GUIDE ME

A GUIDancE book for the submission and the review process of MEdical ethics committees.

Background

In 2012, the authors H. Raspe, A. Hüppe, D. Strech and J. Taupitz supported by the Association of Medical Ethics Committees in Germany e.V. (AKEK) published an open-access book with the translated title „Recommendations for the review of clinical trials through ethics committees“. The book covers legal, medical, ethical and biometrical principles that apply for clinical studies to be reviewed by the members of medical ethics committees. The book has been actively promoted by the Federal Ministry of Education (BMBF) and by the Research German Research Foundation (DFG), e.g. in the related calls on clinical trials. Nine years later, the AKEK and the joint project group „Biostatistics in Medical Ethics Committees“ of the German Association for Medical Informatics, Biometry and Epidemiology e.V. and the German Region of the International Biometrical Society formulated the urgent need for a major revision and a transformation into a more manual-oriented version. Moreover, whereas the previous version was dedicated to members of medical ethics committees (the reviewers), the new version is additionally intended to guide the medical researchers (the applicants).

With this project, the authors aim to realize this new guidance manual.

Objectives

The revised book is conceived as a guidance both for researchers/applicants and reviewers, with the final goal of improving the quality of medical research and the protection of participants in clinical studies. The concrete scientific objectives of the project are:

• Comprehensive review of the current legal, ethical and methodological requirements/standards for clinical research projects in the review process by ethics committees in Germany.
• Transparent, concise and systematic presentation of these requirements and standards in a manual-style handbook serving a as a guidance, and offering recommendations for reviewers in medical ethics committees and for applicants (academic researchers, clinical research organisations, industrial sponsors etc.).
• Improving the quality of the review process by medical ethics committees and thereby also of the medical research projects themselves. In this regard, the project contributes to the improvement of the clinical research infrastructure in Germany.

Methodology

The different working packages concentrate on four main methodological approaches:

1. Including external experience: by consulting external partners from different disciplines and organizations, representing the most topic-relevant working groups and societies (e.g. medicine, clinical pharmacology, bioethics, biostatistics, law, ethics committee staff, patients).
2. Revising the content of the book: by performing a state-of-the-art analysis of the practice-oriented legal, ethical and methodological standards and principles, based on an extensive review of literature, primary sources (laws, guidelines, recommendations) and practices.
3. Revising the structure of the book: by developing a restructured and user-friendly presentation of the material, for example, according to study types and legal aspects (e.g. trials with drugs under the Clinical Trials Regulation 536/2014; trials with medical devices under the Medical Devices Regulation 2017/745; trials under the law on radiation protection; non-regulated clinical studies). Where appropriate, it will be distinguished between recommendations for the application and recommendations for the review. A general introduction on ethical principles, legal sources and methodological considerations will provide the reader with the necessary context.
4. Adding material to the book: by developing a comprehensive selection of online material that applicants and reviewers can consult as ready-to-use guidance, e.g. checklists for different study types, templates for required documents (e.g. study protocols, informed consent), or text suggestions for study protocols, reviewer reports and other documents for aspects that commonly apply in the application or review process.

Expected results / Implications / Perspectives

• Finding how to structure an optimal guidance book in order to offer the best support for the application and review process of German medical ethics committees.
• Publication of the book as open-access, in order to allow access for all interested persons and guarantee a broad readership. • Enhancement of user friendliness by providing checklists and text suggestions as free online material, in order to facilitate the application and review process.
• Initially focus on the German national legislation and administrative structures, with the potential perspective of serving as example for other national and international applications in the future.