{"id":3812,"date":"2017-01-20T12:26:11","date_gmt":"2017-01-20T12:26:11","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Hurst_-__Vulnerability.pdf"},"modified":"2017-01-20T12:26:11","modified_gmt":"2017-01-20T12:26:11","slug":"hurst_-__vulnerability-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/hurst_-__vulnerability-2\/","title":{"rendered":"Hurst_-__Vulnerability"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Hurst_-__Vulnerability<\/a><\/p>\n

WMA expert conference on the Revision of the Declaration of Helsinki
\nCape Town, 5-7.12.2012
\nPr Samia Hurst, MD
\nInstitute for Biomedical Ethics
\nGeneva University Medical School
\nsamia.hurst@unige.ch
\nVulnerability
\nSome forms of vulnerability seem obvious
\nOthers are clearly not obvious
\nVulnerability
\n\u2022 Definitions and lists
\n\u2022 Problems
\n\u2022 Possible solutions
\nDefinitions
\nDeclaration of Helsinki (DoH), Paragraph 9
\n\u2018Some research populations are particularly vulnerable and need
\nspecial protection. These include\u2026\u2019
\nCIOMS, Commentary on Guideline 13
\n\u2018Vulnerable persons are those who are relatively (or absolutely)
\nincapable of protecting their own interests. More formally, they may
\nhave insufficient power, intelligence, education, resources, strength, or
\nother needed attributes to protect their own interest\u2019
\nICH-GCP (1.61) Vulnerable Subjects
\n\u2018Individuals whose willingness to volunteer in a clinical trial may be
\nunduly influenced by the expectation, whether justified or not, of
\nbenefits associated with participation, or of a retaliatory response from
\nsenior members of a hierarchy in case of refusal to participate\u2019
\nLists
\nDeclaration of Helsinki:
\n\u2026These include those who cannot give or refuse consent for
\nthemselves and those who may be vulnerable to coercion or undue
\ninfluence.
\nUS (Common Rule) 45 CFR 46:
\n– children, prisoners, pregnant women and foetuses
\nICH-GCP:
\n-members of a group with hierarchical structure (medical students,
\nhospital and laboratory personnel, employees in the pharmaceutical
\nindustry), unemployed or impoverished persons, ethnic minority group,
\nhomeless persons, nomads, refugees, minors
\nProblems
\nDefinitions:
\nIncomplete: incapacity to protect one\u2019s interests, susceptibility to coercion
\nLists:
\nAbsence of an explicit organizing principle leads to confusion (pregnancy
\ndoes not remove the capacity to consent for example)
\nIncompleteness, obsolescence, absurdity, labeling
\nGeneral:
\nLack of clarity as to what protection of vulnerable persons mean,
\npotentially counterproductive effects.
\nDeclaration of Helsinki
\nParagraph 9
\n\u2018Some research populations are particularly vulnerable and need
\nspecial protection. These include those who cannot give or refuse
\nconsent for themselves and those who may be vulnerable to coercion
\nor undue influence.\u2019
\nParagraph 16
\nThe responsibility for the protection of research subjects must always
\nrest with the physician or other health care professional and never the
\nresearch subjects, even though they have given consent.
\nInconsistent
\nImplicitly states \u2013 without justification- that vulnerability is
\ninherently based on a deficit on the part of the vulnerable person.
\nOptions
\nDissolve: Vulnerability is a matter of degree. The same protections
\nshould apply. Although they will require greater effort, this does not
\nrequire any additional principles.
\nProblem: invisibility, inappropriate uniformity in protocol design and
\nREC review.
\nList: Attempt to devise a list of vulnerable groups or persons which
\nadheres to an appropriate \u2013and explicit- organizing principle.
\nProblem: \u2026 incompleteness, obsolescence, absurdity, labeling
\nInstruct: provide clarification of vulnerability and the required
\nprotections.
\nVulnerability
\nHurst S.: Vulnerability in Research and Health Care; Describing the Elephant in the
\nRoom? Bioethics. 2008; 22(4):191-202
\nA greater likelihood of incurring a wrong in the context of research.
\nAny wrong. For any reason.
\n9. Medical research is subject to ethical standards that promote
\nrespect for all human subjects and protect their health and rights.
\nSome research populations are particularly vulnerable and need
\nspecial protection. These include those who cannot give or
\nrefuse consent for themselves and those who may be vulnerable
\nto coercion or undue influence.
