{"id":3861,"date":"2017-01-20T13:02:24","date_gmt":"2017-01-20T13:02:24","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Bomoon_Choi.pdf"},"modified":"2017-01-20T13:02:24","modified_gmt":"2017-01-20T13:02:24","slug":"bomoon_choi-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/bomoon_choi-2\/","title":{"rendered":"Bomoon_Choi"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Bomoon_Choi<\/a><\/p>\n

Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f Provisions of 2008 Declaration of Helsinki related with the vulnerable
\n\u00a1\uf0a1\u202f Concepts of vulnerability in the DoH
\n\u00a1\uf0a1\u202f Definitions and inclusions
\n\u00a1\uf0a1\u202f Comments
\n\u00a1\uf0a1\u202f Provision 9:
\nSome research populations are particularly vulnerable and need
\nspecial protection. These include who cannot give or refuse consent
\nthemselves and those who may be vulnerable to coercion or undue
\ninfluence.
\n\u00a1\uf0a1\u202f Consent-based
\n\u00a1\uf0a1\u202f Need of special protection
\n\u00a1\uf0a1\u202f Under undue influence, including coercion
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea
\n\u00a1\uf0a1\u202f Provision 17:
\nMedical research involving a disadvantaged or vulnerable population
\nor community is only justified if the research is responsive
\nto the health needs and priorities of this population or community,
\nand if there is a reasonable likelihood that this population
\nor community stands to benefit from the result of the research.
\n\u00a1\uf0a1\u202f Disadvantaged \u2013 par with the vulnerable
\n\u00a1\uf0a1\u202f Unfair benefits as result of research interaction
\n\u00a1\uf0a1\u202f Exploitation potential
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f Provision 21:
\nMedical research may only be conducted
\nif the importance of the objective outweighs the inherent risks
\nand burdens to the research subjects.
\n\u00a1\uf0a1\u202f Research value outweighs inherent risks of research subjects.
\n\u00a1\uf0a1\u202f No primacy of research subjects\u2019 own interests
\n\u00a1\uf0a1\u202f Probably vulnerable by potential of exploitation
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f Provision 26:
\n\u2026 if the potential subject is in a dependent relationship with
\nthe physician, or may consent under duress. \u2026
\n\u00a1\uf0a1\u202f Relationship factors as undue influence
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f Provision 31:
\nThe physician may combine medical research with medical care
\nonly to the extent that the research is justified by its potential preventive,
\ndiagnostic or therapeutic value and if the physician has good reason
\nto believe that participation in the research study will not adversely affect
\nthe health of the patients who serve as research subjects.
\n\u00a1\uf0a1\u202f Dependent on the physician\u2019s belief and judgment on research value.
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f Provision 27: incompetent subjects, informed consent
\n\u00a1\uf0a1\u202f Provision 28: incompetent subjects, assent
\n\u00a1\uf0a1\u202f Provision 29: unconscious patients, emergency patients\u2026
\n\u00a1\uf0a1\u202f Provision 35: unproven intervention
\n\u00a1\uf0a1\u202f Incapacity for consent
\n\u00a1\uf0a1\u202f Without established evidence of safety and effectiveness
\n\u00a1\uf0a1\u202f Critical and desperate state with increased likelihood of taking risks
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f Who needs special protection
\n\u00a1\uf0a1\u202f Incapacity for consent
\n\u00a1\uf0a1\u202f Under undue influence, under duress
\n\u00a1\uf0a1\u202f Disadvantaged
\n\u00a1\uf0a1\u202f When research objectives are important
\n\u00a1\uf0a1\u202f Who is in a dependent relationship with the physician
\n\u00a1\uf0a1\u202f Whose condition renders them unable to consent
\n\u00a1\uf0a1\u202f Who is in critical state or is desperate in need of even an unproven intervention
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f Individual factors \u2013 mental & physical condition
\n\u00a1\uf0a1\u202f Factors inherent to research design \u2013 e.g. research value, level of evidence
\n\u00a1\uf0a1\u202f Research context \u2013 e.g. situation, information disparity
\n\u00a1\uf0a1\u202f Undue influence \u2013 e.g. relational factors, coercion, hierarchy..
\n\u00a1\uf0a1\u202f Broader context \u2013 e.g. disadvantaged, SES, minorities, service access\u2026
\n\u00a1\uf0a1\u202f Inclusive enough to comprise almost all research subjects
\n\u00a1\uf0a1\u202f Consent-based
\n\u00a1\uf0a1\u202f Harm-based
\n\u00a1\uf0a1\u202f As a claim to special protection
\n\u00a1\uf0a1\u202f Based on legal principle, governed by
\nregulatory agencies
\n\u00a1\uf0a1\u202f Validity problem \u2013 Human behavior is
\naffected by a wide range of influences
\n.
\n\u00a1\uf0a1\u202f Harms come in degrees.
