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The Trovan Trial Case Study: After profits or to save lives? Available at: http://www.amanet-trust.org/discuss/viewtopic

The Trovan Trial Case Study: After profits or to save lives? Available at: http://www.amanet-trust.org/discuss/viewtopic.php?t=11. Aceme Nyika Ethics Coordinator AFRICAN MALARIA NETWORK TRUST Tanzania Commission for Science and Technology Building P.O. Box 33207, Dar es Salaam, Tanzania

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The Trovan Trial Case Study: After profits or to save lives? Available at: http://www.amanet-trust.org/discuss/viewtopic

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  1. The Trovan Trial Case Study: After profits or to save lives?Available at: http://www.amanet-trust.org/discuss/viewtopic.php?t=11 Aceme NyikaEthics Coordinator AFRICAN MALARIA NETWORK TRUST Tanzania Commission for Science and Technology Building P.O. Box 33207, Dar es Salaam, Tanzania Tel: 255 (022) 2700018, Fax: 255 (022) 2700380 E-mail: anyika@amanet-trust.org

  2. Outline of presentation • Nyumbani orphanage • International Collaborative Research at Nyumbani • Controversy Breaks Out • Researchers applied for Ethical Approval in 2002 • Unpacking the ethical issues: Interactive discussion

  3. Kenyan AIDS Orphans at Nyumbani • Nyumbani orphanage was opened in 1992 by Father Angelo D’Agostino • The orphanage was registered as a limited company under Kenyan law, Companies Act Cap 486 • Aim to accommodate children orphaned by the HIV/AIDS pandemic. • The AIDS orphans were drawn mainly from the slums of Nairobi. • By the year 2000, was home to over 70 orphans.

  4. International Collaborative Research at Nyumbani • Some HIV positive orphans at Nyumbani seemed to survive longer without any medication than is generally the case with HIV positive-children of the same age. • Researchers started genetic studies on orphans. • Dr. Moses Otsyula (Institute of Primate Research, Kenya) and Dr Sarah Rowland-Jones (University of Oxford, UK)

  5. Controversy Breaks Out • In 2001 Dr. Moses Otsyula alleged that Dr. Sarah Rowland-Jones’ team stole blood samples from his lab when he was in the USA to explore potential collaboration with Harvard University • He alleges that the team collected more samples without ethical approval • Papers based on the samples were published

  6. Controversy continued • Dr. Sarah Rowland-Jones claimed that the Oxford team had been invited by Dr Moses Otsyula to Kenya and that they had been led to believe by Dr. Moses Otsyula that ethical approval for the study had been granted • Dr. Sarah Rowland added that the Oxford team had been given permission by Father Angelo D’Agostino to conduct the research on the orphans • Father Angelo D’Agostino had allegedly said that Nyumbani Home had all the necessary documents authorising collection of blood samples from the orphans and for conduct of the research.

  7. Ethical approval in 2002 • Researchers applied for Ethical Approval in 2002 • The ethical approval was granted but not with retroactive effect. • Kenya’s National Council for Science and Technology, a government body that was mandated with reviewing and approving research in Kenya, initiated an investigation into the matter. • As the controversy was unfolding, a researcher from Cambridge University, Dr. Eric Miller, visited the Nyumbani orphanage to explore possibilities of conducting collaborative research on the nutritional benefits to HIV positive people of certain food supplements.

  8. VULNERABILITY Were the children vulnerable?

  9. RESEARCH ON VULNERABLE GROUPS Should research ever be conducted on vulnerable groups?

  10. EXTRA PROTECTION How was the protection of the orphans compromised?

  11. Dr. Moses Otsyula’s allegations What are your views on the allegations?

  12. Dr. Sarah Rowland-Jones’ response What are your views on her response?

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