Terms of Reference: Scientific Advisory Board on Vaping Products

Preface

On November 22, 2016, the Government introduced Bill S-5, the proposed Tobacco and Vaping Products Act, which would create a new legislative framework to regulate the manufacture, sale, labelling and promotion of vaping products in Canada. Health Canada, in collaboration with the Canadian Institutes of Health Research, has established the Scientific Advisory Board on Vaping Products to review the scientific literature and provide recommendations on the vaping products framework as new scientific evidence on the health benefits and harms of these products becomes available.

These Terms of Reference were endorsed by members of the Scientific Advisory Board on Vaping Products on November 20, 2017.

1.0 Mandate

The mandate of the Scientific Advisory Board on Vaping Products is to monitor and analyze scientific evidence around the benefits and harms of vaping products and inform Health Canada as emerging evidence on this issue becomes available.

From the review of the emerging evidence, the scientific advisory board will assess the net public health impact of current federal approaches to regulating vaping products, and provide advice and recommendations to Health Canada officials on whether to further restrict or liberalize the regime established as part of the proposed Tobacco and Vaping Products Act.

The Scientific Advisory Board on Vaping Product's role is to provide advice and make recommendations to Health Canada. Health Canada has the responsibility and sole authority to make decisions with respect to the mandate of this advisory body.

2.0 Reporting structure/governance

The Scientific Advisory Board on Vaping Products operates under the Health Canada Policy on External Advisory Bodies. All elements of this policy apply to this advisory board.

Health Canada is represented by the Director General, Tobacco Control Directorate who is the Executive Secretary to the Scientific Advisory Board on Vaping Products.

3.0 Membership nomination process

Members of the Scientific Advisory Board on Vaping Products are recruited through a targeted nomination process, co-led by Health Canada and CIHR. The recruitment process will be guided by a set of compositional requirements, which will include a range of general criteria and an attempt to have broad representation across appropriate disciplinary, geographic, gender, and cultural dimensions (described further in section 3.1).

The goal of this process is to ensure that, together, advisory body members have a range of knowledge, expertise, and experience and reflect a variety of perspectives to promote diversity and inclusiveness in advisory body membership.

The Chair and advisory body members are appointed by the Executive Secretary. They are appointed at pleasure, and appointments may be ended without cause or consultation.

In considering who to appoint, the Executive Secretary may consult with:

  • staff at Health Canada and CIHR
  • other federal departments and agencies
  • provincial and territorial health authorities
  • external organizations, associations, academic or research-based institutions, or experts
  • the Chair and members of the advisory board
  • the public

3.1 Membership considerations

The Scientific Advisory Board on Vaping Products will have 8 to 12 members. The Executive Secretary, in consultation with the Chair, may adjust the number of members from time to time to ensure the appropriate range of knowledge, expertise, experience, and perspectives. This will be particularly relevant following the initial meeting of the Board where potential gaps in expertise among members will be discussed.

Exclusion from consideration for membership includes candidates with affiliations with the tobacco industry or vaping industry within the last 10 years. Past affiliation with the pharmaceutical, medical device or health product industries is subject to the disclosure of affiliation and interests described in section 3.2.

Membership includes, but is not limited to, the following areas of knowledge, expertise and experience:

  1. Scientific or technical knowledge and specialized expertise: see Table 1 for more detail.
  2. Excellence in their field: top researchers will be identified based on criteria such as publication record, contribution to major discoveries, and position as a leader or founder of a research centre, company, or other entity.
  3. Credibility: members would need to be perceived as an objective voice for the scientific evidence, without any demonstrated or perceived bias.
  4. Awards and distinctions: awards or distinctions (e.g., Canada Research Chairs, fellows of scientific academies) will be considered beneficial.
  5. Ability and experience: members should have demonstrated the ability to successfully contribute to similar processes or committees and be able to understand and work with competing perspectives on an issue with multiple dimensions. This may also include organizational experience representing people who share a point of view or interest.
  6. Breadth of experience: knowledge across more than one area of expertise as noted in Table 1 should be considered an asset.
  7. Practical experience: first hand clinical or personal experience (e.g., patient, consumer, or caregiver) will be considered an asset.
  8. Any other relevant background that will bring useful input to the advisory body and complement the knowledge, expertise, and experience of other members, including but not limited to, geographic, gender, and cultural diversity.

