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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. Population 40 million Population growth rate 1.8% GDP per capita US$2 500/annum Gini coefficient 0.58
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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 • 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 • 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