{"id":3836,"date":"2017-01-20T12:26:51","date_gmt":"2017-01-20T12:26:51","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Summary_DoH_-_Blackmer.pdf"},"modified":"2017-01-20T12:26:51","modified_gmt":"2017-01-20T12:26:51","slug":"summary_doh_-_blackmer-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/es\/summary_doh_-_blackmer-2\/","title":{"rendered":"Summary_DoH_-_Blackmer"},"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\/Summary_DoH_-_Blackmer.pdf'>Summary_DoH_-_Blackmer<\/a><\/p>\n<p>Consensus<br \/>\nbuilding\/summing<br \/>\nup<br \/>\nDr. Jeff Blackmer<br \/>\nDr. Urban Wiesing<br \/>\nGeneral<br \/>\n\u2022 Document should be better organized for ease of use and<br \/>\nreadability<br \/>\n\u2022 Should have universal applicability<br \/>\n\u2022 Basic ethical principles and standards that can be applied<br \/>\nworldwide<br \/>\nVulnerable groups<br \/>\n\u2022 Clarify and strengthen existing language<br \/>\n\u2022 Build on current paragraphs<br \/>\n\u2022 Don\u2019t try and develop comprehensive lists<br \/>\nBiobanks<br \/>\n\u2022 Need to clarify consent requirements<br \/>\n\u2022 Open consent versus wide consent with the right to<br \/>\nwithdraw<br \/>\n\u2022 Whether to address the issue of disclosure of incidental<br \/>\nfindings (specific to biobanks or in general)<br \/>\n\u2022 Don\u2019t need specific paragraph on the topic<br \/>\nPost study arrangements<br \/>\n\u2022 DoH needs to continue to address this issue<br \/>\n\u2022 Importance of continuity of care from the research to the<br \/>\ncommunity setting<br \/>\n\u2022 Burden of providing access should be shared (and agents<br \/>\nshould be identified)<br \/>\n\u2022 Benefits to host communities should be fair and not<br \/>\nrestricted by responsiveness requirement<br \/>\nResearch Ethics Committees<br \/>\n\u2022 Important role for DoH in presenting basic principles and<br \/>\nminimum standards<br \/>\n\u2022 Balance this with being too specific\/proscriptive<br \/>\n\u2022 Clarification of role of local REC compared to remote<br \/>\nREC\u2019s when study sponsor is not local or trial is multi-<br \/>\nnational<br \/>\nEnhancement<br \/>\n\u2022 Consensus that, while important, issue is either<br \/>\nsufficiently captured by relevant current articles or may<br \/>\neven fall outside of the framework of the DoH<br \/>\nPositions of international<br \/>\norganizations<br \/>\n\u2022 Important role of DoH as high level principle-driven<br \/>\ninternational standard<br \/>\n\u2022 Need to continue to strive for balance between sufficient<br \/>\ndetail to assist researchers and others versus too much<br \/>\ndetail that would undermine local circumstances<br \/>\n\u2022 Important role of REB\u2019s, need to also involve them in<br \/>\ndiscussions of post trial access and benefits<br \/>\n\u2022 Post trial access must be made transparent and<br \/>\ndescribed prior to approval<br \/>\n\u2022 Responsible agents must be identified<br \/>\n\u2022 No consensus on best approach to use to determine<br \/>\nmost appropriate post trial benefits\/access<br \/>\n\u2022 Any additions or changes to the DoH should only be<br \/>\nmade where there is a sound and compelling ethical<br \/>\nrationale for doing so<br \/>\n\u2022 Should only revise provisions that create problems<br \/>\nInsurance\/compensation\/prot<br \/>\nection<br \/>\n\u2022 Paragraph 14 may not be strong enough<br \/>\n\u2022 Should consider a more definitive commitment to some<br \/>\nform of protection and allowances for \u201cfair<br \/>\ncompensation\u201d in the case of complications or adverse<br \/>\noutcomes<br \/>\n\u2022 May benefit from a separate paragraph<br \/>\nUnproven interventions\/off<br \/>\nlabel use<br \/>\n\u2022 Paragraph 35 \u2013 complex issue<br \/>\n\u2022 Delete paragraph? Part of paragraph? First sentence?<br \/>\n\u2022 Important distinction between \u201cunproven\u201d and \u201coff-<br \/>\nlabel\u201d<br \/>\n\u2022 Strengthen requirement to tie it to research and more<br \/>\nclearly reflect the purpose of the paragraph<br \/>\n\u2022 Move up in document (Para 4\/5)?<br \/>\nBroad consent \u2013 Paragraph 25<br \/>\n\u2022 Broad\/general consent is acceptable to most subjects<br \/>\n\u2022 \u201cBroad consent is ethically acceptable\u201d<br \/>\n\u2022 Option of tiered consent<br \/>\n\u2022 Need for last sentence?<br \/>\n\u2022 Change \u201creuse\u201d to \u201csingle or multiple uses\u201d; timeline?;<br \/>\n\u201cfuture uses\u201d<br \/>\nResearch in children<br \/>\n\u2022 No consensus on need to include children separately in the<br \/>\nDoH<br \/>\n\u2022 Concepts of assent\/dissent\/cognitive abilities (Para 28)<br \/>\n\u2022 Encourage research in populations under-represented in<br \/>\nresearch (Para 5)<\/p>\n"},"caption":{"rendered":"<p>Summary_DoH_-_Blackmer Consensus building\/summing up Dr. Jeff Blackmer Dr. Urban Wiesing General \u2022 Document should be better organized for ease of use and readability \u2022 Should have universal applicability \u2022 Basic ethical principles and standards that can be applied worldwide Vulnerable groups \u2022 Clarify and strengthen existing language \u2022 Build on current paragraphs \u2022 Don\u2019t try [&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\/Summary_DoH_-_Blackmer.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/es\/wp-json\/wp\/v2\/media\/3836"}],"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=3836"}]}}