Membership should include, but is not limited to, people with the following backgrounds:

  • scientists, researchers, academics, and individuals with specialized expertise
  • health professionals, including those with practical and clinical experience
  • experts professionally recognized in their fields

Membership should include, but is not limited to, the following sectors/disciplines:

Biomedical / basic science (Number of experts: 2-3)
Specific area of expertise Justification
Medical device design, testing, and approval The committee could benefit from the expertise of a biomedical engineer and/or medical device designer familiar with medical and physiological design and testing of new devices as they are brought to market, including regulations and standards governing research, testing, clinical trials, and approval for use in humans.
Physiology / toxicology / pharmacology A biologist or clinician/scientist with an understanding of the physiological effects of nicotine and other chemicals present in tobacco and vaping products as well as differences that might relate to gender and/or human development. Clinical science relating to the effects of substances on the body (dynamics), the absorption, distribution, metabolic processes, and excretion of substances (kinetics), and the influence of genetic variation on toxicity/side effects (genomics) are all important.
Methodologist / infrastructure Expertise in conducting various pre-market safety and efficacy studies would help to identify promising research practices. Experts should have knowledge of conducting pre-clinical studies including in vitro (test tube) and in vivo (animal) testing; and clinical trials involving human subjects. It would be considered an asset if experts had knowledge of the infrastructure needed to conduct and coordinate multi-centre trials, as well as the development and maintenance of collaborative networks. This may also include experts working to maintain data repositories and sharing to facilitate study.
 
Clinical / individual-level benefits/harms (Number of experts: 3-5)
Specific area of expertise Justification
User perspectives Consumers, patients, caregivers, and those with practical experience or expertise in relevant consumer or patient issues could help identify important dynamics for the committee to consider and would support CIHR's commitment to patient-oriented research.
Addiction specialist/clinical medicine A practicing clinician with experience in treating addiction, prescribing and monitoring treatments, and working directly with patients and families will help to provide insight into the issues and challenges of substitution therapies. Clinicians should have academic connections and/or be affiliated with relevant hospitals / academic health centres (e.g., CAMH).
Cardiology and respiratory physiology An important category of potentially adverse effects of vaping is disruptions to normal heart and/or respiratory function. A cardiologist, respirologist, and/or cardiorespiratory expert would be valuable in assessing the current state of knowledge in these areas.
Pathology Pathologists, including medical examiners, forensic pathologists, and coroners, are particularly well suited to considering the available data on effects of vaping and are uniquely qualified to understand and contextualize data from cases involving deaths following exposure.
Neuroendocrine system The committee may also benefit from the expertise of an endocrinologist, specifically to examine any evidence of interaction of vaping products with hormonal and/or neurosecretory systems. Expertise in neurology and neuroscience are also directly relevant because of vaping interactions with brain and nervous system development.
Evidence-based medicine specialist Experts familiar with conducting systematic reviews and meta-analysis and applying those products in the context of clinical guidelines will strengthen this assessment.
 
Population and public health benefits/harms (Number of experts: 3-5)
Specific area of expertise Justification
Occupational and environmental health and safety The committee will need to assess factors that may directly and indirectly affect health, such as exposure to second-hand vaping "smoke". A member from a multidisciplinary field such as occupational or environmental health would provide a holistic perspective on the interaction between the hazards, environment (e.g., air quality), and human health.
Risk assessment, management, and communication Expertise is required in risk management - a field that considers assessment, communication, and response to risk. Members could consist of academic researchers (generalists and/or someone specific to public health) and/or practitioners. A statistician could also provide insight into quantitative risk assessment and risk communication effectiveness. Expertise in this area will also help to guide the committee in the assessment of a range of evidence types and help to reflect on the notion of risk and what kinds of risk are acceptable.
Epidemiology The panel will need to consider the connections between behaviour, population health, regulatory environments, and public policy. An expert in population health will ultimately contribute a better understanding of issues related to at-risk populations (e.g., indigenous populations, youth, etc.) and various social determinants of health (e.g., income status, education, etc.). They would also be able to speak to how the societal context (e.g., social norms and acceptance) influences our understanding of use, research, and interventions. Monitoring and surveillance expertise will also be important to understand patterns and trends in adverse reactions across different age, gender, socio-economic, and cultural groups. An individual in this area would also be an expert in risk analysis and management.

