Sample and Data sharing in the era of "big data" in biology

Dr. Anne Cambon-Thomsen, MD, DR CNRSInserm and University of Toulouse III Paul Sabatier,

UMR 1027: Epidemiology and public health analysesSocietal platform « Genetics and society »

www.u1027.inserm.fr ; http://societal.genotoul.fr/

EUCCONET seminar, 8/7/2013, INED, Paris« International access to cohort data »

Outline

• Large scale biology and bioresources/data sharing

• The ethical dimensions and legal framework of bioresources/ data sharing– Revision of data protection Directive

• ELSI aspects, international coordination: ELSI 2.0• Towards incentives; example of BRIF initiative• Conclusion

EUCCONET seminar 8/7/13, Paris 2

International collaboration

“…The full benefits for which the subjects gave their samples will be realized through maximizing collaborative high quality research. Therefore there is an ethical imperative to promote access and exchange of information.”

Data Storage and DNA Banking for Biomedical Research: Technical, Social and Ethical Issues, ESHG, 2001, art. 17.

What does prevent sharing of bioresources ? Technical aspects?Protection of individuals?Intellectual / institutional protection?Lack of rewarding mechanisms?

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Why is sharing cohort samples and data important?

• Enable research• Build on existing resources• Construct communities• Optimise fund investment in research• Ethical imperative• Policies in place (in light of open access)• But…

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Why are such resource sharing important…. and poorly done?

• Much biomedical/epidemiological research is based on using bioresources

- Their access to all relevant researchers is essential

- Promoting their sharing is crucial- There are today ~ no incentive to that.

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What to share and when?« One of the lessons from the Human Genome Project (HGP) was

the recognition that making data broadly available before publication can be profoundly valuable to the scientific enterprise and lead to public benefits. This is particularly the case when there is a community of scientists that can productively use the data quickly — beyond what the data producers could do themselves in a similar time period, and sometimes for scientific purposes outside the original goals of the project.” NATURE|Vol 461|10 September 2009, 168-170

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In Research, Data Sharing = set of practices aiming at allowing and facilitating the re-use of data gathered or produced in the context of (publicly funded) research by other researchers (does not imply necessarily free access)

éminaire Data sharing-BRIF 6/6/20136

An OECD text of reference• In 2004, the ministries of science and

technology asked OECD to define guidelines based on agreed principles in order to facilitate access to digitalised data issued from publicly funded research.

• OECD Principles and guidelines for access to data from publicly funded research (2007)

http://www.oecd.org/dataoecd/9/60/38500823.pdf

Séminaire Data sharing-BRIF 6/6/2013 7

Landscape of data sharing (1)• Principles for rapid release of genome sequence data from

the HGP formulated at a meeting in Bermuda 1996; • Bermuda meetings (1996, 1997 and 1998)• 2003 Fort Lauderdale meeting, – rapid prepublication release (resource for scientific community)– responsibilities of the resource producers, resource users, and the

funding agencies. – OECD 2004

• 2008 Amsterdam meeting extended to proteomics• 2009 Toronto statement on pre-publication data release• 2010 : Oxford Int Conf on data sharing (+P3G)

Séminaire Data sharing-BRIF 6/6/2013

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The landscape of data sharing (2)

• 2011: Sharing research data to improve public health: joint statement of purpose (+ Comment in Lancet, 10/1/11)

• 2011: A data sharing Code of Conduct for international genomic research

• 2012: The tension between data sharing and the protection of privacy in genomics research.

Annu Rev Genomics Hum Genet 13, 415 (2012)

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The landscape of data sharing (3)

• June 2013: Global alliance; Geneticists push for global data-sharing

• International organization aims to promote exchange and linking of DNA sequences and clinical information: 69 institutions in 13 countries

• Nature 498, 16–17 (05 June 2013) | doi:10.1038/498017ahttp://www.nature.com/news/geneticists-push-for-global-data-sharing-1.13133

• A project between Indiana University (E Meslin) - UMR 1027 - Consortium GEN2PHEN

“Big Data Sharing by Genomics and Health Informatics Researchers: Identifying the “Top Ten” Impediments and Solutions”

EUCCONET seminar 8/7/13, Paris 10

Guiding principles• Human dignity• Human rights and fundamental freedoms• Autonomy• Privacy• Non-discrimination and non-stigmatization

But also• Solidarity• Common good Duty to explicit, Duty to use,

Duty to share : transparency

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Balancing values evolve“Ethics does not consist of a static set of theories or

principles that can unproblematically be ‘applied’ to new situations.”

