{"id":3787,"date":"2017-01-20T12:25:31","date_gmt":"2017-01-20T12:25:31","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/DoH_Cape_Town_Enhancement_-_Wiesing.pdf"},"modified":"2017-01-20T12:25:31","modified_gmt":"2017-01-20T12:25:31","slug":"doh_cape_town_enhancement_-_wiesing-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/doh_cape_town_enhancement_-_wiesing-2\/","title":{"rendered":"DoH_Cape_Town_Enhancement_-_Wiesing"},"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\/DoH_Cape_Town_Enhancement_-_Wiesing.pdf'>DoH_Cape_Town_Enhancement_-_Wiesing<\/a><\/p>\n<p>Research on Enhancement \u2013<br \/>\nan Issue for the Declaration of<br \/>\nHelsinki?<br \/>\nUrban Wiesing, T\u00fcbingen<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nEnhancement \u2013 an issue?<br \/>\n\u2022 The practice of enhancement is growing.<br \/>\n\u2022 Neuroenhancement, aesthetic surgery,<br \/>\nfitness\u2026<br \/>\n\u2022 The debate on enhancement is growing.<br \/>\n\u2022 The efforts in enhancement will increase!<br \/>\n\u2022 Enhancement is an issue of the future!<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nResearch on enhancement \u2013 an issue?<br \/>\n\u2022 Mainly off-label use<br \/>\n\u2022 Currently no evidence for all of the alleged<br \/>\nenhancement technologies about efficacy,<br \/>\neffectiveness, safety, unwanted effects.<br \/>\n(Except drugs with unacceptable side-<br \/>\neffects).<br \/>\n\u201cThe claimed and assumed benefits are often<br \/>\nexaggerated.\u201d (Saskia Nagel)<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nResearch on enhancement \u2013 an issue?<br \/>\n\u2022 Research on enhancement is necessary.<br \/>\n\u2022 Current use is not based on valid information.<br \/>\n\u2022 Scientific evidence is also needed for a social<br \/>\nand political debate!<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nNorms in research on enhancement?<br \/>\n\u2022 All norms for research involving human beings<br \/>\nare valid in research on enhancement.<br \/>\n\u2022 In addition: There is no health benefit in case of<br \/>\nsuccessful research on enhancement.<br \/>\n\uf0a7 Risk\/benefit assessment is different<br \/>\n\u2022 The patient must be informed about the nature<br \/>\nof the research: no health benefit!<br \/>\n\uf0a7 Informed consent is different<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nResearch on enhancement is not<br \/>\nexplicitly mentioned in the DoH<br \/>\nArt. 7 : \u201cThe primary purpose of medical research<br \/>\ninvolving human subjects is to understand the causes,<br \/>\ndevelopment and effects of diseases and improve<br \/>\npreventive, diagnostic and therapeutic interventions<br \/>\n(methods, procedures and treatments).\u201d<br \/>\nResearch on enhancement: research with medical<br \/>\ntechnologies for non-medical purposes<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nAre the norms for research on<br \/>\nenhancement covered by the DoH?<br \/>\nYes, implicitly:<br \/>\nPart B: PRINCIPLES FOR ALL MEDICAL RESEARCH<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nAre the norms for research on<br \/>\nenhancement covered by the DoH?<br \/>\nrisk\/benefit assessment:<br \/>\nArt. 18: \u201cEvery medical research study involving human subjects<br \/>\nmust be preceded by careful assessment of predictable risks and<br \/>\nburdens to the individuals and communities involved in the<br \/>\nresearch in comparison with foreseeable benefits to them and to<br \/>\nother individuals or communities affected by the condition under<br \/>\ninvestigation.\u201d<br \/>\nArt. 21: \u201cMedical research involving human subjects may only be<br \/>\nconducted if the importance of the objective outweighs the<br \/>\ninherent risks and burdens to the research subjects.\u201d<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nAre the norms for research on<br \/>\nenhancement covered by the DoH?<br \/>\nInformed consent:<br \/>\nArt 24: \u201cIn medical research involving competent human<br \/>\nsubjects, each potential subject must be adequately<br \/>\ninformed of the aims, methods, sources of funding, any<br \/>\npossible conflicts of interest, institutional affiliations of<br \/>\nthe researcher, the anticipated benefits and potential<br \/>\nrisks of the study and the discomfort it may entail, and<br \/>\nany other relevant aspects of the study.\u201d<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nA proposal for a new paragraph:<br \/>\nThe norms of the Declaration are also valid for<br \/>\nmedical research on enhancement. The<br \/>\nrisk\/benefit assessment must be extremely<br \/>\ncareful, if no medical benefit can be gained by<br \/>\nthe research. The participants must be<br \/>\ninformed about the non-medical purposes of<br \/>\nthe research.<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nFinal remarks<br \/>\n\u2022 The final decision whether to implement a paragraph<br \/>\non research on enhancement is a political decision.<br \/>\n\u2022 There are other issues that could be regulated explicitly<br \/>\nin the DoH as well.<br \/>\n\u2022 Other considerations have to be taken into account<br \/>\n(length of the DoH, importance of the issue, are<br \/>\nexplicitly mentioned norms necessary?\u2026)<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<br \/>\nResearch on Enhancement &#8211;<br \/>\nan Issue for the Declaration<br \/>\nof Helsinki?<br \/>\nUrban Wiesing, T\u00fcbingen<br \/>\nInstitut f\u00fcr Ethik und<br \/>\nGeschichte der Medizin<\/p>\n"},"caption":{"rendered":"<p>DoH_Cape_Town_Enhancement_-_Wiesing Research on Enhancement \u2013 an Issue for the Declaration of Helsinki? Urban Wiesing, T\u00fcbingen Institut f\u00fcr Ethik und Geschichte der Medizin Enhancement \u2013 an issue? \u2022 The practice of enhancement is growing. \u2022 Neuroenhancement, aesthetic surgery, fitness\u2026 \u2022 The debate on enhancement is growing. \u2022 The efforts in enhancement will increase! \u2022 Enhancement is [&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\/DoH_Cape_Town_Enhancement_-_Wiesing.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3787"}],"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=3787"}]}}