3.2 Affiliations and Interests

To be considered for appointment, potential members of the Scientific Advisory Board on Vaping Products are required to complete and return the Affiliations and Interests Declaration Form.

In keeping with the Privacy Act, a completed Affiliations and Interests Declaration Form is considered confidential. Health Canada will not make public any information in the form without the member's permission. However, as a condition of membership, members will allow Health Canada to publish, on its website and in print, a Summary of Expertise, Experience, and Affiliations and Interests, based on the completed declaration form.

In addition to publishing the summary, the Chair will also ask members to make a verbal statement of their relevant affiliations and interests at the beginning of an advisory body meeting.

Members must update their declaration in writing whenever their situation changes. Health Canada will review declarations before making appointments and on an ongoing basis, at least on an annual basis, as well as any time the advisory body mandate is changed. Affiliations and associations with the tobacco industry, vaping industry or pharmaceutical industry will exclude a member from serving on the Board.

Members are expected to conduct themselves in an appropriate manner. They may not use their position on an advisory body for their private gain or for the gain of any other person, company, or organization.

3.3 Confidentiality

To support their ability to provide well-informed advice, members of the Scientific Advisory Board on Vaping Products may receive confidential information. Everyone must sign a Confidentiality Agreement before participating in the Scientific Advisory Board on Vaping Products as a member, presenter, or observer.

The Confidentiality Agreement prohibits the disclosure of any confidential information received through participation in the advisory body, including information received orally or in writing, through email correspondence, telephone calls, print materials, meeting discussions, etc.

Health Canada will mark information according to the level to which it is protected under the Policy on Government Security.

The Chair will ensure that everyone participating in the meeting, telephone discussion, email exchange, or in another form of communication has received clear instructions on the confidentiality of the proceedings.

3.4 Security clearance

All members of the Scientific Advisory Board on Vaping Products are required to attain an appropriate security clearance. Health Canada provides the required forms to candidates for appointment.

3.5 Indemnification

All members serve on the Scientific Advisory Board on Vaping Products on a volunteer basis. Health Canada undertakes to provide its volunteer advisory body members with protection against civil liability provided the volunteer member acts in good faith, within the scope of their volunteer duties; and does not act against the interests of the Crown.

Members act collectively as an advisor to Health Canada with respect to the mandate of their advisory body but they are not final decision-makers. Health Canada has the ultimate responsibility and accountability for any decision resulting from the advice and recommendations received from the external advisory body.

3.6 Travel and expenses

Members will be reimbursed for expenses incurred on approved travel for the Scientific Advisory Board on Vaping Products, such as trip costs and accommodation, according to the Treasury Board's Directive on Travel, Hospitality, Conference and Event Expenditures.

3.7 Tenure

Members are appointed by the Executive Secretary for a period of three years, with the possibility of renewal. After 3 years, renewal will be staggered. Membership will be reviewed on a regular basis by the Executive Secretary in collaboration with the Chair to ensure a range of expertise, experience, and perspectives, continuity of membership on the advisory body, and a systematic rotation of membership.

3.8 Resignation process

It is preferable for a member to provide 14 days notice of the intent to resign. The resignation letter must be in writing and be addressed to the Executive Secretary and to the Chair of the Board. The letter should state the effective date of the resignation.

3.9 Reasons for termination

The Executive Secretary may end a member's appointment by writing to the member stating the reasons the appointment is being concluded and the effective date. Appointments may end for a variety of reasons: e.g., the member's term is complete; the mandate of the advisory body has been completed; the advisory body's mandate has changed, thus requiring a different membership, etc.

