[email protected]@sls.aphp.fr Ethics in public health policy development and research for A/H1N1 influenza Marc.

[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


Research agenda during an outbreak


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


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)



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”



Specific questions arising about research ethicsWHO Technical Consultation (June 10-11, 2009)Research Ethics in International Epidemic Response


“ [...] even in an infectious disease emergency or other crisis situation, the principles and values embodied in international and national ethics guidelines must be upheld”



Specific questions arising about research ethics referencesWHO Technical Consultation (June 10-11, 2009)Research Ethics in International Epidemic Response


Example of an issue arising from this : Risk-Benefit analysis, trials requiring antiviral treatment on very mild forms, etc.



Links between research activities and public health activitiesWHO Technical Consultation (June 10-11, 2009)Research Ethics in International Epidemic Response


“ [...] 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. ”



Links between research activities and public health activitiesWHO Technical Consultation (June 10-11, 2009)Research Ethics in International Epidemic Response


Example: public health surveillance and epidemiological research


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



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 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





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 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



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)



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

- Other occupations- General population


Priority settingEthical 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 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 issues



Ex. since Apr. 09 :- Border management- Quarantines (boats, hotels, etc.)- School closures- Etc.

Some in line with international recommendations, some not.



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


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



More discussions /research needed on :

Global messages and their understanding by populations

Transparency in hyper-complex situations


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.

[email protected]@sls.aphp.fr Ethics in public health policy development and research for A/H1N1 influenza Marc.

Documents

public health research

research information

research ethics references

research ethics committees

public health activities

espaceeth ethics

research priorities

espaceeth research agenda