Knoppers and Chadwick, Nat Rev Genet, 2005

“However, informed consent is far from being a magical solution to ethical preoccupations,…”

Cambon-Thomsen, Nat Rev Genet, 2004

“A focus on informed consent is also highly convenient for researchers and their institutions, and above all commercial enterprises. The reason is simple: insofar as individual rights delimit the domain of ethics, they shield other substantive issues from critical scrutiny.”

Garrath, Genomics, Society, Policy, 2005EUCCONET seminar 8/7/13, Paris 12

Specific questions• What are the ethical challenges in sharing

internationally children cohort data? • Is large scale biobanking, cohort and genome

analysis methods modifying the picture of privacy protection and non discrimination from the ethical point of view ?

• What is the evolution of the EU legal framework ?

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Ethical issues• Numerous studies/markers might immediately or

later on, in case of long term analyses, reveal predictive information : issue of incidental findings and issue of public release.– How to handle such potential information must be

foreseen (duty to inform?).

• Issues of re-identification (cross of databases)• Sharing of data and samples• Growing maturity of child to take into account• Right to know/right not to know for parents

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The present debate on unsolicited findings

• Huge debate about sequencing becoming a usual practice

• ACMG recommendations• ESHG recommendations• Debates in « Science • Consultation on the topic (in general) by the

USA “Presidential Commission for the Study of Bioethical Issues”. [ended July 5]

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Patient Autonomy and Incidental Findings (IF) in Clinical Genomics

• This paper (S Wolf et al. in Science, Policy Forum, May 16)

– pushes back against these recommendations, and offer compelling reasons why patient autonomy must remain firmly in place as science advances,

– urges ACMG to reconsider their recommendations.“Returning genetic IF without patient consent is misguided.”

• Another paper– same issue (Mc Guire et al.) supports ACHG views“Laboratories have an obligation to report clinically beneficial IF”

So the debate goes on. What do you think?16The 10th International Workshop on Advanced Genomics

Tokyo, May 21-23, 2013

Science 18 January 2013: Vol. 339 no. 6117 pp. 321-324 - Report + Interview + 39 p Supp. Material.

Identifying Personal Genomes by Surname InferenceMelissa Gymrek1,2,3,4, Amy L. McGuire5, David Golan6, Eran Halperin7,8,9,Yaniv Erlich1

1Whitehead Institute for Biomedical Research, Cambridge, MA , USA. 2Harvard–Massachusetts Institute of Technology (MIT) Cambridge, MA , USA. 3Program in Medical and Population Genetics, MIT and Harvard, Cambridge, MA , USA. 4Dept Molecular Biology &Diabetes Unit, Massachusetts General Hosp, Boston, MA , USA. 5Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX , USA. 6Department of Statistics and Operations Research, Tel Aviv University, Tel Aviv , Israel. 7School of Computer Science, Tel Aviv University, Tel Aviv , Israel. 8Department of Molecular Microbiology and Biotechnology, Tel-Aviv University, Israel. 9The International Computer Science Institute, Berkeley, CA , USA.

Science 18 January 2013: Vol. 339 no. 6117 pp. 275-276 - Policy Forum - Research Ethics

The Complexities of Genomic IdentifiabilityLaura L. Rodriguez1, Lisa D. Brooks1, Judith H. Greenberg2, Eric D. Green11National Human Genome Research Institute, National Institutes of Health (NIH), Bethesda, MD, USA. 2National Institute of General Medical Sciences, NIH, Bethesda, MD , USA.