An appointment may also be ended for cause when, for example, a member fails to act according to the Terms of Reference, or breaks the Confidentiality Agreement, or repeated failure to participate in Board activities.

4.0 Roles and responsibilities

4.1 Members

Members of the Scientific Advisory Board on Vaping Products have a responsibility to give their best advice to Health Canada. To do so, they must consider all input received that is related to the mandate of the advisory body.

Other responsibilities include to:

  1. be available and prepared to participate in advisory body meetings, including Internet meetings, email exchanges, conference calls, and videoconferencing
  2. be available and prepared to attend a public input activity related to the advisory body's mandate, if requested
  3. participate in the discussions on the advisory body's recommendations, advice, or report to Health Canada
  4. notify the secretariat and the Chair of any changes in their affiliations and interests related to the advisory body's mandate during the time they are members of the advisory body
  5. make an oral statement of affiliations and interests at the beginning of a meeting, if requested to do so by the Chair
  6. direct any media inquiries to the secretariat and notify the secretariat about the inquiry
  7. attend a public consultation, if requested to do so by the executive secretary.

4.2 Chair

The Chair of the Scientific Advisory Board on Vaping Products has additional responsibilities, including to:

  1. provide input on the selection of advisory body members
  2. chair advisory body meetings
  3. invite members to make a presentation at a meeting, when relevant and appropriate
  4. facilitate a full and frank discussion among advisory body members in fulfillment of the advisory body's mandate, including in formulating its recommendations, advice, or report to Health Canada
  5. identify when information and discussions are considered confidential and clarify expectations regarding this protected information
  6. seek consensus on the advisory body advice among all advisory body members, and if there is not agreement, ensure that this diversity of opinion is noted in the meeting records or report
  7. ensure the preparation of the meeting records or report and the delivery of the advisory body's advice to Health Canada
  8. act as the media spokesperson for the advisory body
  9. support, in any other way, the fulfillment of the advisory body's mandate.

4.3 Secretariat

The secretariat of the Scientific Advisory Board on Vaping Products is managed by Health Canada and includes representatives from Health Canada and CIHR. The secretariat is the administrative liaison between advisory body members and Health Canada and is a resource for members.

The secretariat provides leadership and strategic advice in the management of the advisory body and works closely with the Chair and the Executive Secretary. In addition, the responsibilities of the secretariat include to:

  1. coordinate the member appointment process
  2. coordinate the preparation of materials for advisory body members and meetings, observers, and others, and coordinate the timing of their distribution
  3. assist with the work of the advisory body, as required
  4. provide administrative support to advisory body members
  5. support public access to information about the advisory body, as appropriate
  6. act as a liaison between Health Canada and the advisory body
  7. assist the Chair in carrying out the Chair's responsibilities
  8. carry out any additional duties as appropriate to support the advisory body, including a risk assessment and mitigation strategies for members who volunteer on an advisory body
  9. undertake any tasks delegated to it by the Executive Secretary
  10. report to the Executive Secretary on the activities of the advisory body
  11. assist with a review or audit of the advisory body

4.4 Executive Secretary

The advisory body's Executive Secretary makes decisions about the administration and operation of the advisory body. The Executive Secretary works closely with the Chair and secretariat.

The Executive Secretary, or a delegate, reports back to the advisory body at the beginning of each meeting on next steps and, if applicable, the impact of the advice received.

4.5 Media and communications

The Chair will act as the media spokesperson for the advisory board. In the event the Chair is unavailable to speak to the media, the Executive Secretary, in consultation with the Chair, will appoint a member to be the spokesperson to speak to the media on behalf of the advisory body.

A member may discuss advisory body work with the media or at conferences or other external events only with prior permission from the Executive Secretary.

All media requests related to the advisory body's statements or activities will be directed to Media Relations, Health Canada, who will coordinate responses with the Executive Secretary and the designated media spokesperson.

