The Ethical Advisory Board (EAB)
The PanCanRisk Consortium entails the development of bioinformatics tools for the discovery of novel rare cancer risk variants both in coding and regulatory regions in large cohorts, the validation of the variants and cancer risk genes found in model systems and in prospective cohorts and the development of cancer-risk panels and bioinformatics tools to be used in the clinic.
The members of Ethics Advisory Board (EAB) of the Consortium PanCanRisk is composed by 3 independent and external members with relevant experience in ethics:
– Helena Machado, Research Professor at Centre for Social Studies, University of Coimbra, Portugal
– Carlos Romeu, Tenured Professor of Criminal Law at Univrsity of the Basque Country, Spain
– Vincenzo Lorenzo Pascali, Professor at Facoltà di Medicina e Chirurgia, Sede di Roma. Istituto di sanita’ pubblica, Italy
The EAB of the consortium PanCanRisk had a meeting on the 14Th December 2016, at the Centre for Genomic Regulation (CRG). PRBB building (Aula Room) ,Barcelona (Spain) with the aim of performing an Ethical Screening of the activities of the consortium PanCanRisk and to assess any new ethical issues that might arise during the development of the activities of the consortium.Participants in the meeting were: Helena Machado, Carlos Romeu, Vincenzo Lorenzo Pascali, Ángel Carracedo, Esther Sande, Ceres Fernandez, Stephan Ossowski, Kelly Rabionet, Oliver Stegle, Gabriela Palacios and Mahesh Shah.MethodologyThe Ethical Screening applied the following methodology in order to reach ethical deliberation (details are provide in Section “Revision of Ethical Guidelines”):Step 1 – Identification of Ethical Issues specific to the activities of the consortium PanCanRiskStep 2 – Ethics review outcomesStep 3 – Additional screening requirementsStep 4 – Ethics Checks/AuditStep 5 –Recommendations Identification of Ethical Issues
Considering the Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin, adopted by the Committee of Ministers on 11 May 2016 at the 1256th meeting of the Ministers’ Deputies, the EAB of the consortium PanCanRisk proceed to the identification of ethical issues specific to the consortium PanCanRisk on the basis of the following principles:
The need for maintenance and further realisation of human rights and fundamental freedoms;
Considering that one of the aims of the Convention for the Protection of Human Rights and Fundamental Freedoms (ETS No. 5) is the protection of private life;
Considering that the aim of the Convention on Human Rights and Biomedicine (ETS No. 164) and of its Additional Protocol concerning biomedical research (CETS No. 195), as defined in Article 1 of both instruments, is to protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine;
Acknowledging the fact that personal data must be adequately protected in accordance with data protection principles as laid down in the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (ETS No. 108);
Taking into account national and international professional standards in the area of biomedical research;
Recognising the value of biomedical research for the advancement of health care and for the improvement of the quality of life and the potential of collections of biological materials of human origin to facilitate the realisation of these benefits;
Stressing that research is often transdisciplinary and international, as reflected in the establishment of international research infrastructures that pool and share samples and data across national borders, and underlining the importance of interoperability in this context;
Taking into account the current and planned development of collections of biological materials of human origin at national level and the existence of collections set up for clinical purposes;
Recalling that biomedical research on biological materials should be carried out freely subject to the provisions legal provisions ensuring the protection of the individual;
Stressing that the paramount concern should be the protection of the human being whose biological materials are obtained, stored or used for research;
Emphasising that the interest and welfare of the person whose biological materials are used in research shall prevail over the sole interest of society or science;
Affirming that particular protection shall be given to persons who may be vulnerable in the context of research, especially to those who are not able to consent;
Considering that new developments in the field of biomedical research, in particular in the field of genetics, increase issues regarding protection of privacy;
Recognising that every person has the right to accept or refuse to contribute to biomedical research and that no one should be forced to contribute to it;
Emphasising the importance of earning trust and stressing the role of good and transparent governance of biological materials of human origin stored for research purposes, including the establishment of an appropriate feedback policy;
Recalling that researchers should be allowed fair access to collections developed on the basis of donations of biological materials of human origin made in a spirit of solidarity;
Resolving to take such measures as are necessary to safeguard human dignity and the rights and fundamental freedoms of the individual with regard to biomedical research on biological materials of human origin.
