DSEN Primer on Managing Researchers’ Conflict of Interest

This document is intended to serve as a reference tool and to provide basic information to assist DSEN funded researchers as they give consideration to their team’s management of Conflict of Interest (COI) and need to declare to CIHR any real or perceived COI which may affect or appears to influence the independence of DSEN research. This document describes actions DSEN researchers should consider undertaking to assist the DSEN Coordinating Office (DSEN CO) in implementing principles of transparency. The document also gives answers to frequently asked questions.

Table of contents

Introduction

In Canada and worldwide, more information is needed on the safety and effectiveness of pharmaceuticals when used by diverse patient populations outside the controlled experimental environment of clinical trials. The Canadian Institutes of Health Research and Health Canada have partnered to establish and expand the Drug Safety and Effectiveness Network (DSEN) to increase:

  1. the evidence on drug safety and effectiveness available to regulators, policy-makers, health care providers and patients, and
  2. the capacity within Canada to undertake high-quality post-market research in this area.

DSEN research is conducted at arm’s length from the regulator and is independent from the regulated (i.e. pharmaceutical industry). DSEN is designed to function autonomously while supporting unconflicted and independent research that is expected to be carried out with impartiality.

Application / scope

The DSEN funded research teams are expected to grow over time and researchers joining existing teams are required to abide by principles outlined in this primer document that apply to anyone involved in DSEN funded research. Such persons include, but are not limited to, Nominated Principal Investigators (NPIs), Principal Investigators, Co-Investigators, collaborators, students, trainees, research staff, as well as any independent individuals performing work for a DSEN funded team through independent contracts or agreements between the two parties and of which CIHR may not be aware.

Definitions

Generally speaking, a person is in a conflict of interest (COI) when she/he exercises an official power, duty or function that provides an opportunity to further his or her private interests or those of his or her relatives or friends or to further another party’s commercial interests. DSEN funded researchers may have had, or potentially face, a conflict when their duties for DSEN could be seen as conflicting with their other professional or private interests or those of their family, friends, or business associates.

A material COI is one which, in the circumstances, could reasonably be expected to affect the independence or impartiality of the person with the interest. Determination of materiality is contextual. In the context of DSEN, persons with a current or recent material interest stemming from contextually relevant industries are considered to be in COI. Factors including the following increase the risk that a COI is material:

  1. Potential for professional or personal benefit; 
  2. Professional or personal proximity to the issues under consideration by DSEN funded researchers; and
  3. Direct or indirect financial interest in the outcomes of decisions taken upon the results of research performed.

It is impossible to list all situations where a conflict may arise and therefore, in case of any doubt, it is best to disclose immediately and recuse oneself from the conflicting situation, in accordance with the principles set out in this primer document. Examples of types of interests in which a person may have engaged in during the last five years that could give rise to a potential or actual COI, include but are not limited to:

  1. Grants/Research Project Funding/Awards in respect of the duties and responsibilities of the role in DSEN research involves any receipt of or pending application for funding from pharmaceutical industry,
  2. Stock shareholder of a contextually relevant industry,
  3. Substantive consulting fees received from a contextually relevant industry (i.e. pharmaceutical)
  4. Other (Receipt of Intellectual Property rights/Patent Holder, Salary, Speaker’s honoraria),and
  5. Other special interests.

DSEN funding agreement

DSEN Funding Agreements stipulate that the NPI should adopt and implement a Code of Conduct to adequately manage any real or perceived COI with respect to use of the grants provided under this agreement. DSEN thus expects all the DSEN teams to develop their COI principles in accordance with CIHR, Tri-council, and their respective research institution’s policies on ethical research conduct and COI management. DSEN also anticipates that team members (existing and new) involved in DSEN research abide by these principles and that the NPI oversees these practices within his or her DSEN team. In addition, DSEN is mandated to be at arm’s length from industry for any specific research project.

The funding agreement also specifies that if the NPI becomes aware that there is a real or perceived material conflict between the team’s participation in DSEN-funded research and the personal interest of a member, she/he should immediately disclose it to the Executive Director of DSEN in writing. If the NPI is uncertain as to whether a COI exists, or as to how to deal with one, she/he should consult the Executive Director of DSEN. The NPI should also ensure that team members do not assist persons, organizations, or commercial entities in their dealings where this would result in preferential treatment to the persons or organizations; and do not take advantage of, or benefit materially from information that is obtained in the course of their participation in DSEN activities.

Disclosure

DSEN researchers are asked to remain free of any real or apparent COI while working on DSEN Queries. If it is not possible to avoid a COI, then it should be disclosed and appropriate steps to minimize or manage the conflict should be taken.

All real or perceived conflict in the context of DSEN must be disclosed to the DSEN Executive Director. Also, any question regarding a potential COI is recommended to be directed to the DSEN Executive Director through the NPI. Researchers should disclose additional information they may have in their possession that might influence the outcomes of DSEN Query investigation. Those required to disclose COI (researchers, trainees, etc.) are accountable for their required action.

Confidentiality

All documents and information related to DSEN activities are considered confidential and for application to DSEN business only, unless the information is publicly available.

Reference

Frequently Asked Questions

  1. Will DSEN accept research funding or co-funding from Drug Companies?

    No. DSEN research is independent of the pharmaceutical industry and funded entirely by the federal government through CIHR.

