Final Report Summary - CONTRACT (Consent in a trial and care environment)
Executive summary:
CONTRACT focused on consent and how the legal concepts of informed consent, primarily those in the European data protection Directive and in the clinical trials Directive, impact on clinical research. The concept of informed consent in the two directives was analysed from a legal, ethical, information technology (IT)-related and clinical point of view. CONTRACT aimed to provide a comparative overview of how European clinical trials deal with consent issues, define good practices and provide policy recommendations with a view to creating a clearer framework for informed consent within the European Union (EU). In order to secure the results of the project in the longer term, a helpdesk has been created to provide targeted advice for trial organisers and clinical researchers.
In a first phase, the project focused on giving a picture of issues and concerns of a proper handling of informed consent in transnational and European research trials. To do so, CONTRACT had identified research projects with vulnerable patient groups or with particularly sensitive issues of consent in a first step. These projects were primarily EU-funded. In a second step, a questionnaire developed by the CONTRACT partners had been circulated among a large number of stakeholders via diverse channels. The goal of the questionnaire was to explore legal, technical and clinical issues of proper handling informed consent issues. The response rate to the questionnaire was in the first phase lower than expected, so that the CONTRACT partners decided to leave the questionnaire open beyond the initial pilot phase.
The responses obtained through the questionnaire were analysed and afterwards complemented by a study of the legal framework of informed consent in national legislation in a group of four Member States (MS). The aim of the analysis was to identify similarities and differences in handling consent issues in European projects. Based on this work done in the first year of the project, the CONTRACT partners drafted a set of guidelines for the preparation of informed consent forms also identifying best practice examples of handling informed consent.
Based on the results obtained from the questionnaire and the set of guidelines on informed consent, the CONTRACT partners produced a policy-oriented study providing recommendations as to how different concepts of informed consent could be better coordinated and harmonised within Europe. This study included concrete recommendations for the European Commission (EC) regarding coordination approaches for future legislative action and the use of soft law instruments to strengthen patients' rights and the usability of their personal data on the other hand.
Finally, the CONTRACT partners established a helpdesk to provide support in legal, ethical, IT-related and clinical questions related to informed consent and data protection in translational research. The helpdesk was launched publically in September 2012. The most significant component of the helpdesk is the informed consent generator, which uses a three-stage process to create IC-forms (templates) for an end user. The continuation of the helpdesk after end of CONTRACT was ensured by its hosting through the Centre for Data Protection (CDP), a Belgian non-profit organisation founded be the project partners LUH and Custodix.
Project context and objectives:
CONTRACT sought to establish methods to understand the way the European data protection Directive and the clinical trials Directive have had and continue to have an impact on the success of translational research. The project focused on informed consent as a fundamental precondition for the legal processing of personal data and for carrying out a legally admissible trial. CONTRACT aimed to support EC to achieve a clear community framework in order to support dynamic and sustainable health systems by providing clarity regarding application of EC law to health services and support MS in areas where coordinated action can bring added value to health systems. The project did so by delivering a survey showing how ongoing and upcoming European and national translational projects deal differently with consent issues, defining good practices, giving policy recommendations and offering a help desk for partner projects on consent issues.
Both directives define consent. However, already the definitions differ significantly. A closer look clearly shows that not only the definitions are different but that the legal concepts behind them differ as well. CONTRACT helped to understand how the differing concepts of informed consent have consequences on translational research activities and how new legal approaches can help to support translational research and to protect patient rights at the same time.
Translational research requires as the term implies the translation of basic discoveries in clinical applications and vice versa the translation of clinical knowledge in new research approaches. Translational research is therefore about communication and exchange of information. The flow of data crossing boundaries between care and research, between different clinical disciplines and different research groups in different nations is a fundamental precondition for translational research. The possible benefits for research and care are clearly visible and make it easy to see why the EC has decided to place translational research at the centre of 2010 activities in the health domain.
The data to be exchanged is in most cases personal data. Behind every dataset there is a human being's biography and anamnesis. Every patient is concerned about privacy issues and expects with good reason that his personal data is processed legally. Data protection regulations require that the data are only collected for specified, explicit and legitimate purposes and not further processed in a way incompatible with those purposes. They require in many cases the patient's informed consent for processing the data. Doctors are obviously for ethical and legal reasons aware of the risks that going beyond this informed consent might entail. They are also quite aware that they need to ask for prior consent when treating a patient and when asking a patient to participate in a trial.