The Ethics Advisory Board (EAB) of the Consortium PanCanRisk adopted the following method to reach ethical deliberation: (step 1) – identification of ethical issues to be considered in the activities of the Consortium PanCanRisk; (step 2) – Ethics review outcomes; (step 3) – Identification of additional ethics screening requirements; (step 4) –Assessment for the need of a ethics audit; (step 5) –Recommendations.
Step 1 – Identification of Ethical Issues
Details on the procedures and criteria that are used to identify/recruit research participants must be provided.
Details on the informed consent procedures that are being implemented must be provided provided.
The Informed Consent Forms and the Information Sheet must be written in language and terms understandable to the participants.
The Informed Consent Forms and the Information Sheet must assure the right of the participants:
To know that participation is voluntary
To ask questions and receive understandable answers before making a decision
To know the degree of risk and burden involved in participation
To know who will benefit from participation
To know the procedures that will be implemented in the case of incidental findings
To know how their data will be collected, protected during the project or reused at the end of the research
To withdraw themselves, their samples and data from the project at any time without affecting their current or future healthcare
To know of any potential commercial exploitation of the research.
The protocol of the study has to be submitted for scrutiny to the competent local/national ethical boards/bodies to obtain written authorization to conduct the research.
Ethical approvals for the collection of personal data by the competent University Data Protection Officer / National Data Protection authority must be obtained.
Measures for prevention of the risk of enhancing vulnerability/stigmatisation of individuals/groups must be taken.
Justification must be given in case of collection and/or processing of personal sensitive data.
Detailed information must be provided on the procedures that will be implemented for data collection, storage, protection, retention and destruction and confirmation that they comply with national and EU legislation.
Confirmation must be provided that the existing data is publicly available.
In case of data not publicly available, relevant authorisations must be provided.
Detailed information on that procedures that will be implemented to provide a proper process in order to consider the right to be forgotten and subsequent obligations must be provided.
Information regarding any potential function creep risks, dual use and misuse of data must be provided. Information about procedures to document and mitigate them must be provided.
Other Ethics issues
At the present state of the development of the activities of the Consortium, there are not any other ethics issues that should be taken into consideration.
Step 2 – Ethics review outcomes
The EAB considers that the consortium PanCanRisk has implemented in ethical adequate manner the following procedures:
Procedures and criteria used to identify/recruit research participants are clear and adequate.
The Informed Consent Forms and the Information Sheet are written in language and terms understandable to the participants.
The Informed Consent Forms and the Information Sheet assure the right of the participants:
To withdraw themselves, their samples and data from the project at any time
The protocol of the study was submitted for scrutiny to the competent local/national ethical boards/bodies and the written authorization to conduct the research was obtained.
Ethical approvals for the collection of personal data by the competent University Data Protection Officer / National Data Protection authority were obtained.
Measures for prevention of the risk of enhancing vulnerability/stigmatisation of individuals/groups were taken.
Detailed information on the procedures that will be implemented for data collection, storage, protection, retention and confirmation that they comply with national and EU legislation were provided.
The EAB considered that the ethics of outcome for the current state of the activities of the consortium is a positive Ethics Clearance.
Step 3 – Additional screening requirements
The following additional information related to the activities of the consortium should be provided in the future reports of the PanCanRisk Consortium:
Detailed information on the procedures that will be implemented to provide a proper process in order to consider the right to be forgotten and subsequent obligations must be provided.
Step 4 – Ethics Checks/Audit
The EAB does not recommend an Ethics audit for this project.
Step 5 – Recommendations
Relevant documentation related to the implementation of the Consortium’s protocol for T “material transfer agreement” must be provided.