{"id":3773,"date":"2017-01-20T12:25:07","date_gmt":"2017-01-20T12:25:07","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Cape_Town_12-Arnason.pdf"},"modified":"2017-01-20T12:25:07","modified_gmt":"2017-01-20T12:25:07","slug":"cape_town_12-arnason-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/cape_town_12-arnason-2\/","title":{"rendered":"Cape_Town_12-Arnason"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Cape_Town_12-Arnason<\/a><\/p>\n

Vilhj\u00e1lmur \u00c1rnason
\nBiobanks
\nExpert Conference on the Revision of the
\nDeclaration of Helsinki
\nWMA, Cape Town, December 5\u20137, 2012
\nThe issues
\n\u2022 Obtaining information
\n\u2022 The question of consent
\n\u2013 articles 24 and 25
\n\u2022 Protecting information
\n\u2022 Access to information
\n\u2013 Article 23
\n\u2022 Returning information
\n\u2013 article 33
\n\u00c1rnason, WMA Cape Town 2
\nWhat kind of biobanks?
\n\u2022 In my discussion, I am concerned with organized
\ncollection of human biological samples \u2013 and the
\ndata (medical, genealogical, life-style) associated
\nwith them \u2013 used for research purposes. In
\nparticular, I have in mind large population-based
\nbiobanks as resources for genetic research
\n\u2022 These biobanks have raised various challenges for
\nexisting ethical frameworks, but I will only address
\nthree which are pertinant for a possible revision of
\nDoH
\n\u00c1rnason, WMA Cape Town 3
\nEntering a biobank
\n\u2022 A major ethical challenge raised by biobanks
\nconcerns the question of consent
\n\u2022 The DoH states (art 24)
\n\u2013 In medical research involving competent human subjects,
\neach potential subject must be adequately informed of the
\naims, methods, \u2026 the anticipated benefits and potential
\nrisks of the study and the discomfort it may entail \u2026
\n\u2022 This is ill suited for database\/biobanks research
\nwhere future research uses cannot be specified at
\nthe time of consent which might require frequent
\nrecontact. Hence the need for a separate article:
\n\u00c1rnason, WMA Cape Town 4
\nArticle 25 (2008)
\n\u2022 \u201cFor medical research using identifiable human
\nmaterial or data, physicians must normally seek
\nconsent for the collection, analysis, storage
\nand\/or reuse. There may be situations where
\nconsent would be impossible or impractical to
\nobtain for such research or would pose a threat
\nto the validity of the research. In such situations
\nthe research may be done only after
\nconsideration and approval of a research ethics
\ncommittee.\u201d
\n\u00c1rnason, WMA Cape Town 5
\nAnalysis
\n\u2022 Specific informed consent no longer required
\n\u2013 \u201cconsent for collection, analysis, storage and\/or
\nreuse\u201c
\n\u2022 Is this sufficient?
\n\u2022 It depends on how \u201cconsent\u201c is fleshed out
\n\u2022 Two main options
\n\u2022 One time open consent
\n\u2022 Wide consent with the right to withdraw
\n\u00c1rnason, WMA Cape Town 6
\nPermission based on trust
\n\u2022 Open consent relying on ethics committees to
\ndecide on the use of samples
\n\u2022 It is debated whether this can be regarded as
\na consent at all since the participants\u2018 decision
\nis not based on any knowledge of the use of
\nthe samples. It is a permission based on trust
\n\u2013 One argument for this policy is that it would
\nmaximize the research flexibility and thus the
\nbenefits to be reaped from the biobanks resource
\n\u00c1rnason, WMA Cape Town 7
\nThe question of benefits
\n\u2022 Clear public benefits can be used as an argument to
\ncounter emphasis on consent (context of
\nreciprocity). The medical benefits of population
\nbiobank research remain controversial.
\n\u2022 The ethos of voluntariness (DoH, 22), the objectives
\nof non-deception and non-coercion, are also
\nimportant public benefits or interests at stake
\n\u2013 Participants should not be regarded as a passive resource
\nto be mined for maximum benefits, restricting ethical
\nissues to those of protection and security. There is a public
\ninterest in facilitating conditions for agency
\n\u00c1rnason, WMA Cape Town 8
\nConsent with a right to withdraw
\n\u2022 The ethos of voluntariness and the ethos of
\ntrust can be reconciled through a policy of a
\nbroad consent for participation in biobank
\nresearch, provided that participants
\n\u2013 are informed on a regular bases of the nature of
\nthe ongoing research using the biobank
\n\u2013 are given ways to withdraw from particular
\nresearch projects
\n\u2013 these procedures would underpin trust and public
\nawareness\/engagement
\n\u00c1rnason, WMA Cape Town 9
\nA suggestion
\n\u2022 Change to article 25
\n\u2013 \u201cFor medical research using identifiable human material or
\ndata, physicians must normally seek consent for the
\ncollection, analysis, storage and\/or reuse. There may be
\nsituations where consent would be impossible or
\nimpractical to obtain for such research or would pose a
\nthreat to the validity of the research.
