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Fritz Thyssen Foundation - Citizen Science Project Overview

Fritz Thyssen Foundation - Project: Analysis and Regulation of Therapy-oriented Citizen Science Projects.

The Fritz Thyssen Foundation is funding the research project "Analysis and Regulation of Therapy-oriented Citizen Science Projects" at Martin Luther University starting 01.06.2020.

Citizen Science projects provide a growing framework of opportunities for public, non-institutionalized participation not only in nature observation projects, but also in health research and medical research projects. Likewise, new impulses for collaborative forms of engagement between institutionalized science and non-institutionalized Citizen Science projects arise from Citizen Science projects, e.g., in large-scale research projects with significant data requirements.

Citizen Science is, in general terms, a form of open-access science in which projects are carried out with the assistance of people or entirely by people who are not involved in the day-to-day operations of universities and other (state funded) research institutions of the institutionalized sciences. One of the things that currently characterizes the field is its large actual, factual project pipeline compared to addressing the associated ethical, legal, and social issues.

One aspect of the field of Citizen Science, which has not yet been systematically quantified, are projects that focus on the development or further development of medicinal therapies for the treatment of human diseases. This is sometimes referred to as "patient citizen science". To some extent, this also includes activities in connection with the rapidly growing field of "Quantified Self," also referred to as self-tracking, insofar as the data obtained in this way are used in the development of therapies. For example, therapy-oriented Citizen Science projects can already be found in diabetes research, antibiotics research, Alzheimer's research, cystic fibrosis research, multiple sclerosis research, and research into the fragile X syndrome. In the USA, it has already been observed that even gene therapy approaches using the CRISPR/Cas system have been developed and applied outside the institutionalized scientific and medical community.

In general, therapy-oriented Citizen Science projects also take different forms, ranging from cooperation between institutionalized scientists and laypersons to projects initiated and carried out entirely by laypersons. In therapy-oriented Citizen Science projects, people also participate who do not necessarily have a scientific-medical education, as is typically the case in professional therapy development. In addition, the development of therapies in therapy-oriented Citizen Science projects takes place in different local, structural settings than it has been the case in institutionalized science to date.

The field of these therapy-oriented Citizen Science projects has not yet been systematically investigated in Germany, neither from an empirical nor from an ethical and legal point of view. Conducting therapy-oriented Citizen Science projects has so far taken place under the perception radar of ethical and legal review, so that ethical and, above all, legal assessments for therapy-oriented Citizen Science projects are lacking. It is therefore unclear which ethical standards should be applied in such projects and which legal framework is relevant for such projects. For example, it is also unclear whether and to what extent such projects are permissible at all.

This reserach project, which is funded by the Fritz Thyssen Foundation, will first identify legal as well as ethical issues of therapy-oriented Citizen Science projects and develop approaches to solving these issues. This will also provide the basis for future studies in this area.

The project is guided by the following consecutive research questions:

• What criteria define a therapy-oriented Citizen Science project?
• How is the field of therapy-oriented Citizen Science projects positioned in quantitative and qualitative terms?
• What is the (German) constitutional framework of therapy-oriented Citizen Science projects? What is the significance of the right to science from the International Covenant on Economic, Social and Cultural Rights (UN Social Covenant) in relation to therapy-oriented Citizen Science projects?
• What legal framework exists for therapy-oriented Citizen Science projects, also in regard to the constitutional framework? To what extent is there a need for legal action in view of the chances and risks of therapy-oriented Citizen Science projects?
• Which (medico) ethical standard should be applied to therapy-oriented Citizen Science projects?

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