public population project in genomics and...

PUBLIC POPULATION PROJECT IN GENOMICS AND SOCIETY

ANNUAL REPORT

2015

FROM DISCOVERY TO POLICY

P u b l i c P o p u l a t i o n P r o j e c t i n G e n o m i c s a n d S o c i e t y

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THE PUBLIC POPULATION PROJECT IN GENOMICS AND SOCIETY (P3G) AT A GLANCE

Founded in 2003 to respond to the growing needs and demands of the international genomics research community, the Public Population Project in Genomics and Society (P3G) is a not-for-profit international consortium hosted by the McGill University/Genome Quebec Innovation Centre. The Chair of the Board is Professor Bartha Maria Knoppers, PhD, Canada Research Chair in Law and Medicine, Director of the Centre of Genomics and Policy, Faculty of Medicine, Department of Human Genetics, McGill University (Canada). P3G is under the Scientific Direction of Dr. Paul Burton, University of Bristol (UK).

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P3G MISSION AND OBJECTIVESP³G’s mission is to lead, catalyze, and coordinate international genomic research so as to optimize the access and use of large cohort studies, biobanks, research databases and other similar health and social research infrastructures for the improvement of the health of individuals and populations.

To achieve this, the Consortium is committed to the following objectives:

1. Providing global perspectives and strategic approaches to the optimization of data access and use,

2. Catalyzing multidisciplinary and international scientific expert input,

3. Engaging studies, cohort and biobank resources/infrastructures and their users in a dynamic knowledge-based exchange,

4. Disseminating and valorizing knowledge relevant to the mission of P³G, and,

5. Serving the needs of the P³G Research Programmes and Platforms.

P³G brings the genomics, epidemiology, social science, ELSI/policy-making and information technology communities together. Through its network of experts and platforms, P3G offers policy direction to large-scale research infrastructures.

P3G CHARTER OF FUNDAMENTAL PRINCIPLES P3G aspires to the highest standards of ethical comportment and research integrity. The fundamental principles that underpin its activities are:

n PROMOTION OF THE COMMON GOOD: P3G will optimize the benefits of collaborative research for the benefit of all.

n RESPONSIBILITY: Protection of the interests of all affected stakeholders including families, groups, populations, researchers and research sponsors is the highest priority. Every effort will be made to respond to the concerns of stakeholders in a timely and appropriate manner.

n M U T U A L R E S P E C T : T h e development and sustainability of P3G is based on responsibility, collaboration, co-operation, trust and mutual respect for others, which includes recognition

of cultural diversity and the scientific specificity of the projects involved.

n ACCOUNTABILITY: All standards, processes and procedures will be transparent and clear, developed on the basis of consensus, and aim to create best practices in the networking of population genomics resources.

n PROPORTIONALITY: All research materials (such as data and samples) must be protected to the highest standards of privacy and propriety, while at the same time allowing and promoting the free exchange of ideas, data-sharing and openness for the benefit of all.

Adopted by P3G Board of Directors: March 23, 2007

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This past year has seen a host of developments which all promise to segue into yet more innovations. A major event o f 2015 was the launch of P3G’s Canadian International Data Sharing Initiative (Can-SHARE, see p.4). This pan-Canadian 3-year research program will enable the development of policies and tools to foster innovation in the use of genomic data for research and health care, for patients

in Canada and worldwide. Stemming from Canada’s contribution to the Global Alliance for Genomics and Health (GA4GH), the Can-SHARE initiative is expected to reinforce P3G’s international leadership in the genomic policy arena.

The GA4GH has continued to benefit from the support of P3G as a key contributor to the Regulatory and Ethics Working Group (REWG). As part of this Working Group and subject to the

Framework for Responsible Sharing of Genomic and Health-Related Data, P3G’s participation in different Task Teams has contributed to the development of policies on accountability, ethics review equivalency, consent, and individual access. An international data sharing lexicon is also being finalized. P3G’s participation in the GA4GH fosters the global exchange of information and ideas. P3G is also contributing to the discussion on the revision of privacy and research laws in Europe and the United-States, and is following the debate on the invalidity of the Safe Harbour Agreement and the new EU-US Privacy Shield. As always, P3G is on the front lines to analyse these policy developments.

Finally, the fourth International Biobanking Summit (IBS IV), held jointly with ISBER, BioSHaRE, ESBB and Biobank Norway, under the theme “International Biobanking and ‘Big Data’ Meet Innovative Governance?” examined the integration of Big Data into biomedical research, and the challenges this poses. The event once again emphasized how synergy between like-minded organizations can only be strengthened by working together. We look forward to the IBS V in Vienna in 2016 !

MESSAGE FROM CHAIR – BARTHA MARIA KNOPPERS

Professor Bartha Maria KnoppersPrincipal Investigator and Chair of the Board

MESSAGE FROM THE EXECUTIVE DIRECTOR - ANNE MARIE TASSÉ

With the launch of the Can-SHARE project, the obtention/renewal of 10 collaboration agreements with national and international research projects and the development of a new P3G-IPAC service (namely the DataTrust), 2015 has been an exciting year for P3G.

