{"id":3796,"date":"2017-01-20T12:25:46","date_gmt":"2017-01-20T12:25:46","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/DoH_Dec_Presentation_2012_Vulnerable.pdf"},"modified":"2017-01-20T12:25:46","modified_gmt":"2017-01-20T12:25:46","slug":"doh_dec_presentation_2012_vulnerable-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/doh_dec_presentation_2012_vulnerable-2\/","title":{"rendered":"DoH_Dec_Presentation_2012_Vulnerable"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

DoH_Dec_Presentation_2012_Vulnerable<\/a><\/p>\n

Vulnerable Groups
\nWMA Expert Conference on the Revision of the Declaration of Helsinki
\n5-7 December 2012; Cape Town \u2013 South Africa
\nProfessor A Dhai
\nDirector Steve Biko Centre for Bioethics
\nFaculty of Health Sciences
\nUniversity of the Witwatersrand
\nJohannesburg
\nOutline
\n\u2022 Notion of Vulnerability
\n\u2022 Vulnerability and Exploitation
\n\u2022 Categories of Vulnerability
\n\u2022 Authoritative Documents
\n\u2022 DoH on vulnerability \u2013 strengths and
\nweaknesses
\nNotion of Vulnerability
\n\u2022 Vulnerability referred to increasingly in health research.
\n\u2022 Linked in most research ethics guidelines and codes to questions of justice in
\nselection of participants, limitations of capacity to provide informed consent,
\nunequal relationships between disadvantaged groups and researchers and
\nsponsors, … .
\n\u2022 Generally accepted that one of the principle tasks of ethics in research is
\nprotecting vulnerable participants from exploitation and other forms of harm
\n\u2022 \u201cVulnerable\u201d originated from the Latin term \u201cvulnerare\u201d, which means \u201cto
\nwound\u201d. *
\n\u2022 Dictionary meaning of vulnerable : \u201cexposed to being attacked or harmed, either
\nphysically or emotionally\u201d.*
\n*South African Concise Oxford Dictionary
\nNotion of Human Vulnerability
\n\u2022 Being human, by implication, denotes vulnerability.
\n\u2022 All humans exposed at some stage or other to the risk of suffering harm
\nagainst personal integrity – physical, emotional, psychological and \/ or spiritual.
\n\u2022 Human vulnerability :
\n\u2013 intrinsically connected to the essential notion of personal integrity
\n\u2013 perceived as an inescapable dimension of human life
\n\u2013 an integral component in the shaping of human relationships.
\n\u2013 acknowledges that at some point, all human beings may lack the ability to
\nprotect themselves from harms which at times may even be inflicted by other
\nhuman beings.
\n\u2022 While human kind as such is vulnerable, there are individuals, groups and
\nsituations for whom greater attention needs to be paid.
\nUnited Nations Educational, Scientific and Cultural Organization. Draft Report of IBC on the Principle of Respect for Human
\nVulnerability and Personal Integrity. International Bioethics Committee (IBC). 2011; http:\/\/www.unesco.org\/new\/en\/social-
\nand-human-sciences\/themes\/bioethics\/international-bioethics-committee\/ibc-sessions\/eighteenth-session-baku-2011\/
\nNotion of Human Vulnerability
\n\u2022 Notion of vulnerability is closely linked with the notion of personal integrity.
\n\u2022 Where participants are vulnerable, there is potential for their autonomy to be infringed.
\n\u2022 Impact negatively on their rights \u2013 bodily and psychological integrity & human dignity.
\n\u2022 Human beings are moral agents and hence have rights to their own values and
\npreferences
\n\u2022 When vulnerable, one or more of the elements of informed consent could be eroded \u2013
\nparticipate in research as a consequence of coercion and \/ or lack of understanding.
\n\u2022 *Kipnis
\n\u2022 \u201c… in the minds of many investigators the paradigmatic research subject remains more
\nor less a mature, respectable, moderately well-educated, clear thinking, literate, self-
\nsupporting US citizen in good standing \u2013 that is, a man who could understand a 12-
\npage consent form and act intelligently on the basis of its contents.\u201d
\n\u2022 This description – far cry from typical research participant in Africa where levels of
\nliteracy are low and poverty rife. Yet, in collaborative international research,
\nconsent forms presented to the Research Ethics Committees for review and
\napproval are often those designed for the literate US citizen.
\n*Kipnis K. Vulnerability in Research Subjects: A Bioethical Taxonomy. Commissioned Paper. In Ethical and Policy Issues in Research Involving Human Research Participants.
\nBethesda, MD: National Bioethics Advisory Commission. 2001
\nVulnerability and Exploitation
\n\u2022 Vulnerability associated with strong potential for exploitation.
\n\u2022 *Resnik – three basic elements, at least one of which is
\nrequisite for exploitation
\n\u2022 harm, disrespect and injustice
\n\u2022 In practice, elements usually not present in isolation but often overlap and interact.
\n\u2022 Operational level, exploitation explained as the sum total of
\nrisks and harms with risks referring to the possibility of harm
\nand harm referring to actual injury or damage.
\n\u2022 Exploitation would result where, despite the risk of harm being recognised, the risky
\naction is embarked upon with resultant harms.
\n*Resnick D.B. Exploitation in Biomedical Research. Theoretical Medicine and Bioethics. 2003; 24: 233-259.
\nRisk Categories in Research
\n\u2022 Usually four:
\n\u2022 Physical
\n\u2022 Psychological
\n\u2022 Social
\n\u2022 Economic.
\n\u2022 These are exacerbated where participants are
\nvulnerable.
\nVulnerability Categories \/ Frameworks
\n\u2022 UNESCO two fundamental categories:
\n\u2013 special disabilities, disease & limitations imposed by stages of human life
\n\u2013 social, political and environmental determinants.
\n\u2022 Kipnis proposes a bioethical taxonomy with six types of vulnerability –
\ndistinguished by a positive response to a unique question.
\n\u2013 cognitive, juridic, deferential, medical, allocational and infrastructural.
\nVulnerability exists as a broad spectrum, rather than a simple present \/ absent
\ndichotomy, – possible to identify individuals \/ groups that are particularly
\nvulnerable in research. Two sources of vulnerability at a conceptual level :
\n\u2022 while often appearing independently, may coexist and are sometimes interrelated
\n\u2013 Intrinsic – due to internal qualities of individuals themselves, e.g., medical
\nillnesses, mental disabilities and extremes of age.
\n\u2013 extrinsic, as a result of external circumstances, e.g., social
\nSocial Vulnerability
\n\u2022 Usually involves groups:
\n\u2022 Stereotyping
\n\u2022 Discrimination
\n\u2022 Stigmatization
\n\u2022 Social victimization
\nVulnerability: Authoritative Documents
\n\u2022 UNAIDS \/ SA DoH Guidelines:
\n\u2013 limited economic development
\n\u2013 inadequate protection of human rights & discrimination on
\nbasis of health status
\n\u2013 inadequate community \/ cultural experience with understanding
\nof scientific research
\n\u2013 limited availability of health care & treatment options
\n\u2013 limited ability of individuals in community to provide informed
\nconsent
\nVulnerability: Authoritative Documents
\n\u2022 CIOMS 2002:
\n\u2013 \u201c\u2026 substantial incapacity to protect one\u2019s own interests owing to such
\nimpediments as lack of capability to give informed consent, lack of
\nalternative means of obtaining medical care or other necessities, or
\nbeing a junior or subordinate member of a hierarchical group.\u201d
\n\u2022 Ethical justification
\n\u2013 Couldn\u2019t be carried out as well with non-vulnerable persons
\n\u2013 Problem related to vulnerability
\n\u2013 Participants and class will have reasonable availability to products
\n\u2013 Risks without health benefits will not be greater than routine unless
\nauthorized
\n\u2013 Supplemental consent when needed
\nVulnerability: Authoritative Documents
\n\u2022 CIOMS 2002:
\n\u2022 \u201cResearch in certain fields … May present risks to the
\ninterests of communities, societies, or racially or
\nethnically defined groups. Information might be
\npublished that could stigmatize a group or expose its
\nmembers to discrimination \u2026\u201d
\n\u2022 \u201cPlans to conduct such research should be sensitive to
\nsuch considerations, to the need to maintain
\nconfidentiality during and after the study,.. .\u201d
\nVulnerability: Authoritative Documents
\n\u2022 NBAC
\n\u2022 \u201cResearch that is designed to study a group or that
\nretrospectively implicates a group may \u2026result in members
\nof the group facing, among other things stigmatization &
\ndiscrimination in insurance & employment whether or not
\nthey contributed samples to the study\u201d
\n\u2022 \u201cSocial perceptions are pervasive and often insidious and can
\naffect persons\u2019 conceptions of certain groups. Thus
\ninvestigators, IRB members, and research sponsors should be
\nsensitive to such perceptions and their effects and allow
\nmembers of such groups to participate in decision making
\nand oversight processes. Involving the community in the
\nvarious stages of the research process, especially in study
\nplanning, can be helpful in reducing stereotyping and
\nstigmatization.\u201d
\nVulnerability: Authoritative Documents
\n\u2022 DoH : strengths – protection of vulnerabilities provisions in
\nmost articles.
\n\u2022 Specific mention of vulnerability
\n\u2013 9. \u201cSome research populations are particularly vulnerable and need
\nspecific protections.\u201d
\n\u2013 17. \u201c … Involving a disadvantaged or vulnerable population or
\ncommunity is only justified if the research is responsive to the health
\nneeds and priorities of this population or community and if there is a
\nreasonable likelihood that this population or community stands to
\nbenefit from the results of the research .\u201d
\nVulnerability: Authoritative Documents
\n\u2022 DoH : some weaknesses
\n\u2013 \u201cReasonable likelihood\u201d – no guarantee to a level of benefits that is
\nfair
\n\u2013 protections against group harms and community consultation to
\nprevent social harms. art22 specific to community consultation for
\nvoluntary participation.
\n\u2013 Art 14 \u2013 no firm commitment to compensation for research related
\ninjury. \u201cThe protocol should include information regarding … provisions
\nfor treating and \/ or compensating subjects who are harmed as a …\u201d
\n\u2013 art15 \u2013 RECs. No mention of competency for review and CPD
\n\u2013 No article on biobanks
\nThank You<\/p>\n"},"caption":{"rendered":"

DoH_Dec_Presentation_2012_Vulnerable Vulnerable Groups WMA Expert Conference on the Revision of the Declaration of Helsinki 5-7 December 2012; Cape Town \u2013 South Africa Professor A Dhai Director Steve Biko Centre for Bioethics Faculty of Health Sciences University of the Witwatersrand Johannesburg Outline \u2022 Notion of Vulnerability \u2022 Vulnerability and Exploitation \u2022 Categories of Vulnerability \u2022 Authoritative […]<\/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\/DoH_Dec_Presentation_2012_Vulnerable.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3796"}],"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=3796"}]}}