© FIMM - Institute for Molecular Medicine Finland www.fimm.fi

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 6th, 2015

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› 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 FinlandBuilding a bridge from discovery to medicine

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FIMM has increasingly been faced with questions and concerns related to bioethics

BOLD = fairly new elements in Finnish cohorts

• 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=Y7aPi8Nv3BM

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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?

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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 metadataCopy right ConsumablesOpportunity for ownership or deletion

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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 processTraining, SOPs, File Notes How stringent should

these rules be?

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3. How should confidential medical information be managed?

› Informed consent

› Biobank vs. Primary research program

› Ownership vs. Management of confidential data

› CollectionPaper vs. Online: Authentication, Identification

› Analysis

› Storage and TransferData security, VAHTI, Register description, Material

Transfer Agreement, Proactive management over time

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3. Data deletion vs. inactivation

Intention to treat (ITT) analysis: harms

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4. What confidential medical information can be returned and how?

› Medical information versus genetic information

› Common genetic findings versus rare variants

› Planned versus incidental findingsMedically 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 riskLicensed health care professionals

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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

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SWE

Participant

materialsResearch plan Ethical

evaluation Other

General

information

Invitation letter and information materials

Clarity of design Cover letter

Participants

Recruitment adsConsent 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

ActsData 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

OtherInsurance 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

5. How can we act ethically every time?Guidelines & ethical approval process

Personal Data Act

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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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