As mentioned in Professor Knoppers’ message, the Can-SHARE initiative

was launched in September 2015. As the lead institution, P3G is proud to coordinate the activities of the REWG and 5 of its Task Teams (consent, privacy/security, accountability, paediatrics, and ethics review equivalency), as well as oversee the development of Canadian-led demonstration projects.

In addition, several projects such as MSSNG (Hospital for Sick Children), the Personalize my Treatment Initiative (Exactis

Anne Marie TasséExecutive Director

Innovation), Opti-Thera (CRCHUM) or SPIRIT (CHU Ste-Justine) have been added to those previously benefiting from P3G-IPAC services (see figure on p.5). Details on the nature of the services provided to the P3G-IPAC projects can be found on pages 5-6.

Also of importance is the development of a new service, the DataTrust, whereby P3G acts as an independent third-party supporting the process of returning individual-level results to the participant’s electronic medical record, in accordance with applicable ethical and legal frameworks. This service specifically targets translational research projects (when appropriate) and safeguards the independence of the research team when returning research results, while enhancing ethical compliance with privacy and confidentiality norms. The IPAC International Advisory Board will further advise on its modalities in 2016.

We invite all interested parties to visit our website for additional information on our projects, services, upcoming meetings, as well as to keep an eye on P3G Newsletters.


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REWG ELSI support to CANADIAN-LED GA4GH Demonstration Projects: Matchmaker Exchange: Address the common challenge of

exome and genome sequencing, and provide access to a collective knowledge base through a single point of entry

Beacon Project: Address barriers to international genetic data sharing by fostering the creation and development of Beacons that locate “shareable” data

BRCA Challenge: Translate the rapid expansion of sequencing capacity into useful knowledge in its future database. Its intent is to provide an umbrella under which many groups can collaborate.

Clinical Cancer Genomics: Learn from the experiences of other disease areas, and ensure complementarity of clinical cancer genome initiatives

NEW INITIATIVESWith the support of Genome BC and Telus, the Can-SHARE programme will select promising Canadian-led initiatives (Pilot Projects), which will benefit from the administrative support and ethical and legal guidance of the REWG and its Task Teams.

Can-SHARE (Canadian International Data Sharing Initiative) is a pan-Canadian programme that enables innovation in the use of genomic data for health care for patients in Canada and worldwide. Launched in September 2015 and funded by Genome Canada, the Canadian Institutes of Health Research (CIHR), and co-funded by Genome Quebec, Genome BC and Ontario Genomics, Can-SHARE creates policies and tools for Canadian clinicians and researchers to share genomic and clinical datasets across Canada and with international partners. It proposes to advance Canadian leadership to develop ‘Big Data’ access and sharing efforts in Canada and in the Global Alliance for Genomics and Health (GA4GH) by providing:

Policy support through the work of GA4GH’s Regulatory and Ethics Working Group (REWG) Task Teams: Consent Task Team: Develop core elements of consent to enable

responsible data sharing

Privacy/Security Task Team: Develop a Policy for genomic and clinical data sharing in line with the aims of the Security Working Group

Accountability Task Team: Build mechanisms to ensure trust in the responsible sharing of data

Paediatric Task Team: Explore regulatory and ethical issues related to data sharing in paediatrics generally and particularly in genomic newborn screening (NBS)

Ethics Review Equivalency Task Team: Develop a system that allows for mutual recognition of ethics review mechanisms between jurisdictions

FOCUS ON CAN-SHARE

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FOCUS ON THE P3G-IPAC

P3G-IPAC PROJECTS MSSNG Database Autism Speaks recently launched the MSSNG project, with the overall goal to store and analyze the world’s largest collection of genomes of people with autism and their families. The immediate goal of the project is to sequence the whole genomes of 10,000 individuals and their families by the end of 2015. The MSSNG project is using a cloud platform to address the challenges of managing, analyzing and disseminating the genomic and phenotype information. In addition to providing as hoc ethics guidance for REB applications at recruiting sites, the P3G-IPAC has assisted in the development of the MSSNG Data Sharing Policy and Procedures and related access forms, the MSSNG Data Access Agreement, as well as the Return of Results Policy. The IPAC has undertaken a retrospective review of current consent forms for screening cohorts at recruiting sites which are eligible for inclusion in the database, and has developed the MSSNG Universal Consent Form, for prospective cohorts. Upcoming activities include the creation and maintenance of a Data Access Compliance Office for controlled access

International Genome Sample Resource (IGSR)The IGSR has been established at EMBL-EBI in the United Kingdom. It will continue to support data generated by the 1000 Genomes Project, supplemented with new samples and data. The P3G-IPAC has supported IGSR by reviewing and adapting various ELSI policies and documents of the 1000 Genomes Project to the goals of IGSR.