Science 18 January 2013: Vol. 339 no. 6117 p. 262 - News & Analysis Genetics

Genealogy Databases Enable Naming of Anonymous DNA Donors

John Bohannon

Science 8 February 2013: Vol. 339 no. 6120 p. 647 - Letter Legal Limits to Data Re-IdentificationStephen WilsonLockstep Consulting Pty Ltd, Five Dock (Sydney) NSW 2046, Australia.

Science 1 March 2013: Vol. 339 no. 6123 p. 1032 - Letter Data Re-Identification: Prioritize PrivacyAmy Gutmann. Chair, Presidential Commission for the Study of Bioethical Issues and President, University of Pennsylvania, Philadelphia, PA, USA

Science 1 March 2013: 1032-1033 - Letter

Data Re-Identification: Societal Safeguards Russ B. Altman, Ellen Wright Clayton, Isaac S. Kohane, Bradley A. Malin, and Dan M. Roden1Department of Bioengineering, Stanford University, Stanford, CA, USA. 2Center for Biomedical Ethics and Society, Vanderbilt University, Nashville, TN, USA. 3Department of Pediatrics, Children's Hospital Boston, Boston, MA, USA. 4Department of Biomedical Informatics, Vanderbilt University, Nashville, TN, USA. 5Department of Medicine, Vanderbilt University, Nashville, TN, USA..

Science 1 March 2013: Vol. 339 no. 6123 p. 1033 - LetterData Re-Identification: Protect the ChildrenDavid Gurwitz Human Molecular Genetics and Biochemistry, Sackler Faculty of Medicine, Tel Aviv University, Israel

Hastings Cent Rep. 2013 May-Jun;43(3):15-8.Found your DNA on the web: reconciling privacy and progress.Gutmann A, Wagner JW.

EU Data protection revision: potential implications for

health research

Slides prepared in collaboration with with V. Anastasova, A. Mahalatchimy,

E. Rial-SebbagUMR 1027 Inserm-Université de Toulouse III Paul Sabatier, Toulouse

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Introduction The main instrument for the legal protection of personal data

in the EU: Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

Purpose: To find the right balance between a high level of protection for the privacy of individuals and the free movement of personal data within the EU.

The Directive is currently under revision Proposal for a Regulation on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation) , 25/01/2012, then various comments and amendments proposals.

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Objectives of the revision To modernize the EU legal system regarding

technological developments;

To improve the clarity and coherence of the EU legal framework ;

To achieve effective legal implementation of data protection and of the rules allowing their lawful free movement;

To continue guaranteeing a high level of individuals’ protection (personal rights) in the processing of personal data in all areas of the EU’s activities.

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Agenda I/ Health data protection in the proposal of regulation:

1/ From “Directive” to “Regulation” 2/ New category of sensitive data: genetic data 3/ Enhancement of fundamental rights 4/Reinforcement of international collaboration: transfer to Third Countries5/Data protection impact assessment 6/New mechanisms of data protection 7/ Data protection authorities : EC and supervisory

authorities

II/ Emergence of legal regime for the processing of data of a child in the proposal of regulation

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II/ Emergence of legal regime for the processing of data of child in the proposal of regulation (1)

• Directive: No particular mention regarding children.

• Proposal of Regulation: General provisions dedicated to processing of personal data of a child

– Purpose: balance between appropriate protection and special attention to the opinion of the child;

– Initiative also supported by the Data Protection Working Party and the Council of Europe;

Potential Implications for research studies involving children .

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II/ Emergence of legal regime for the processing of data of child in the proposal of regulation (2)

• Regarding definition of child:

– uniformed definition for more clarity: any person below the age of 18 years (reference to UN Convention on the Rights of the Child, 1989);

• Regarding fundamental rights of children:

– Information in the decision making process : clear and simple, adapted to comprehension of a child able to express his/her opinion;

– Consent/Assent: processing of data of a child below the age of 13 years is lawful if and to the extent that consent is given or authorised by the child's parent or custodian;

– Special attention to the right to be forgotten and erasure of personal data : respect of child’s wish when he/she reaches the legal majority;

