Periodic Reporting for period 1 - FACILITATE (FrAmework for ClInicaL trIal participants daTA reutilization for a fully Transparent and Ethical ecosystem)
Berichtszeitraum: 2022-01-01 bis 2022-12-31
The current availability of both qualitative and quantitative health data is unprecedented in the history of mankind. Soon technology-computing, connectivity and storage capacity will enable further availability of health data exponentially in two ways: increasing computerization and quantifying self and mobile-health. Both these advances have potential issues. The increased computerization of medical processes and procedures would need to provide means to link data to information and to knowledge in a virtuous interexchange while quantifying self and mobile-health, (i.e. the possibility for each person, healthy or not, to measure their medical condition through smartphones, wearable sensors and any other digitally reducible phenotypes) by becoming the primary source of health data that would need to be reconciled with data access, usage, portability, privacy and – in Europe – with GDPR compliance.
The overall goal of this 4-years project is the development of a patient centred process prototype to allow the direct generation and the return of clinical trials data to study participants. By putting the study participants at the very core of their data portability and secondary use the FACILITATE project will make it easier to integrate both local and pan-European implementations considering best practices and data protection regulations.
The OVERALL OBJECTIVE is expected to be achieved through the development of a new ethical, legal, and regulatory framework overcoming the current limitations and discrepancies between European Member States to enable the return of clinical trial data to study participants and other healthcare professionals involved in their care which is further realized by building a prototype process enabling the re-use of those data for future research needs. Thus, the project intends to show that such processes are technically implementable.
The overall goal of this 4-years project is the development of a patient centred process prototype to allow the direct generation and the return of clinical trials data to study participants. By putting the study participants at the very core of their data portability and secondary use the FACILITATE project will make it easier to integrate both local and pan-European implementations considering best practices and data protection regulations.
The OVERALL OBJECTIVE is expected to be achieved through the development of a new ethical, legal, and regulatory framework overcoming the current limitations and discrepancies between European Member States to enable the return of clinical trial data to study participants and other healthcare professionals involved in their care which is further realized by building a prototype process enabling the re-use of those data for future research needs. Thus, the project intends to show that such processes are technically implementable.
In response to the concern about the impact of the legal and ethical existing constraints regarding return and secondary use of data, we defined work group specific tasks that resulted in essential input for the development of a new process. This allowed us to now enter the second year of the project and shift the perception of a strictly layered approach toward a flexible integrated approach that will be able to absorb ongoing developments and adaptations both at national as well as EU level regulation of ethical and legal constraints regarding clinical trial data return to patients and secondary use of data for future research. The impact of the efforts of WP2 and Wp3 in the first year can be associated with optimizing a possible flexible yet trustworthy approach by demonstrating that we can provide an integrated legal and ethical base enabling us to a fundamental shift in how to deal with these two pressing issues in the next phase of the project.
One of FACILITATE’s missions in the first year was to define the legal and ethical constraints in place in the EU considered to be the basis from which to construct an innovative approach to CT data return and secondary use of CT data for research which is a most urgent challenge. Several main problematic issues emerged, the most pressing of which was the apparent lack of agreement about how to provide a truly integrated legal/ethical approach to consent responsible for making decisions of when, to who, what and under which conditions CT could be returned to patients. It turns out that legal and ethical views were very varied. To overcome this divergence between the legal and ethical systems that give form to CT data return as well as issues around CT data reuse for future research, WP meetings were set up to foster a productive discussion.
Significant legal and ethical issues keep being an issue and therefore the FACILITATE project produced several working documents that outline best practices in each field of expertise as well as the challenges but also provides guidance and direction for how to move forward, proposing potential activities and tactics that might mitigate risks and take advantage of opportunities. For example, with regards to CT data return and reuse, a new view on consent is key for providing trust.
FACILITATE has set up a WG guided by the project leaders to define the use cases needed for the next phase of the project and with the scope to come to define a core minimum set of ethical and legal requirements that provide a new flexible and adaptive approach using several different types of disease. FACILITATE also developed a glossary to enable a practical guide to more efficient communication across fields of expertise that would help to identify, select and measure the core requirements to be implemented in the process. This was done together with stakeholder input using interviews and focus groups and will subsequently be shared with the expert decision committees of representatives ranging from data protection authorities and ethics committees from various countries to more technical experts. The project is majorly invested in harmonizing outcomes to be generated in diverse CT setting.