BioSHaREBioSHaRE is a consortium of leading biobanks and international researchers from all domains of biobanking science. Concluded in November 2015, BioSHaRE aimed to obtain the large sample sizes needed to investigate current questions in multifactorial diseases, notably on gene-environment interactions, by developing harmonization and standardization tools. In this project, ELSI tools have proven necessary for the use of pooled datasets from different cohorts and biobank studies. In that context, a consent screening tool was developed, as well as an ethical and legal harmonization method (including an access tracking form for the use of pooled datasets). The P3G-IPAC was also involved in the coordination of ELSI Stream of BioSHaRE, and the development of the Framework for Responsible Sharing of Genomic and Health-Related Data. In conclusion to the BioSHaRE activities, P3G prepared a Special Issue for the Biopreservation and Biobanking journal, on the development of ELSI tools within the BioSHaRE project. This Special Issue will be available in 2016.

Canadian Alliance for Healthy Hearts and Minds (CAHHM)The CAHHM is a landmark national research study aimed at understanding the causes and the development of chronic diseases such as heart disease, stroke, dementia and cancer. For this project, the P3G-IPAC provides ELSI Interoperability services and more specifically is involved in 1) finalizing Regional Cohort Consent Forms; 2) developing the Access Policy for the project; and 3) disseminating the results of the Management Policy on the Return of Severe Structural Abnormalities.

DACO –Data and Sample

Access Request/Authorization and

Compliance

P3G-IPAC Database

(Generic Clauses/Agreements)

Canadian Alliance for Healthy Hearts and

Minds (CVCD)

Personalize my Treatment

(PMT Platform)

BioSHaRE.EU

Global Alliance for Genomics and Health

(GA4GH)

Opti-Thera

MSSNG Database (Autism Speaks)

Canadian Partnershipfor Tomorrow Project

(CPTP)

International Cancer Genome Consortium

(ICGC)

International Genome Sample Resource (IGSR)

Sino-Quebec Perinatal Initiative in Research and Information Technology

(SPIRIT)

Plateforme de génomique pédiatrique

PRECeDI-RISE

P3G-DataTrust

ELSI Interoperability

DACO –Data and Sample

Access Request/Authorization and

Compliance

T h e P 3G I n t e r n a t i o n a l Po l i c y interoperab i l i ty and data Access Clearinghouse (IPAC) provides a “one stop” screening service for policy interoperability and access authorization. Guided by an International Advisory Board of experts, the P3G-IPAC provides inter operability services to assist inter-national researchers in meeting ethical and legal regulatory requirements governing genetic/genomic research in their home countries. P3G-IPAC team members include international ethical, legal and social (ELSI) expertise in the fields of biomedical research, biobanks, regenerative medicine, gene therapies, cancer, pediatrics, pharmacogenomics, rare diseases, and bioethics/law. IPAC services and tools include, but are not limited to: consent, access (data/samples), MTA’s/DTA’s, commercialization, IP, confidentiality/privacy, research ethics and governance. The P3G-IPAC also provides Data Access Compliance Services to international research consortia.


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From January 1 to December 31, 2015, the ICGC Data Access Compliance Office (DACO) processed 342 applications (including resubmissions and renewals), thus bringing the total amount of processed applications to 908. Additionally, DACO approved 21 new Data Usage Agreements for users who require administrative access to the ICGC controlled data. During this period, the average time for DACO to process a new application was 5 days, whereas resubmitted applications were quickly processed in an average of 1.5 days. In recent months, the standard DACO Application for Access to ICGC Controlled Data form was updated to include new clauses allowing for cloud computing access to the controlled data. As of December 31st, 2015, DACO had a total of 991 approved users distributed within 184 approved projects from 28 countries.

Opti-TheraThe Opti-Thera project aims to create a unique platform (KIIN) for the deployment and integration of pharmacogenomics tools in primary care settings. The project stems from current research done by the investigators on drug interactions and genomic determinants of diabetes complications. It aims to create a flexible platform for the assessment of different biomarkers independently of their “omics” origin by combining in-depth phenotypic (drug-drug interaction analysis, diabetes complications) and genetic analyses in order to improve decision-making pertaining to pharmacotherapy. Ongoing P3G-IPAC collaboration with the Opti-Thera research team and its partners has led to the creation of a first draft of the Opti-Thera DataTrust governance framework which sets out the roles and responsibilities, as well as the procedures governing the return of research results and the activities of the DataTrust. P3G-IPAC has also developed a template consent form for the project, to allow participants to choose to be included in the DataTrust return of results component of the project.

Quebec Perinatal Initiative Research and Information Technology (SPIRIT)The SPIRIT Project aims to harmonize data and biospecimen storage and processing norms across three Quebec and Chinese birth and perinatal health cohorts. The P3G-IPAC is currently developing a Governance Framework for the use of these cohorts’ databases, and accompanying publication and intellectual property policies.

