SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
Where the subject matter of research is directly related to children or is a clinical condition that can be investigated only in children, or it is necessary to verify the applicability of adult data to children, it may be permitted to conduct a study in children.
If a child is capable of expressing assent, written consent of the child’s parents, or custodian, where applicable, must be also obtained, in addition to the child’s assent.
The ethics committee will be informed on the clinical, ethical, psychological and social aspects of the trial by a pediatrician who holds a doctoral or medical residency degree in pediatric dentistry, and give consideration to the protocol accordingly. An ethics committee cannot approve any clinical trial in children unless a favorable view for conducting the study in children has been given by a pediatrician. If deemed necessary for these trials, the opinion of a pediatrician or a pediatric dentist holding a doctoral or medical residency degree in a field relevant to the subject matter of the trial will be consulted, and the decision on whether or not to authorize the trial will be based on such opinion
Regulation on Clinical Trials of Medicinal and Biological Products 2014.
A detailed guideline is available (Guidance on Ethical Approaches for Clinical Trials Conducted with A Pediatric Population 2013).
Yes
Special provisions apply
Where the subject matter of research is directly related to incapacitated persons or is a clinical condition that can be investigated only in incapacitated persons or all existing therapy options to treat the incapacitated person’s condition have been exhausted, it may be permitted to conduct a study.
The ethics committee will be informed on the clinical, ethical, psychological and social aspects of the trial by a physician specialized in the subject matter being investigated, and give consideration to the protocol accordingly.
Regulation on Clinical Trials of Medicinal and Biological Products 2014
Yes
Special provisions apply
Where the subject matter of research is directly related to persons unconscious or in intensive care, or is a clinical condition that can be investigated only in persons unconscious or in intensive care or all existing therapy options to treat their condition have been exhausted, it may be permitted to conduct a study in persons unconscious or in intensive care.
The ethics committee will be informed on the clinical, ethical, psychological and social aspects of the trial by a physician specialized in the subject matter being investigated, and give consideration to the protocol accordingly.
Written consent must be obtained of legal representatives or relatives of persons unconscious or in intensive care.
Written consent must be obtained of legal representatives or relatives of persons unconscious or in intensive care.
In the event a person unconscious or in intensive care or their legal representative or relatives cannot be reached to obtain their written consent, persons unconscious or in intensive care may be included in a trial, under the responsibility of the principal investigator or an investigator who is a medical doctor, provided the following requirements have been met:
a) The ethics committee must have given consideration to the proposed study protocol and other pertinent documents to determine whether the trial in question sufficiently meets ethical requirements.
b) In cases occurring suddenly, requiring urgent medical intervention and where existing therapy options have been completely exhausted, there is common medical view that the study will directly benefit persons unconscious or in intensive care.
If a person unconscious or in intensive care becomes capable of weighing the information provided to them and reaching a sound decision, they must be removed from the trial immediately if they wish to withdraw from the study at any stage, or refuse to take part in it (Regulation on Clinical Trials of Medicinal and Biological Products 2014).
Regulation on Clinical Trials of Medicinal and Biological Products 2014
Yes
Special provisions apply
Where the subject matter of research is directly related to pregnant, puerperal or breastfeeding women or is a clinical condition that can be investigated only in pregnant, puerperal or breastfeeding women, it may be permitted to conduct a study in pregnant, puerperal or breastfeeding women.
The ethics committee will be informed on the clinical, ethical, psychological and social aspects of the trial, particularly with regard to fetal or infant health, by a physician specialized in the subject matter being investigated, and give consideration to the protocol accordingly.
Regulation on Clinical Trials of Medicinal and Biological Products 2014
