Biobanks, data protection and issues of integrity Finnish and Nordic perspectives

Biobanks, data protection and issues of integrity: Finnish and Nordic perspectives

Promoting Health Research and Innovation Bergen, May 12-14 2014

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General trends and challenges • Medical ethics based regimes focused on intervention and

consent – Ill-fit for for biobanks

• Later in 2000 Hki Declaration, Cioms guidelines, CoE Rec on biobanks) provided exemptions from consent in epidemiological research

• At the same time, notion of ”informational self-determination” increasingly powerful– Genetic/genomic studies & big data raised concern– New EU Data Protection Regulation pending

• Right to feedback of results• ”Incidental findings” and duty of care• Children/non-competent in biobanksMay 12, 2014

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Nordic strengths and initiatives• Good research environment

– Church records and land property since 1600s – Personal IDs – Pro bioscience (Eurobarometre-survey 2010) – Trust on public governance – Health records and sample collections since decades – Register based research tradition

• NordForsk initiative NORIA-net on Registries: aim to increase unique data registries and biobanks in the Nordic countries

• BBMRI-pilot for colorectal cancer to test cross-border research using biobanks, patients records and registries

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Integrity in biobank research

• One of bioethical basic principles: autonomy, dignity, integrity, vulnerability

• Strong connection to human rights• Integrity means, i.e, respect for personal identity,

privacy, bodily untouchableness, intrinsic sphere of one’s own life, respect of wholeness.– Importance of consent procedure– Use of anonoymous samples and data against this

background?

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Some data protection principles & possible obstacles for biobanking

• Person’s data protection rights : access to data, rectification, erasure and right to object. – Processing shall be purpose bound– However, the further retention of the data should be allowed where it

is necessary for historical, statistical and scientific research purposes, for reasons of public interest in the area of public health

• Fair and transparent processing require information & explicit consent – for what estimated period, which recipients receive the data, what is

the general logic of the data that are undergoing the processing and what might be the consequences of such processing

• Contradicts with broad-consent in biobanking

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Proposed Data Protection Regulation

• Recital 123 a: The processing of personal data concerning health, as a special category of data, may be necessary for reasons of historical, statistical or scientific research. Therefore this Regulation foresees an exemption from the requirement of consent in cases of research that serves a high public interest.

• Biobanks may be regarded merely as registers and not research; an infrastructure (LifeGene in Sweden) – do exemptions count?

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Feedback of results as a special challenge

• Increasing demands based on informational self-determination and right to know

• Main challenges and practical issues to be overcome such as– Organizational & human resources, – quality of results (scientific & clinical validity and utility), source of results– lots of information, but how about interpretation?– counseling (Genetic/genomic testing shall precede appropriate

counselling– privacy & data protection– implications for and funding of health care, – needs of family members etc.

• Right-to-know/right-not-know – consent procedure crucial • OECD Guidelines: only validated results should be communicated

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Key features of Biobank Act (in force since Sept 1, 2013)

• Broad consent for future research purposes• Transfer of old samples to biobanks (opt-out)• Supervision under Valvira (National Supervisory Auhtority for

Health and Welfare)• Metadatabase for preliminary info about available samples and

data• Equal access for all researchers that meet the access criteria• Obligation to publish• Return of analysis results to biobank• Can be combined with patient records and national health

registers• Right to check one’s information at biobank (incl. also health)

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Biobank Act 39 § 2

A registered individual has the right to receive, upon request, information concerning his or her health as determined based on a sample. When providing information determined based on the sample, the person must be provided with an opportunity to receive an account of the significance of the information. A fee may be charged for clarifying the significance of the information that, at maximum, corresponds to the expenses incurred by providing the clarification.

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Biobank Decree – clinically significant findings

- If person has chosen so in consent, he/she can be contacted to inform about clinically significant findings.