  2. Do the shared funding agreement that’s CIHR has with pharmaceutical manufacturers extend to DSEN?

    No. DSEN is not included in CIHR shared funding or other agreements with the pharmaceutical industry. CIHR partners with certain pharmaceutical companies and their industry association; Canada's Research-Based Pharmaceutical Companies (Rx&D) to support specific research projects that have been evaluated as “excellent” through a rigorous, independent peer review process. However, such partnerships with pharmaceutical industry partners including and not limited to Rx&D, BIOTECanada, and the Canadian Generic Pharmaceutical Association (CGPA) are not possible for DSEN-funded research.

  3. Can industry participate in DSEN’s activities?

    CIHR and Canada's Research-Based Pharmaceutical Companies (Rx&D) have a formal relationship covering industry-CIHR partnership in research funding. The CIHR/Rx&D Program focuses the strengths of both organizations to optimize the impact of health research, spanning the often complex and always challenging developmental path from bench to bedside. DSEN is not part of this agreement. The pharmaceutical industry including and not limited to Rx&D, BIOTECanada, and the Canadian Generic Pharmaceutical Association (CGPA) is welcome to participate in DSEN’s scientific activities but not in funding its research and under the condition that it adheres to DSEN transparency principles. DSEN and industry maintain arm’s length interactions and do not co-fund any DSEN’s research or related activities.

  4. How will DSEN ensure that results of funded research projects are made public?

    • The DSEN Coordinating Office (CO) acts as a Knowledge Translation (KT) hub for the linkage and dissemination of information and results between different stakeholders and decision makers.

    • DSEN brings knowledge creators and knowledge users together to ensure that DSEN research addresses identified information gaps and that the results are disseminated to relevant user groups, policy makers, etc. through regular interactions amongst the Steering Committee.

    • DSEN CO holds annual KT forums to disseminate research results.

    • Research results and publications lever existing KT channels.

    • Research Centres are expected to contribute to the development of new KT tools.

    • CIHR-funded researchers are required to adhere with Tri-Agency Open Access Policy on Publications and make their peer-reviewed publications accessible within 12 months of publication.

  5. After receiving funds from DSEN and in the event that the team invites or contracts an external research professional to work on a DSEN Query, what is the procedure to insure that they abide by CIHR and DSEN COI guidelines?

    The NPI is responsible to challenge any investigator, student, etc. that participates in DSEN funded research regarding Conflict of Interest as outlined in the DSEN Primer document (available on CIHR website) for managing Conflict of Interest. It is advisable to distribute this Primer to all participating researchers and review potential conflicts on a regular basis.

  6. Is it a real COI situation if a DSEN NPI or PI accepts a position with pharmaceutical industry while on a sabbatical leave from his or her research institution?

    Yes. During this time, and for 5 years following this relationship with industry, the researcher will be in a material conflict of interest.

  7. What is public and what is confidential in DSEN business?

    DSEN operates in a highly transparent fashion. DSEN envisions that only patient level info will be maintained in confidence. Otherwise, its prioritized research agenda and study results will be publicly available as prescribed or otherwise determined by the Government of Canada Policy on Communications or Access to information and will be posted on CIHR website.

  8. What is the definition of Conflict of Interest in the context of DSEN?

    In the context of DSEN, persons with material interest stemming from contextually relevant industries either currently or in the past 5 years are considered to be in conflict of interest. It is impossible to list all situations where a conflict may arise, factors including the following increase the risk that a conflict of interest is material:

    1. Potential for professional or personal benefit; 

    2. Professional or personal proximity to the issues under consideration by DSEN funded researchers; and

    3. Direct or indirect financial interest in the outcomes of decisions taken upon the results of research performed by the interested party.

  9.  Who has responsibility to verify that a researcher funded by the DSEN is not in a position of conflict of interest, either real or perceived - the NPI, the researcher him/herself, or the DSEN CO? (e.g. to verify that the DSEN-funded researcher is not simultaneously funded by industry or additional, conflicting CIHR funds, such as to create a real or perceived COI)

    The NPI of the grant and if he or she requests determination, the DSEN Executive Director is available to clarify and assist the NPI in making this determination.

  10.  What information relevant to COI must be provided by the researchers, and to whom?

    It is strongly recommended that DSEN funded NPIs discuss the concepts of Conflict of Interest in the context of DSEN with all participating researchers, students, etc. as outlined in the Primer document on managing researchers’ Conflict of Interest (available on CIHR website).

  11. Is there a formal and/or standard process in place to assess information provided by DSEN researchers relevant to COI and, if not, how is this information assessed?

    The principals addressed in DSEN’s Primer on managing research Conflict of Interest (COI) (available on CIHR website) should be reviewed and disseminated by the NPI of DSEN grants. Referral of uncertain instances of COI to the DSEN Executive Director will assist in resolution of COI concerns on the part of the NPI.

  12.  What actions are taken in the event that a COI is identified, and by whom? Is there a standard process in place to transparently manage conflicts of interest, real or perceived?

    The process is disclosure to the DSEN Executive Director at the earliest time that a Conflict of Interest is determined. The materially conflicted participant must withdraw from the research. The continuation of the research project will be assessed by DSEN, possibly in consultation with the DSEN Steering Committee (DSEN SC).

Acronym List

Acronym Meaning
CGPA Canadian Generic Pharmaceutical Association
CIHR Canadian Institutes of Health Research
COI Conflict of Interest
DSEN Drug Safety and Effectiveness Network
DSEN CO Drug Safety and Effectiveness Network Coordination Office
DSEN SC Drug Safety and Effectiveness Network Steering Committee
KT Knowledge Translation
NPI Nominated Principal Investigator
PI Principal Investigator
Rx&D Canada's Research-Based Pharmaceutical Companies
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