WP8 Ethics requirements
The PIANOFORTE consortium undertakes to observe current ethics legislations and regulations in the countries where their research is carried out relating both to ethics and data protection issues. Where required under national regulations or rules, each consortium partner seeks the approval of their relevant ethics committees prior to starting research activities and documents the approval status to the coordinator.
The project involves several clinical studies. The clinical and epidemiological work of PIANOFORTE adheres to established conventions governing such research, in particular, Directive 95/46/EC, the Helsinki Declaration, and the 1977 Oviedo Convention of the Council of Europe on human rights and biomedicine. The consortium undertakes to observe current ethics legislation and regulations in the countries where their research is carried out relating both to ethics and data protection issues. Where required under national regulations or rules, each consortium partner seeks the approval of their relevant ethics committees prior to starting research activities and documents the approval status to the coordinator.
The main ethical issues in PIANOFORTE concern the following: - The collection of data and biological samples from children and adults—both healthy persons and patients.
- The utilization of medical records and images and, questionnaires, to collect information (and personal data) regarding health condition, treatments, radiation and other exposures, lifestyle, and other potential risk factors for the endpoints under study.
- Storage of biological samples and of biological, health and epidemiological data; transfer of anonymized data, images, and samples between centers for the purposes of collation, analysis and storage.
- Animal welfare, a major requirement, for the use of animal models (rodents).
The basic ethical principles to be maintained include doing good, not doing harm, and protecting the autonomy, wellbeing, safety, and dignity of all research participants.
Ethical review should be well informed, fair, and transparent while seeking full justification for the proposed research. Ethical review should protect researchers, subjects, and institutions in field sites from harm.
Regarding personal data, those data will be as anonymized as possible in the frame of each action/project. If they are not anonymized, processing shall be realized in accordance with the European and national legislations.
Requirements and rules regarding ethics, transfer of biological material or personal data shall be specified on a case-by-case basis in each consortium agreement depending on the action/project.
PIANOFORTE ethics committees
This committee ensures that the PIANOFORTE works meet the high ethical and scientific standards expected by society. It ensures that research involving human subjects, epidemiological studies or animals’ experiment are carried out according to the ethical standards and scientific merit of research; that the rights of research participants and researchers are protected; and that society, which provides the resources for research, will ultimately benefit from it.The objective is to ensure compliance with the 'ethics requirements' set out in this work package.
Lead: IRSN, France
