Key ethical principles for Personalized/ Precision Medicine. Health Ethics and Policy
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1 Key ethical principles for Personalized/ Precision Medicine Professor EFFY VAYENA Health Ethics and Policy Chair SPHN ELSIag NN 22/11/17 1
2 WEF, 2017 NN 22/11/17 2
3 Health Data Sources
4 E. Vayena, J. Dzenowagis, M. Langfeld, 2016
5
6 Vayena et al. Bulletin of the World Health Organization, in press
7 Governance PRIVACY DATA ACCESS & SHARING OWNERSHIP & CONTROL INTEROPERABILITY DATA QUALITY SECURITY Infrastructure
8 Source: OECD 8
9 Aim: to enable nationwide accessibility and exchange of health data of patients and healthy citizens. 22/11/17 9
10 Top-down and bottom up SPHN enables approaches to make the best out of the personal health data of patients and citizens and to justify the confidence of patients in research. SPHN is a funding initiative which enables research on a national scale. Incentive based approach De-centralised approach SPHN creates a dynamic network of existing data sources and will not build a centralized database. Step-wise approach start with public institutions and move on to include private institutions Shared values SPHN stimulates and supports the meaningful, responsible and lawful use of personal health data. 22/11/17 10
11 Swiss Personalised Health Network 22/11/17 11
12 ELSI advisory group Ethical, Legal, Societal Implications Mandate: u Identify key ELSI challenges u Invite other SPHN bodies to submit ELSI concerns u Provide advise to SPHN (principled recommendations) u Submit the recommendations to the NSB for approval 12
13 Shared Values ELSI advisory board Ethical Framework for Responsible Data Processing 22/11/17 13
14 14
15 What we searched for Principles = statements indicating a valuable state of things, a right, interests to be protected or promoted, activities to be encouraged, or risks to be avoided. Guidelines = requested or prescribed actions needed to achieve what the principles indicate as valuable. What we obtained A set of the most frequently recalled principles being relevant for SPHN activities A draft framework composed of relevant principles and suitable guidelines 15
16 ACCOUNTABILITY RESPECT FOR PERSONS The rights and dignity of individuals, families and communities participating in research must be respected, protected and promoted. Privacy and confidentiality must be safeguarded. DATA FAIRNESS PRINCIPLES PRIVACY Data that can be used for research purposes and research results should be made available for further research use to advance the common good of scientific knowledge. Accountability mechanisms should ensure fair, lawful and transparent data processing. 16 Copyright Showeet.com
17 RESPECT FOR PERSONS Accountability Data fairness Respect for persons The rights and dignity of individuals, families and communities contributing health data in the context of research and clinical care, as well as other types of data that can be useful for biomedical research must be respected, protected and promoted. Privacy GUIDELINES u Consent u Use of broad consent u Clinically actionable findings should be communicated u Mechanisms in case of revocation of consent u Return of results if requested Copyright Showeet.com 17
18 PRIVACY Privacy and confidentiality Respect for must be safeguarded. persons Accountability GUIDELINES u Following pre-defined standards of data security, confidentiality, coding and anonymization. u Raising privacy awareness in data operators. Privacy Data fairness Copyright Showeet.com 18
19 Respect for DATA FAIRNESS persons Data that can be used for research purposes and research results should be made available for further research use to advance the common good of scientific knowledge. Accountability Privacy GUIDELINES u Timely access. u No profit but cost claims possible. u No exclusivity rights agreements. Data fairness 19 Copyright Showeet.com
20 ACCOUNTABILITY Respect for Accountability Accountability persons mechanisms Accountability should ensure fair, lawful and transparent data processing. Privacy Privacy Data fairness Data fairness GUIDELINES u Transparent governance structures. u Procedures for authorizing data access requests by other SPHN partners. u Ethical assessment of data access requests by third parties. Copyright Showeet.com 20
21 The Ethical Framework Additional guidelines needed Samples Clinical actionability The framework can be amended in the future (live document) Possible uses beyond SPHN 21
22 still early days but institutions (hospitals, research centers) committed to comply with the framework; committed to become compliant within the funding period; each accelerated the process of developing institutional data governance; harmonization of governance policies amongst institutions. 22/11/17 22
SPHN: FRAMEWORK FOR RESPONSIBLE DATA PROCESSING. Professor Effy Vayena, University of Zurich Chair of the ELSIag
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