{"id":3755,"date":"2017-01-20T11:53:45","date_gmt":"2017-01-20T11:53:45","guid":{"rendered":"https:\/\/www.wma.net\/wp-content\/uploads\/2017\/01\/Rid.pdf"},"modified":"2017-01-20T11:53:45","modified_gmt":"2017-01-20T11:53:45","slug":"rid-2","status":"inherit","type":"attachment","link":"https:\/\/www.wma.net\/fr\/rid-2\/","title":{"rendered":"Rid"},"author":2,"comment_status":"open","ping_status":"closed","template":"","meta":[],"acf":[],"description":{"rendered":"

Rid<\/a><\/p>\n

Institute of Biomedical Ethics
\n7\/3\/2012 Page 1
\nShould the Declaration of
\nHelsinki become more
\n\u201crisk-based\u201d?
\nDr med Annette Rid
\nWMA Satellite Meeting during the 11th World Congress of Bioethics:
\n\u201cThinking ahead \u2013 The future of the Declaration of Helsinki\u201d
\nRotterdam, Netherlands, June 26, 2012
\nInstitute of Biomedical Ethics
\nThe case for \u201crisk-adapted\u201d research protections
\nRisk-adapted systems of research oversight 1) calibrate various safeguards and
\nprotections to the level of risk posed to participants (e.g., ethical review) and
\n2) set upper risk limits for certain types of research (e.g., pediatric research)
\nEthical case
\n– Balance between protecting study participants and promoting valuable
\nresearch
\n– Focus oversight on risky research
\nRegulatory case
\n– Efficiency in ensuring that ethical and regulatory requirements are met
\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? – Annette Rid Page 2
\nInstitute of Biomedical Ethics
\nThe risk-adapted Declaration of Helsinki (2008)
\nExplicit risk-adapted elements
\n– Research with incompetent subjects that has no likelihood of benefit for
\nthem: only if minimal risk and minimal burden (\u00a727)
\n– Medical research with medical care: only if no adverse health effect
\n(\u00a731)
\n– Placebo controls when a proven intervention exist: only if no risk of
\nserious or irreversible harm (\u00a732) )
\nImplicit risk-adapted elements
\n– Waiver of consent in research with identifiable human material or
\ndata when consent is impossible or impractical to obtain (\u00a725)
\n– Emergency research without informed consent if the research cannot
\nbe delayed (\u00a729)
\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? – Annette Rid Page 3
\nInstitute of Biomedical Ethics
\nProblems of current research protections
\nOverprotection in low-risk research
\n– Criticism from stakeholders
\n– Current framework developed in reaction to blatant abuse
\n– New research methods that generally pose low risks (e.g., genetic
\nresearch, biobanking, health services research)
\nUnderprotection in high-risk research
\n– Cases of poor risk management (e.g., TeGenero dosing)
\n– No explicit upper risk limit in research with competent consenting
\nparticipants
\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? – Annette Rid Page 4
\nInstitute of Biomedical Ethics
\nProposals for risk-adapted research oversight
\nInternational
\n– OECD Global Science Forum (2011)
\n– European Commission (2011)
\n– European Medical Research Council \/ European Science Foundation (2009)
\n– Roadmap Initiative for Clinical Trials in Europe (2010)
\n– European Medicines Agency (2011)
\nNational
\n– U.S. Department of Health and Human Services \/ FDA (2011)
\n– U.K. National Research Ethics Service (2008\/2010)
\n– U.K. Department of Health, Medical Research Council, Medicines and
\nHealthcare Products Regulatory Agency (2011)
\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? – Annette Rid Page 5
\nInstitute of Biomedical Ethics
\nStratification of research risks
\n1) Risks of \u201cnon-beneficial\u201d research interventions
\n– Minimal \/ greater than minimal risk (U.S. DHHS, U.K. NRES)
\n1) Risks of \u201cbeneficial\u201d research interventions
\n– Marketed interventions used under licensed indication (ECRIN, OECD,
\nU.K. DH \/ MRC \/ MHRA, EC)
\n– Marketed interventions used outside of licensed indication (ECRIN,
\nOECD, U.K. DH \/ MRC \/ MHRA)
\n– Non-marketed interventions (ECRIN, OECD, U.K. DH \/ MRC \/ MHRA)
\n1) Mixed approach (EMRC \/ ESF)
\n7\/3\/2012 \u201cShould the Declaration of Helsinki become more \u201crisk-based?\u201d – Annette Rid Page 6
\nInstitute of Biomedical Ethics
\nRisk-adapted safeguards and protections
\n1) Research ethics review
\n– Excused, exempt, expedited, full review (U.S. DHHS, U.K. NRES, ECRIN,
\nOECD, EMRC \/ ESF)
\n– No continuing review, continuing review (U.S. DHHS)
\n– Informational risks excluded from review (U.S. DHHS)
\n2) Informed consent process
\n– \u201cLight\u201d patient information, regular information (ECRIN)
\n3) Safety monitoring & management
\n– Simplified safety reporting, periodic safety reporting (ECRIN, EC)
\n– Safety monitoring (ECRIN, OECD, EMRC \/ ESF, U.K. DH \/ MRC \/ MHRA)
\n– Insurance (ECRIN, OECD, EMRC \/ ESF, EC)
\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? – Annette Rid Page 7
\nInstitute of Biomedical Ethics
\nCritical appraisal of current proposals
\nRisk stratification
\n– A more nuanced risk stratification is needed, but the marketing status
\nof study interventions is a poor indicator of risk
\nRisk-adapted protections
\n– Research ethics review is widely calibrated to risk: sensible in terms of
\nprotecting participants\u2019 interests, but participants\u2019 rights also need to be
\nprotected (e.g., research involving deception)
\n– Safety monitoring & management are widely adapted to risk: sensible
\nsince the goal is to protect participants\u2019 interests
\n– Risk-adapted requirements for the informed consent process are not
\nwidely endorsed: appropriate since the relationship between risk and
\nconsent remains to be clarified
\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? – Annette Rid Page 8
