World Health Organization 13 September, 2018 WHO Training Manual Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care Learning Objective 7.3 Explain the potential conflicts of interest of health care workers participating in emergency research activities L.O. XX Title

Outline Key definitions and concepts Problem solving tools and the model for the ethical management of conflicts Case study Discussion Wrap up Suggested time 0-15 (15 min) 16-25 (10 min) 26-55 (30 min) 56-85 86-90 (5 min) Activity Introduction Presentation problem-solving tools Case study and discussion, phase 1 Case study and discussion, phases 2 and 3 Summary and conclusion L.O. XX Title

Definition: Conflict of Interest A situation in which a person has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties as, say, a public official, an employee, or a professional. (MacDonald, McDonald and Norman 2002) Any factor that might tend to undermine a competent researcher’s ability to make scientifically reliable judgments concerning research strategy, evidence or conclusions. (Davis 1999) A set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest. (Institute of Medicine 2009) There are many definitions of COI used in the academic literature and which can apply to a diversity of professional or institutional contexts. For example, in a business or public sector context, a COI can be defined as “a situation in which a person has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties as, say, a public official, an employee, or a professional” (MacDonald, McDonald and Norman 2002). While this definition is clear, it does not give details that would be of specific use to researchers or healthcare workers in public health settings. Also, it does not speak to the risk involved in the COI situation, which can include bias in research methods, harm to participants, or threat to the reputation of an organisation, institution or to the research enterprise as a whole. A definition more directly applicable to the research context is “any factor that might tend to undermine a competent researcher’s ability to make scientifically reliable judgments concerning research strategy, evidence or conclusions.” (Davis 1999) Finally, to bring in the professional component of judgment, COI can be defined as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.” (Institute of Medicine 2009)

Financial Interests Recruiting patients Stock options Research grants

Non-financial Interests “If there’s no money, there’s no conflict…” Tendency to focus on what’s measurable ($$$) Non-financial interests often ignored completely Given much less attention in policies Not considered very harmful Less problematic than financial interests Recognizing these threatens professional identity Objectivity, neutrality, independence Non-financial interests can be especially problematic, because they are less recognized and less understood.

Determining the workforce costs of the AIDS epidemic Case Study Determining the workforce costs of the AIDS epidemic Hint: Use the facilitator’s discussion guide to lead the discussion

Managing COI in Practice Being in a COI is not unethical …the issue is how to handle it. Guidance: Identify COI, avoid when possible Discuss with all concerned Remove person from sensitive decisions Sometimes 1 and 3 are impossible. So 2 (transparency & dialogue) becomes crucial.

A Model for Ethical COI Management in Public Health Identifying the actors Where in the world are the COI? They’re “in the researcher” and “in the research setting” Phase 1 The Context What is and What if? Phase 2 Take Home Messages What can we do better in the future? Phase 3

A Model for Ethical COI Management in Public Health Educational PHASE Know what a COI is and appropriate policies Financial or non-financial? What policies are you subject to? PHASE 1 Know yourself, the actors and evaluate the risk Where in the world are the COI? They’re “in the researcher” and “in the research setting” Who’s involved, what are their/your interests? Is there a problematic COI situation (actual/potential; financial/non-financial)? PHASE 2 Know the context and how to manage it What is? and What if? What are the benefits/risks of different resolution strategies? Identification What is a COI? Is there a COI, and if so, what sort? Financial or non-financial?   Evaluation Who’s involved in the situation? What are the risks of the COI, and for whom? Management What are the possible management strategies, and who should be involved? What are the risks and benefits of different resolution mechanisms? Reflection What can we learn from this experience: what worked and what did not? What policies or procedures could be implemented or enhanced to avoid or manage similar situations in the future? How can the situation contribute to enriching a COI definition in the context of emergency research and education? PHASE 3 “Take Home Messages” What can we do better in the future: As a team - for future education and practice In terms of practice - to inform policy makers.

Summary Beyond a pejorative view of “conflict of interest” Attention to non-financial and institutional COI Recognise some COI are endemic, unavoidable Be proactive and systematic: “Better prevent than cure” Use & limits of policies, procedures, guidelines Self-awareness, humility Discuss integrity & ethical conduct

Sources MacDonald, C.; McDonald, M.; Norman, W. 2002. “Charitable Conflicts of Interest” Journal of Business Ethics 39(1): 67-74. Davis, M. 1999. Ethics and the University (London, UK: Routledge) Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Edited by B. Lo and M.J. Field, Washington, D.C.: Institute of Medicine Committee on Conflict of Interest in Medical Research, Education, and Practice, National Academies Press, 2009. http://www.nap.edu/catalog.php?record_id=12598

Chapter authors Acknowledgements Potvin, Marie-Josée, Reproductive Ethics Research Group, School of Public Health, Université de Montréal, Montréal, Québec, Canada Williams-Jones, Bryn, Department of Social and Preventive Medicine, School of Public Health, Université de Montréal, Montréal, Québec, Canada L.O. XX Title