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Principles and Practices: The implementation of ethical guidelines for research on HIV Geneva, 2-3 June 2003 PowerPoint Presentation
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Principles and Practices: The implementation of ethical guidelines for research on HIV Geneva, 2-3 June 2003 Ethical guidelines for HIV vaccines: Generic versus specific issues and the question of exceptionalism José Esparza WHO-UNAIDS HIV Vaccine Initiative Initiative for Vaccine Research

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Principles and Practices: The implementation of ethical guidelines for research on HIVGeneva, 2-3 June 2003

Ethical guidelines for HIV vaccines: Generic versus specific issues and the question of exceptionalism

José Esparza

WHO-UNAIDS HIV Vaccine Initiative

Initiative for Vaccine Research

why to develop specific guidelines for hiv vaccine research
Why to develop specific guidelines for HIV vaccine research?
  • HIV/AIDS research was the driving force for the development of ethical review activities in many developing countries.
  • Vaccine research is specially sensitive because it involves the administration of biological products (experimental vaccines) to thousands (and eventually millions) of healthy people.
  • The perception exists that...
    • Vaccine research is very profitable for scientists and industry (glory and money).
    • Vulnerable volunteers in developing countries are used to test dangerous products before the vaccine is used in industrialized countries.
  • Need to ensure that vaccines tested in developing countries are made available in these countries.
an ethical disbalance on hiv aids research
An ethical disbalance on HIV/AIDS research?
  • The bulk of biomedical research on HIV/AIDS has been done to develop antiretroviral drugs, which (thus far) have mostly benefited patients in industrialized countries.
  • A safe, effective and affordable preventive vaccine is the best long term hope in developing countries, although not enough is being done to develop that vaccine (because of scientific, logistical, ethical and financial disincentives).
  • According to the late Jonathan Mann, the “paralysis in AIDS vaccine development violates ethical principles and human rights” (1998)
the unaids guidance document on ethical considerations in hiv preventive vaccine research
The UNAIDS Guidance Document on “Ethical considerations in HIV preventive vaccine research”
  • Regional consultations in 1998 (Brazil, Uganda, Thailand, Washington)
  • 120 participants, including ethicists, lawyers, activists, social and biomedical scientists, etc.
  • Plenary meeting in Geneva (1998)
  • Extensive discussion (1999)
  • Publication of the document in May 2000.
  • Use and adaptation by countries
some lessons learned
Some lessons learned
  • Reaching consensus in several regional consultations is not equivalent to reaching global consensus (different regional realities).
  • “Global” guidelines do not replace the need for decision making at the community and national level (guidelines can only offer guidance, and suggest standards and process for achieving standards).
  • Dilemma between choosing between the “highest” and the “highest attainable” standards.
  • Standards are moving targets.
unaids 18 guidance points
HIV vaccine development

Vaccine availability

Capacity building

Research protocols and study populations

Community participation

Scientific and ethical review

Vulnerable populations

Clinical trial phases

Potential harms

Benefits

Control group

Informed consent

Informed consent- special measures

Risk.reduction interventions

Monitoring informed consent and interventions

Care and treatment

Women

Children

UNAIDS 18 Guidance Points
unaids guidance point 16 care and treatment 1
UNAIDS Guidance Point 16: Care and treatment (1)
  • Care and treatment for HIV/AIFDS and its associated complications should be provided to participants in HIV preventive vaccine trials, with the ideal being to provide the best proven therapy (an established intervention), and the minimum to provide the highest level of care attainable in the host country in light of the circumstances listed below. A comprehensive care package should be agreed upon through a host/community/sponsor dialogue which reaches consensus prior to initiation of the trial, taking into consideration the following:
unaids guidance point 16 care and treatment 2
UNAIDS Guidance Point 16: Care and treatment (2)
  • level of care and treatment available in the sponsor country
  • highest level of care available in the host country
  • highest level of treatment available in the host country, including the availability of antiretroviral therapy outside the research context in the host country
  • availability of infrastructure to provide care and treatment in the context of the research
  • potential duration and sustainability of care and treatment for the trial participant
follow up of guidance point 16 and the question of exceptionalism
Follow-up of guidance point 16(and the question of exceptionalism)
  • With expanded access to antiretroviral therapies globally, the issue of level of care for HIV vaccine volunteers is not longer “IF” but “HOW”.
  • Standards and approaches proposed for vaccine trials should/would also be applicable to other AIDS prevention research.
  • WHO-UNAIDS consultation (17-18 July 2003)
    • scientific, ethical, operational and financial considerations
    • vaccines, microbicides, behavioural interventions
  • How (high) standards on HIV/AIDS research will influence standards for other research?