1.0 Purpose of the Guidelines
1.1 These Conflict of Interest (COI) Guidelines are intended to ensure the highest ethical standards and maintenance of the integrity of the research undertaken by and/or sponsored by CADTH. The principles of transparency and disclosure are essential to achieving these objectives. By disclosing relevant personal, occupational, or financial connections or interests with a Party (defined in section 2.3), Participants in CADTH activities will ensure that conflicts of interest are identified and resolved, thereby preserving the objectivity and credibility of CADTH programs and processes.
2.0 Definitions
In these COI Guidelines:
2.1 'HTA agency' means, unless otherwise stated, a not-for-profit organization that evaluates health technologies, including drugs, for the betterment of health outcomes. The agency can reside in any country in the world.
2.2 “Participant” means, unless otherwise stated, contractors, reviewers, patient representatives, committee members, panel members, and any experts and consultants retained to assist in CADTH activities.
2.3 “Party” means a drug or health technology manufacturer (including such manufacturer’s parent corporation, subsidiaries, affiliates, and associated corporations).
2.4 “Project” means the CADTH activity in which the Participant is, or will be, engaged.
2.5 “CADTH Scientific Advice Program” means a voluntary, fee-for-service consultation for pharmaceutical companies. Through this Program, CADTH offers advice on early drug development plans from a health technology assessment perspective.
3.0 Applicability
3.1 These COI Guidelines apply to all Participants.
Scope of Conflict of Interest
4.1 A COI refers to situations in which personal, occupational, or financial considerations, either direct or indirect, may affect, or appear to affect, the objectivity or fairness of Participants in a CADTH Project. A COImay be real, potential or perceived in nature.
4.2 A real COI arises where a Participant in the CADTH Project has a financial or other personal interest with a Party that may compromise, or have the appearance of compromising, their work on the Project (for example, a close family connection such as a spouse or child, or financial interest, with a Party).
4.3 A potential COI incorporates the concept of foreseeability; i.e., when a Participant in the CADTH Project can foresee that a private or personal interest may someday be sufficient to influence their work on the Project, but has not yet influenced their work (for example, an identified future commitment with a Party).
4.4 A perceived (or apparent) COI may exist when there is a reasonable apprehension, which a reasonably well-informed person could reasonably have, that a Participant has a COI, even if, in fact, there is neither a real nor a potential conflict.
5.0 Disclosures
5.1 Before a Participant undertakes any Project on behalf of CADTH, the Participant must disclose any COI, as described in section 4.0, by completing and submitting a Conflict of Interest Disclosure Form in the form and manner prescribed by CADTH.
5.2 All Participants must complete the COI Disclosure Form annually. However, the obligation to disclose is ongoing and Participants must inform CADTH of any COI that arises during the period of their engagement with CADTH as soon as it is known to them.
5.3 Schedule 1 Disclosures
5.3.1 Without limiting the generality of the foregoing, Participants are required to disclose to CADTH all interests or activities that occurred during the past two (2) years in which they, their immediate family members, or the department or organization for which they have managerial responsibility, benefited. Information shared may pertain to:
- receipt of gifts from a Party
- receipt from a Party of funding for, or payment of, travel
- receipt of funding or honoraria from a Party for speaking engagements
- receipt of funding or honoraria from a Party for giving educational lectures
- receipt of funding or honoraria from a Party for organizing conferences
- receipt of funding or honoraria from a Party for writing articles or editorials
- receipt of any other financial support or honoraria from a Party.
5.4 Schedule 2 Disclosures
5.4.1 Without limiting the generality of the foregoing, Participants are required to disclose to CADTH all interests or activities that occurred during the past five (5) years in which they, their immediate family members, or the department or organization for which they have managerial responsibility, benefited. Information shared may pertain to:
- employment with a Party
- receipt of payment as an advisor or consultant for a Party
- receipt of funding or honoraria from a Party for research grants
- receipt of payment from a Party for academic appointments (including endowed chairs)
- receipt of funding or honoraria from a Party for personal education.
5.4.2 Participants are required to disclose all of their stocks or stock options (related to a Party) totalling more than $10,000 (excluding mutual funds).
5.5 Schedule 3 Disclosures
5.5.1 In addition to Disclosures made under sections 5.3 and 5.4, Participants are required to disclose to CADTH any other activities or interests that affect or appear to affect the Participant’s objectivity or fairness.
5.5.2 Participants are required to disclose all potential or pending future commitments with a Party. The information to be disclosed relates to all interests and activities as described in Schedule 1 and Schedule 2 Disclosures outlined in sections 5.3 and 5.4.
5.6 Schedule 4 Disclosures
5.6.1 Participants are also required to disclose any activity with the CADTH Scientific Advice Program or any similar international programs. This disclosure is required for any work that CADTH may perform in the future related to drugs that have received advice from these programs. This disclosure includes all past, potential and/or pending future commitments.
6.0 COI Resolution
6.1 The CADTH executive have the authority to determine if the circumstances or interests of a Participant amount to a COI with respect to work being undertaken by CADTH.
6.2 The CADTH executive have the authority to remove a Participant from the Project when it is deemed that the COI(s) impede the Participant’s objectivity (real or perceived) on the Project.
7.0 Confidentiality of Conflict of Interest Declarations
7.1 Unless the Participant has been advised of, and agreed in advance to, a planned exception to this policy, the content of each completed Conflict of Interest Disclosure Form, and the declaration of conflicts disclosed to CADTH, shall remain confidential to:
- the CADTH executive or their designates
- the Chair of the CADTH Board
- members of CADTH Committees and Panels.
7.1.1 If the Participant has contributed expertise or acted in an authorship role to a CADTH publication, a summary of the Participant’s COI declaration may be included in that publication. The Participant will be advised in advance of CADTH’s intention to publish this information.
8.0 Amendment to the COI Guidelines
After appropriate consultation, the COI Guidelines may be amended at any time by CADTH.
I have read and understood the Conflict of Interest (COI) Guidelines and I agree to be bound by the obligations contained therein. I understand that it is my responsibility to report to CADTH any real, potential, or perceived conflicts of interest as defined in the CADTH COI Guidelines, and to disclose the information requested in the COI Guidelines.
I understand that this information may be shared with:
- the CADTH executive or their designates
- the Chair of the CADTH Board
- members of CADTH Committees and Panels.
I also understand that the information disclosed will not be made public unless otherwise agreed to (see section 7.0), and will be retained on file by CADTH.
I have reviewed my activities and interests as they relate to the matters itemized in the Disclosures section (section 5.0) of the COI Guidelines. Attached in Schedules 1, 2, 3, and 4 is a list of those activities and interests.
I hereby certify that I have disclosed all relevant information, with respect to any matter involving a Party, that may place me in a real, potential, or perceived COI situation. Except as otherwise disclosed in Schedules 1, 2, 3, and 4 attached, I declare that I have no COIto report, as defined in the COI Guidelines.
I promise to inform CADTH of any change in circumstances that may create a COI as soon as it is known to me.
