- 1 Preamble
- 2 Premises
- 3 Declaration of Conflicts of Interest
- 4 Ethical principles of relationships for partnerships within the consortium, its advisory boards, with EUPATI Network members and with patients within EUPATI
- 5 Additional ethical principles for partnerships within the consortium, its advisory boards and with EUPATI Network members
- 6 And an additional ethical principle for interaction with patients
- 7 Ethical principles for Involving patients into EUPATI-related social research
- 8 Ethical principles for educational information collection, material production and dissemination
- 9 Glossary
IMI’s EUPATI project is establishing a patient-led academy to provide scientifically reliable, objective, comprehensive information to patients on medicines R&D. Thus it will increase the capacity of well-informed patients to be effective advocates and advisors, e.g. in medicines development, with regulatory authorities and in ethics committees.
In the EUPATI project no medical research is performed. However, elements of the project, distributed across its various Work Packages, involve social research and interactions with patients and members of the public at large. The outcome of EUPATI will be objective training, education and information material on medicines research and development as well as an infrastructure that allows its broadest possible dissemination within the given resource and budget constraints. Planning and execution of EUPATI is performed in partnership by a Consortium consisting of representatives from patient organisations, pharmaceutical industry, academia and NGOs.
This EUPATI Ethical Framework applies to all those involved in carrying out work for the EUPATI project. This includes:
- EUPATI Consortium members
- People seconded to and employed through the EUPATI project
- Subcontractors for elements of the EUPATI project
- Members of the Project Advisory Board (PAB), of the Regulatory Advisory Panel (RAP) and of the Ethics Panel (EP)
All EUPATI Consortium members as well as the members of the PAB, RAP and EP are required to confirm in writing that they have read and will adhere to the EUPATI Ethical Framework, also ensuring their employees and sub-contractors involved in EUPATI adhere to it as well. This is coordinated by the EUPATI Project Secretariat.
The elaboration and supervision of adherence to this EUPATI Ethical Framework is provided by the EUPATI Ethics Panel (Work Package 2 Task Force 5, two co-leaders from academia [including research ethics committees] and a patient deputy co-leader. Approximately 50% of the members are patient representatives from different disease areas and countries).
The core remit of the EUPATI Ethics Panel is to provide the infrastructure and access to the required intelligence and genuine expertise in ethics and law as pertains to the medicines development processes and patient advocacy. It advises the Project Steering Committee, Executive Committee and Work Packages on ethical aspects of the project, including conflicts of interest, including – amongst others –
- Interaction and communication within the Consortium
- Generation and dissemination of information to patients
- Communication within the EUPATI Network
- Communication to patients and public at large
This document is based on the convictions that:
- The patients’ experience and perspective of their disease is unique in its kind and therefore should be valued as specialist knowledge that is different from the professional knowledge of medical specialists and clinical researchers in pharmaceutical industry and academia, members of ethics committees and clinicians.
- The perspective of patients is frequently represented by patient organisations which integrate the experience of their members and disseminate this combined knowledge to help improve the disease conditions and quality of life of their members. Incorporating this patient expertise into the clinical development process will lead to clinical research and treatments that are more adapted to the real needs of patients.
- A partnership between patient organisations, pharmaceutical companies, academia and NGOs can generate benefits for all parties in their attempts to accelerate the development of new treatments options.
- The integrity, credibility and independence of all involved partners, as well as the constraints and obligations under which all stakeholder operate, should be respected at all times by all partners.
- Adherence to the EUPATI Code of Conduct by all EUPATI members ensures trustful and successful execution and completion of the project.