– EC may lay down standard forms for specific methods to obtain verifiable consent (potential establishment of European methods about the assent of the child which data are used in research study);

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II/ Emergence of legal regime for the processing of data of child in the proposal of regulation (3)

• Regarding the concept of transparency : any information about the research and the way of communication should be in such a clear and plain language that the child can easily understand;

• Regarding the transfer to third countries: clearly explained during the decision making process and expressly mentioned in the informed consent form (assent of mature child);

• Regarding the data protection impact assessment: duties in research to conduct privacy impact assessment when the study could potentially impact personal privacy of the child;

• Regarding code of conduct and certification: incitation to set up codes of conduct concerning information and protection of children, including in paediatric research.

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Conclusion (1)

The provisions exposed above are proposals: necessity to wait for the final version of the Regulation;

More clarification regarding the data processing for scientific research purposes (definition) and their legal regime (consent/assent and exemption);

Necessity to integrate specific provisions on processing of data of children in research studies;

Respect of other relevant legislation for the processing of personal data for the purposes of historical, statistical or scientific research: article 4 (Clinical trials on minors) of Clinical trials Directive;

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Some proposed amendments to the Regulation proposal for « Data

protection » • Deleted exception “or for historical,

statistical and scientific research purposes.”– Justification: “Processing of sensitive data for

historical, statistical and scientific research purposes is not as urgent or compelling as public health or social protection. Consequently, there is no need to introduce an exception which would put them on the same level as the other listed justifications.”

Inauguration CONSTANCES, Paris 7/3/13 28

Some elements to discuss in Regulation proposal: consent (1)

1/ Initial proposal (January, 2012): “Consent should be given explicitly by any appropriate method enabling a freely given specific and informed indication of the data subject's wishes, either by a statement or by a clear affirmative action by the data subject, ensuring that individuals are aware that they give their consent to the processing of personal data.”

- For all Sensitive Data- For Data processing

concerning…scientific research consent could be one condition but not the only one

Some elements to discuss in Regulation proposal: consent (2)

2/ EU Parliament amendments on the legal regime (Dec., 2012) “The amendments to paragraphs (…) ensure that health data, which is extremely sensitive, may only be used without the consent of the data subject if it serves an exceptionally high public interest and in this case must be anonymised or at least pseudonymised using the highest technical standards.”

• For processing of personal data concerning health which is necessary for … scientific research purposes, shall be permitted only with the consent of the data subject (…)

Currrent actions

• Protestations (Scientific societies, consortia, institutions…)

• Things are not « frozen » yet• Example of ethical with a legal dimension :

– tension between legitimity of research and certain aspects of persons ’ protection

– when tools become rules• Words counts:

– persons’ protection regarding their data use vs data protection

Inauguration CONSTANCES, Paris 7/3/13 31

Next steps Input of the EC on paediatric research: establishment of a uniform

practice;

National regulations remain necessary for research including paediatric research (collaboration EC and national supervisory authorities);

Provisions to be followed up:

Data protection by design;

Data protection and privacy. Discussion at the EU parliament soon Vote end of year?

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THANKS TO:

My colleagues jurists

Velizara Anastasova

Gauthier Chassang

Aurélie MahalatchimyEmmanuelle Rial-Sebbag

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Summary (1)1. The evolving status of genetic information available

• Data versus results; raw data versus interpretated data• Changing of degree of identifiability over time• Changing in capacity of interpretation• Mixture of health related/non health related information• Production of genetic information “unuseful at least

presently” routinely• Issue of what is done with this “extra information” (notion

of filter) • Perception of genetic information changing• Source and access to genetic information changing (ex:

direct to consumer, internet sharing of information)

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Summary (2)2. How data and biological sample sharing policies

in science deal with discrimination risk• Lots of information (also in consent)• Not promising full anonymity, but access policy and

defined categories of uses• Rely on technology • Responsibility of researchers and their institutions• Transparency of procedures

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Summary (3)3. Empowering versus protecting: what is most

efficient? - when you cannot guarantee full anonymity - when privacy concept/practice is changing

