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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.
South Africa
Legislations
  1. National Health Act No. 61, DH: Chapter 9 (2003)

Regulations
  1. DH: Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa (2006)

Guidelines
  1. Ethics in Health Research: Principles, Structures, and Processes (2004)
MRC:
  1. Guidelines on Ethics in Medical Research: General Principles (2002)
  2. Guidelines on Ethics in the Use of Biohazards and Radiation (2003)
  3. Guidelines on Ethics in HIV Vaccine Trials (2003)
  		 


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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