A problem is that these different manifestations of consent are not homogenous. They differ in scope, necessity and in the conditions they need to comply with in order to be valid. They differ in their legal basis, in their doctrine and in the consequences a breach of consent might have. Those differences cause a tremendous legal and ethical complexity which becomes even more prevalent when the patient belongs to a vulnerable group. This complexity produces uncertainty and doubt amongst researchers and clinicians. Due to this complexity, IT-systems set up for care and for trials are frequently seen as different worlds. They lack the interfaces needed to make the data transferable. Doubt and complexity in relation to the legal, ethical and technical side of a framework for a trial can cause the end of translational research before it has even begun and this effect has a dramatic impact on patient groups already disadvantaged by their specific vulnerability.
CONTRACT supported translational research projects ongoing and upcoming. It developed a multidisciplinary approach in delivering facts and figures on different approaches to informed consent both in European projects and in European MS. CONTRACT analysed the IT-related representation of these different understandings and the outcome of these differences in the daily clinical and / or research routine.
Furthermore, CONTRACT advised translational research projects in all issues of informed consent and delivered concrete policy recommendations as to how EU could jointly protect patient's rights and support translational research by a better structured approach towards consent issues. CONTRACT focused on issues of informed consent in vulnerable patient groups as the requirements were of the most demanding complexity there.
Project results:
WP1 - Coordination and management
The central goals for the management of the CONTRACT project were to:
- ensure the timely and effective achievement of project tasks, milestones and deliverables;
- establish and maintain robust governance structures to facilitate the coordination of work, decision-making and quality management;
- establish effective and transparent communication structures both within the project and vis-a-vis EC; and
- guarantee high standards of administrative and financial management in the project and ensure accountability via quality management and reporting.
The project kick-off meeting was held in Hannover on 21-22 October 2010 in conjunction with an initial stakeholder networking session. Transparent project governance structures were established with the confirmation of the steering committee and the external advisory board. The project coordination office established internal reporting structures and project-specific templates to control project progress and expended resources on a biannual basis. Project communication structures were underpinned by a consortium mailing list and a shared online repository containing all project-relevant documentation. A quality management handbook for the project was prepared by the project coordination office and made available to all project partners to establish common standards for the implementation of the project.
Further project meetings were held during the second reporting period in Gent, Belgium on 19-20 January 2012 and were focused on discussing the questionnaire answer rate and establishing the schedule and collaboration between partners in WP4 for drafting the policy recommendations for the EC. Another consortium meeting was held in Homburg on 19-20 June and had served for the preparation and coordination of the CONTRACT team for the second stakeholder workshop. Finally, on 7 September 2012 the consortium met for the last time in Hannover, Germany and among others took care of preparations for the joint conference of AcademicGMP and CONTRACT on the 'impact of EU legislation on therapeutic advance'.
There was close interaction with the external advisory board since the project outset and the consortium profited greatly from the participation of two members of the EAB, Dag Wiese Schartum and Cecilia Magnusson Sjöberg, at the first stakeholder meeting in Hannover in September 2011. The EAB also received the informed consent guide for review and took part in the discussion on the direction and focus of the infrastructure developed in the WP5 (Helpdesk).
Project lifetime was marked by intensive networking with other EU projects and various stakeholder organisations to promote CONTRACT, the questionnaire and to gain feedback from practitioners. Highlights included the presentations held at the European Network for Cancer in Children and Adults (ENCCA) participation at the meetings of SIOP Europe and SIOP, a meeting with professors of the Hannover Medical School (MHH) to promote the project, networking during a number of related projects, such as P-Medicine and VPH and finally a close cooperation with the Academic-GMP project, a 'sister project' financed by EC in the same topic as CONTRACT.
WP2 - Problem analysis
The major objective for WP2 was to analyse the current situation concerning the legal, ethical, technical and clinical handling of consent in European projects dealing with vulnerable patient groups by means of a questionnaire survey distributed to a wide range of stakeholders and practitioners.
WP2 analysed the current situation concerning the legal, ethical, technical and clinical handling of consent in European projects dealing with vulnerable patient groups. The proposed methodology for this WP was a project-based questionnaire to identify existing practices and problems encountered in translational research throughout Europe.
The questionnaire and its analysis were conducted in three stages:
- identification of target projects and stakeholders;
- development of the questionnaire, including the validation of a pre-final version of the questionnaire by sending it to different stakeholder groups to obtain feedback for optimisation of the questionnaire;
- dissemination of the final questionnaire and analysis of the results of the questionnaire.
The aim of the survey was to show how ongoing and upcoming European and national translational projects deal differently with consent issues. This was the basis for delivering concrete policy recommendations as to how EU could jointly protect patient rights and support translational research by a better-structured approach towards consent issues.
The questionnaire and its analysis were conducted in three stages. In a first step, the target projects and the relevant stakeholders were identified. 221 projects were contacted directly and asked to participate in the survey.