What to do? - Define responsibilities and make them publicly known - Define professional/community relevant “sanctions”- Empower individuals and groups through information- Organise observatories of practices

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Outline

• Large scale biology and bioresources/data sharing

• The ethical dimensions and legal framework of bioresources/ data sharing– Revision of data protection Directive

• ELSI aspects, international coordination: ELSI 2.0• Towards incentives; example of BRIF initiative• Conclusion

EUCCONET seminar 8/7/13, Paris 37

ELSI research and policy jungle

• Important questions debated – in many settings– In many countries– In many ways

• Resulting in non harmonised policies, that reflect in difficulties to share data/resources

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Génétique et sociétéLa plateforme sociétale de la génopole Toulouse Midi-Pyrénées, GIS Genotoul – « Une plateforme sur les enjeux sociétaux des biotechnologies »

http://societal.genotoul.fr

Responsable : Anne Cambon-Thomsen, anne.cambon-thomsen@univ-tlse3.frCoordination /juridique: Emmanuelle Rial-Sebbag, emmanuelle.rial@univ-tlse3.frManager : Soraya Dauriac, soraya.dauriac@inserm.frContact général : societal.genotoul@toulouse.inra.fr Contact appui projets : appui-projets@genotoul.societal.fr

EXEMPLES DE REALISATIONS

• Human Sample Exchange Regulation Navigator hSERN www.hsern.eu

• Service « Ethique et réglementation » dans l’Infrastructure BIOBANQUES (http://www.biobanques.eu/)

Gis GenoToul - Bureau 27 juin 2013

Obstacles to international ELSI research coordination

• Fragmentation• Repetition/duplication• Cultural and legal aspects are national/

regional• Policy / Decision makers often have a national

horizon • No easy « general portal » to address

questions and search for experts

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ELSI 2.0 for genomics and society

• Coordinate• Analyse• Exchange• Avoid replicate• Be prospective and responsive• Facilitate • Accelerate• Amplify policy impact

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An international initiative:

« We need an international infrastructure for the ethical, legal social implications of genomic research »

Kaye et al. Science, 2012, 336, 673-74

http://www.p3g.org/elsi-20

The 10th International Workshop on Advanced Genomics Tokyo, May 21-23, 2013

The notion of collaboratory for ELSI research on biobanks and genomics

EUCCONET seminar 8/7/13, Paris 43ELSI 2.0 for Genomics and Society Science, 2012, 336, 673-674

What are the blocking factors of the shared use of bioresources

• Technical ones (quality etc.)• Institutional ones

– No exchange, sharing or access policy– No practical help– Cost

• Intellectual property ones• Information ones

– No easily available information on content– Restricted use to pre-defined professional circles

• No obvious positive spin off : incentives? 44EUCCONET seminar 8/7/13, Paris

What are the needs for assessing the use of Bioresources ?

• For institutions: need to justify their use to– Patients– Funders– Users

• For researchers/practitioners: need of documented long term recognition of the effort of quality biobanking

• For individuals donating: need to be reassured that this is used, in reality

• For the public: need to be sure that the major investment is justified and has an impact at society level

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include both biological samples with associated data (medical/epidemiological, social), databases independent of physical samples and other biomolecular and bioinformatics research tools (BRIF group working definition).

The BRIF initiative is a work in progress, currently developing a framework for: - creating a tool for calculating research impact of bioresources based on a metric (algorithm) and a unique digital resource identifier (analogy Journal IF)

- assessing requirements for citation/acknowledgement of bioresources in order to trace their use in research

Online discussion forum/ GEN2PHEN knowledge centre: http://www.gen2phen.org/groups/brif-bio-resource-impact-factorContacts: laurence.mabile@univ-tlse3.fr, anne.cambon-thomsen@univ-tlse3.fr

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Objective: increase sharingPurpose: recognition of the effort involved in establishing, maintaining and sharing resourcesChallenge: how to overcome the feeling of loss that may prevail

Idea: Transforming a loss into an advantage.« The more it is shared, the more it contributes to science, the more it is recognised »Virtuous circle!