5.0 Management and Administration

5.1 Transparency

Transparency of the Scientific Advisory Board on Vaping Products is served by:

  • ensuring that meeting schedules are predictable, where possible
  • posting advisory body materials on Health Canada's website. These materials include the following:
    • Terms of Reference
    • Membership list and biographies
    • Meeting agendas
    • Meeting highlights

5.2 Meeting agendas

The Executive Secretary, in consultation with the Chair and with input from the members, sets the meeting agenda, including identifying questions and issues for discussion. Members may be canvassed for relevant agenda items at least five weeks before regularly scheduled meetings.

5.3 Meeting notice and invitations

All meetings are scheduled at the call of the Executive Secretary or secretariat, in consultation with the Chair. Meetings may be limited to advisory body members only or may be opened to presenters and observers by invitation.

The secretariat sends out the invitations to attend a meeting.

Members generally receive the agenda and briefing material two weeks in advance and presentations two days before a meeting.

5.4 Frequency, type, and location of meetings

Meetings will be held two times a year. Additional meetings or teleconferences may be held on an as-needed basis at the discretion of the Executive Secretary, in consultation with the Chair.

For teleconferences and other similar meetings, members must make every effort to ensure that a secure line is used and that no one else can listen to the proceedings unless the person has been previously approved by the Chair and secretariat.

5.5 Observers

The secretariat, or the Chair in consultation with the Executive Secretary, may allow individuals, organizations, or members of the general public to observe a meeting or part of a meeting. Observers may not provide input on agenda items or participate in the discussions, unless specifically invited to do so by the Chair.

As part of the opening remarks at an advisory body meeting, the Chair will:

  • identify, by name and organization, the people attending all or part of the meeting as observers
  • confirm with the secretariat that the observers have signed the Confidentiality Agreement and met Reliability Check standards, if required
  • state the requirements and expectations regarding any confidential matters being discussed at the meeting
  • clarify that observers may not participate in the discussions, either by speaking or by otherwise expressing their support for or disagreement with what is being said, unless specifically invited to do so by the Chair (the Chair may ask observers who do not respect these rules to leave the meeting)

5.6 Invited presenters

The secretariat, or the Chair in consultation with the Executive Secretary, may invite individuals with particular expertise or experience to provide input on a specific topic or agenda item. Invited guests may participate in the discussions if the Chair specifically invites them to do so, but they do not participate in the formulation of advice.

5.7 Requirements of presenters and observers

Presenters and observers may be required to complete:

  • Declaration of Affiliations and Interest Form
  • Confidentiality Agreement
  • Personnel Screening, Consent and Authorization Form

5.8 Public input

If Health Canada decides to seek broad public input on a topic related to the mandate of the advisory body, the Executive Secretary will consult with the Chair on the process to be used and the organization of the public input activity.

5.9 Deliberations and reports

Advice from the Scientific Advisory Board on Vaping Products will be provided to Health Canada officials in the form of minutes, with formal report and recommendations as needed.

The Scientific Advisory Board on Vaping Products is encouraged to reach a consensus in providing advice whenever possible. When a consensus is not possible, the meeting record will reflect the diversity of opinions.

The Scientific Advisory Board on Vaping Products must have quorum when making recommendations or providing advice to Health Canada. Quorum is one half of the members plus one.

Minutes and/or formal reports will summarize the proceedings to effectively reflect the advice and recommendations offered. Remarks are not attributed to individuals in the minutes or records of proceedings.

Minutes and/or formal reports will be prepared by the secretariat and circulated to members for review and confirmation.

Meeting highlights and/or formal reports may be posted on Health Canada's website.

5.10 Review

A review will be conducted every three years to determine whether administrative, management, or other improvements are required to increase the efficiency and effectiveness of the Scientific Advisory Board on Vaping Products. A review may also be carried out to determine the ongoing relevance of the advisory body's mandate and to inform disbanding or renewal decisions.

During the review process, feedback may be sought from the advisory body's chair, members, participants, observers, and others.

The review may be conducted by officials from CIHR and Health Canada, or by consultants managed by these groups. The Review Report will be submitted to the Executive Secretary, who may then authorize its distribution to advisory body members.

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