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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.
New Zealand
Legislations
  1. Health Research Council Act 1990, Sections 24 and 25
  2. New Zealand Bill of Rights Act, Article 10 (1990)
  3. Health and Disability Commissioner Act 1994
  4. New Zealand Public Health and Disability Act 2000, Section 16
  5. Injury Prevention, Rehabilitation, and Compensation Act 2001
  6. Medicines Act 1981(2005)
  7. Official Information Act (1982)
  8. Public Records Act (2005)
  9. Privacy Act 1993 (2006)

Regulations
  1. HDC: The Code of Health and Disability Services Consumers’ Rights (the Code of Rights) (2004)    
  2. Health Information Privacy Code 1994

Guidelines

HRC:
  1. Guidelines for Researchers on Health Research Involving Māori (1998)     
  2. Guidelines on Ethics in Health Research (2005)
NEAC:
  1. Goals, Objectives, and Desired Outcomes of an Ethical Review System (2003)
  2. Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities (2006)
MOH:
  1. Operational Standards for Ethics Committees (2006)
  2. RMI: Guidelines on Clinical Trials: Compensation for Injury Resulting from Participation in an Industry Sponsored Clinical Trial (1997)     
  3. Medsafe: New Zealand Regulatory Guidelines for Medicines, Vol. 3: Interim Good Clinical Research Practice Guidelines (1998)
  		 


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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