The Trovan Trial Case Study: After profits or to save lives? Available at: http://www.amanet-trust.org/discuss/viewtopic.php?t=11

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The Trovan Trial Case Study After profits or to
save lives?Available at http//www.amanet-trust.
org/discuss/viewtopic.php?t11
Aceme NyikaEthics Coordinator AFRICAN MALARIA
NETWORK TRUST Tanzania Commission for Science and
Technology Building P.O. Box 33207, Dar es
Salaam, Tanzania Tel [phone], Fax 255
[phone] E-mail anyika_at_amanet-trust.org
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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

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Kenyan AIDS Orphans at Nyumbani

• Nyumbani orphanage was opened in 1992 by Father
  Angelo DAgostino
• 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.

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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)

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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

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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 DAgostino
  to conduct the research on the orphans
• Father Angelo DAgostino 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.

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Ethical approval in 2002

• Researchers applied for Ethical Approval in 2002
• The ethical approval was granted but not with
  retroactive effect.
• Kenyas 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.

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VULNERABILITY

• Were the children vulnerable?

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RESEARCH ON VULNERABLE GROUPS

• Should research ever be conducted on vulnerable
  groups?

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EXTRA PROTECTION

• How was the protection of the orphans compromised?

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Dr. Moses Otsyulas allegations

• What are your views on the allegations?

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Dr. Sarah Rowland-Jones response

• What are your views on her response?