\n\u00a1\uf0a1\u202f No same danger, no similar risks
\n\u00a1\uf0a1\u202f No definite line between vulnerable an
\nd non-vulnerable
\n\u00a1\uf0a1\u202f Wide grey area, needs clarification
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f No specification about how each group differs in regard to vulnerability
\n\u00a1\uf0a1\u202f No difference in the source and type of vulnerability between individuals included in a
\ngroup
\n\u00a1\uf0a1\u202f No differential criteria for special protection according to each characteristics of rese
\narch, research environment
\n\u00a1\uf0a1\u202f Conflict with the principle of respect
\n\u00a1\uf0a1\u202f Potential of labeling
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f Which characteristics should be seen as rendering a subject vulnerable?
\n\u00a1\uf0a1\u202f Which circumstances should be seen as rendering subjects vulnerable?
\n\u00a1\uf0a1\u202f How different is each subject\u2019s vulnerability?
\n\u00a1\uf0a1\u202f Which type and what level of vulnerability is?
\n\u00a1\uf0a1\u202f What sort of protections properly address these various vulnerability?
\n\u00a1\uf0a1\u202f How to incorporate the principle of respect and to move beyond the dichotomy of \u2018act
\nive researcher\u2019 and \u2018passive research subject\u2019?
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f The concepts of vulnerability inevitably depend on non-scientific and individual subje
\nctive considerations.
\n\u00a1\uf0a1\u202f Research by its nature implies that there always will be considerable uncertainty reg
\narding outcomes. Assessing risks and benefits of forefront research becomes more a
\nnd more problematic with the development of science and technology.
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f Underlying principles throughout DoH\u2019s past revisions remain same.
\n\u00a1\uf0a1\u202f The principle of protection: \u2018Research subjects are inherently vulnerable and researc
\nhers have potential to exploit subjects in the interests of science.\u2019
\n\u00a1\uf0a1\u202f By broad inclusion, the principle reflects the public needs of our times, rather than los
\ning its force.
\n\u00a1\uf0a1\u202f \u201cPerhaps what is surprising is not the realization that all research subjects could be considered vulnerabl
\ne, but rather that it has taken so long to recognize this to be the case.\u201d
\nF Grinnell(2004) Am J Bioethics. 4,3;72-
\n\u00a1\uf0a1\u202f What matters is not the principle, but how to interpret it and to realize it.
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f The DoH is the product of HISTORY.
\n\u00a1\uf0a1\u202f The DoH is a document of ETHICAL PRINCIPLES.
\n\u00a1\uf0a1\u202f The DoH has certain size.
\n\u00a1\uf0a1\u202f The DoH has been referred to and regarded as a last resort at all times.
\n\u00a1\uf0a1\u202f Generally, principle guides reasoning, and is interpreted into regulations and guidelin
\nes in countries.
\n\u00a1\uf0a1\u202f Regulations and guidelines change with times, while principles endure.
\n\u00a1\uf0a1\u202f Regulation is based upon applicability and depend on the infrastructure of a society.
\nEach regulation would differ according to healthcare system, law system, social\/cultu
\nral structure of countries.
\n\u00a1\uf0a1\u202f Quite volume of books would be required to specify all the regulations and guidelines
\n.
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f What matters is not the principle of protection, but
\n\u00a1\uf0a1\u202f How to set regulations balancing between \u2018the principle of protection\u2019 and
\n\u2018the principle of respect\u2019
\n\u00a1\uf0a1\u202f How to apply regulations appropriately
\n\u00a1\uf0a1\u202f How to make it sure that the regulations are being followed
\n\u00a1\uf0a1\u202f Who shares the duty to avoid the potential harms and wrongs?
\n\u00a1\uf0a1\u202f Who has the responsibility for the harms and wrongs?
\n\u00a1\uf0a1\u202f How to adjust them properly with times and to go with the change of society
\nand technology development
\nBomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association
\n\u00a1\uf0a1\u202f Principle of protection as a broad definition of vulnerability and a broad inclusion
\n\u00a1\uf0a1\u202f With a considerable scope for interpretation and specification
\n\u00a1\uf0a1\u202f It would be sufficient, if the principle accompanies
\n\u00a7\uf0a7\u202f Requirement of balanced view with the principle of respect
\n\u00a7\uf0a7\u202f Clear description about responsibility of oversight
\n\u00a7\uf0a7\u202f Clear positioning of accountability of harms and wrongs<\/p>\n"},"caption":{"rendered":"

Bomoon_Choi Bomoon Choi, M.D. Professor of Psychiatry, School of Medicine, Catholic University of Korea Korean Society of Medical Ethics Korean Medical Association \u00a1\uf0a1\u202f Provisions of 2008 Declaration of Helsinki related with the vulnerable \u00a1\uf0a1\u202f Concepts of vulnerability in the DoH \u00a1\uf0a1\u202f Definitions and inclusions \u00a1\uf0a1\u202f Comments \u00a1\uf0a1\u202f Provision 9: Some research populations are particularly vulnerable […]<\/p>\n"},"alt_text":"","media_type":"file","mime_type":"application\/pdf","media_details":{},"post":null,"source_url":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Bomoon_Choi.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3861"}],"collection":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/comments?post=3861"}]}}