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Marc Guerrier Espace éthique / AP-HP, WHO CC for Bioethics, Paris

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Presentation on theme: "Marc Guerrier Espace éthique / AP-HP, WHO CC for Bioethics, Paris"— Presentation transcript:

1 Ethics in public health policy development and research for A/H1N1 influenza
Marc Guerrier Espace éthique / AP-HP, WHO CC for Bioethics, Paris Andreas Reis WHO-HQ ETH, Geneva Ross Upshur Joint Center for Bioethics, CanPrep, WHO CC for Bioethics, Toronto

2 Research agenda during an outbreak

3 Research agenda during an outbreak
This meeting is part of the current pandemic response Mechanisms 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 decisions New research questions might be emerging in the near future as the pandemic evolves

4 Research activities & public health ethics during international infectious diseases outbreaks

5 Research activities & public health ethics during international infectious diseases outbreaks
Lessons learned while setting retrospective and prospective studies since April 09 Time-consuming processes (ex. research ethics committees usually take several weeks/months to assess projects) Specific research ethics questions arising (ex. antiviral clinical trials) Links between research activities and public health activities (ex. population monitoring)

6 Time-consuming processes, (including RECs)
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”

7 Specific questions arising about research ethics
Research activities & public health ethics during international infectious diseases outbreaks Specific questions arising about research ethics WHO 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”

8 Specific questions arising about research ethics references
Research activities & public health ethics during international infectious diseases outbreaks Specific questions arising about research ethics references WHO 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.

9 Links between research activities and public health activities
Research activities & public health ethics during international infectious diseases outbreaks Links between research activities and public health activities WHO 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. ”

10 Links between research activities and public health activities
Research activities & public health ethics during international infectious diseases outbreaks Links between research activities and public health activities WHO 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

11 Sharing knowledge, information, samples

12 Sharing knowledge, information, samples
Lessons learned since April 09 (and before) In a number of instances, rapid information sharing is occurring (sometimes raising specific ethical issues, such as confidentiality) The Indonesia H5N1 samples episode brought important discussions Research information – sometimes critical – (raw data, results) are often held back, or kept confidential

13 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.

14 Gold standards in knowledge: evidence-based information for public health decisions

15 Knowledge is still being generated, ex :
Gold standards in knowledge: evidence-based information for public health decisions Knowledge is still being generated, ex : Use of masks: ongoing research Use of antivirals: ongoing research Vaccine interactions (seasonal / H1N1 2009) Pandemic modelling: ongoing research Vaccination: ongoing research

16 Gold standards in knowledge: evidence-based information for public health decisions

17 The usual ways web consider medical knowledge Standards ‘for evidence’
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

18 Heathcare workers Rights and duties

19 Heathcare workers Rights 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

20 Heathcare workers Rights 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)

21 Heathcare workers Rights and duties
The discussion on vaccination « duties » may be extended to : Other occupations General population

22 Priority setting Ethical issues

23 Priority setting & access to resources Ethical 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

24 Priority setting Ethical 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 ?

25 Public health ‘distancing measures’ Ethical issues

26 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.

27 Public health ‘distancing measures’ Ethical issues
Further discussions/research needed on public health measures that could involve individual liberties or confidentiality

28 Trust and confidence In public health response measures

29 Trust and confidence In 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

30 Trust and confidence In public health response measures
More discussions /research needed on : Global messages and their understanding by populations Transparency in hyper-complex situations

31 Conclusion The options taken by a research agenda for influenza outbreaks will be strengthened by its explicit ethical underpinnings Research ethics during global infectious outbreaks deserves further studies Ethical aspects of research implementation directly influence research More research is needed on key ethical topics of response and planning for influenza outbreaks 2009 and after The interactions between researches in : ethics, medical sciences, public health policies and social science are of the utmost importance.


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