Transcript Practical Ethical Issues in HIV Research in South Africa

Practical Ethical Issues in HIV
Research in South Africa
William M Pick
Acting President Medical Research
Council & Professor Emeritus
University of the Witwatersrand
South Africa
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Population 40 million
Population growth rate 1.8%
GDP per capita US$2 500/annum
Gini coefficient 0.58
IMR 45/1 000
8.5% of GDP on health care
– 60% private
• Disclosure
• Informed consent
• “ubuntu”
• Role of Govt
Vaccine development
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African Vaccine development
Clade
Intellectual property
1998 - workshop “Ethical issues…HIV
vaccine trials” - informed consent;
standards of care
• HIVNET, IAVI, Fogarty International, MRC
• 2-3 year delay
Care & Treatment
• Sponsors and Investigators must ensure
treatment and care for HIV-infected during
trial
• Treatment & care components :
– counselling; baseline screening and immune
monitoring; preventive methods and means;
prevention & treatment of opportunistic
infections and common morbidity;STI
treatment;TB prevention & treatment;
– Treatment & care components(contd) :
– Physician visits; nutrition; palliative care,
including pain control and spiritual care;
referral to social and community support;
family planing; home-based care, and
Antiretroviral therapy (ART).
• Sponsor /Investigator obligations depend
on:
– context of the trial, sponsor-host collaboration
& resources of sponsor
– design of trial, multi-national with arm in
sponsor country
– active promotion of welfare of recipients
– need to reduce inequitable access to health in
sponsor & host countries
• Sponsor /Investigator obligations (contd):
– fair distribution of overall risks and benefits of
research
– availability Or development of mechanisms to
ensure treatment (incl ART)
– international human rights standards
– risk to participants, incl false beliefs of vaccine
efficacy & increased risk behaviour; increased
susceptibility to infection or disease
Early Debates
• Some consensus:
– trial participants should receive better treatment
and care than in the public sector
– an improvement over what they would
ordinarily obtain
– some argued treatment rested on compensation
for injury - risk behaviour - false belief in
vaccine efficacy
– others argued distributive justice multinational inequities
• No Consensus:
• obligations of sponsors
– components of an acceptable package of
treatment and care
– the provision of anti-retrovirals
National Health Research Ethics
Committee February 2003
• sets norms for health research in RSA
• Agreed:
– sponsors and investigators should ensure access
to or provide care including ARV
– HIV infected AFTER trial referred to existing
health care services
– HIV infected at screening for participation in
trial referred to existing health care services
– Trial participants who become infected during
trial, then withdraw, but continue appropriate
follow-up receive same treatment as if they had
not withdrawn
– sponsors should contribute funds to ensure
treatment & care of participants PRIOR to
initiation of any trial
– National Trust Fund to facilitate Rx and Care
for trial participants
– Rx and care according to South African HIV
Clinician’s Society Guideline, until national
govt guidelines in place
– Guidelines to be reviewed regularly
– Trial linked health care service centres should
have capacity strengthened - - lasting benefit
– High quality care could act as incentive to
participate BUT reflects active promotion of
welfare of participants, fair treatment of
participants