The German Stem Cell Network Has Compiled a Sample Text for Informed Consent

Sara Gerke speaking — GSCN Conference in Jena in September, 2017

At the General Meeting of the German Stem Cell Network (GSCN) in Jena in September 2017, Tobias Cantz and I proposed the establishment of a new GSCN strategic working group.

This new working group, known as ELSA, focuses on the ethical, legal and social aspects of the modern life sciences. ELSA aims to serve as a country-wide interdisciplinary platform for the exchange of information and for the analysis and discussion of challenges facing basic and applied stem cell research in Germany.

One of ELSA’s key goals is to support the process of harmonization at national and international levels. After its establishment, ELSA got to work on pursuing this goal immediately. Together with GSCN Managing Director Daniel Besser and colleagues from the Berlin Institute of Health (BIH) and the Berlin-Brandenburg Center for Regenerative Therapies (BCRT), namely Harald Stachelscheid, Andreas Kurtz and Claudia Schaar and Nils Hoppe, I compiled an informed consent sample text for the donation of somatic cells for human induced pluripotent stem cell (hiPSC) research.

This sample text for informed consent has only recently been published in German, and it has now been translated into English for the international use of cell lines.

It provides a useful template for researchers, giving information about and informed consent for the use of somatic cells and related data in the creation of hiPSCs for medical research purposes.

This sample text also responds to recent developments in the field of hiPSC research, and gives donors the opportunity to opt-out of allowing the creation of gametes (sperm and egg cells) from hiPSCs in their declaration of consent.

You can download the German version of the sample text for informed consent here (Word Document) and the English translation of this sample text here (Word Document). The sample text for informed consent will be updated regularly to capture the latest developments in stem cell research and changes in law. We are currently working on a second version.

For more information about ELSA, check out the recently published article by myself and Tobias Cantz in the GSCN annual magazine, out now.

ELSA will also organize a symposium on the ethical, legal and social aspects of stem cell research in September 19-20^th, 2018, at the German Cancer Research Center (DKFZ) in Heidelberg, Germany as part of the 6^th Annual GSCN Conference. The ELSA Symposium will give researchers the chance to present their work in oral and poster presentations. It will also offer three workshops on cell therapy and genome editing, organoids, and gametes. For online registration and abstract submission for the 6^th Annual GSCN conference (including the ELSA symposium) see here.

Sara Gerke

Sara Gerke joined the Petrie-Flom Center's Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL) in August 2018. As Research Fellow, Medicine, Artificial Intelligence, and Law, Sara oversees the day-to-day work of the Center’s component of this collaborative project, including conducting law, policy, and ethics research; drafting reports and recommendations; and coordinating the Center's efforts with collaborators at the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen as well as other partners.