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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.



  1. Newfoundland and Labrador: Bill 23: An Act to Establish a Health Research Ethics Authority for the Province of Newfoundland and Labrador (2006)
  2. Northwest Territories: Scientist Act (1988)  
  3. Nunavut: Nunavut Scientists Act (1988)   
  4. Quebec:
    Civil Code of Quebec, S.Q., c. 64: Articles 11, 20, 21, 22, 24 and 25 (1991)
    An Act Respecting Health Services and Social Services R.S.Q., c.S-4.2: Articles 19.1 and 19.2
  5. Yukon Territory: Yukon Scientists and Explorers Act (2000)
  6. Privacy Act, Sections 7-8 (1983)
  7. Personal Information Protection and Electronic Documents Act, Articles 5 and 7 (2001)Note: Each of the Canadian provinces and territories has also enacted privacy legislation


  1. Good Clinical Practice Consolidated Guideline (1997)
  2. Regulations Amending the Food and Drug Regulations (1024 – Clinical Trials) (2004)


  1. RCAP: Ethical Guidelines for Research (1993)
  2. National Defence: Research Involving Human Subjects (1998)
  3. Correctional Service of Canada: Commissioner’s Directive - Research: DCOO9 (2004)
  4. PRE:  Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2005)
  5. FRSQ: Research Ethics and Scientific Integrity Guidelines (2003)
  6. CIHR: CIHR Best Practices for Protecting Privacy in Health Research (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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