Commissions d’éthique suisses relative à la recherche sur l'être humain
Commissioni etiche svizzere per la ricerca sull'essere umano
Swiss Ethics Committees on research involving humans
Template: Declaration of consent: (Studies with children and adolescents)
Written informed consent to participate in a study
§ Please read this form carefully.
§ Please ask if there is anything you do not understand or would like to know
study Number: (competent ethics committee)STUDY Title: (IN SCIENTIFIC AND SIMPLIFIED WORDING)
Sponsor (full address):
Location of the study:
Study leader
Surname and first name in block capitals:
Participant
Surname and first name in block capitals:
Date of birth: / female male
• The undersigned doctor has explained to me verbally and in writing the aims and schedule of the study with [as applicable: therapeutic or medical product], the expected effects, benefits and disadvantages and the possible risks.
• All questions about participation in this study have been answered to my satisfaction. I can keep the written information for participants dated [date/version] (two parts) and will receive a copy of my written declaration of consent. I accept the contents of the written information for participants issued for the above-mentioned study.
• I am taking part in this study of my own free will. I can decide not to participate at any time and without having to give a reason, and this will not have any negative consequences for any further medical treatment I have.
• If applicable: I have been informed of other possible treatments and therapeutic procedures.
• I have been given sufficient time to make my decision.
• If applicable: I have been informed that there is an insurance that covers any harm that may be caused provided I can prove that this occurred as a result of the study.
• If applicable: I agree to my GP being informed that I am participating in the study.
Yes No
If the study protocol stipulates that GPs have to be informed: I am aware that my GP will be informed that I am participating in the study.
• If applicable: If chance findings come to light, I would like
a) to be informed in every case
b) not to be informed
c) to leave the decision to the following person: ......
• I am aware that my personal data (if applicable: and samples) will be forwarded for research purposes only and in encrypted form. I agree to competent experts representing the study sponsor, authorities and Cantonal Ethics Committees inspecting my original data for review and control purposes, subject to the requirements of strict confidentiality.
• I am aware that I must comply with the requirements and restrictions set out in the information for participants throughout the study. In the interests of my health, the study doctor can withdraw me from the study at any time.
• If applicable for studies involving children under the age of 14:
The undersigned testify that a verbal briefing has been given, and that the child, who is capable of exercising judgement, has agreed to take part in the study and/or has shown no sign of resistance to participation.
Place, date / Signature of study participantIf applicable for studies involving children and adolescents <18 years or adults under guardianship: signature of legal representative
Confirmation by the study doctor: I hereby confirm that I have explained the nature, significance and scope of the study to this participant and/or his/her legal representative. I declare that I fulfill all the obligations associated with this study. If, at any time during the study, I learn of any information that might affect the willingness of the participant to take part in the study, I shall inform him/her/legal representative without delay.
Place, date / Signature of the study doctorDecl. of consent children/adolescents Version of 31.12.2013 Page 1/2