FACILITATE has created a website and an editorial strategy to enable ample possibility for communication that includes core knowledge regarding the project, updates, stakeholder involvement activities, presentations, and a series of webinars on outcomes. FACILITATE has extended awareness of the project through a website, social media channels, newsletters and infographics, helping to draw more followers in the research community so that they can benefit from the knowledge being generated by the project.
One of FACILITATE’s missions in the first year was to define the legal and ethical constraints in place in the EU considered to be the basis from which to construct an innovative approach to CT data return and secondary use of CT data for research which is a most urgent challenge. Several main problematic issues emerged, the most pressing of which was the apparent lack of agreement about how to provide a truly integrated legal/ethical approach to consent responsible for making decisions of when, to who, what and under which conditions CT could be returned to patients. It turns out that legal and ethical views were very varied. To overcome this divergence between the legal and ethical systems that give form to CT data return as well as issues around CT data reuse for future research, WP meetings were set up to foster a productive discussion.
Significant legal and ethical issues keep being an issue and therefore the FACILITATE project produced several working documents that outline best practices in each field of expertise as well as the challenges but also provides guidance and direction for how to move forward, proposing potential activities and tactics that might mitigate risks and take advantage of opportunities. For example, with regards to CT data return and reuse, a new view on consent is key for providing trust.
FACILITATE has set up a WG guided by the project leaders to define the use cases needed for the next phase of the project and with the scope to come to define a core minimum set of ethical and legal requirements that provide a new flexible and adaptive approach using several different types of disease. FACILITATE also developed a glossary to enable a practical guide to more efficient communication across fields of expertise that would help to identify, select and measure the core requirements to be implemented in the process. This was done together with stakeholder input using interviews and focus groups and will subsequently be shared with the expert decision committees of representatives ranging from data protection authorities and ethics committees from various countries to more technical experts. The project is majorly invested in harmonizing outcomes to be generated in diverse CT setting.
FACILITATE has created a website and an editorial strategy to enable ample possibility for communication that includes core knowledge regarding the project, updates, stakeholder involvement activities, presentations, and a series of webinars on outcomes. FACILITATE has extended awareness of the project through a website, social media channels, newsletters and infographics, helping to draw more followers in the research community so that they can benefit from the knowledge being generated by the project.
New models of consent could really bring together the two main objectives of the project if the process results to be adaptable and flexible to differences in national laws and the ever changing and important safeguards based on ethical principles. FACILITATE carried out research into existing informed consent methods and procedures as well as promising new approaches towards consent. Also, scientific journal articles and findings were reviewed and complemented with a questionnaire that surveyed different stakeholders for their experiences and views of the legal constraints regarding CT data sharing and informed consent procedures. Findings will lead to the production of a report that will explain the basic needs of the process and emphasize the need to above all create a trusted environment.
Peer-reviewed journal articles on and articles with reference to FACILITATE, white papers, research articles, and reports will be produced and disseminated to increase understanding of the progress of FACILITATE. These publications sustain the results and impact of the project, enhance knowledge, contribute to critical thinking, illustrate legal and ethical integration of core principles, and create awareness regarding informed consent allowing the return of data to patients and secondary use of CT data by creating trusted new standards in a GDPR compliant manner. The GDPR is characterized by different interpretations among EU countries which severely hamper the development of a set of commonly accepted core standards.
The next phase of FACILTATE will focus on defining use cases to be employed in creating the prototype process that will allow the safe and trusted return of data to patients as well as their secondary use for future research. Different stakeholder groups, of which patients are the core will be continuously involved.
Peer-reviewed journal articles on and articles with reference to FACILITATE, white papers, research articles, and reports will be produced and disseminated to increase understanding of the progress of FACILITATE. These publications sustain the results and impact of the project, enhance knowledge, contribute to critical thinking, illustrate legal and ethical integration of core principles, and create awareness regarding informed consent allowing the return of data to patients and secondary use of CT data by creating trusted new standards in a GDPR compliant manner. The GDPR is characterized by different interpretations among EU countries which severely hamper the development of a set of commonly accepted core standards.
The next phase of FACILTATE will focus on defining use cases to be employed in creating the prototype process that will allow the safe and trusted return of data to patients as well as their secondary use for future research. Different stakeholder groups, of which patients are the core will be continuously involved.