S3-2_Joseph Tham

Ethics of Research
in Conflict Settings
Joseph Tham, LC, MD, PhD 譚傑志
UNESCO Chair in Bioethics and Human Rights, Rome, Italy
Faculty of Bioethics, APRA
Universita Europea di Roma
jtham@unescobiochair.org
Challenges
of research
in conflict
settings
• Commonly in settings of
• Developing countries
• Political instability
• Scientific capacities
• Terrorist orgs
• Humanitarian
organizations, NGOs
• Priorities to aid first
• Human resources
limited
• Personnel safety
• Research capacities /
tools / infrastructures
Really necessary? Justification of research
• Cannot obtain results otherwise?
• Chemical warfare, trauma, bombs, etc.
• Health / humanitarian consequences of conflict
• Statistics: Mortality, morbidity, malnutrition,
• Effect on hospitals, healthcare, staff, etc.
• Feasibility and effectiveness of interventions
• E.g., Food provisions, surgeries, psych intervention,
medications, etc
• Valid delivery models
• Evidence-based?
• Food, treatments, etc.
Ethical
concerns
• Necessity and feasibility of research
• Research Design
• Ethical review
• Informed consent
• Vulnerable groups
• Benefits to participants
Ethical framework for research: benchmarks used by MSF
Ethics of research in conflict setting
Declaration of Helsinki
(2013)
UNESCO Declaration of
Bioethics and Human Rights
(2005)
Necessity of
Research
16-18 14 Social Responsibility and
Health
Informed consent 25-32 6 Consent
7 Persons without capacity to
consent
Vulnerability 19-20 8 Respect of Human
Vulnerability and personal
integrity
Benefits to
participants
8, 34 3 Human Dignity and Human
Rights
15 Sharing of Benefits
DoH and Necessity of
research in conflict settings
• Recruitment of participants, community
involvement. Local culture and partnership
• Harm–benefit ratio
• Scientific validity
18. Physicians may not be involved in a research study involving
human subjects unless they are confident that the risks have been
adequately assessed and can be satisfactorily managed.
When the risks are found to outweigh the potential benefits or when
there is conclusive proof of definitive outcomes, physicians must
assess whether to continue, modify or immediately stop the study.
DoH 25-32 and Informed Consent
in conflict settings
Informed consent
• Extra vulnerable groups
• Threats to life, survival, family…
• Hidden coercion by authorities, military
• Incentives to participate (for safety and survival)
• Adequacy of research protocols
• Independence of reviews (from political influence)
25 Voluntary
26 adequately informed
27 not dependent situations
DoH and legal protections
Health, human rights, and the conduct of clinical research within oppressed populations – PMC (nih.gov)
Problems:
DoH speaks of international
human rights law, but the
country’s laws may not cover
violations of the rights of
participants in clinical trials.
There is not one exhaustive
statute that prevents the
government and the private
sector from partnering with
rogue states or abusers of
human rights.
DoH and benefits of research for
participants
• 8. While the primary purpose of medical research is to generate new
knowledge, this goal can never take precedence over the rights and interests of
individual research subjects.
• 34. In advance of a clinical trial, sponsors, researchers and host country
governments should make provisions for post-trial access for all participants
who still need an intervention identified as beneficial in the trial. This
information must also be disclosed to participants during the informed consent
process.
• 20. Medical research with a vulnerable group is only justified if the
research is responsive to the health needs or priorities of this group and the
research cannot be carried out in a non-vulnerable group. In addition, this
group should stand to benefit from the knowledge, practices or interventions
that result from the research.
Virtue ethics 德不孤必有鄰
•Do no harm 仁
•Proportionality 衡
•Prudence 智
•Justice 義
•Fortitude 勇
•Temperance 節
Bibliography
• Ethics of conducting research in conflict settings – PMC (nih.gov)
• Health, human rights, and the conduct of clinical research within
oppressed populations | Globalization and Health | Full Text
(biomedcentral.com)
• Health, human rights, and the conduct of clinical research within
oppressed populations – PMC (nih.gov)
• The revision of the Declaration of Helsinki: past, present and future
– PMC (nih.gov)
• WMA Declaration of Helsinki – Ethical Principles for Medical
Research Involving Human Subjects – WMA – The World Medical
Association
• Universal Declaration on Bioethics and Human Rights – UNESCO
Digital Library
• The Belmont Report. Ethical principles and guidelines for the
protection of human subjects of research – PubMed (nih.gov)
• web-cioms-ethicalguidelines.pdf (who.int)