SSStudyParticipantsInformedConsent object
Yes
Informed consent form is defined as 'a documented proof of consent, given based on detailed and comprehensible information about the study'.
The person who volunteers to participate into the research or his legal representative shall, before commencement of the investigation, be given information on the purpose, methodology of the investigation, the expected benefits, foreseeable risks, difficulties, aspects that are not appropriate in light of the health and personal characteristics of the person, the conditions at which the investigation will be conducted, continued, and the fact that the person has the right to withdraw from the investigation at any stage he may so desire, sufficiently, and comprehensibly, by a principal investigator from the investigation team or an investigator who is a medical doctor or dentist, who is well-informed on the subject of the investigation.
The consent of the volunteer, which the volunteer has given at his own free will in order to be included into the research, which is not dependent on provision of a benefit, will be taken and this fact shall be documented with the informed consent form.
The volunteer can leave the research at any time he way wish at his own consent with or without showing grounds, and he will not lose his rights at the time of subsequent medical follow up and treatment.
Specific requirements for obtaining informed consent apply to vulnerable population (minors, incapacitated persons, unconscious persons, etc).