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(Letzte Aktualisierung: 02.04.12)

Framework conditions

Legal and ethical framework conditions for networked medical research

The analysis of legal and ethical framework conditions for medical research networks and the suggestion of solutions has, from the outset, constituted one of the core tasks of the TMF. To this end, the TMF has prepared numerous expert opinions and has consulted with the competent national institutions on the resulting proposals for solutions. Already during its first years of existence, the TMF succeeded in preparing generic data protection concepts for networked medical research projects and was able to coordinate these with the competent employees of the Data Protection Officers at both federal and state level.

Competence networks and numerous other cooperative research projects have used this generic template to develop and accelerate the progress of their specific data protection concepts. Furthermore, these data protection concepts and any necessary changes and additions were submitted to the respective state Data Protection Officers with reference to the TMF template. Thus they consequently underwent a simplified assessment process. As a result of this process, the TMF experts not only gained experience but also gave advice and created a basis for further development of the generic concepts.

The work of the TMF on the implementation of bioethical regulations also plays a key role in the organization of networked medical research: A comprehensive checklist for informed consent in clinical research has been approved by the ethics committees and the Data Protection Officers and is now available as a book. In 2007, this information was also electronically processed and made freely available on the Internet as an online assistant. This simplifies the creation of documents which, for individual researchers, is often a very complex and time-consuming process. (www.tmf-ev.de/pew).


Contact person at the TMF Office

Johannes Drepper

Phone: +49 30 31 01 19 53

E-Mail

Products related to this topic

(You will find further products in the overview of TMF products.)



P075011 - Training Documents on Medical Device Regulation

P014012 - Software library for data protection concept (model A)

P062011 - Clinical Evaluation, Clinical Studies and HTA for Medical Devices

P010211 - BMB Co-operation in the EU

P999071 - Specimen contracts - Contracted software developement and cession of utilisation rights

P999061 - Expert Opinion on Biobanking in Germany

P999051 - Assessment of data protection concepts

P052012 - Specimen Contract for data custodianship

P052011 - Legal Opinion on data custodianship

P042011 - Legal Opinion on electronic archiving

P039031 - Legal Opinion on data protection in medical research

P022022 - Specimen Texts for matters of exploitation

P022021 - Legal Opinion on rights of utilisation

P017031 - Informed Consent - Checklist

P017021 - Informed Consent – Online-Assistent

P017011 - Informed Consent – Guideline

P015021 - PID service

P015011 - PID generator

P014011 - Reference implementation of data protection concept (model A)

P010021 - Data Protection Concept for Biobanking

P010012 - Specimen Contracts for Biobanking

P010011 - Legal Opinion on Biobanking

P000021 - Generic data protection concepts

P000011 - Pseudonymisation software

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