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KSSHP

• Large regional clinical biobanks (n=5-6) together with hospital districts and universities

• Unique collaboration and concept in Europe

• National population based at THL Biobank

• Engagement to activities of BBMRI.fi and BBMRI-ERIC

Finnish biobanks

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Nordic biobank legislation

• Biobank Acts - Iceland – Lög om lifsýnasöfn (110/2000) - Norway – Helseforskningsloven (44/2008) - Sweden – Lag om biobanker i hälso- och sjukvård

m.m. (2002:297)- Finland – Biobank Act (688/2012)

• Denmark – no specific biobank act • Other relevant acts complete, data protection

regimes in particularMay 12, 2014

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Summary (1)

• Consent as the main rule• Opt-out in Denmark, Iceland and Norway• Secondary uses allowed in all countries under certain rules • Many other laws to be applied; complex long procedures

to use registers• Most Nordic countries has rules for biobank organisation,

person in charge, license requirement, ethical evaluation (excl. Denmark)

• Finland: equal access, Norway: priority access to own researchers

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Summary (2)

• Data protection regulation and interpretation strong, but different rules rgd. access, consent etc. -which organisation decides

• Different notions of data processing concepts (e.g., not applied to anonymous use, or if not identiable by reasonable means)

• Right to health-related information in Finland and Norway

• Nordic Committee on Bioethics has revised its biolawtables www.ncbio.org covering also biobank legislation

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Characteristics of a good biobank• Good governance, organisation and transparency• Respect for participants’ integrity - using broad consent

with good information and possibility to monitor biobanks’ activities

• Actively used and results are published• Simple and functionable access procedure, avoid

unnecessary bureacracy; equal access• One research protocol evaluation should enable also use of

registers (now many authorities decide!) –like in Norway.• Public-private partnerships increase value and accelerate

translational medicine and benefit society: win-win (reasonable benefit-sharing mechanisms)

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Innovation cycle in publicly funded biobanks Pathamasiri et al., Nat Biotech

2011;29:321.

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LEGISLATION ON BIOBANKSSWEDEN, DENMARK, NORWAY, ICELAND

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Sweden

Lag om biobanker i hälso- och sjukvård m.m.2002:297• Applies only to clinical samples if stored more than 2 mths

– Not applied to research collections

• Applies only to identifiable samples• Many hundreds local biobanks • Law requires a person in charge • Biobanks shall be registered to Socialstyrelsen that maintains

general biobankregister and supervises – Svenska Biobanksregistret SBR

• Report SOU 2010:81: broader scope of application and opt-out

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SWEDEN

• Informed consent as main rule to store samples• A person may pose restrictions:

diagnostics/research/educations/development• If the person prohibits storage of samples, they may not be

saved even if justified for his/her own further diagnostics• Research use requires ethical review procedure

– Ethical review Board considers a need for a new consent and may place restrictions

www.biobanksverige.se

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Denmark

• No biobank specific act, but several acts Sundhedslov 546:2005 Sct on scientific committees and evaluation of biomedical research

projects (“research act”) 402:2003 Data protection act

• Biobank shall be notified to data-authority as “a register” • Main rule under Sundhedslov: prior information and opt-out

for use of clinical samples (specific register)• Ethical review board considers the need for a consent• Data protection act: consent not needed for research with

important public interest

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NORJALOV 2008-06-20 nr 44: Lov om medisinsk og helsefaglig forskning- Scope of application: medical and health research on human beings and

their samples and data (not clinical trials)- Use of personal data in the same act (Chapter 7)- Informed consent as main rule for research (13 §, 15 §)

- Broader consent for research purposes possible (14 §)- Secondary uses (deviation from original consent) possible based on ethical review board

(15 §)- Consent is not needed for use anonymous samples and data

- Research use of clinical samples (28 §) - Prior information and opt-out (register for denials)- Ethical review board may decide on secondary uses without a consent, if

significant public interest and welfare and integrity not compromises.)

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NORJA

• Establishment of a biobank requires ethical review • Public biobank register (ethical review board notifies)• Nominated person in charge • Ethical review board can decide also about disclosure

of register data for research (35 §) (significant public interest, welfare and integrity of the participant)

• Right to know about results (40 §)

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ICELAND

• Lög om lifsýnasöfn (110/2000) • Applied to all longitunal cohorts (> 5 v)• Establishment of a biobank requires licence • Samples shall be stored without personID, data-authority

decides on the use of codekey • 7 § 1. Mainrule explicit consent for research (research

biobank)• 7 § 2.Presumed consent to store and use clinical samples

(precondition adequate information and opt-out),• Research requires permission both from ethical committee

and data-authority.

May 12, 2014