Declaration of consent

Before voluntary participation in a clinical trial, the trial participant (patient or test person) must submit a written declaration of consent or an informed consent form (ICF) in accordance with § 40 AMG, § 20 MPG, § 3 (2b) of the GCP regulation and the Declaration of Helsinki.

Before voluntary participation in a clinical trial, the trial participant (patient or test person) must submit a written declaration of consent or an informed consent form (ICF) in accordance with § 40 AMG, § 20 MPG, § 3 (2b) of the GCP regulation and the Declaration of Helsinki.

The study participant has the right to receive detailed information (patient information) and must be given sufficient time to consider before signing the consent form and starting the clinical trial. Before signing the informed consent form, the investigator must discuss the patient information in a personal interview and answer questions from the trial participant.

The patient information is regulated by GCP - just like the consent - and must be comprehensible, explain the content and the course of the study, contain information about the drug or medical device, inform about the rights and obligations of all parties involved and about possible advantages and disadvantages as well as risks and side effects of the study.

The clarification and obtaining of the signature may only be obtained from licensed physicians. The date and signature on the declaration of consent must be provided by the investigator and the trial participant themselves - the physician may also not prescribe the date. The patient information sheet must also contain information on data protection, any patient insurance policies/test person insurance that may have been taken out, and the right to withdraw consent.

The patient information or declarations of consent must be evaluated and approved by the ethics committee. To ensure that the documents meet the requirements, they are usually prepared by a Clinical Research Organisation (CRO) in consultation with the sponsor.

In exceptional cases, the clinical trial can also be conducted with study participants who are not able to give consent, if the declaration of consent is signed by the legal representative (§ 41 AMG, § 21 MPG, § 3 GCP regulation).