SSStudyParticipantsVulnerablePopulation object
Yes
Special provisions apply
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.
In cases where the research directly interests children or it is a clinical situation that can be investigated only on children or in cases where it is compulsory to prove the applicability of data that have been obtained as a result of researches conducted on adult persons also in respect of children, if the research does not pose a foreseeable risk for the health of the volunteer and if there is a general medical opinion to the effect that the research will produce a direct benefit on volunteers, permission may be granted for a research to be conducted on children within the framework of the principles specified below:
a) There must be a general medical opinion to the effect that the clinical research does not involve a known risk on children.
b) If the child has the power to disclose his own consent, in addition to his own consent, also the written consent of his guardians or parents shall be taken.
c) If the child refuses to participate in the research or if the child wishes to withdraw from the research at any stage of the research, the child will be taken out of the research.
d) If the child has the capacity to make an evaluation regarding the information provided to him and form an opinion on this subject, all the information related to the research shall be explained to the child in an appropriate manner.
e) The ethics committee shall be given information regarding clinical, psychological and social problems in connection with the investigation by a pediatrician and the protocol shall be evaluated from that stance.
f) In all kinds of clinical trials that will be conducted on children, ethics committee shall not grant approval for such trial unless there is place an affirmative opinion of a pediatrician for such research to be conducted on children. In case it is deemed necessary for these studies, opinion shall be taken from a physician or dentist who has completed his doctorate or specialization degree in the branch related to the subject of the research and the decision as to whether permission will be granted or not for such research shall be made according to such opinion.
f) For clinical trials that will be conducted on children, no persuasive incentives or financial offers may be made, except reimbursement of compulsory expenses that will arise as a result of children’s participation into the research.
Regulation On Medical Device Clinical Trials 2014
A detailed guideline is available (Guidance on Ethical Approaches for Clinical Trials Conducted with A Pediatric Population 2013).
Yes
Special provisions apply
If the subject of the trial directly concerns incapacitated persons or if it is clinical case that can be investigated only on incapacitated persons or in cases where the existing treatment options related to the disease of the incapacitated person have been entirely consumed, if it does not involve a foreseeable risk for the health of the incapacitated person, and if there is a general medical opinion to the effect that the research shall bring a direct benefit for the incapacitated persons, permission maybe granted for a research to be conducted on incapacitated persons within the principles specified below:
a) There must be a general medical opinion to the effect that the clinical trial does not involve any known risk on incapacitated persons.
b) If such incapacitated person has the capacity to give his own consent, the written consent of the his own and the consent of his guardian shall be taken.
c) If the incapacitated person has the capacity to evaluate the information given to him and form an opinion in this respect, and if refuses to participate in the research or if they wish to withdraw from the research at any stage of the research they will be promptly taken out of the research.
d) The ethics committee shall be given information regarding clinical, ethical, psychological and social problems in connection with the investigation by a physician specialised in the relevant branch and a psychiatrist, and the protocol shall be evaluated from that stance.
d) For the clinical trials that will be conducted on incapacitated persons, no persuasive incentives or financial offers may be made, except reimbursement of compulsory expenses that will arise as a result of their participation into the research.
Regulation On Medical Device Clinical Trials 2014
Yes
Special provisions apply
If the subject of the trial directly concerns unconscious persons or if it is clinical case that can be investigated only on unconscious persons or in cases where the existing treatment options related to the disease of the unconscious person have been entirely consumed, if it does not involve a foreseeable risk for the health of the unconscious person, and if there is a general medical opinion to the effect that the research shall bring a direct benefit for the unconscious persons, permission maybe granted for a research to be conducted on unconscious persons within the principles specified below:
a) There must be a general medical opinion to the effect that the clinical trial does not involve any known risk on unconscious persons.
b) Written consent shall be taken from the legal representatives of such unconscious persons, if any, and if there is no legal representative, his relatives,
c) If the unconscious persons regain the capacity to evaluate the information given to them and form an opinion in this respect, and if they refuse to participate in the research or if they wish to withdraw from the research at any stage of the research they will be promptly taken out of the research.
d) The ethics committee shall be given information regarding clinical, ethical, psychological and social problems in connection with the investigation by a physician specialised in the branch related to the subject of the research, and the protocol shall be evaluated from that stance,
e) For the clinical trials that will be conducted on unconscious persons, no persuasive incentives or financial offers may be made, except reimbursement of compulsory expenses that will arise as a result of their participation into the research.
Yes
Special provisions apply
In case the written consents cannot be taken since the legal representatives or relatives of the unconscious persons being inaccessible, the unconscious persons may be included into the research under the responsibility of the principal investigator or an investigator who is a physician, in case of presence of the conditions listed below along with the provisions of the first paragraph:
a) The ethics committee must have evaluated in prior whether or not the proposed research protocol or other documents cover the ethical matters under such research sufficiently.
b) If there is a general medical opinion to the effect that the research will bring direct benefit for the unconscious persons
in cases, such as cardiac arrest, head trauma, central nervous system infections, bleeding in the brain, where the physician must promptly intervene and where the existing treatment alternatives have been entirely consumed.
Yes
Special provisions apply
If the subject of the trial directly concerns pregnant postpartum or breastfeeding women or if it is clinical case that can be investigated only on pregnant, postpartum or breastfeeding women, if it does not involve a foreseeable risk for the health of the volunteer or the fetus or the baby, and if there is a general medical opinion to the effect that the research shall bring a direct benefit for the volunteers, permission maybe granted for a research to be conducted on pregnant, postpartum and breastfeeding women within the principles specified below:
a) There must be a general medical opinion to the effect that the clinical trial does not involve any known risk on the pregnant, postpartum and breastfeeding women and the fetus or the baby.
b) The written consent of the pregnant, postpartum and breastfeeding women shall be taken.
c) If the pregnant, postpartum and breastfeeding women refuse to participate in the research or if they wish to withdraw from the research at any stage of the research, they will be taken out of the research.
d) The ethics committee shall be given information regarding clinical, ethical, psychological and social problems in connection with the investigation by a physician specialised in the relevant branch particularly in respect of the fetus or baby health, and the protocol shall be evaluated from that stance.
e) For the clinical trials that will be conducted on pregnant, postpartum and breastfeeding women, no persuasive incentives or financial offers may be made, except reimbursement of compulsory expenses that will arise as a result of their participation into the research.
Regulation On Medical Device Clinical Trials 2014