Canadian Partnership for Tomorrow Project (CPTP)The Canadian Partnership for Tomorrow Project (CPTP) is Canada’s largest population health research platform. It contains a wealth of data from more than 300,000 Canadians aged 35-69 who have volunteered to share information about their health, lifestyle, environment and behaviour over their adult lives. CPTP aims to create a legacy that will benefit both current and future generations by strengthening population research in Canada, by producing excellent evidence to inform health care improvements, and by offering the maximum benefit to the people of Canada and to the health systems on which they rely. Following the success of the Pilot phase testing out access to CPTP data in 2014, the goal for P3G-IPAC in 2015 has been to work on expanding and further revising the project’s access policy and related documentation to incorporate biosamples. In this context, the P3G-IPAC has been working on developing and revising documentation on access procedures (e.g. Access Policy, Data and Biosamples Access Application Form, Intellectual Property Policy, Publications Policy, etc.), developing the Terms of Reference for the access bodies and providing ongoing support on ethical and legal issues. The P3G-IPAC has also been developing Access Operating Procedures, such as – procedures for managing queries, review by the Access Office for completeness and feasibility, and decision-making by the Access Committee – to further complement and complete the access documentation.

PRECeDI-RISEFor the PRECeDI-RISE project, funded in the context of the first call of the Marie Curie Research and Innovation Staff Exchange (RISE) 2014 of Horizon 2020, P3G is involved in an exchange programme and will be receiving 3 European scholars.

Personalize my Treatment (PMT) PlatformThe Personalize my Treatment (PMT) Platform is a large-scale longitudinal, pan-Canadian oncology platform that aims to match patients to biology-driven clinical trials based on the molecular profile of their tumours. The P3G-IPAC assisted Exactis Innovation’s PMT Platform in finalizing its policy documents (e.g. ethics, consent, return of results, biospecimen and data access, re-contact policies, etc.) and standard operating procedures, as well as the consent form for the project. It also provided guidance on various ethical and legal questions, which arose during the research ethics submission process. The project is currently recruiting participants at one site and is expected to launch at other sites, shortly. Although most of the ethics ramp-up work has now been completed, P3G-IPAC continues to provide ad hoc support to the team as the project evolves and other sites across Canada are approached.

International Cancer Genome Consortium (ICGC)ICGC has brought together 74 international projects from 17 countries investigating 50 different types of cancers through the creation of a central data repository. The DACO office moved to P3G-IPAC in 2013 and is responsible for controlled data access requests for projects that conform to the goals and policies of ICGC, on an ongoing basis.

FOCUS ON THE P3G-IPAC

IPAC INTERNATIONAL ADVISORY BOARDHadi Abderrahim, QatarRuth Chadwick, UKDon Chalmers, AustraliaEllen Clayton, USAJantina de Vries, South AfricaMats Hansson, SwedenNils Hoppe, GermanyChingli Hu, ChinaKazuto Kato, Japan

Jane Kaye, UKJean McEwen, USAPedro Rondot Radío, ArgentinaEmmanuelle Sebbag, FranceSharon Terry, USASusan Wallace, UKJohn Wilbanks, USA

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UPDATE FROM THE SCIENTIFIC DIRECTORS

In collaboration with P3G, the Policy Research Programme (PRP) at the Centre of Genomics and

Policy (CGP, McGill University) analyses the emerging ethical and legal issues related to some of the IPAC projects. For example, in 2015, the PRP studied transfer guidelines and health policies related to research on perinatology health services in Shanghai and Quebec under the Sino-Québec Perinatal Initiative in Research and

Information Technology (SPIRIT). The PRP is also engaged in 1) the legal aspects surrounding insurance and the use of genetic information; 2) the evolution and role of a trusted third party; and, 3) conflict of interest issues in public-private partnerships for personalized medicine as part of the Opti-Thera project, to implement Optimized Therapeutic drug responses and Optimized Theranostics strategies through the creation of a Knowledge and Information Integrating Node (KIIN).

THE POLICY RESEARCH PROGRAMME (led by Professor Bartha Knoppers)

Professor Bartha Maria KnoppersDirector

RESEARCH PROGRAMMES

THE MAELSTROM RESEARCH PROGRAMME (led by Drs Isabel Fortier and Vincent Ferretti)

The year 2015 marked the end of two major projects that helped launch the Maelstrom Research (MR) programme and greatly contributed to its current position as an international leader in data harmonization and integration for epidemiological research . BioSHaRE and the Québec-Europe Harmonization Platform for Research (PHQE) were two international projects funded by European and Canadian granting agencies whose aims were to facilitate collaborative research in epidemiology through

the development of innovative tools and methods. Support received through these projects allowed MR to develop and disseminate its software suite and expand its repository of epidemiological studies. Through the PHQE initiative (phqe.maelstrom-research.org), MR catalogued over 20 000 variables from 25 studies from the province of Québec as a means to encourage the use of existing data collected by large epidemiological studies and promote research collaborations. In the BioSHaRE project (www.bioshare.eu), MR harmonized over 150 variables across 11 studies in eight different countries, which served to address research questions related to metabolically healthy obesity and environmental determinants of chronic diseases. As part of its contribution to BioSHaRE, MR also coordinated the establishment of a federated network of harmonized databases to conduct pooled analyses using the DataSHIELD approach (www.datashield.org).

While both projects ended in late 2015, the resources developed by the Maelstrom team and its partners under these funding schemes will continue to serve international consortia in epidemiology over the coming years.

