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Research protocol

Article 3 of the WMO states that a committee can only issue a positive decision on the research protocol if:

  • The scientific research contributes to new insights in the field of medical science;
  • Such new insights can only be obtained through research with subjects and not with less intrusive research;
  • The importance of the research to the subjects and other current or future patients is in proportion to the objections (burden) and the risk for the subject. This takes into account the circumstances of persons belonging to the group of the subjects;
  • The study involves only a minimal risk and a minimal burden compared to the standard treatment of the subject's condition in the case of non-therapeutic research in incapacitated subjects or in subjects under the age of 16 years. If there is no standard treatment in these cases, a committee may issue a positive decision if the research involves only a minimal risk and a minimal burden considering the nature and severity of the subject's condition;
  • The research meets the requirements of a proper methodology of scientific research;
  • The research is carried out in appropriate institutes and by or under the supervision of professionals;
  • Any reimbursement to the subject did not form part of the reason for participating in the study if the subject is under 18 years of age (minor);
  • Any reimbursement to the subject did not disproportionately form part of the reason for participating in the study if the subject is 18 years of age or older (adult);
  • The person who carries out the research and the institution where the research is carried out receive a reimbursement not exceeding an amount that is reasonable in relation to the nature, extent and aim of the research;
  • The protocol clearly states how heavy the burden is on the subject and the extent to which the subjects can benefit from the research;
  • The protocol indicates which criteria subjects must meet in order to participate in the research;
  • The results of the research will be made available by the CCMO through the CCMO register, unless the person who carries out the research objects to this;
  • The research also complies with any other reasonable requirements.