Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
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