Translational research in genomic medicine: Institutional and social aspects (Tri-Gen)
Tri-Gen is a tri-national project funded by the ELSA-GEN initiative.
Translational research and translational medicine have proliferated in recent years: Internationally, a number of programmes and institutions are implemented under this banner. Translational activities in biomedical research are advocated as a solution to several challenges in the biomedical field: to improve the quality of health care provision by making basic research findings and methods (especially those stemming from the Human Genome Project and related post-genomic research) more readily available to patient-oriented research and clinicians (“bench to bedside”), to orient biomedical research towards clinical needs (“bedside to bench”), to improve the productivity of pharmaceutical research and pharmaceutical companies, and to integrate public health aspects as well as social, ethical and legal aspects into biomedical research.
As translational research evolves at the centre of negotiations between molecular biology and medicine, commerce, public health and innovation policy, the project aims at understanding how new forms of innovation policy and governance are functioning within this shifting configuration. The project aims at drawing a reflexive, critical portrait of translational research based on the sociology of knowledge and innovation studies. It will explore various ways in which translational research is conducted in Austria, Finland and Germany. Moreover, the forms of governance and institutional innovations that are developing with translational research will be analysed. Recommendations will be derived how they can be further improved.
The project will seek to:
· define and map the discourses and practices of translational research, through a review of the state of the art and the origins of the concept, and a survey of current activities in Austria, Finland and Germany;
· study the modalities of evidence and utility assessment in genomic and genetic testing as translational practices;
· study genetic counselling as a case for the potential involvement of patients in translational activities;
· analyse emerging forms of innovation policy and governance processes pertaining to translational research;
· discuss the results during an international conference with external experts.
Guiding questions in the Tri-Gen project are
· How is translational research enacted? How did this concept emerge, in which context, by whom and for which purposes is it being used?
· What is the detailed process of translational research, as it is being executed right now in biomedicine, and what is its novelty?
· What forms of governance, institutional innovations and organisational arrangements are emerging among actors engaging in translational research?
· What is the role of policy in translational research, and what have been the characteristics of steering and funding efforts?
· What is the role of translational activities in the relationship between biomedicine and society, how are ethical, legal and social aspects represented in translational activities?
· What conditions seem favourable to the practice of translational research, and which impacts can be expected?
The project is organised along the following subprojects (SPs):
SP 1: Defining and mapping translational research:
A review of the state of the art and the origins of the concept, through literature review, metaphor analysis, semi-structured interviews with scientists, industrialists and health policy-makers, document analysis and a survey of current activities in Austria, Finland and Germany.
Lead: Fraunhofer ISI, together with IHS, HEL
SP 2: Evidence generation and assessment in translational research - case studies
A study of the modalities of evidence generation on genomic testing interventions, including for evaluating clinical validity and clinical utility, using the areas of cardiovascular genetics and genomics as well as cancer genomics as examples. The work for the subproject will be based on literature, a survey and interviews.
Lead: MHH, together with UMIT, Fraunhofer ISI
SP 3: Translation, genetic counselling and patient involvement
With a goal to feed clinical findings back into bench research, translational research will provide a renewed opportunity to involve patients in genomic medicine, notably through the genetic counselling process. This subproject will look at how patients evolve in this process, by interviews and a stakeholder workshops.
Lead: HEL, together with IHS, Fraunhofer ISI
SP 4: Innovation policy and governance in translational research
This subproject will identify emerging forms of innovation and governance processes in biomedicine associated with translational research, and draw the impact of these configurations on the interactions between patients, researchers, clinicians, industry and policy-makers and “society”.
Lead: IHS, together with Fraunhofer ISI, HEL, MHH, UMIT
SP 5: Integration and presentation of results and recommendations
During an international conference, the research team will present the results of the project and will discuss them with external experts. Conclusions and recommendations will be drawn on the status of translational research, its potential impacts for scientists, practitioners, policy-makers and industry and the governance forms emerging around this new practice.
Lead: Fraunhofer-ISI, with IHS, HEL, MHH, UMIT
The exchange of junior scientists between the project partners’ institutions is an integral part of the Tri-Gen project.