Nyumbani orphanage case in Kenya involving Oxford University, are not described.For each trial, selected information sources areprovided. Most sources are publicly accessible websites, but some require a subscription.
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The case descriptions also refer to norms in widely accepted international codes that have (probably) beenviolated. The most cited reference is the Declaration ofHelsinki (DoH) of the World Medical Association (WMA).European regulations specify that the trials providing theunderlying data for marketing applications of new drugsneed to comply with the Declaration of Helsinki. TheWorld Health Organization (WHO) Guidelines for GoodClinical Practice (GCP) for trials on pharmaceuticalproducts also endorses the DoH as the accepted basisfor clinical trial ethics. Some important paragraphs fromthe declaration are briefly summarized below.8. Vulnerable research populations require specialprotection.11. Research must be based on knowledge of laboratory and animal experimentation.13. The protocol for a clinical trial should bereviewed by an independent ethical review committee. The researchers must report any serious adverse events to this committee.16. The design of all studies should be publicly available.17. Investigations should be ceased if the risks ar efound to outweigh the potential benefits.19. The research is only justified if there is areasonable likelihood that the populations in which the research is carried out stand tobenefit from the results of the research.20. Participation in a trial must be voluntary and participants must be informed.22. Physicians should obtain freely-given informedconsent from each participant