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[email protected] www.espace-ethique.org
Ethics in public health policy development and research for A/H1N1 influenza
Marc GuerrierEspace éthique / AP-HP, WHO CC for Bioethics, Paris
Andreas ReisWHO-HQ ETH, Geneva
Ross UpshurJoint Center for Bioethics, CanPrep, WHO CC for Bioethics, Toronto
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Research agenda during an outbreak
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Research agenda during an outbreak
This meeting is part of the current pandemic responseMechanisms by which Public Health Needs, and hence Research Priorities are defined during an outbreak are of the utmost importance : the scope of work goes beyond research or scientific issues
An explicit consensual view on Public Health Needs with regard to the pandemic underpins decisionsNew research questions might be emerging in the near future as the pandemic evolves
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Research activities & public health ethics during international infectious diseases outbreaks
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Research activities & public health ethics during international infectious diseases outbreaks
Lessons learned while setting retrospective and prospective studies since April 09
1. Time-consuming processes (ex. research ethics committees usually take several weeks/months to assess projects)
2. Specific research ethics questions arising (ex. antiviral clinical trials)
3. Links between research activities and public health activities (ex. population monitoring)
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Research activities & public health ethics during international infectious diseases outbreaks
Time-consuming processes, (including RECs)WHO Technical Consultation (June 10-11, 2009)Research Ethics in International Epidemic Response
(Draft Report, Carl Coleman & Voo Teck Chuan)
“ [...] it is crucial to streamline the ethics review process and to establish appropriate, flexible mechanisms and procedures for ethical oversight not limited to traditional REC systems”
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Research activities & public health ethics during international infectious diseases outbreaks
Specific questions arising about research ethicsWHO Technical Consultation (June 10-11, 2009)Research Ethics in International Epidemic Response
(Draft Report, Carl Coleman & Voo Teck Chuan)
“ [...] even in an infectious disease emergency or other crisis situation, the principles and values embodied in international and national ethics guidelines must be upheld”
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Research activities & public health ethics during international infectious diseases outbreaks
Specific questions arising about research ethics referencesWHO Technical Consultation (June 10-11, 2009)Research Ethics in International Epidemic Response
(Draft Report, Carl Coleman & Voo Teck Chuan)
Example of an issue arising from this : Risk-Benefit analysis, trials requiring antiviral treatment on very mild forms, etc.
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Research activities & public health ethics during international infectious diseases outbreaks
Links between research activities and public health activitiesWHO Technical Consultation (June 10-11, 2009)Research Ethics in International Epidemic Response
(Draft Report, Carl Coleman & Voo Teck Chuan)
“ [...] The participants noted that defining the boundary between public health-oriented research and practice remains a critical challenge in public health ethics. The purpose in distinguishing the two activities goes beyond semantic concerns because of the different ways in which public health research and practice are regulated in many countries. ”
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Research activities & public health ethics during international infectious diseases outbreaks
Links between research activities and public health activitiesWHO Technical Consultation (June 10-11, 2009)Research Ethics in International Epidemic Response
(Draft Report, Carl Coleman & Voo Teck Chuan)
Example: public health surveillance and epidemiological research
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Sharing knowledge, information, samples
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Sharing knowledge, information, samples
Lessons learned since April 09 (and before)
1. In a number of instances, rapid information sharing is occurring (sometimes raising specific ethical issues, such as confidentiality)
2. The Indonesia H5N1 samples episode brought important discussions
3. Research information – sometimes critical – (raw data, results) are often held back, or kept confidential
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Sharing knowledge, information, samples
A specific overarching ‘set of rules’ governing raw research data, peer-review and publication during global public health emergencies should be discussed.
This should address how reciprocity and responsibility principles (among others) could be fairly applied in such settings.
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Gold standards in knowledge: evidence-based information for public health decisions
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Gold standards in knowledge: evidence-based information for public health decisions
Knowledge is still being generated, ex :
1. Use of masks: ongoing research2. Use of antivirals: ongoing research3. Vaccine interactions (seasonal / H1N1 2009)4. Pandemic modelling: ongoing research5. Vaccination: ongoing research
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Gold standards in knowledge: evidence-based information for public health decisions
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Gold standards in knowledge: evidence-based information for public health decisions
The usual ways web consider medical knowledge • Standards ‘for evidence’• Thresholds for decision-making
(ex. vaccine, masks, antivirals, etc.)
Are challenged by rapidly evolving global threats
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Heathcare workersRights and duties
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Heathcare workersRights and duties
Since April 09• Abstenteeism : overall not a real issue so far, reason for
absenteeism is illness (and not refusal to work)
• Vaccination uptake : very contrasted picture according to countries (no vaccine available, ‘high’ uptake, very low uptake, incentive/project of mandatory vaccination, etc)
• Issue of role-model of HCP
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Heathcare workersRights and duties
Further discussions / research needed:
Duty/Rights/Reciprocity for healthcare workers, and certain professional categories – no clear policies in many countries
• Ex1. Human resources and severe pandemic outbreaks• Ex2. Should there be some kind obligation (or pressure ?) for
vaccination, to which extent? – Influenza vaccination in general is at stake – Levels are individual, relatives, collective & viral (mutations)
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Heathcare workersRights and duties
The discussion on vaccination « duties » may be extended to :
- Other occupations- General population
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Priority settingEthical issues
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Priority setting & access to resourcesEthical issues
Since April 09
• Vaccines (and antivirals)– Global level: complex mechanisms of distribution (commercial, non-
commercial). Both raise ethical issues of global justice.– Local levels: priorities change with location and time
• Key healthcare resources, as ICUs– In some locations : near the red line in first wave, preparing for new
surge– In some countries : discussions on ICU access
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Priority settingEthical issues
Further discussion & research needed :
• Vaccines / Antivirals at global level– Ethical underpinnings of resource allocation among countries, public
health goals
• Key healthcare resources, as ICUs- Ex. should severity scores (as SOFA) be used ? What non medical
criteria should be adopted ?
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Public health ‘distancing measures’Ethical issues
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Public health ‘distancing measures’Ethical issues
Ex. since Apr. 09 :- Border management- Quarantines (boats, hotels, etc.)- School closures- Etc.
Some in line with international recommendations, some not.
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Public health ‘distancing measures’Ethical issues
Further discussions/research needed on public health measures that could involve individual liberties or confidentiality
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Trust and confidenceIn public health response measures
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Trust and confidenceIn public health response measures
Since Apr 2009 :
- Population behavior with regard to vaccination- Recommendations on prevention measures (hand
cleaning, masks)
Have shown that population involvement is not granted
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Trust and confidenceIn public health response measures
More discussions /research needed on :
Global messages and their understanding by populations
Transparency in hyper-complex situations
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Conclusion
1. The options taken by a research agenda for influenza outbreaks will be strengthened by its explicit ethical underpinnings
2. Research ethics during global infectious outbreaks deserves further studies
3. Ethical aspects of research implementation directly influence research4. More research is needed on key ethical topics of response and planning
for influenza outbreaks 2009 and after5. The interactions between researches in : ethics, medical sciences,
public health policies and social science are of the utmost importance.