Ethical Issues in Global Health Research Royal Institute of Health Sciences Thimphu, Bhutan Aug 13, 2013 Kaveh Khoshnood, PhD Associate Professor Yale School of Public Health Royal Institute of Health Sciences Thimphu, Bhutan Aug 13, 2013 Kaveh Khoshnood, PhD Associate Professor Yale School of Public Health

My Journey in Global Health I - Places Iran U.S. China, Russia, several African countries, Mexico, Middle East II – Projects Volunteer with U.S based NGO working on HIV/AIDS as a MPH student Activist project to reduce HIV/AIDS among drug injectors in New Haven, CT, USA via syringe exchange program HIV/AIDS and TB related epidemiological and prevention research New interest in prevention of violent conflict research III – People Inspired by brave young people responding to urgent public health issues despite significant challenges

How Did I Get Interested in Research Ethics? 1.HIV/AIDS Prevention Researcher 2-Director of Global Health Internships and Fellowships for students at Yale University

What I Have Learned about Research Ethics 1.Ethical considerations raise important questions about the core purpose of research 1.Ethical and methodological aspects of a research study are inextricably linked 1.Ethical analysis an essential component of the research process, goes beyond following IRB rules and requires: –moral reasoning and interpretation of ethical principles and regulation. –paying close attention to the contextual factors

What Are Ethical Principles?

“Universal” Guiding Principles for Ethical Conduct of Research 1.Respect for persons (ensuring voluntary & informed consent) 2. Beneficence/non-maleficence (do good, minimize harm) 3. {Distributive} Justice (fair distribution of benefits & risks)

Golden Rule “Do not impose on others what you do not wish for yourself.” Confucius

Some Fundamental Questions about Research 1.What is the core purpose of research? 2.What are the benefits of research and who benefits? 3.What are the obligations of researchers and to whom ?

Definiti on of Research in U.S. Regulation “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” [45 CFR (d)… What’s missing ?

What are the benefits of research and who benefits? “ Medical” research seldom results in improvements in health and saving lives in poor countries

“Translating” Research into Improved Standards of Care and Public Health Practice Rich Countries – more likely to occur due to availability of: –Infrastructure / functioning health systems –Funds –Expertise Poor Countries – Seldom happens (esp. for poor subpopulations within these countries) due to: –Shortage of all of the above

What are the obligations of researchers and to whom ?

Researchers Obligation? To conduct the most rigorous research in order “to develop or contribute to generalizable knowledge” (standard expectation of funders, employers {academic institutions} and IRBs)

Is that good enough?

“We’re good enough to study but not good enough to care for” Haitian Woman with AIDS

A Higher Duty for Researchers? to reduce global inequities and to alleviate suffering Consistent with ethical guidelines (Helsinki, CIOMS, etc.) stating that “research should be responsive to the needs of the host country”

Context of Research Matters

Scientific Research in Context (1) Science is not value free 90% of medical research funds is spent on 10% global burden of disease Research often occurs in context of poverty, marginalization, human rights violations and lack of adequate social and health services

Scientific Research in Context (2) Research and researchers’ interests can outweigh interests of subjects and communities Acquiring new knowledge is often valued more than applying existing knowledge

Is Knowing ethical Principles Enough?

Need for Ethical Analysis Ethical analysis goes beyond knowing ethical principles and following IRB rules It requires moral reasoning and interpretation of ethical principles and regulation

“If research is regarded as the ‘brain’ of global health, then ethics serves as its conscience” - Zulfiqar Ahmed Bhutta

Tashi Delek !