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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.

Norway
Legislations
  1. Oviedo Convention on Human Rights and Biomedicine (2006)
  2. Law regarding Ethics and Integrity in Research (2006)
  3. Act on Research in Health Care (2008) (Norwegian)
  4. Personal Data Act No. 31 (2000)

Regulations
  1. REK: Terms of Reference for the Regional Committees for Medical Research Ethics, Norway (2003)
  2. Regulation Relating to Clinical Trials on Medicinal Products for Human Use (2003)
  3. Regulations on the Processing of Personal Data (2003)

Guidelines

NEM:
  1. Research Ethical Review in Norway (1998)
  2. Standard Operating Procedures for the Regional Committees for Medical Research Ethics (2002)
NESH:
  1. Guidelines for Research Ethics in the Social Sciences, Law, and the Humanities (2001)
NENT:
  1. Research Ethics Guidelines for Science and Technology (2007) (Norwegian)
Guidelines for the Regulations Concerning Clinical Trials of Human Drugs (1999)
Guidance to the Regulation (2004) (Norwegian)
 
 


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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