The Ethics Committee provides text blocks to support the applicant in filling out patient information and informed consent forms and to facilitate assessment by the Ethics Committee.
Drug trials and medical product trials may be conducted on (e.g., unresponsive) patients who are unable to give consent only with the consent of legal representatives—under certain conditions—in "emergency situations."
The necessity for inclusion of people who are unable to give consent must be substantiated in writing.
The patient must be informed in detail about the trial as soon as his/her condition permits it. In particular, he/she must be informed that a no-fault insurance policy was concluded. This information must include the policy number and the name and address of the insurance company.
If a minor is eight years or older and able to give consent, he/she must be informed and asked to give consent in addition to the parents or legal guardians. In addition, written consent (date, signature) must be obtained from individuals 14 years and above. At least two information leaflets are required:
If the consent of several people is required, the clinical trial may not be conducted if informed consent is withdrawn by any of the people.
