders as a whole.
• Embody the Values and Guiding Principles in their professional and personal lives.

Article 8.3.7: Advisory Committee Terms

Advisory Committee members serve for two (2) year terms and may be renewed, at the discretion of the Steering Committee, indefinitely.

Article 8.3.8: Advisory Committee Resignations

Advisory Committee members may resign at any time by providing written notice to one of the Steering Committee Co-Chairs.

 Article 8.4: Working Groups

To accomplish its mission in a collaborative manner, IMSCC may at any time establish through a simple majority vote any number of working groups. Working groups are standing entities of IMSCC and are not limited in term. Working groups may have multiple projects, tasks, or activities. Each working group will have two (2) Co-Chairs, determined by a simple majority vote of the working group and approved by the Steering Committee, with one (1) Co-Chair serving concurrently as a liaison to the Steering Committee. There are no term limits for working group Co-Chairs.

Article 8.5: Consequences for Non-Compliance by Convening Organization and Steering Committee

Article 9: Funding, Budget, and Fundraising

Support will be provided through financial and in-kind contributions from its members and other supporters and potentially through government partnerships, as appropriate. Funding may also be obtained through sponsorships of specific IMSCC events or activities. IMSCC may also accept funding from SIC for specific activities that advance the IMSCC mission. Funds will be maintained by Sepsis Alliance staff and will have access to and full responsibility for oversight, auditing, and review of any deposits and expenditures.

Sepsis Alliance sequesters all advocacy activities within a separate operating unit and all activities are tracked, reported, and partitioned from other operating units and business activities of Sepsis Alliance. Contributions made to Sepsis Alliance in furtherance of IMSCC goals are managed separately and are not used for advocacy activities. Sepsis Alliance’s advocacy activities comply with all federal lobbying laws and reporting requirements and are reviewed regularly by the Sepsis Alliance Board of Directors’ independent Advocacy Committee and Audit Committee.

Article 10: Communication and Transparency

Minutes will be taken at all meetings of the Steering Committee and working groups. Meeting summaries will be made publicly available on the IMSCC website. IMSCC will disseminate updates to all IMSCC members on the activities of the Steering Committee and working groups every other month (including any meeting minutes). IMSCC will also produce an annual report describing the activities of the prior year, planned future initiatives, and a financial statement. The Steering Committee and all working groups must provide a summary of the prior year’s activities to Sepsis Alliance staff by September 1 of each calendar year. The annual report will be made publicly available on the IMSCC website 30 days after the end of the fiscal year.

Article 11: Conflicts of Interest

All members of the Steering Committee and working groups must comply with the SIC Conflicts of Interest Policy. Disclosure statements are to be completed by all Steering Committee and working members once a year and are to be made available upon request by any SIC and IMSCC members. If a new conflict of interest arises during the time between annual disclosures, it is the obligation of the Steering Committee or working group member to provide an update to their Conflicts of Interest statement. The Steering Committee and working groups are responsible for determining, in consultation with Sepsis Alliance staff, whether a conflict exists and what mitigating steps will need to be taken.

Article 12: Code of Conduct

All members of IMSCC must comply with the SIC Code of Conduct at all times.