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Startseite > Informations for Researchers > Planing a Collection or Study: Modular Informed Consent

Modular Broad Informed Consent (IC) for the collection of clinical biospecimen and data (in German language)

First in October 2016, the Ethics Committee of the Medical Faculty, University of Kiel approved a generic, modular informed consent document for the collection of biospecimen along with medical data, paving the way for a broad consent while greatly reducing the time and effort required for application and review. This modular broad informed consent (IC) was last revised in 2020 and the revised version, v. 2.1 (see download link below), was approved by the Ethics Committee in June 2020.

Biobanks as well as studies and research projects seeking a broad consent for the use of data and biospecimen now have the option to use this document and only need to adapt the included variable modules to be study- or biobank-specific. The fixed modules in the text have already been positively reviewed by the Ethics Committee and largely correspond to the „Template text for information and consent for the use of biospecimen and associated data in biobanks" recommended by the "Arbeitskreis Medizinischer Ethikkommissionen in Deutschland" (AKEK) (version 3.1 according to the AKEK-decision of June 21, 2019).

The use of our modular document reduces the effort both in the application and in the review by the ethics committee.

We would like to point out that a template text for this purpose is also provided on the webpage of the Ethics Committee. The template that you can find here on the P2N website has been harmonized with the template on the Ethics Committee website. The content of both templates differs with regard to the regulation of the handling of additional/incidental findings and the possibility of using the external, independent trustee office in Greifswald, Germany for pseudonymization.

In the variable modules, the following topics must be adapted or defined in more detail by you as the scientist (the relevant sections are marked in red in our sample text) :

- The focus of the collection / biobank

- Range of use for the biospecimen ("broad consent" or specified study with closely related questions).

- Here, reference is made only to tissue, blood and urine. If a biobank wishes to use other biospecimen (e.g. cerebrospinal fluid, saliva, smears, stool), the text must be supplemented accordingly.

- Type and quantity of blood/urine/other samples.

- Justification for indefinite storage

- If intended: Performing genetic analyses

- Other data that may be required, e.g. genetic data

- Modalities of pseudonymization of data and samples (internally - or via the external trustee office of the University Medical Center Greifswald)

In case of using our modular information and consent form, P2N's ELSI service will be happy to advise you on the formulation of the variable modules.

Contact: Dr. rer. medic. Gesine Richter MA, MBA;    E-Mail: gesine.richter@iem.uni-kiel.de

Download the P2N-IC-Template here (version 2.1 as MS-Word file) or here in RTF-format.