List of websites: http://www.contract-fp7.eu/site/
CONTRACT focused on consent and how the legal concepts of informed consent, primarily those in the European data protection Directive and in the clinical trials Directive, impact on clinical research. The concept of informed consent in the two directives was analysed from a legal, ethical, information technology (IT)-related and clinical point of view. CONTRACT aimed to provide a comparative overview of how European clinical trials deal with consent issues, define good practices and provide policy recommendations with a view to creating a clearer framework for informed consent within the European Union (EU). In order to secure the results of the project in the longer term, a helpdesk has been created to provide targeted advice for trial organisers and clinical researchers.
In a first phase, the project focused on giving a picture of issues and concerns of a proper handling of informed consent in transnational and European research trials. To do so, CONTRACT had identified research projects with vulnerable patient groups or with particularly sensitive issues of consent in a first step. These projects were primarily EU-funded. In a second step, a questionnaire developed by the CONTRACT partners had been circulated among a large number of stakeholders via diverse channels. The goal of the questionnaire was to explore legal, technical and clinical issues of proper handling informed consent issues. The response rate to the questionnaire was in the first phase lower than expected, so that the CONTRACT partners decided to leave the questionnaire open beyond the initial pilot phase.
The responses obtained through the questionnaire were analysed and afterwards complemented by a study of the legal framework of informed consent in national legislation in a group of four Member States (MS). The aim of the analysis was to identify similarities and differences in handling consent issues in European projects. Based on this work done in the first year of the project, the CONTRACT partners drafted a set of guidelines for the preparation of informed consent forms also identifying best practice examples of handling informed consent.
Based on the results obtained from the questionnaire and the set of guidelines on informed consent, the CONTRACT partners produced a policy-oriented study providing recommendations as to how different concepts of informed consent could be better coordinated and harmonised within Europe. This study included concrete recommendations for the European Commission (EC) regarding coordination approaches for future legislative action and the use of soft law instruments to strengthen patients' rights and the usability of their personal data on the other hand.
Finally, the CONTRACT partners established a helpdesk to provide support in legal, ethical, IT-related and clinical questions related to informed consent and data protection in translational research. The helpdesk was launched publically in September 2012. The most significant component of the helpdesk is the informed consent generator, which uses a three-stage process to create IC-forms (templates) for an end user. The continuation of the helpdesk after end of CONTRACT was ensured by its hosting through the Centre for Data Protection (CDP), a Belgian non-profit organisation founded be the project partners LUH and Custodix.
Project context and objectives:
CONTRACT sought to establish methods to understand the way the European data protection Directive and the clinical trials Directive have had and continue to have an impact on the success of translational research. The project focused on informed consent as a fundamental precondition for the legal processing of personal data and for carrying out a legally admissible trial. CONTRACT aimed to support EC to achieve a clear community framework in order to support dynamic and sustainable health systems by providing clarity regarding application of EC law to health services and support MS in areas where coordinated action can bring added value to health systems. The project did so by delivering a survey showing how ongoing and upcoming European and national translational projects deal differently with consent issues, defining good practices, giving policy recommendations and offering a help desk for partner projects on consent issues.
Both directives define consent. However, already the definitions differ significantly. A closer look clearly shows that not only the definitions are different but that the legal concepts behind them differ as well. CONTRACT helped to understand how the differing concepts of informed consent have consequences on translational research activities and how new legal approaches can help to support translational research and to protect patient rights at the same time.
Translational research requires as the term implies the translation of basic discoveries in clinical applications and vice versa the translation of clinical knowledge in new research approaches. Translational research is therefore about communication and exchange of information. The flow of data crossing boundaries between care and research, between different clinical disciplines and different research groups in different nations is a fundamental precondition for translational research. The possible benefits for research and care are clearly visible and make it easy to see why the EC has decided to place translational research at the centre of 2010 activities in the health domain.
The data to be exchanged is in most cases personal data. Behind every dataset there is a human being's biography and anamnesis. Every patient is concerned about privacy issues and expects with good reason that his personal data is processed legally. Data protection regulations require that the data are only collected for specified, explicit and legitimate purposes and not further processed in a way incompatible with those purposes. They require in many cases the patient's informed consent for processing the data. Doctors are obviously for ethical and legal reasons aware of the risks that going beyond this informed consent might entail. They are also quite aware that they need to ask for prior consent when treating a patient and when asking a patient to participate in a trial.
