The field of "Translational Bioethics" explores ethical and regulatory issues in pre-clinical and clinical research as well as in big data research. In empirical studies translational bioethics analyses, among other things, how legal requirements or ethical recommendations (e.g. informed consent, risk-benefit-assessments, or patient engagement) are applied in research practice. On the basis of study results and in close cooperation with researchers, patient representatives and other relevant stakeholders, proposals are then developed on how these guidelines and recommendations can be implemented more effectively and efficiently in practice.
Extent, Predictors, and Management of Publication Bias in Animal ResearCh (EMBARC)
EMBARC examines to what extent, in what form and in what time previously approved animal testing applications have published their results and study methods. EMBARC will then use expert interviews on publication bias to examine the attitudes and approaches of the various stakeholders in the context of animal research.
Biobanks are collections of samples from human origin, such as tissue or blood samples, which are combined with clinically relevant data. The samples are stored as a long-term resource for future research projects. Samples stored in biobanks can be valuable for different research purposes in biomedicine. The objective of FairBBank (2014-2017) was the analysis of challenges and potentials for a fair allocation of samples in biobank based research.
GEENGOV: Governance of Research using Genom Editing Technology in Humans
GEENGOV is concerned with issues of regulating research that employs modern genome editing (e.g. CRISPR-Cas9) technology on somatic cells of humans. The project focuses on three important questions: (1) How can risk-benefit-assessments of GEEN-studies on human somatic cells be conducted systematically and professionally? (2) How can we ensure valid informed consent is provided by patients and participants of studies or so called “Heilversuche” employing such technology? (3) Is there a need for additional regulation by the state or other institutions (governance) or are established regulatory mechanisms and institutions sufficient?
Good Justification Practice
The project Good Justification Practice investigates how research decisions in translational biomedicine can be justified prospectively in order to meet bioethical requirements. What is necessary to be able to assess in advance whether probability statements about the expected success of a research project in translational biomedicine are well-founded? Which criteria can be used to accomplish this?
The „HiGHmed“ consortium is funded by the Federal Ministry of Education and Research (BMBF) under the Medical Informatics Initiative. HiGHmed involves a dedicated Work Package “Ethics and Stakeholder”. This Work Package undertakes interdisciplinary research on ethical, policy and social issues with regard to Big Data and the collection, linking, and use of patient data in medical research and health care. Central aims of the Work Package are the development of normative frameworks and practice-oriented recommendations for governance solutions. The involvement of various stakeholders is a central concern. The results will not only support HiGHmed, but target also national and international debates.
STRUCTURES (Structure and Transparency in Translational Research) focuses on normative and practical challenges in two intertwined tools for governing translational research: A) a more explicit and structured risk-benefit analysis in early human studies and B) a more comprehensive and standardized registration and reporting of preclinical animal research.