\nresearch may be done only
\nafter consideration and approval of a research ethics
\ncommittee.\u201d
\n\u00c1rnason, WMA Cape Town 10
\nProtection
\n\u2022 Secure protection of confidentiality of samples
\nshould not be used as a reason against obtaining
\nconsent or the right to withdraw from research
\n\u2022 It should serve as a reason for participants to decide
\nwhether to enter samples into biobanks and not
\nwithdrawing from research projects
\n\u2022 This amounts to controlling access to the data and
\ntheir use and ensuring that medical and personal
\ninformation is exclusively used for research purposes
\nand is not shared with third parties
\n\u00c1rnason, WMA Cape Town 11
\nReturning information
\n\u2022 While samples have been collected for many
\nbiobanks with the intention of doing basic genetic
\nresearch for production of generalizable knowledge,
\nthe question of responsible return of information to
\nindividuals is increasingly discussed.
\n\u2022 This relates to DoH, article 33
\n\u2013 At the conclusion of the study, patients entered into the
\nstudy are entitled to be informed about the outcome of
\nthe study and to share any benefits that result from it, for
\nexample, access to interventions identified as beneficial in
\nthe study or to other appropriate care or benefits.
\n\u00c1rnason, WMA Cape Town 12
\nGuidelines
\n\u2022 Managing return needs to be based on the
\nethical principles of non-maleficence,
\nbeneficence and respect for autonomy
\n\u2022 Incidental findings should be returned iff they
\n\u2013 are analytically valid
\n\u2013 reveal risk of a serious health condition that can
\nbe acted upon, cured or prevented
\n\u2013 There is no indication that the recipient would
\nprefer not to know
\n\u00c1rnason, WMA Cape Town 13
\nResponsible return
\n\u2022 Was the question of return raised in the initial
\nconsent form?
\n\u2022 Answer to this does not provide a necessary
\ncondition for returning results. This needs to be
\nassessed in a context of clinical counselling.
\n\u2022 The relevant thing is to find out whether people
\nwould like to be informed of a genetic finding for
\nwhich there are established therapeutic or
\npreventive interventions or other available actions
\nthat might change the clinical course of the disease.
\n\u00c1rnason, WMA Cape Town 14
\nAddition to DoH
\n\u2022 In light of recent developments in biobanks
\nresearch and future prospects, there is a need
\nto add a statement about return of findings in
\nthe DoH
\n\u2022 This could possibly be done by adding a
\nsentence to article 33 that would specifically
\naddress responsible return of incidental
\nfindings in the course of research on human
\nmaterial or by a short new article.
\n\u00c1rnason, WMA Cape Town 15
\nSources
\n\u2022 V. \u00c1rnason: \u201cCoding and Consent. Moral Challenges of the Database Project in
\nIceland\u201d, Bioethics 18 (2004:1), 39\u201361.
\n\u2022 V. \u00c1rnason: \u201cDatabase Research: Public and Private Interests\u201d, Cambridge
\nQuarterly of Health Care Ethics 20 (2011:4), 563\u2013571.
\n\u2022 A Cambon-Thomsen: \u201cThe social and ethical issues of post-genomic human
\nbiobanks\u201c. Nature Reviews. Genetics 5 (2004), 866\u2013873.
\n\u2022 F. Colledge, B. Elgar, H.C. Howard: \u201cThe impact of paragraph 25 on informed
\nconsent for biobank samples\u201c. Institute for Biomedical Ethics. Ppt. Lecture.
\n\u2022 M. Knoppers, M.H. Abdul Rahman: \u201cBiobanks in the Literature\u201d. In: A. Capron, ed.
\nEthical Issues in Governing Biobanks: Global Perspectives (Ashgate 2008), 13\u201322.
\n\u2022 WHO. Genetic Databases: Assessing the Benefits and Impact on Human and
\nPatient Rights
\n\u2022 WMA Declaration on Ethical Considerations regarding Health Databases, 2002.
\n\u2022 S.M. Wolf et. al.: \u201cManaging incidental findings and research results in genomic
\nresearch involving biobanks\u201c. Genetics in Medicine 14 (2012:4), 361\u2013384.
\n\u00c1rnason, WMA Cape Town 16
\nThank you!
\n17\u00c1rnason, WMA Cape Town<\/p>\n"},"caption":{"rendered":"

Cape_Town_12-Arnason Vilhj\u00e1lmur \u00c1rnason Biobanks Expert Conference on the Revision of the Declaration of Helsinki WMA, Cape Town, December 5\u20137, 2012 The issues \u2022 Obtaining information \u2022 The question of consent \u2013 articles 24 and 25 \u2022 Protecting information \u2022 Access to information \u2013 Article 23 \u2022 Returning information \u2013 article 33 \u00c1rnason, WMA Cape Town […]<\/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\/Cape_Town_12-Arnason.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3773"}],"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=3773"}]}}