On June 29, 2015, a data portal giving an overview of the Health and Risk Factor Questionnaire data harmonized by the MR team across the five regional cohorts of the Canadian Partnership for Tomorrow Project (CPTP) was launched (portal.partnershipfortomorrow.ca). The portal, developed by MR and powered by our Mica software, helps the research community identify CPTP data and biosamples of interest and includes a data access interface. In the Integrative Analysis of Longitudinal Studies of Aging (IALSA) project, MR catalogued 43 new aging cohorts from around the world and published over 216 000 variables they collect on its website to facilitate data discovery amongst IALSA investigators.

The year 2016 will see the beginning of new collaborations with European and Canadian consortia. Among these is MINDMAP, a European Union-funded project aiming to identify opportunities offered by the urban environment for the promotion of mental wellbeing and cognitive function of older individuals in Europe. This project will bring together longitudinal studies across cities in Europe, the US and Canada to explore the causal pathways and multi-level interactions between the urban environment and the social, behavioural, psychosocial and biological determinants of mental health and cognitive function in aging populations. MR will actively participate in the data harmonization activities of the MINDMAP consortium and provide support in establishing an infrastructure for co-analysis across population registries and participating cohort studies.

Isabel FortierDirector

http://www.bioshare.eu

http://www.datashield.org


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During 2015, ELSI2.0 continued to strengthen its network of international researchers interested in the ethical, legal and social implications of research in the life sciences. The highlight of our year was our first international ELSI2.0 conference, entitled ‘Translation in Healthcare: Exploring the Impact of Emerging Technologies’. With 135 delegates from over 20 countries the event held at Oxford University was a huge success and a valuable oppor tunity to showcase our achievements. The conference also

hosted the official launch of our ELSI2.0 website and online platform. A Special Issue in BMC Medical Ethics will collect papers emanating

from discussions held during the conference and the collaborations they stimulated.

Three years on from the launch of our Network, we took time to reflect back on our achievements and consider effective strategies for the next 3 years. 6 new members have been recruited to our steering committee both to replace those who have stood down and to increase membership. We thank Dr. Kelly Edwards (University of Washington, USA) Alastair Kent (Genetic Alliance, UK) Jantina de Vries (University of Cape Town, South Africa) for their service and dedication. Whilst the focus to date has been on growing our membership, 2016 will see the launch of our new ‘Making Connections’ activity - pop-up forums and networked groups to support collaborative endeavours or identified research synergies. A strategic committee comprised of the leaders of several pilot Making Connections groups will produce guidance to assist those interested in establishing their own groups – further details of how to do so will be released in the spring, accompanied by information on existing groups.

THE INTERNATIONAL PAEDIATRIC RESEARCH PROGRAMME (led by Dr Ellen Wright Clayton)

For 2015, a key event was the meeting held on May 11-12 in Montreal, under the theme “Re-contact in Biomedical Research: Implications of Attaining Majority”. This Think Tank meeting brought together fourteen participants and was an occasion for the group to think about the issue of re-contacting children in many different contexts: biobanks and longitudinal studies, clinical research

and newborn screening programs. Following the rich and diverse presentations and discussions, the platform prepared a manuscript entitled “Attaining Majority in Biomedical Research: Re-contact for Consent?”. All the Paediatric Research Programme members present contributed to the manuscript and are listed as co-authors. The paper was submitted to the IRB: Ethics & Human Research Journal.

THE ELSI 2.0 COLLABORATORY RESEACH PROGRAMME (led by Professor Jane Kaye)

UPDATE FROM THE SCIENTIFIC DIRECTORS

Jane KayeDirector

Ellen Wright Clayton Director

http://www.p3g.org/p3g-international-paediatric-research-platform

http://www.p3g.org/p3g-international-paediatric-research-platform

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P3G MEMBERS

INSTITUTIONAL MEMBERS:

P3G’s Institutional members are organizations conducting, using or collaborating with or planning to be involved in with health studies, biobanks, research databases and other similar health research infrastructures. These organizations are committed to complying with the P3G Mission and to providing P3G with relevant knowledge and expertise. Institutional members have voting rights. Institutional members of P3G for the year 2015 were:

Alberta Health Services - Cancer Care (Canada)

Canadian Partnership for Tomorrow Project (Canada)

CARTaGENE (Canada)

Centre of Genomics and Policy, McGill University (Canada)

Estonian Genome Project of the University of Tartu (Estonia)

Genome Quebec (Canada)

Helmholtz Zentrum Munchen (Germany)

IBBL (Luxembourg)

INSERM (France)

King Abdullah International Medical Research Center (Saudi Arabia)

National DNA Biobank (Spain)

Ontario Health Study (Canada)

Shanghai Clinical Research Center (China)

UK BioBank (UK)

P3G Network: In addition to the institutional members listed above, the P3G network includes more than 530 individuals from academic, public or private organizations, supporting P3G’s activities and helping to further the objectives of P3G so as to provide the community with the benefit of their knowledge and expertise.