What is needed?

• Guidelines and tools are needed to maximise access by researchers to collections of biological materials and attached databases, and to recognise efforts involved in such and other bioresources.

• At publication level there is no standardized way to cite and acknowledge the bioresources used and their contributors

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International working group: steps- Jul/Sep 2010: launch of online BRIF discussion group

(/Gen2phen Knowledge Centre) http://www.gen2phen.org/groups/brif-bio-resource-impact-factor

• Documents on BRIF (original publications)• Discussion posts• Chart

- Jan 2011: BRIF workshop, Toulouse, FR

- Feb/Mar 2011: constitution of working subgroups- From June 2011: publications

on behalf of the BRIF working group- Oct 2013: 2nd BRIF workshop, Toulouse, FR

- From jan 2013: pilot studiesBRIF Working Group Editors-Rome,

21/6/2013 49

Participants characteristics

jul/10 - apr/12: 135 members, 21 countries, >95 institutions

Legend:

<5 5≤ >10 10≤ >20 20≤ >30 BRIF Working Group Editors-Rome,

21/6/2013

50

Represented competences

Biobank partnersComputational

biologistsComputer scientistsGenome/genetics

scientistsEpidemiologists

Jurists, lawyersEthicists Experts in impact factorsBibliometricistsJournal EditorsResearchers/users

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Key elements towards BRIF- Creating a bioresource unique identifier, or digital ID

- Standardizing bioresource acknowledgement in papers using this identifier

- Identifying parameters to take into account when creating the BRIF metrics

- Bioresource parameters (ex: size; age…)- Bioresource policy parameters (analysing bioresource data

access and sharing policies and classifying their impact on usability)- Parameters reflecting the use of the bioresource (ex:

nb of projects supported /year; nb of MTA or DTA)

- Creating a BRIF metrics and test it

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BRIF & Digital Identifiersco-chaired by G. A. Thorisson, University of Leicester, UK andP.A. Gourraud, University of California SF, USA

BRIF Parameterschaired by B. Parodi, National Inst. Cancer Res. Genoa, IT

BRIF in Access & Sharing Policieschaired by E. Rial-Sebbag, Inserm UMR1027, Toulouse, FR and J. Harris, Norwegian Institute of Public Health, Oslo, Norway

BRIF and Journal Editorschaired by A. Cambon-Thomsen, Inserm UMR1027, Toulouse , FR and E. Bravo, Istituto Superiore di Sanità, Rome, Italy

BRIF disseminationchaired by L. Mabile, Inserm UMR1027, Toulouse , FR

BRIF working subgroups

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PUBLICATIONS:INITIAL PAPERS:

-CAMBON-THOMSEN A. Assessing the impact of biobanks. Nat Genet, 2003, 34, (1) : 25-26 -KAUFFMANN F., CAMBON-THOMSEN A. Tracing biological collections: between books and clinical trials. JAMA, 2008;299(19): 2316-2318

RECENT PAPERS: -CAMBON-THOMSEN A, THORISSON GA, MABILE L on behalf of the BRIF workshop group. The role of a bioresource research impact factor as an incentive to share human bioresources. Nat Genet, 2011, 43: 503-4 -BRAVO E, CAMBON-THOMSEN A, DE CASTRO P, MABILE L, NAPOLITANI F, NAPOLITANO M, ROSSI AM. Citation of bioresources in journal articles: moving towards standards. European Science Editing 2013;39(2) 36-38 -MABILE et al and the BRIF working group. Quantifying the use of bioresources for promoting their sharing in scientific research. http://www.gigasciencejournal.com/content/2/1/7

BRIF publications

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Inserm/Université de Toulouse III, UMR 1027 Persons involved in ELSI of biobanks & genetics and sharing pliciesAnne-Marie Duguet, MD, health lawLaurence Mabile, BRIF project managerGauthier Chassang, juristAnna Pigeon, juristEmmanuelle Rial-Sebbag, juristAnne Cambon-Thomsen, MD

55EUCCONET seminar 8/7/13, Paris

Thank you !

