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

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

3. www.fimm.fi ›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, EU- OPENSCREEN, ELIXIR) Institute for Molecular Medicine Finland Building a bridge from discovery to medicine

4. www.fimm.fi FIMM has increasingly been faced with questions and concerns related to bioethics BOLD = fairly new elements in Finnish cohorts www.generisk.fi (in Finnish)www.generisk.fi 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=Y7a Pi8Nv3BM

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6. 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?

7. 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

8. 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?

9. 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

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

11. 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

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

13. www.fimm.fi SWE Participant materials Research plan Ethical evaluation Other General information Invitation letter and information materials Clarity of design Cover letter Participants Recruitment ads Consent forms Summary Funding Register description FIN Sample size and selection of subjects Advantages and disadvantages Clarity of participant materials Adequacy of financial and scientific resources Acts Data Protection Act Biobank Act Medical Research Act 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) Staff compensation Participants’ insurance coverage and compensation Other resources/costs Expenses and budget Funding sources Human resources Buildings and equipment Selection criteria Informed consent Treatment Name Researchers Introduction Research method SWE FIN Other Insurance coverage and compesnation Expenses and resources Research register Publication method Research design Scope & timetable Sample size and rationale Data processing Staff guidelines SWE FIN Research forms Experimental design Samples and handling Research type Research groups Physical contact and validity What genes/why 13 5. How can we act ethically every time? Guidelines & ethical approval process Personal Data Act

14. www.fimm.fi 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)

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