A problem is that these different manifestations of consent are not homogenous. They differ in scope, necessity and in the conditions they need to comply with in order to be valid. They differ in their legal basis, in their doctrine and in the consequences a breach of consent might have. Those differences cause a tremendous legal and ethical complexity which becomes even more prevalent when the patient belongs to a vulnerable group. This complexity produces uncertainty and doubt amongst researchers and clinicians. Due to this complexity, IT-systems set up for care and for trials are frequently seen as different worlds. They lack the interfaces needed to make the data transferable. Doubt and complexity in relation to the legal, ethical and technical side of a framework for a trial can cause the end of translational research before it has even begun and this effect has a dramatic impact on patient groups already disadvantaged by their specific vulnerability.
CONTRACT supported translational research projects ongoing and upcoming. It developed a multidisciplinary approach in delivering facts and figures on different approaches to informed consent both in European projects and in European MS. CONTRACT analysed the IT-related representation of these different understandings and the outcome of these differences in the daily clinical and / or research routine.
Furthermore, CONTRACT advised translational research projects in all issues of informed consent and delivered concrete policy recommendations as to how EU could jointly protect patient's rights and support translational research by a better structured approach towards consent issues. CONTRACT focused on issues of informed consent in vulnerable patient groups as the requirements were of the most demanding complexity there.
Project results:
WP1 - Coordination and management
The central goals for the management of the CONTRACT project were to:
- ensure the timely and effective achievement of project tasks, milestones and deliverables;
- establish and maintain robust governance structures to facilitate the coordination of work, decision-making and quality management;
- establish effective and transparent communication structures both within the project and vis-a-vis EC; and
- guarantee high standards of administrative and financial management in the project and ensure accountability via quality management and reporting.
The project kick-off meeting was held in Hannover on 21-22 October 2010 in conjunction with an initial stakeholder networking session. Transparent project governance structures were established with the confirmation of the steering committee and the external advisory board. The project coordination office established internal reporting structures and project-specific templates to control project progress and expended resources on a biannual basis. Project communication structures were underpinned by a consortium mailing list and a shared online repository containing all project-relevant documentation. A quality management handbook for the project was prepared by the project coordination office and made available to all project partners to establish common standards for the implementation of the project.
Further project meetings were held during the second reporting period in Gent, Belgium on 19-20 January 2012 and were focused on discussing the questionnaire answer rate and establishing the schedule and collaboration between partners in WP4 for drafting the policy recommendations for the EC. Another consortium meeting was held in Homburg on 19-20 June and had served for the preparation and coordination of the CONTRACT team for the second stakeholder workshop. Finally, on 7 September 2012 the consortium met for the last time in Hannover, Germany and among others took care of preparations for the joint conference of AcademicGMP and CONTRACT on the 'impact of EU legislation on therapeutic advance'.
There was close interaction with the external advisory board since the project outset and the consortium profited greatly from the participation of two members of the EAB, Dag Wiese Schartum and Cecilia Magnusson Sjöberg, at the first stakeholder meeting in Hannover in September 2011. The EAB also received the informed consent guide for review and took part in the discussion on the direction and focus of the infrastructure developed in the WP5 (Helpdesk).
Project lifetime was marked by intensive networking with other EU projects and various stakeholder organisations to promote CONTRACT, the questionnaire and to gain feedback from practitioners. Highlights included the presentations held at the European Network for Cancer in Children and Adults (ENCCA) participation at the meetings of SIOP Europe and SIOP, a meeting with professors of the Hannover Medical School (MHH) to promote the project, networking during a number of related projects, such as P-Medicine and VPH and finally a close cooperation with the Academic-GMP project, a 'sister project' financed by EC in the same topic as CONTRACT.
WP2 - Problem analysis
The major objective for WP2 was to analyse the current situation concerning the legal, ethical, technical and clinical handling of consent in European projects dealing with vulnerable patient groups by means of a questionnaire survey distributed to a wide range of stakeholders and practitioners.
WP2 analysed the current situation concerning the legal, ethical, technical and clinical handling of consent in European projects dealing with vulnerable patient groups. The proposed methodology for this WP was a project-based questionnaire to identify existing practices and problems encountered in translational research throughout Europe.
The questionnaire and its analysis were conducted in three stages:
- identification of target projects and stakeholders;
- development of the questionnaire, including the validation of a pre-final version of the questionnaire by sending it to different stakeholder groups to obtain feedback for optimisation of the questionnaire;
- dissemination of the final questionnaire and analysis of the results of the questionnaire.
The aim of the survey was to show how ongoing and upcoming European and national translational projects deal differently with consent issues. This was the basis for delivering concrete policy recommendations as to how EU could jointly protect patient rights and support translational research by a better-structured approach towards consent issues.
The questionnaire and its analysis were conducted in three stages. In a first step, the target projects and the relevant stakeholders were identified. 221 projects were contacted directly and asked to participate in the survey.
List of websites: http://www.contract-fp7.eu/site/