\nInstitute of Biomedical Ethics
\nRecommendations for revising the Declaration
\n1) Clarify the role of risk in research
\n2) Streamline the use of risk (maintaining the minimal risk threshold)
\n3) Accommodate risk-adapted ethical review
\n1) Introduce risk-adapted safety monitoring & management
\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? – Annette Rid Page 9
\nInstitute of Biomedical Ethics
\n1) Clarifying the role of risk in research
\n– Revise \u00a76 \u201c(\u2026) the well-being of the individual research subject must
\ntake precedence over all other interests\u201d to emphasize that it is ethical
\nto expose participants to some level of risk for the benefit of others
\n\uf0aa Proposed wording \u00a76 : \u201cIn medical research involving human subjects,
\nthe individual subjects should not be exposed to excessive risks for the
\nsake of scientific progress or social welfare\u201d
\n– This revision also removes the inconsistency between \u00a76 and \u00a721
\n\u201cMedical research (\u2026) may only be conducted if the importance of the
\nobjective outweighs the inherent risks and burdens to the research
\nsubjects\u201d
\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? – Annette Rid Page 10
\nInstitute of Biomedical Ethics
\n2) Streamlining the use of risk
\n– Streamline the different uses of risk and replace with \u201cminimal risk\u201d
\ndefined as a low likelihood of harm or burden
\n\uf0aa Proposed wording: \u201cA research interventions poses minimal risks if it
\nis associated with a very low likelihood of serious physical,
\npsychological or social harm (e.g., <0.1 per 100\u2019000) and\/or a low\nlikelihood of significant harm (e.g., <10 per 100\u2019000)\u201d\n- Adapt the provisions on research without informed consent (\u00a727) and\nadd minimal risk requirements to the paragraphs on waivers of\nconsent (\u00a725) and emergency research (\u00a729)\n- Adapt the provision on placebo controls (\u00a732): minimal risk in\nresearch without informed consent, no excessive risk with consent\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? - Annette Rid Page 11\nInstitute of Biomedical Ethics\n3) Accommodating risk-adapted ethical review\n- Revise \u00a715 \u201cThe research protocol must be submitted for (\u2026)\napproval to a research ethics committee before the study begins (\u2026)\u201d\nto allow for exceptions from ethical review and ethical review by less\nthan a full committee in low-risk research\n\uf0aa Proposed wording \u00a715: \u201cReview by less than a full research ethics\ncommittee may be appropriate in research involving no more than\nminimal risks.\u201d\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? - Annette Rid Page 12\nInstitute of Biomedical Ethics\nAccommodating risk-adapted ethical review ctd.\n- Revise \u00a715 \u201cNo change to the protocol may be made without (\u2026)\napproval by the committee\u201d to allow for exceptions from continuing\nreview in minimal risk research\n\uf0aa Proposed wording \u00a715: \u201cChanges to the protocol should normally be\napproved by the committee, but exceptions may be appropriate in\nminimal risk research.\u201d\n- Add factors unrelated to risk that should trigger regular ethical review\n\uf0aa Proposed wording \u00a715: \u201cFull ethical review is required in research\nthat raises concerns other than risk (e.g., research involving\ndeception, research with vulnerable populations).\u201d\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? - Annette Rid Page 13\nInstitute of Biomedical Ethics\n4) Allowing risk-adapted safety management\n- Revise \u00a720 \u201cPhysicians may not participate in a research study (\u2026)\nunless they are confident that the risks (\u2026) can be satisfactorily\nmanaged\u201d to encourage risk-adapted safety management\n\uf0aa Proposed wording \u00a720: \u201cResearchers should monitor and plan for\naddressing adverse events. Safety monitoring should be\nproportionate to the risks posed by a study.\u201d\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? - Annette Rid Page 14\nInstitute of Biomedical Ethics\nObjections and replies\n1) Risk-adapted provisions weaken subject protections\nNo, they specify the combination of safeguards that is necessary for\nprotecting participants at the given level of risk\n2) Risk-adapted provisions weaken the Declaration\nNo, they strengthen the Declaration by better balancing research and\nprotection and staying in sync with current practice and developments\n3) Risk-adapted provisions require setting controversial risk thresholds\nNo, controversy will be limited by continuing to use the minimal risk threshold\n4) Considerations of risk do not exhaust the ethics of research\nYes, this will become evident in other parts of the Declaration\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? - Annette Rid Page 15\nInstitute of Biomedical Ethics\nThank you\nrid@ethik.uzh.ch\n7\/3\/2012 Should the Declaration of Helsinki become more \u201crisk-based\u201d? - Annette Rid Page 16\n\n<\/p>\n"},"caption":{"rendered":"

Rid Institute of Biomedical Ethics 7\/3\/2012 Page 1 Should the Declaration of Helsinki become more \u201crisk-based\u201d? Dr med Annette Rid WMA Satellite Meeting during the 11th World Congress of Bioethics: \u201cThinking ahead \u2013 The future of the Declaration of Helsinki\u201d Rotterdam, Netherlands, June 26, 2012 Institute of Biomedical Ethics The case for \u201crisk-adapted\u201d research protections […]<\/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\/Rid.pdf","_links":{"self":[{"href":"https:\/\/www.wma.net\/fr\/wp-json\/wp\/v2\/media\/3755"}],"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=3755"}]}}