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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
Kenya

Legislations

  1. Science and Technology Act (2001)
  2. HIV and AIDS Prevention and Control Act, Chapter 14 (2006)
  3. Pharmacy and Poisons Act, Chapter 244 (2001)


Guidelines 

  1. NCST: Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya (2004)
  2. MOH: Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines (2005)
  		 


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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