{"id":3738,"date":"2017-01-20T11:53:17","date_gmt":"2017-01-20T11:53:17","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Colledge.pdf"},"modified":"2017-01-20T11:53:17","modified_gmt":"2017-01-20T11:53:17","slug":"colledge-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/colledge-2\/","title":{"rendered":"Colledge"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"<p class=\"attachment\"><a href='https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Colledge.pdf'>Colledge<\/a><\/p>\n<p>Flora Colledge<br \/>\nBernice Elger<br \/>\nHeidi C Howard<br \/>\nOverview<br \/>\n1. Changes<br \/>\n2. Implications and benefits<br \/>\n3. 3 key issues<br \/>\n4. Conclusion<br \/>\nPrevious versions 1964 &#8211; 2000<br \/>\n\u201c22. In ANY research on human beings, each potential subject must be<br \/>\nadequately informed of the aims, methods \u2026 the anticipated benefits and<br \/>\npotential risks of the study and the discomfort it may entail\u2026 the<br \/>\nphysician or another appropriately qualified individual must then seek<br \/>\nthe potential subject\u2019s freely-given informed consent\u2026\u201d<br \/>\n\u201c1. The World Medical Association has developed the Declaration of<br \/>\nHelsinki as a statement of ethical principles to provide guidance to<br \/>\nphysicians and other participants in medical research involving human<br \/>\nsubjects. Medical research involving human subjects INCLUDES research<br \/>\non identifiable human material or identifiable data.\u201d<br \/>\nA new paragraph &#8211; 2008<br \/>\n\u201c25. For medical research using identifiable human<br \/>\nmaterial or data, physicians must normally seek consent<br \/>\nfor the collection, analysis, storage and\/or reuse. There<br \/>\nmay be situations where consent would be impossible or<br \/>\nimpractical to obtain for such research or would pose a<br \/>\nthreat to the validity of the research. In such situations<br \/>\nthe research may be done only after consideration and<br \/>\napproval of a research ethics committee.\u201d<br \/>\nWhy discuss human material and<br \/>\ndata separately?<br \/>\nObtainment \u2013 research and clinical<br \/>\nSamples stored, sometimes indefinitely<br \/>\nPossible uses far into the future \u2013 unknowable<br \/>\nPossible use of archived samples<br \/>\nNo risk of physical harm<br \/>\nPotential for harms through identifiability<br \/>\nAmbiguous terms<br \/>\n\u201c25. For medical research using identifiable human<br \/>\nmaterial or data, physicians must normally seek consent<br \/>\nfor the collection, analysis, storage and\/or reuse. There<br \/>\nmay be situations where consent would be impossible<br \/>\nor impractical to obtain for such research or would pose<br \/>\na threat to the validity of the research. In such<br \/>\nsituations the research may be done only after<br \/>\nconsideration and approval of a research ethics<br \/>\ncommittee.\u201d<br \/>\nImplications<br \/>\nIn certain cases\u2026<br \/>\nNot mandatory to obtain fresh consent every time a new<br \/>\nstudy is proposed<br \/>\nNot mandatory to obtain consent when samples are<br \/>\nincluded in biobank<br \/>\nEthics committees will determine the permissibility of<br \/>\nthe study without accompanying consent<br \/>\nBenefits<br \/>\nMay widen sample pools<br \/>\nOld samples could be useable<br \/>\nResearch may be quicker\/cheaper\/less biased<br \/>\nRare samples could be useable<br \/>\nSamples of the deceased could be useable<br \/>\nThree emerging issues<br \/>\n1. The importance of seeking consent<br \/>\n2. Public engagement and trust<br \/>\n3. Confusion over applicability and standards<br \/>\n1. Seeking consent<br \/>\nSafeguard for patients and physicians<br \/>\nRespect- recognition of autonomy<br \/>\nDependent on meaning of impossible or impractical<br \/>\nWho decides? Puri et al.<br \/>\n2. Public trust<br \/>\nPublic perception of biobank research: Kaufman et al.<br \/>\nPublic views on consent\/ re-consent: Eurobarometer,<br \/>\nHoeyer et al., Johnsson et al.<br \/>\nFuture projects \u2013 place for broad consent?<br \/>\n3. Applicability<br \/>\nPrimacy of Declaration and national\/institutional rules<br \/>\nUse of the paragraph is not widely evidenced<br \/>\nIncreased burden for ethics committees<br \/>\nConcluding comments<br \/>\n1. Clarification of the scope of \u00abimpractical\u00bb and<br \/>\n\u00abthreat to validity\u00bb needed<br \/>\n2. Different implications for existing and new samples<br \/>\n(collection) require clarification<br \/>\n3. Better understanding of the risks of biobank<br \/>\nresearch needed<br \/>\nThank You<br \/>\nThank you to our sponsors: the University of Basel, the<br \/>\nMarie Curie FP7 Initiative, and the Kathe Zingg-<br \/>\nSchwichtenberg Foundation<br \/>\nflora.colledge@unibas.ch<\/p>\n"},"caption":{"rendered":"<p>Colledge Flora Colledge Bernice Elger Heidi C Howard Overview 1. Changes 2. Implications and benefits 3. 3 key issues 4. Conclusion Previous versions 1964 &#8211; 2000 \u201c22. In ANY research on human beings, each potential subject must be adequately informed of the aims, methods \u2026 the anticipated benefits and potential risks of the study and [&hellip;]<\/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\/Colledge.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3738"}],"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=3738"}]}}