\n9. Medical research is subject to ethical standards that promote
\nrespect for all human subjects and protect their health and rights.
\nSome research populations are particularly vulnerable and need
\nspecial protection. These include those who cannot give or
\nrefuse consent for themselves and those who may be vulnerable
\nto coercion or undue influence.
\n9. Medical research is subject to ethical standards that promote
\nrespect for all human subjects and protect their health and rights.
\nSome research populations are particularly vulnerable and need
\nspecial protection. These include those who cannot give or
\nrefuse consent for themselves and those who may be vulnerable
\nto coercion or undue influence. The responsibility for the
\nprotection of research subjects must always rest with the
\nphysician or other health care professional and never the
\nresearch subjects, even though they have given consent.
\n9. Medical research is subject to ethical standards that promote
\nrespect for all human subjects and protect their health and rights.
\nSome research populations are particularly vulnerable and need
\nspecial protection. These include those who cannot give or
\nrefuse consent for themselves and those who may be vulnerable
\nto coercion or undue influence. The responsibility for the
\nprotection of research subjects must always rest with the
\nphysician or other health care professional investigators and
\nnever the research subjects, even though they have given
\nconsent.
\n9. Medical research is subject to ethical standards that promote
\nrespect for all human subjects and protect their health and rights.
\nSome research populations are particularly vulnerable and need
\nspecial protection. These include those who cannot give or
\nrefuse consent for themselves and those who may be vulnerable
\nto coercion or undue influence. The responsibility for the
\nprotection of research subjects must always rest with the
\nphysician or other health care professional investigators and
\nnever the research subjects, even though they have given
\nconsent. This implies a duty to guarantee equal protection for
\nvulnerable participants, whose health and rights are more
\ndifficult to protect.
\n9. Medical research is subject to ethical standards that promote
\nrespect for all human subjects and protect their health and rights.
\nThe responsibility for the protection of research subjects must
\nalways rest with the investigators and never the research
\nsubjects. This implies a duty to guarantee equal protection for
\nvulnerable participants, whose health and rights are more
\ndifficult to protect.
\n9. Medical research is subject to ethical standards that promote
\nrespect for all human subjects and protect their health and rights.
\nThe responsibility for the protection of research subjects must
\nalways rest with the investigators and never the research
\nsubjects. This implies a duty to guarantee equal protection for
\nvulnerable participants, whose health and rights are more
\ndifficult to protect.
\n16. Researchers\u2019 Ethical Obligations:
\n16.0: Researchers have an obligation to implement the principles
\ncontained in the present declaration at all stages of research.
\nThis implies a duty to guarantee equal protection for vulnerable
\nparticipants, whose health and rights are more difficult to protect.
\nPossible concerns
\nVirtually all studies will recruit vulnerable persons
\nWe lose subsidiarity
\nWe lose protections associated with REC structure
\nThis is not per se a problem, if the protections extended to them are appropriate.
\nProtection against being recruited in exploitative research is required for all
\nAs is protection against non-existence of research targeting one\u2019s needs
\nProtection against conflicts of interests in RECs should also apply to everyone.
\nProtection against sloppy protections is easier with clearer standards
\nConclusion
\n\u2022 Don\u2019t list the vulnerable
\n\u2022 Provide a clear guidance: vulnerability is a matter of degree.
\n\u2013 Protecting vulnerability implies a duty to guarantee equal
\nprotection for vulnerable participants, whose health and rights
\nare more difficult to protect
\n\u2022 Stick to the general guidance: require a case by case
\nspecification but don\u2019t do it within the DoH.
\n\u2022 As far as vulnerabiliy is concerned, scrap the rest: all other
\nso-called protections of vulnerability should really apply to
\neveryone.<\/p>\n"},"caption":{"rendered":"

Hurst_-__Vulnerability WMA expert conference on the Revision of the Declaration of Helsinki Cape Town, 5-7.12.2012 Pr Samia Hurst, MD Institute for Biomedical Ethics Geneva University Medical School samia.hurst@unige.ch Vulnerability Some forms of vulnerability seem obvious Others are clearly not obvious Vulnerability \u2022 Definitions and lists \u2022 Problems \u2022 Possible solutions Definitions Declaration of Helsinki (DoH), […]<\/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\/Hurst_-__Vulnerability.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3812"}],"collection":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media"}],"about":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/types\/attachment"}],"author":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/comments?post=3812"}]}}