{"id":3775,"date":"2017-01-20T12:25:12","date_gmt":"2017-01-20T12:25:12","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/CIOMS_presentation_WMA_-_Delden.pdf"},"modified":"2017-01-20T12:25:12","modified_gmt":"2017-01-20T12:25:12","slug":"cioms_presentation_wma_-_delden-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/cioms_presentation_wma_-_delden-2\/","title":{"rendered":"CIOMS_presentation_WMA_-_Delden"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

CIOMS_presentation_WMA_-_Delden<\/a><\/p>\n

CIOMS ethical guidelines for
\nBiomedical Research:
\nsome issues for the revision
\nProf dr JJM van Delden MD PhD
\nProfessor of medical ethics, UMC Utrecht
\nPresident CIOMS
\nj.j.m.vandelden@umcutrecht.nl
\nWhat is CIOMS?
\n\u2022 An NGO: international, non-governmental, non-profit
\norganization
\n\u2022 Forum to consider and prepare advice on
\ncontentious issues in research ethics and safety of
\npharmaceuticals…
\n\u2022 … for WHO, public health authorities, academia,
\npharmaceutical industry and others.
\n\u2022 Established 1949 by WHO and UNESCO
\n\u2022 Offices located in Geneva, Switzerland
\nCIOMS BM research ethics guidelines
\n\u2022 Purpose: indicate how fundamental ethical principles
\nand Declaration of Helsinki can be applied effectively
\nin medical research world-wide in different:
\n\u2013 cultures, religions, traditions, socioeconomic
\ncircumstances;
\n\u2013 with special attention for low and middle income
\ncountries.
\n\u2022 Content: 21 guidelines plus commentaries (!)
\n\u2022 Use: 2002 Guidelines have been widely used, notably
\nin developing countries.
\n\u2013 Indication: translation into several languages, including French,
\nSpanish, Portuguese, Chinese, Arabic, Czech, and Vietnamese.
\nRevision of CIOMS guidelines
\n\u2022 For many reasons CIOMS decided to revise the 2002
\nglns:
\n\u2013 changes in other relevant documents
\n\u2013 changes in the field of research
\n\u2013 changes in existing regulations and ethical practices by
\nhealth authorities
\n\u2013 developments within research ethics
\n\u2022 Process started in 2012
\n\u2022 So I will show issues to deal with, rather than fixed
\npositions
\nObligations of researchers: overview
\n1. Pre-trial obligations
\n2. (Obligations during the trial)
\n3. Post-trial obligations
\nPre-trial obligations: issues
\n\u2022 Responsiveness to health needs & priorities
\n(CIOMS, DoH)
\n\u2022 Justifying exclusion of groups (CIOMS)
\n\u2022 Not a limitative list
\nCIOMS guideline 10
\n\u2022 Before undertaking research in a population or
\ncommunity with limited resources, the sponsor and
\nthe investigator must make every effort to ensure
\nthat:
\n– the research is responsive to the health needs and
\nthe priorities of the population or community in
\nwhich it is to be carried out; and
\n– any intervention or product developed, or
\nknowledge generated, will be made reasonably
\navailable for the benefit of that population or
\ncommunity.
\nResponsiveness: comments
\n\u2022 Intuitively a good requirement: avoids
\nexploitation
\n\u2022 Not so clear what it means
\n\u2022 What is a health need\/priority? When is research
\njustifiably called responsive?
\n\u2022 Relation with reasonable availability!
\n\u2022 People in LMIC may want to study diseases
\nthat are no priority
\nCIOMS guideline 12
\nGroups or communities to be invited to be subjects
\nof research should be selected in such a way that
\nthe burdens and benefits of the research will be
\nequitably distributed. The exclusion of groups or
\ncommunities that might benefit from study
\nparticipation must be justified.
\nJustifying exclusion: comments
\n\u2022 Participation in research seems to have become a
\ngood which should be distributed equitably: very
\ndifficult to realize (whose duty?)
\n\u2022 no group (including vulnerable people) should be
\ndeprived of its fair share of the benefits of research,
\nboth direct and indirect
\n\u2022 May mean that we have to do away with the
\nsubsidiarity
\nPost-trial obligations
\n\u2022 Responsiveness and reasonable availability
\n(CIOMS)
\n\u2022 Fair benefits approach (NIH, DoH?)
\nReasonable availability
\n\u2022 Ensures certain type of benefits is provided
\n\u2022 Identifies addressee
\n\u2022 Prior agreements necessary
\n\u2022 Down side:
\n\u2013 exact level is not defined (how much? How long?)
\n\u2013 applies to Phase III (IV) research mainly, not to
\nother phases or epidemiological research
\nFair Benefits Approach
\n\u2022 Wider range of benefits (e.g. infrastructure)
\n\u2022 Wider applicability (not just phase III)
\n\u2022 Collaborative partnership
\n\u2022 Prior agreement
\nFB or RA: a heated debate?
\n\u2022 In reality: a lot in common
\n\u2022 Main differences:
\n\u2013 type of benefit made available
\n\u2013 Position of responsiveness as starting point
\n\u2022 In common:
\n\u2013 Sense of obligation \u201cto close the circle\u201d (na\u00efve idea about time line?)
\n\u2013 No clear idea about exact level of benefits required
\n\u2013 Also in RA other benefits than the study product could be part of the
\nagreement
\n\u2013 Prior agreement through negotiation, about which participants are
\ninformed
\n\u2022 Real ethical question (for both!): why exactly do we have
\nthese obligations? And to whom?
\nConclusions
\n\u2022 Ethical concerns augment when conducting
\nresearch in LMIC
\n\u2022 Intuitively clear that we owe participants in
\ndeveloping countries special obligations
\n\u2022 Supercontractual obligations may be
\nnecessary, but need further justification
\n\u2022 Revised CIOMS guidelines (2015?) will provide
\nyet another provisional fixed point<\/p>\n"},"caption":{"rendered":"

CIOMS_presentation_WMA_-_Delden CIOMS ethical guidelines for Biomedical Research: some issues for the revision Prof dr JJM van Delden MD PhD Professor of medical ethics, UMC Utrecht President CIOMS j.j.m.vandelden@umcutrecht.nl What is CIOMS? \u2022 An NGO: international, non-governmental, non-profit organization \u2022 Forum to consider and prepare advice on contentious issues in research ethics and safety of pharmaceuticals… […]<\/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\/CIOMS_presentation_WMA_-_Delden.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3775"}],"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=3775"}]}}