Assessment of Applications

In preparing its assessment of a clinical trial protocol, the NBC shall pay particular attention to the following:

  • the value and procedures of the clinical trial of a medicinal product or device;
  • whether the assessment of the intended benefits and risks involved is satisfactory
  • the trial protocol;
  • the qualifications of the investigator/principal investigator and assistants;
  • the investigators brochure;
  • the quality of the facilities;
  • is the written information for participants satisfactory, and are the procedures to be followed in obtaining informed consent satisfactory;
  • are evt arguments for including individuals incapable of giving informed consent satisfactory, with regard to legal limitations;
  • are provisions for insurance or compensation if the participation in the clinical trial results in injury or death - it has to be possible to make such claims within Icelandic jurisdiction:
  • does insurance or compensation to cover the liability of the investigator and sponsor for compensation;
  • the amount and, as applicable, the means of compensation to the investigators and subjects and what conceivable right to compensation they have;
  • the arrangement for enrolling participants.