SSStudyParticipantsInformedConsent object
Not specified
Definition Informed consent form: 'a documented proof of consent, given based on detailed and comprehensible information about the study'
Prior to participation in the trial, the subject, or the subject’s legal representative, will be informed by the principal investigator or by an investigator who is also a physician or dental practitioner fully knowledgeable in the subject matter of trial, sufficiently and in a manner comprehensible to the subject or the subject’s legal representative, on the objective, methodology, expected benefits, foreseeable risks, challenges, and any aspects unfavorable to the subject’s health or personal characteristics, as well as the conditions under which the study will be conducted and carried out, and that the subject is free to withdraw from the trial whenever the subject so wishes. The subject’s consent will be obtained that he or she will be participating in the trial by his or her completely free will, and this will be documented on a Subject’s Informed Consent Form.
Specific requirements for obtaining informed consent apply to vulnerable population (minors, incapacitated persons, etc).