Keynote speaker USA Keynote speaker Do H guideline

(Keynote speaker, USA)

(Keynote speaker, 德國)

引言人建議 Do. H guideline之應修正之部份 Problems with the Declaration • At least 6 major problems Confuses patient care and research Disorganized bordering on incoherence Repetitive provisions Contradictory provisions Contains vacuous statements Makes ethical judgments that appear to lack justification

Keynote speaker建議Do. H guideline可修正之方向 The next revision: • The character of the Do. H should remain. • The size should not increase. • The Do. H must remain distinct from other guidelines! • Not a revolution, but an evolution • The aim is a more appropriate and updated version of the Do. H. • If there are no strong arguments for a change, the paragraph will remain.

Keynote speaker之結論摘要 Conclusion • Reformat and refocus the Declaration. • Given you an initial attempt at that reformulation. • Careful statement of principles is needed.

Keynote speaker之結論摘要 Conclusion • The Declaration is to remain relevant and to remain a short document, then n It must become a broad statement of principles much like a Constitution. n This means it will be interpreted and specified by particular laws and regulations in countries. • Thus the Declaration is “Constitution-like”and its form should reflect this.

Vulnerable groups報告之結論 Conclusion • Don’t list the vulnerable • Provide a clear guidance: vulnerability is a matter of degree. -Protecting vulnerability implies a duty to guarantee equal protection for vulnerable participants, whose health and rights are more difficult to protect • Stick to the general guidance : require a case by case specification but don’t do it within the Do. H. • As far as vulnerability is concerned, scrap the rest: all other so-called protections of vulnerability should really apply to everyone.

世界衛生組織代表報告重要內容摘要 Strengthening ethics review systems

• Vulnerable populations(Guidance 8) -Multiple vulnerabilities: cultural, social, economical, political -Multiple groups: women, children, adolescents, sex workers, indigenous, poor, etc. Assess determination of vulnerability at an early stage Design of the protocol should consider incidental risks of social harm and establish measures to prevent them. “If the risk of exploitation is severe, the research should not be conducted. ”

• Normative framework -Consultative Expert Working Group on Research and Development –Financing and coordination -UNAIDS/WHO guidance document • Vulnerable populations • Availability of outcomes • Strengthening ethics review systems -Operational standards/RECs-Oversight of RECs -Improving transparency in research (ICTRP) e. g. Pan African clinical Trials Alliance • Building global consensus e. g. working group of NEC’s on Biobanking

• Joint reviews of multicenter trials e. g. DNDi proposal on African Trypanosomiasis Treatment African Vaccine Regulatory Forum(AVAREF) • Recommendations for the implementation of existing guidance in specific cases e. g. placebo controlled vaccine trials

• Global Summit of NEC’s Working groups of on Biobanking -Identification of questions to be addressed • • Consent Public engagement Role of RECs Harmonization of legal frameworks Governance Benefit sharing etc. -Coordination with on going initiatives in other international organizations

Pan African Clinical trial Alliance -RECs and NRA’s from 20 Sub Saharan African countries (AVAREF) -Focus on coordination and harmonization of ethics review and approval including clinical trail registration bouesseaum@who. int http: //www. who. int/ethics/en (WHO網址)

國際藥廠協會報告重要內容摘要 - Use of placebo in clinical trials - Use of comparators based on differences in standard of care and availability of medicines between developed , emerging and developing countries - Conduct of clinical trials in vulnerable patient populations - Post study access to medical care

• Limited clarify is provided in the Declaration of Helsinki or other ethical guidance documents about: -What constitutes post-study medical care -Which population/s should receive post-study access to medical care -Who is responsible to provide post-study access to medical care -When post-study access to medical care could/should end • Our comments relate to post-study access to study medications

• When conducting clinical trials in vulnerable patient populations particular attention should be given , for example, to: -Ethical justifications for their inclusion -Risks of undue influence, abuse or coercion -Respect for their dignity, rights, safety and welfare, local norms and culture -Expertise and experience required to conduct the clinical study -Challenges of the consent/assent process -Role of legal/authorized representative

本次會議總結報告(共識) 建議Do. H之修正方向 Consensus building/ summing up 報告人: Dr. Jeff Blackmer(加拿大) Dr. Urban Wiesing(德國)

Vulnerable groups(易受傷害群體) • Clarify and strengthen existing language • Build on current paragraphs • Don’t try and develop comprehensive lists

General (原則上Do. H之修正方向) • Document should be better organized for ease of use and readability • Should have universal applicability • Basic ethical principles and standards that can be applied worldwide

Post study arrangements(研究後之安排 ) • Do. H needs to continue to address this issue • Importance of continuity of care from the research to the community setting • Burden of providing access should be shared (and agents should be identified) • Benefits to host communities should be fair and not restricted by responsiveness requirement

Biobanks(人體生物資料庫) • Need to clarify consent requirements • Open consent versus wide consent with the right to withdraw • Whether to address the issue of disclosure of incidental findings (specific to biobanks or in general) • Don’t need specific paragraph on the topic

Enhancement(其他衍生性研究) • Consensus that, while important, issue is either sufficiently captured by relevant current articles or may even fall outside of the framework of the Do. H

Research Ethics Committees (研究倫理委員會) • Important role for Do. H in presenting basic principles and minimum standards • Balance this with being too specific/proscriptive • Clarification of role of local REC compared to remote REC’s when study sponsor is not local or trial is multinational

Positions of international organizations(國際組織之角色) • Important role of Do. H as high level principledriven international standard • Need to continue to strive for balance between sufficient detail to assist researchers and others versus too much detail that would undermine local circumstances

Insurance/compensation/protection (保險/代償/保障) • Paragraph 14 may not be strong enough • Should consider a more definitive commitment to some form of protection and allowances for ”fair compensation” in the case of complications or adverse outcomes • May benefit from a separate paragraph

Unproven interventions/off label use(未經核可之用途) • Paragraph 35 -complex issue • Delete paragraph? Part of paragraph? First sentence? • Important distinction between ”unproven” and “offlabel” • Strengthen requirement to tie it to research and more clearly reflect the purpose of the paragraph • Move up in document(Para 4/5)

Broad consent-Paragraph 25 (較廣的同意範圍) • Broad/general consent is acceptable to most subjects • “Broad consent is ethically acceptable” • Option of tiered consent • Need for last sentence? • Change “reuse” to “ single or multiples uses”; timeline? ; “future uses”

Research in children (在小孩方面的研究) • No consensus on need to include children separately in the Do. H • Concepts of assent/dissent/cognitive abilities(Para 28) • Encourage research in populations underrepresented in research(Para 5)