This document was collated with reference to:
- WMA Declaration of Helsinki, 2008 and 2011
- CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects
- EFPIA: Code of Practice on relationships between the pharmaceutical industry and patient organisations
- EURORDIS: Code of Practice between patients’ organisations and the healthcare industry
- ICH-E6 “Good Clinical Practice” Guideline 1996
- IOM Consensus Report on: Conflict of Interest in Medical Research, Education, and Practice, 2009
- Social Research Association Ethical Guidelines 2003
- FP7 Project: “Patient Partner”: Ethical Principles of Partnership, 2011
- EMA Policy on the handling of conflicts of interests of scientific committee members and experts, April 2012
Declaration of Conflicts of Interest
Conflicts of interest may arise when an individual’s personal, business, occupational or professional interests or loyalties conflict with the interests of the EUPATI project, when writing or reviewing content or taking editorial decisions, and/or EUPATI’s principles on transparency, objectivity and independence. A conflict of interest occurs when, in the course of their EUPATI activities, contributors are privy to EUPATI decisions or documents that provide opportunities to obtain personal, business, economic, occupational or professional benefits for themselves and/or third parties.
Even though the project does explicitly not address any specific indication or treatment, EUPATI is a public-private partnership project involving patients, pharmaceutical industry, academia and NGOs. Therefore, this project is based on utmost transparency. Public declaration and management of potential conflicts of interest are of major importance.
Every member of the EUPATI Consortium or EUPATI Committee, Panel or Task Force performing any task in the project annually completes and updates this personal disclosure form describing his/her professional and non-professional activities and affiliations. This form takes into consideration e.g. Section 3 of the ICMJE’s requirements for Disclosure of Potential Conflicts of Interest.
The completed forms are made publicly available on the EUPATI web portal and are regularly reviewed by the Ethics Panel. Identified potential conflicts of interest are reported to the EUPATI Executive Committee for resolution.
Ethical principles of relationships for partnerships within the consortium, its advisory boards, with EUPATI Network members and with patients within EUPATI
The following ethical principles are guiding the work within this project:
- Respect – EUPATI members endeavour to treat people involved in the EUPATI project with the respect, consideration and courtesy they deserve as individuals and valued members of the EUPATI project
- Trust – about motives as well as the confidence to contribute to the common goal of ultimately providing benefit to patients
- Non-maleficence – EUPATI members do no physical, social or psychological harm to those involved in the EUPATI project
- Equality – EUPATI members treat all participants as equals by not being biased
- Transparency – about roles, responsibilities, constraints, and potential conflicts of interest
Additional ethical principles for partnerships within the consortium, its advisory boards and with EUPATI Network members
- Independence – of decisions and strategies from the organisational interests of the Consortium partners
- Integrity – of behavior and processes
- Objectivity – in decision making, needs evaluation and project outcomes
- Accountability – for input and outcomes achieved
- Acknowledgement – of contributions and achievements
And an additional ethical principle for interaction with patients
- Anonymity and privacy – EUPATI members conceal the identities of participants in project-related activities. EUPATI participants are made aware that they are entitled to reject particular forms of data-gathering (e.g., use of devices such as tape-recorders and video cameras) but that it is not always possible to conceal identities completely, and that anonymity can sometimes be compromised unintentionally.
Elements of the EUPATI project constitute social research. EUPATI members respect the individual’s right to choose to take part in social research and gain written informed consent from patient and public participants for these elements of the project.
- Is informed: given in possession and understanding of all information related to the EUPATI project;
- Is voluntary: given freely and not as a result of coercive pressure (real or perceived);
- Is competent: given by an able person who, by virtue of age, maturity and mental stability, is capable of making a free, considered choice.
- EUPATI members ensure that the potential research participant is fully aware of, and fully understands:
what the research is about;
why it is being conducted;
who it is being conducted for and who is funding it;
what the purpose of the study is and what will happen to the results;
where the results will appear and who is likely to have access to them;
what will be expected of them if they agree to participate and how long their participation will take;
what anonymity and confidentiality mean in practice and
that the participant:
- does not have to participate; and
- having agreed to participate can withdraw any time without detriment to the participant.
