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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 Research agenda during an outbreak

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ethics in public health policy development and research for a h1n1 influenza

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

research agenda during an outbreak3
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

research activities public health ethics during international infectious diseases outbreaks

Research activities & public health ethics during international infectious diseases outbreaks

research activities public health ethics during international infectious diseases outbreaks5
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)
research activities public health ethics during international infectious diseases outbreaks6
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”

research activities public health ethics during international infectious diseases outbreaks7
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”

research activities public health ethics during international infectious diseases outbreaks8
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.

research activities public health ethics during international infectious diseases outbreaks9
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. ”

research activities public health ethics during international infectious diseases outbreaks10
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

sharing knowledge information samples12
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
sharing knowledge information samples13
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.

gold standards in knowledge evidence based information for public health decisions15
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
gold standards in knowledge evidence based information for public health decisions17
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

heathcare workers rights and duties19
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
heathcare workers rights and duties20
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)
heathcare workers rights and duties21
Heathcare workersRights and duties

The discussion on vaccination « duties » may be extended to :

  • Other occupations
  • General population
priority setting access to resources ethical issues
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
priority setting ethical issues24
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 ?
public health distancing measures ethical issues26
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.

public health distancing measures ethical issues27
Public health ‘distancing measures’Ethical issues

Further discussions/research needed on public health measures that could involve individual liberties or confidentiality

trust and confidence in public health response measures29
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

trust and confidence in public health response measures30
Trust and confidenceIn public health response measures

More discussions /research needed on :

Global messages and their understanding by populations

Transparency in hyper-complex situations

conclusion
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.