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BOARD OF DIRECTORSBartha Maria KnoppersChair (Canada)

Jennifer HarrisVice-Chair (Norway)

Thomas J. HudsonDirector (Canada)

Claude LabergeDirector (Canada)

Gert-Jan B. van OmmenTreasurer (Netherlands)

Gerardo Jimenez SanchezDirector (Mexico)

Klaus LindpaintnerDirector (Austria)

Andres Metspalu Director (Estonia) (2015 - )

Martin GodboutDirector (Canada)

Lyle PalmerDirector (Canada) ( - 2015)

CORPORATE INFORMATION

INTERNATIONAL SCIENTIFIC STEERING COMMITTEE MEMBERS

Chair: Paul Burton, University of Bristol, UK

Anthony J Brookes, University of Leicester, UK

Rex Chisholm, NuGene, USA

Isabel Fortier, RI-MUHC, Canada

Pat Goodwin, Wellcome Trust, UK

Jennifer Harris, The Norwegian Institute of Public Health, Norway

Kristian Hveem, BBMRI, Norway

Jane Kaye, HeLEX, UK

Alastair Kent, Genetic Alliance, UK

Bartha Maria Knoppers, CGP-McGill University, Canada

Klaus Lindpaintner, Fisher Scientific, Austria

Julian Little, University of Ottawa, Canada

Peter Riegman, Erasmus MC, The Netherlands

Samuli Ripatti, FIMM-EMBL University of Helsinki, Finland

Ronald Stolk, BioSHaRE EU, University of Groningen, The Netherlands

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CORPORATE INFORMATION

EXECUTIVE STAFF (2015)Anne Marie TasséExecutive Director

Charles Hart RivardAccountant and Director of Operations

Sylvie OuelletteCommunication Officer

Marisa Rossi Administrative Assistant

Emilie de Vries-SéguinArchivist

P3G-IPAC AND CAN-SHARE TEAM (2015)Emily KirbyIPAC CoordinatorCan-SHARE Automatable Discovery and Access Task Team CoordinatorResearch Associate

Yann Joly ICGC Data Access Officer

Susan WallaceICGC Scientific AdvisorCan-SHARE Consent Task Team Coordinator

Ma’n H. Zawati CPTP Access Officer

Erika KleidermanCan-SHARE Coordinator

Adrian Thorogood Can-SHARE REWG CoordinatorCan-SHARE Accountability Task Team Coordinator

Edward S. DoveCan-SHARE Privacy and Security Task Team CoordinatorCan-SHARE Ethics Review Equivalency Task Team CoordinatorResearch Associate

Karine SénécalCan-SHARE Paediatric Task Team Coordinator

Vasiliki Nataly RahimzadehCan-SHARE Ageing and Dementia Task Team CoordinatorResearch Assistant

Joel MinionResearch Associate

LEGAL COUNSEL

Kathleen SauvéStein Monast, S.E.N.C.R.L.70 Dalhousie Street, Suite 300Quebec City, Quebec, CANADA G1K 4B2

FUNDERS

Genome Canada150 Metcalfe Street, Suite 2100Ottawa, Ontario, CANADA K2P 1P1

Génome Québec630 René-Lévesque Blvd. West, Suite 2660Montreal, Quebec, CANADA H3B 1S6

Canadian Institutes of Health Research (Genetics)160 Elgin Street, 9th FloorOttawa, Ontario, CANADA K1A 0W9

HOST/HOME INSTITUTION

McGill University and Genome Quebec Innovation Centre740 Dr Penfield Avenue, Suite 5104Montreal, QC, CanadaH3A 0G1

www.p3g.orgE-mail: [email protected]+1 514-398-1648

ANNUAL GENERAL MEETING

P3G Annual MeetingDate: June 2015

AUDITORS

APSV Inc.7200 Hutchison Street, Suite 200Montreal, Quebec, CANADA H3N 1Z2


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2015 ACTIVITY REPORT

The following are the result of activities led by P3G or its affiliated programmes, or include a mention of P3G’s contribution.

MEETINGS (ORGANIZED OR CO-ORGANIZED BY P3G)

International Biobanking Summit (IBS) IV (ISBER/P3G/ESBB/BioSHaRE/Biobank Norway): International Biobanking and ‘Big Data’ Meet Innovative Governance? Phoenix, USA, May 6, 2015.

P3G International Paediatric Platform Workshop - Re-contact in Biomedical Research : Implications of Attaining Majority.Montreal, Canada, May 11-12, 2015.

Global Alliance for Genomics and Health - Regulatory and Ethics Working Group Meeting on Registered Access. Baltimore, USA, October 7, 2015.

PUBLICATIONS

Bovenberg J, Knoppers BM, Hansell A, de Hoogh K. Exposing participants? Population Biobanks Go Geo. European Journal of Human Genetics. 2015; doi:10.1038/ejhg.2015.43, 1-2.

Burton PR, Murtagh MJ, Boyd A, Williams JB, Dove ES, Wallace SE, Tassé AM, […] Knoppers BM. Data Safe Havens in health research and healthcare. Bioinformatics. 2015; 31(20): 3241-3248.

Dove ES, Joly Y, Tassé AM, P3G International Steering Committee, ICGC Ethics and Policy Committee, Knoppers BM. Genomic cloud computing: legal and ethical points to consider. European Journal of Human Genetics. 2015; 23(10): 1271-1278.