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EUCCONET seminar 8/7/13, Paris 57

1/From “Directive” to “Regulation”

Directive:

A matter of law promoting the harmonization of national laws of EU’s Member States (MS);

MS have to achieve goals while they have the choice on the means; It necessitates transposition in national laws and MS have a leeway to

adapt the rules of a Directive.

Regulation:

Legislative act that is the best EU Legal tool for the harmonization of national rules

It is directly enforceable in all EU MS and need not to be transposed into national laws.

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2/New category of data: genetic data (1) Regulation:

personal data: “any information related to a data subject”;

– sensitive data: “personal data, revealing race or ethnic origin, political opinions, …and the processing of genetic data or data concerning health or sex life…”

genetic data: characteristics “inherited or acquired during early prenatal development”;

– health data: “any information which relates to the physical or mental health of an individual, or to the provision of health services to the individual”;

Health data and genetic data are recognised as personal

sensitive data particular legal protection.MeDALL-Annual meeting 14th and 15th January 2013, Berlin, Germany 59

2/New category of data: genetic data (2) Regime for protection of sensitive data:

Principle: processing of sensitive data including health data is forbidden;

Exception: sensitive data may be processed for historical, statistical or scientific research purposes (fundamental, applied, public or privately funded)only if; person gives his/her consent or processing is necessary for research purposes; these purposes cannot be otherwise fulfilled by processing data

which does not permit or not any longer permit the identification of the data subject;

data enabling the attribution of information to an identified or identifiable data subject is kept separately from the other information as long as these purposes can be fulfilled in this manner.

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3/ Enhancement of fundamental rights• Informed Consent: « any freely given specific, informed and explicit

indication of his or her wishes by which the data subject, either by a statement or by a clear affirmative action, signifies agreement to personal data relating to them being processed»;

– The right to withdraw at any moment;

• Information and access: – information clear and simple, adapted to data subject comprehension – new rights: right to access (rectification), right to lodge a complaint,

right to be forgotten , erasure of personal data….

• Transparency:– new general obligation for the data controller: in policies ; in the

information of and communication with data subjects; towards relevant third parties (e.g. where the subject requests a complete erasure of data, to be forgotten)

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4/Reinforcement of international collaboration: transfer to third Countries

The principle: The transfer is authorized if the third countries are recognized as

providing an adequate level of data protection in research otherwise prohibition in principle (exceptions)…

Reinforcement of cooperation: at the European level, national control authorities; these collaborations will be initiated by the European Commission with

the help of the European Data Protection Board.

The regulation’s scope:

– The regulation aims to protect every European residents even if the processor is out of the European territory.

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5/Data protection impact assessment

• Article 33:

“…processing operations present specific risks to the rights and freedoms of data subjects by virtue of their nature, their scope or their purposes, the controller or the processor acting on the controller's behalf shall carry out an assessment of the impact of the envisaged processing operations on the protection of personal data.”

Transparency

Risk evaluation

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6/New mechanisms of data protection • Purpose: facilitating the international collaborations.

• Code of conduct:– proposed by associations and other bodies representing categories of

controllers or processors;– the following points should be addressed: fair and transparent data

processing, the collection of data, the information of the public and the subject data, information and protection of children…

– national authorities and EC supervise the compliance with the Regulation.

• Certification: – to allow data subject to quickly assess the level of data protection

provided by controllers and processors

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7/Data protection authorities : EC and supervisory authorities

• European Commission (EC):– establishment of a uniform practice: adoption of delegated acts to

specify the criteria, conditions, guarantees and appropriate exceptions to the rights and obligations;

– for the processing of sensitive data ;– examples: definition of forms, procedures and criteria.

• National authorities:– monitoring of the application of the data protection in order to

protect the fundamental rights and freedoms of persons and to facilitate the free flow of personal data within the EU.

– determination of their duties and powers; – examples: UK – Information Commissioner’s Office.

France – CNIL. MeDALL-Annual meeting 14th and 15th

January 2013, Berlin, Germany 65