SPHN: FRAMEWORK FOR RESPONSIBLE DATA PROCESSING. Professor Effy Vayena, University of Zurich Chair of the ELSIag
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1 1 SPHN: FRAMEWORK FOR RESPONSIBLE DATA PROCESSING Professor Effy Vayena, University of Zurich Chair of the ELSIag
2 2 ELSI advisory group Ethical, Legal, Societal Issues Mandate: Identify key ELSI challenges Invite other SPHN bodies to submit ELSI challenges Provide advise to SPHN (principled recommendations) Submit the recommendations to the NSB for approval
3 3 ELSI advisory group Composition Expertise in: health law data protection bioethics sociology of medicine health policy patient safety patient perspectives
4 4 ELSI advisory group Ethical framework for responsible data processing* in the Swiss Personalized Health Network *collection, storage, use, sharing, revision, disclosure, archiving and destruction of data, irrespective of the means
5 5 Why an ethical framework? The law sets the bare minimum The law is rooted in ethical principles that are not always self-evident and need to be articulated To ensure all involved partners and stakeholders are aware of the ethical vision of SPHN To provide advise when there is ambiguity
6 6 The Swiss legal landscape Human Research Act (HRA), Human Research Ordinance (HRO), : Personally identifying Encoded Anonymized Further use of biological material and genetic data (Art. 32 HRA) 1) Informed consent to specific research projects only. (Art. 32 Para. 1 HFG, Art. 28 HRO) 2) "Informed consent" to research projects in general (Art. 32 Para. 2 HRA, Art. 29 HRO) 3) can be used for research purposes in general, if information was given in advance re anonym. & absence of dissent (Art. 32 Para. 3 HRA, Art. 30 HRO) Non-genetic health-related personal data (Art. 33 HRA) 4) "Informed consent" to research projects in general (Art. 33 Para. 1 HRA, Art. 31 HRO) 5) Can be used for research purposes in general, if information was given in advance & absence of dissent (Art. 33 Para. 2 HRA, Art. 32 HRO) Not in the scope of the HRA (Art. 2 Par. 2 lit. c HRA)
7 7 The Swiss legal landscape Human Research Act (HRA), September 2011 Human Research Ordinance (HRO), : 20 September 2013 Federal Act on Data Protection (FADP), June 1992 Human Genetic Testing Act (HGTA), October 2004 Verordnung über das elekronische Patientdossier (EPDV), March 2017
8 8 Methodology Review of available guidance on data sharing Time span Organizations National, international public policy organizations Scientific societies and professional organizations Public research funders Research platforms / consortia Governmental organizations Types of data Biomedical research data Clinical trial data Electronic health records Genetic and genomic data Public health data # documents 49 # organizations 32
9 Methodology International public policy organizations National public policy organizations List of organizations CIOMS; GA4GH; ICH; OECD; P3G; UNESCO ETHIK RAT (DE) Comité d Éthique du CNRS (FR) Office for Science and Technology Policy (US) NEK-CNE (CH) Nuffield Council on Bioethics (UK) President s Council of Advisors on Science and Technology (US) The Royal Society (UK) Swiss Clinical Trial Organization 9 Scientific societies, professional organizations, research platforms and consortia Research funders Governmental organizations WMA; EFPIA; HUGO; ESHG; ICGC; Sanger Institute MRC; NSF; NIH; Wellcome Trust; Public Health Research Data Forum Partners; Cancer Research UK; NHMRC; RCUK; H2020 Council of Europe, G8 Science Ministers, EU Commission
10 10 Guidance documents by category 8% 6% 29% International public policy organizations National public policy organizations Scientific societies & professional organizations Research funders 31% 14% Scientific consortia & insitutes Governments 12%
11 11 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.
12 12 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
13 13 The Ethical Framework Draft discussed and amended by the ELSIag Extensive feedback from other SPHN bodies and stakeholders Executive Board National Steering Board (NSB) Individuals comments Framework approved by the NSB
14 14 Accountability 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 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. Copyright Showeet.com
15 15 Guidelines Accountability Respect for persons Consent Use of general (broad consent) Principles Clinically actionable findings should be communicated Privacy Mechanisms in case of revocation of consent Data fairness Return of results if requested Copyright Showeet.com
16 16 Accountability Respect for persons Guidelines Following pre-defined standards of data security, confidentiality, encoding and anonymization. Principles Raising privacy awareness in data operators. Privacy Data fairness Copyright Showeet.com
17 17 Guidelines Accountability Respect for persons Timely access. No profit but cost claims possible. Principles No exclusivity rights agreements. Privacy Data fairness Copyright Showeet.com
18 18 Guidelines Accountability Accountability Respect Respect for for persons Respect for persons persons Transparent governance structures. Principles Data fairness Data fairness Privacy Privacy Procedures for authorizing data access requests by other SPHN partners. Ethical assessment of data access requests by third parties. Copyright Showeet.com
19 19 The Ethical Framework Additional guidelines needed Samples Clinical actionability Encoding and anonymization procedures The framework can be amended in the future (live document) Possible uses beyond SPHN
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