Griffith LE, van den Heuvel E, Fortier I, Sohel N, Hofer SM, Payette H, Wolfson C, Belleville S, Kenny M, Doiron D, Raina P. Statistical approaches to harmonize data on cognitive measures in systematic reviews are rarely reported. Journal of clinical epidemiology. 2015; 68(2): 154-62.

Howard HC, Knoppers BM, Cornel MC, Clayton EW, Sénécal K and Borry B, endorsed by the European Society of Human Genetics; the P3G International Paediatric Platform; the Human Genome Organisation; and the PHG Foundation. Whole-genome sequencing in newborn screening? A statement on the continued importance of targeted approaches in newborn screening programmes, European Journal of Human Genetics 2015; 23(12):1593-600. doi: 10.1038/ejhg.2014.289

Moraia LB, Kaye J, Tassé AM, Knoppers BM, Mitchell C, Soini S, Hoppe N, Wallace S, Øien M. A comparative analysis of the requirements for the use of data in biobanks based in Finland, Germany, the Netherlands, Norway and the United Kingdom. Medical Law International 2015; 14(4): 187–212.

Sariyar M, Schluender I, Smee C, Suhr S. Sharing and Reuse of Sensitive Data and Samples: Supporting Researchers in Identifying Ethical and Legal Requirements. Biopreservation and Biobanking. 2015;13(4):263-270. doi:10.1089/bio.2015.0014.

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2015 ACTIVITY REPORT ...(con’t)

Sénécal K, Rahimzadeh V, Knoppers BM, Fernandez CV, Avard D, Sinnett D Statement of principles on the return of research results and incidental findings in paediatric research: a multi-site consultative process. Genome. 2015; 58: 541–548. dx.doi.org/10.1139/gen-2015-0092

Shabani M, Knoppers BM, Borry P. From the principles of genomic data sharing to the practices of data access committees. EMBO Molecular Medicine. 2015; doi 10.15252/emmm.201405002, 1-3.

Spjuth O, Krestyaninova M, Hastings J, Shen HY, Heikkinen J, Waldenberger M, Langhammer A, Ladenvall C, Esko T, Persson MA, Heggland J, Dietrich J, Ose S, Gieger C, Ried JS, Peters A, Fortier I, de Geus EJ, Klovins J, Zaharenko L, Willemsen G, Hottenga JJ, Litton JE, Karvanen J, Boomsma DI, Groop L, Rung J, Palmgren J, Pedersen NL, McCarthy MI, van Duijn CM, Hveem K, Metspalu A, Ripatti S, Prokopenko I, Harris JR. Harmonising and linking biomedical and clinical data across disparate data archives to enable integrative cross-biobank research. European Journal of Human Genetics 2015. doi: 10.1038/ejhg.2015.165

Stein LD, Knoppers BM, Campbell P, Getz G, Korbel JO. Create a cloud commons. Nature. 2015; 523(7559): 149-151.

The 1000 Genomes Project Consortium (Knoppers BM). A global reference for human genetic variation. Nature. 2015; 526(7571): 68-74.

Zawati MH, Junker A, Knoppers BM, Rahimzaheh V. Streamlining Review of Research Involving Humans: Canadian Models. Journal of Medical Genetics. 2015; 52(8): 566-569.

PRESENTATIONS

Doiron D and Fortier I. DataSchema: Scientific and Technical Issues. InterConnect Harmonization Workshop, Amsterdam, Netherlands.

Fortier I. From individual cohorts to collaborative data sharing infrastructures. 2015 Annual Meeting of the National Cancer Institute Cohort Consortium, Bethesda, USA.

Fortier I. “Novel” concepts for harmonizing and sharing study data: The BioSHaRE and Maelstrom Research approaches. 12th European Nutrition conference, Federation of European Nutrition Societies, Berlin, Germany.

Fortier I. How to facilitate data harmonization and integration: The Maelstrom Research Agenda. Child Health and Human Development Program, Research Institute of the McGill University Health Centre, Montreal, Canada.

Fortier I and Doiron D. Maelstrom Research tools for data harmonization and co-analysis. Latest Tools and Services for Data Sharing

Fortier I. From individual cohorts to collaborative data sharing infrastructures: How to document, harmonize and integrate data. ERASMUS, Department of Epidemiology, Rotterdam, Netherlands


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Knoppers BM. Biobanks and Big Data. Biobanking in the Context of Personalized Healthcare, Qatar BioBank Inaugural Conference, Doha, Qatar, February 9, 2015.

Knoppers BM. Report of the Ethics and Policy Committee. ICGC – 10th Scientific Workshop, Verona, Italy, February 17, 2015.

Knoppers BM. The Global Alliance for Genomics & Health. Scientific Ethics Advisory Committee (SEAG), Genentech, San Francisco, USA, February 27, 2015.

Knoppers BM. Data sharing initiatives and the work of the Global Alliance, Canadian GE3LS and Health Services & Policy Research Conference, Session 1: Research Policy in Genomics, Vancouver, Canada, April 19, 2015.

