Nordic Bioethics Committee Confidential Medical Information ethics and

Nordic Bioethics Committee: Confidential Medical Information – ethics and legal perspectives © FIMM - Institute for Molecular Medicine Finland www. fimm. fi

Genetic information and research: Questions and concerns Linda Laatikainen May 6 th, 2015 © FIMM - Institute for Molecular Medicine Finland www. fimm. fi

Institute for Molecular Medicine Finland Building a bridge from discovery to medicine › Joint research institute § University of Helsinki, the Hospital District of Helsinki and Uusimaa, National Institue for Health and Welfare and VTT Technical Research Center of Finland § Staff: 190 of which 36% international; 16 FIMM affiliated group leaders § Total funding: 15. 4 M€ (2014), 54% competetive external funding › Research focus § Translational Research and adoption of Personalized Medicine in health care § Human Genomics, Preventative Health Care and Digital Molecular Medicine § Individualized Systems Medicine (ISM) and Precision Therapeutics in cancer, AML etc. › National Technology Centre and Biobanking Infrastructure § Several high throughput, state-of-the-art platforms › International networking § Nordic EMBL Partnership for Molecular Medixcine (4 Nordic nodes) § EU-Life (13 top biomedical research institutes from Europe) § European Strategy Forum on Research Infrastructures (BBMRI, EATRIS, EUOPENSCREEN, ELIXIR) www. fimm. fi

FIMM has increasingly been faced with questions and concerns related to bioethics • • www. generisk. fi (in Finnish) One-off collection of 15 000 subjects Duration of 20+ years via biobank Online questionnaire, PHR, blood tests, genotyping and registry linkage https: //www. youtube. com/watch? v=Y 7 a Pi 8 Nv 3 BM BOLD = fairly new elements in Finnish cohorts www. fimm. fi

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Questions and concerns 1. What is confidential information? 2. Who can collect confidential medical information and how? 3. How should confidential medical information be managed? 4. What confidential medical information can be returned and how? 5. How can we act ethically and in line with latest regulations every time? www. fimm. fi

1. What is confidential information? › Confidential information vs. personal information › Personal information vs. personal medical information › Genetic information vs. other medical information › Medical information in health care vs research › Confidential information now versus in the future › Data versus samples and metadata § Copy right § Consumables § Opportunity for ownership or deletion www. fimm. fi

2. Who can collect confidential medical information and how? › Responsible investigator = medical professional › Research staff § Licensed health care professional (nurse, lab technician, doctor) › Collection center § Hospital, Medical center, Finnish Medicines Agency’s approved research center › Standardized process § Training, SOPs, File Notes How stringent should these rules be? www. fimm. fi

3. How should confidential medical information be managed? › Informed consent › Biobank vs. Primary research program › Ownership vs. Management of confidential data › Collection § Paper vs. Online: Authentication, Identification › Analysis › Storage and Transfer § Data security, VAHTI, Register description, Material Transfer Agreement, Proactive management over time www. fimm. fi

3. Data deletion vs. inactivation Intention to treat (ITT) analysis: harms www. fimm. fi

4. What confidential medical information can be returned and how? › Medical information versus genetic information › Common genetic findings versus rare variants › Planned versus incidental findings § Medically relevant and/or life-threatening › Patient guidance versus Clinical Trial › Communication style and timing (request from patient? ) › Returned to doctor, subject and/or family › Support network defined by traditional versus genetic risk § Licensed health care professionals www. fimm. fi

ü Choice ü Many factors have an impact on health Disclaimers ü This is research ü Calculation may be unsuitable • Disease, medication ü Incomplete information may lead to misleading results ü Only part of relevant factors evaluated www. fimm. fi

5. How can we act ethically every time? Guidelines & ethical approval process Research plan General information Name Researchers Introduction Participants Participant materials Invitation letter and information materials Other Clarity of design Cover letter Sample size and selection of subjects Register description Advantages and disadvantages Recruitment ads Clarity of participant materials Funding FIN Selection criteria Informed consent Ethical evaluation SWE Treatment Experimental design Research method Samples and handling Consent forms FIN Research type Research groups Physical contact and validity What genes/why SWE Expenses and budget Funding sources Data processing Research design Scope & timetable Sample size and rationale Research forms FIN Adequacy of financial and scientific resources Staff guidelines Publication method Other Insurance coverage and compesnation Expenses and resources Acts SWE Data Protection Act Personal Data Act Biobank Act Human resources Buildings and equipment Staff compensation Participants’ insurance coverage and compensation Research register Summary Medical Research Act Other resources/costs NOTE: Members of the Ethics Committee include experts in medicine, ethics, nursing, legal matters and at least two members are lay members (other than a health care professional or part of the research staff) www. fimm. fi 13

5. How can we act ethically and in line with latest regulations every time? › Conflicting standards › New and conflicting laws › Changes in interpretation between experts / boards Intermediate solution › “Imagine being a subject yourself – how would you feel about these decisions” › Effort-intensive continuous learning from peers and experts Valvira: national supervisory authority for welfare and health; THL: national institute for health and welfare; STM: Ministry of social affairs and health; TUKIJA: national committee on medical research ethics; IRB: institutional review boards/ethics committees (e. g. , 4 for HUCH); FIMEA: Finnish medicines agency; TSV: Data protection supervisor; PIF: Pharma Industry Finland; BBMRI: Biobanking and Biomolecular Resources Research Infrastructure; EU; Parlamentary Ombudsman; Collaboration partners (private, public, 3 rd sector) www. fimm. fi

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