Bomoon_Choi
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Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ Provisions of 2008 Declaration of Helsinki related with the vulnerable
¡ Concepts of vulnerability in the DoH
¡ Definitions and inclusions
¡ Comments
¡ Provision 9:
Some research populations are particularly vulnerable and need
special protection. These include who cannot give or refuse consent
themselves and those who may be vulnerable to coercion or undue
influence.
¡ Consent-based
¡ Need of special protection
¡ Under undue influence, including coercion
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea
¡ Provision 17:
Medical research involving a disadvantaged or vulnerable population
or community is only justified if the research is responsive
to the health needs and priorities of this population or community,
and if there is a reasonable likelihood that this population
or community stands to benefit from the result of the research.
¡ Disadvantaged – par with the vulnerable
¡ Unfair benefits as result of research interaction
¡ Exploitation potential
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ Provision 21:
Medical research may only be conducted
if the importance of the objective outweighs the inherent risks
and burdens to the research subjects.
¡ Research value outweighs inherent risks of research subjects.
¡ No primacy of research subjects’ own interests
¡ Probably vulnerable by potential of exploitation
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ Provision 26:
… if the potential subject is in a dependent relationship with
the physician, or may consent under duress. …
¡ Relationship factors as undue influence
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ Provision 31:
The physician may combine medical research with medical care
only to the extent that the research is justified by its potential preventive,
diagnostic or therapeutic value and if the physician has good reason
to believe that participation in the research study will not adversely affect
the health of the patients who serve as research subjects.
¡ Dependent on the physician’s belief and judgment on research value.
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ Provision 27: incompetent subjects, informed consent
¡ Provision 28: incompetent subjects, assent
¡ Provision 29: unconscious patients, emergency patients…
¡ Provision 35: unproven intervention
¡ Incapacity for consent
¡ Without established evidence of safety and effectiveness
¡ Critical and desperate state with increased likelihood of taking risks
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ Who needs special protection
¡ Incapacity for consent
¡ Under undue influence, under duress
¡ Disadvantaged
¡ When research objectives are important
¡ Who is in a dependent relationship with the physician
¡ Whose condition renders them unable to consent
¡ Who is in critical state or is desperate in need of even an unproven intervention
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ Individual factors – mental & physical condition
¡ Factors inherent to research design – e.g. research value, level of evidence
¡ Research context – e.g. situation, information disparity
¡ Undue influence – e.g. relational factors, coercion, hierarchy..
¡ Broader context – e.g. disadvantaged, SES, minorities, service access…
¡ Inclusive enough to comprise almost all research subjects
¡ Consent-based
¡ Harm-based
¡ As a claim to special protection
¡ Based on legal principle, governed by
regulatory agencies
¡ Validity problem – Human behavior is
affected by a wide range of influences
.
¡ Harms come in degrees.
¡ No same danger, no similar risks
¡ No definite line between vulnerable an
d non-vulnerable
¡ Wide grey area, needs clarification
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ No specification about how each group differs in regard to vulnerability
¡ No difference in the source and type of vulnerability between individuals included in a
group
¡ No differential criteria for special protection according to each characteristics of rese
arch, research environment
¡ Conflict with the principle of respect
¡ Potential of labeling
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ Which characteristics should be seen as rendering a subject vulnerable?
¡ Which circumstances should be seen as rendering subjects vulnerable?
¡ How different is each subject’s vulnerability?
¡ Which type and what level of vulnerability is?
¡ What sort of protections properly address these various vulnerability?
¡ How to incorporate the principle of respect and to move beyond the dichotomy of ‘act
ive researcher’ and ‘passive research subject’?
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ The concepts of vulnerability inevitably depend on non-scientific and individual subje
ctive considerations.
¡ Research by its nature implies that there always will be considerable uncertainty reg
arding outcomes. Assessing risks and benefits of forefront research becomes more a
nd more problematic with the development of science and technology.
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ Underlying principles throughout DoH’s past revisions remain same.
¡ The principle of protection: ‘Research subjects are inherently vulnerable and researc
hers have potential to exploit subjects in the interests of science.’
¡ By broad inclusion, the principle reflects the public needs of our times, rather than los
ing its force.
¡ “Perhaps what is surprising is not the realization that all research subjects could be considered vulnerabl
e, but rather that it has taken so long to recognize this to be the case.”
F Grinnell(2004) Am J Bioethics. 4,3;72-
¡ What matters is not the principle, but how to interpret it and to realize it.
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ The DoH is the product of HISTORY.
¡ The DoH is a document of ETHICAL PRINCIPLES.
¡ The DoH has certain size.
¡ The DoH has been referred to and regarded as a last resort at all times.
¡ Generally, principle guides reasoning, and is interpreted into regulations and guidelin
es in countries.
¡ Regulations and guidelines change with times, while principles endure.
¡ Regulation is based upon applicability and depend on the infrastructure of a society.
Each regulation would differ according to healthcare system, law system, social/cultu
ral structure of countries.
¡ Quite volume of books would be required to specify all the regulations and guidelines
.
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ What matters is not the principle of protection, but
¡ How to set regulations balancing between ‘the principle of protection’ and
‘the principle of respect’
¡ How to apply regulations appropriately
¡ How to make it sure that the regulations are being followed
¡ Who shares the duty to avoid the potential harms and wrongs?
¡ Who has the responsibility for the harms and wrongs?
¡ How to adjust them properly with times and to go with the change of society
and technology development
Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
¡ Principle of protection as a broad definition of vulnerability and a broad inclusion
¡ With a considerable scope for interpretation and specification
¡ It would be sufficient, if the principle accompanies
§ Requirement of balanced view with the principle of respect
§ Clear description about responsibility of oversight
§ Clear positioning of accountability of harms and wrongs