Knoppers BM. The Global Alliance for Genomics and Health: Consent Policy, ClinGen/DECIPHER Meeting, Integrated Approaches to Informed Consent: Connections & Interactions, Washington, USA, May 27, 2015.

Knoppers BM. Towards a Human Rights Foundation for Data Sharing, Translation in Healthcare – Exploring the Impact of Emerging Technologies, Plenary III: My Data, Open Data, Big Data, Oxford, UK, June 24, 2015.

Knoppers BM. Operationalizing responsible data sharing and access: GA4GH, BioSHaRE in conjunction with the HandsOn Biobanks Conference, Milan, Italy, July 29, 2015.

Knoppers BM. From ‘Big Data’ to personalized medicine?, International and Interdisciplinary Association on the Pharmaeutical Life Cycle (IIAPC), Montreal, Canada, August 20, 2015.

Knoppers BM. Big Data: Mapping the Policy Landscape, Session: D3 – Big Data, The Canadian Cancer Research Conference, Montreal, Canada, November 9, 2015.

Knoppers BM. Les aspects éthiques de la collaboration international/Ethical aspects of international collaboration in genomics, Rencontres Internationales. Partager la science, partager les valeurs : le challenge de la diversité / International meeting. Sharing science, sharing values: the challenge of diversity, Toulouse, France, December 3, 2015.

Knoppers BM. Defining the Human Right to Benefit from Scientific Progress: Big data and the responsible sharing of genomic and health-related data, Canada Foundation for Innovation, Annual Public Meeting, Ottawa, Canada, December 15, 2015.

Magnan J, Awadalla P, Fortier I, Dummer T, Boileau C. Unlocking the Mysteries of Cancer and Other Chronic Diseases: Canada’s Cohort for Cancer & Chronic Disease Research. CPTP Satellite Event at Canadian Cancer Research Conference, Montreal, Canada.

Sénécal K and Zawati M. Growing up in a biobank, P3G Paediatric Research Platform, Montreal, Canada. May 11-12, 2015.

Tassé AM. Discussion. IBS IV: International Biobanking Summit: International Biobanking and ‘Big Data’ Meet Innovative Governance?, Phoenix, USA, May 6, 2015.


A n n u a l R e p o r t 2 0 1 5

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Tassé AM. Welcome. P3G International Paediatric Platform Workshop, Montreal, Canada, May 11, 2015.

Tassé AM and Zawati M. Ethical, Legal and Social Issues. BCNet Training Session, Lyon, France, November 3, 2015.

Zawati M. Population Biobanking, Autonomy and the Duty to Inform: Streamlining Access to Data while Protecting Participants, Research Group on Health and Law Seminar Series, Montreal, Canada, February 2, 2015.

Zawati M. Returning Severe Structural Abnormalities Post-Research MRI: Ethical and Legal Issues, Canadian Alliance for Healthy Hearts and Minds 1st General Conference, Hamilton, Canada, June 5, 2015.

Zawati M. Beyond a Shadow of a Doubt? Reporting MRI Research Findings in the Canadian Alliance for Healthy Hearts and Minds, Centre of Genomics and Policy Summer Presentations, Montreal, Canada, August 27, 2015.

Zawati M. Fairness and Attribution: Ethical and Legal Considerations in Publications following Access to Population Biobanks, European, Middle Eastern & African Society of Biopreservation & Biobanking (ESBB) International Conference, London, UK, October 1, 2015.

Zawati M. Realizing Benefit by Maximizing Collaboration: The Imperative of Responsible Data Sharing in Biobanks, The Ethics and Governance Council of Taiwan Biobank, 2015 Symposium on Research Ethics in Biobanking, Taipei, Taiwan, November 8, 2015 .

Zawati M. One Flew Over the Author’s Nest: Legal and Practical Considerations in Publications following Access to Population Biobanks, Ethox Centre Seminar Series, Nuffield Department of Population Health, Oxford University, UK, December 1, 2015.

BOOK CHAPTERS

Piccinin A, Fortier I, Saliba M. (2015). Harmonization. Whitbourne S. The Encyclopedia of Adulthood and Aging (Accepted).

Rahimzadeh V, Tassé AM, Ouellette S, Knoppers BM, Fortier I. Towards an International Policy Platform for Population Genomics. Hainaut P, Vaught J, Pasterk M, Zatloukal K. eds. Biobanking of Human Biospecimens (New York: Springer, 2016) (in press).

Ma’n H. Zawati & Bartha Maria Knoppers. Population Biobanks and the Principle of Reciprocity. Hainault P, Vaught J, Pasterk M and Zatlookal K, eds. Biobanking of Human Specimens, (New York: Springer, 2016) (in press).

POLICY STATEMENTS, GUIDELINES AND REPORTS

Bjerring AK, Brownell M, Diverty B, El Emam K, Fortier I, Henry D, Knoppers BM, Laurie G, Lemmens T, Morgan M, Noseworthy TW, Saunders S, Wolfson M, Zelmer J. Accessing Health and Health Related Data in Canada. The Expert Panel on Timely Access to Health and Social Data for Health Research and Health System Innovation (2015).

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