1. Practical Ethical Issues in HIV Research in South Africa William M Pick Acting President Medical Research Council & Professor Emeritus University of the Witwatersrand

2. 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

3. Disclosure Informed consent “ubuntu” Role of Govt

4. 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

5. 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;

6. –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).

7. 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

8. 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

9. 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

10. No Consensus: obligations of sponsors –components of an acceptable package of treatment and care –the provision of anti-retrovirals

11. 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

12. –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

13. –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