- Minimization of inconvenience – EUPATI members attempt to minimize inconvenience where research participants are particularly vulnerable by virtue of age, social status, disability or medical condition.
- Anonymity and privacy – EUPATI members conduct all activities in compliance with the “Charter of fundamental rights of the European Union, in particular with its articles 7 (Respect for private and family life) and 8 (Protection of personal data). EUPATI members conceal the identities of participants in all documents resulting from the research; care is taken in deciding whether or not sensitive information shall form part of the permanent record of this project. Identities and project records are kept confidential, with appropriate data protection measures, whether or not an explicit pledge by EUPATI members to participants has been given. EUPATI participants are made aware that they are entitled to reject particular forms of data-gathering (e.g., use of devices such as tape-recorders and video cameras). EUPATI members clarify with participants the extent to which they are allowed to see transcripts of any interviews, focus groups and field notes
- Research integrity – EUPATI members must avoid falsification or misrepresentation of evidence, data, findings or conclusions
- Respect for ethical and legal framework – EUPATI members ensure full compliance with all applicable European regulatory frameworks and ethical guidelines for social research
- Transparency – EUPATI members make every effort to communicate the results of the EUPATI project, including its research elements, to the participants involved in EUPATI. It is deemed unethical to withhold the publication of any results of research, on whether the results are positive, negative or inconclusive.
Ethical principles for educational information collection, material production and dissemination
EUPATI is a highly collaborative project with partners from very different fields including pharmaceutical companies, academic organisations, NGOs and patient groups. EUPATI members make all reasonable efforts to ensure professional integrity in all aspects of information material collection, selection, adaptation to patients’ needs and dissemination.
- Respect to patent protection – EUPATI members ensure respect of patent protection rules for all material collected for EUPATI purposes
- Objectivity, neutrality, and independence – EUPATI members ensure independence in selection of training / education / information material, objectivity and neutrality in its adaptation to the different patient audiences’ needs, in dissemination and in allocation of resources for production and dissemination. Information provided by EUPATI members is non-directional.
- Transparency – EUPATI members strive for ongoing, complete transparency to patients and the public at large concerning project strategies, decision making rules, procedures, progress and outcomes by adhering to IMI reporting rules as well as by ensuring regular status communication in different media, publications and in face-to-face opportunities
- Conflict of Interest – Information provided within the framework of EUPATI and all its work results are generated with integrity and in an independent way. Should any barrier to this be identified by any partner or individual, it is considered as a conflict of interest and declared as such without any delay and in writing to the ExCo. Competing interests cover anything that might influence the making of balanced, unbiased judgements of importance to patients. This also includes, but is not limited to, potential competing interests in dealings with professional colleagues, scientific journals, industry and the general public
- Personal benefits – EUPATI members take decisions that primarily protect the health and well-being of patients and also advance medical knowledge for the scientific and wider public benefit. No EUPATI members gains financial or other material benefits from this project for themselves, their families or friends
- Distributive justice – EUPATI members ensure fair accessibility of its results to different communities in a fully transparent mode. By communities are understood any of the following:
- different linguistic groups
- groups of persons with different levels of health literacy
- groups of persons with particular physical limitations
- groups of persons having different access to technologies, in particular computer and internet access, etc.
- groups of persons having different access to healthcare provision
- Respect of national legal requirements – EUPATI members strive to ensure that implementation and performance of EUPATI National Platforms take cognisance of all applicable national legal requirements
CIOMS Council for International Organisations of Medical Sciences
EFPIA European Federation of Pharmaceutical Industry Associations
EMA European Medicines Agency
EURORDIS European Organisation for Rare Diseases
FP7 European Commission – Research: Seventh Framework Programme
ICH International Conference on Harmonisation of Technical Requirements for Registration of Medicinal Products for Human Use
ICMJE International Committee of Medical Journal Editors
IOM Institute of Medicine
NGO Non-Governmental Organisation
WMA World Medical Association