Understanding the Impact of the Research Data Alliance

Understanding the Impact of the Research Data Alliance COVID-19 Recommendations and Guidelines on Data Sharing RDA-US Panel on COVID-19 Data Sharing 7 August 2020 RDA COVID-19 Guidelines and Recommendations https: //doi. org/10. 15497/rda 000 52

Agenda • • Introductions Overview of RDA COVID-19 Working Group Initiative Presentations o Indigenous Peoples o Clinical o Omics o Community Participation o Social Sciences • Panel Q&A 08/07/2020 rd-alliance. org @resdatall | @RDA_US 2

Questions & Answers ● Please use the Q&A option to ask questions of the presenter(s). Questions will be addressed at the end of each panelist’s presentation, and also at the end of the panel. ● The Q&A option can be found at the bottom of your Go. To. Webinar screen: ● Please note that this event is being recorded, including questions and answers. 08/07/2020 rd-alliance. org @resdatall | @RDA_US 3

Contributors Moderators Leslie Mc. Intosh, Ph. D, MPH Yolanda Meleco Mary O’Brien Uhlmansiek, MA RDA-US Executive Director RDA-US Business Director RDA-US Implementation & Outreach Director Panelists Stephanie Russo Carroll, Dr. PH, MPH RDA COVID-19 WG - International Indigenous Data Sovereignty IG Chair Associate Director, Native Nations Institute, University of Arizona, Tucson, AZ Dawei Lin, Ph. D RDA COVID-19 Clinical Group Moderator National Institute of Allergy and Infectious Diseases, Rockville, MD Natalie Meyers, MLIS RDA COVID-19 Omics Group Moderator University of Notre Dame, IN Daniel Mietchen, Ph. D RDA COVID-19 Community Participation Group Moderator University of Virginia, Charlottesville, VA Amy Pienta, Ph. D RDA COVID-19 Social Sciences Group Moderator University of Michigan, Ann Arbor, MI 08/07/2020 rd-alliance. org @resdatall | @RDA_US 4

THE RESEARCH DATA ALLIANCE RDA in a Nutshell www. rd-alliance. org building the social and technical bridges that enable open sharing of data Vision Researchers and innovators openly share data across technologies, disciplines, and countries to address the grand challenges of society. Mission RDA builds the social and technical bridges that enable open sharing of data. 45 FLAGSHIP OUTPUTS 100+ ADOPTION CASES including 8 ICT Technical Specifications across multiple disciplines, organisations & countries 106 GROUPS WORKING ON GLOBAL DATA INTEROPERABILITY CHALLENGES 46 Working Groups 60 Interest Groups 10, 896 INDIVIDUAL MEMBERS FROM 145 COUNTRIES (2, 329 US MEMBERS) 69% Academia & Research 14% Public Administration 11% Enterprise & Industry 52 ORGANISATIONAL MEMBERS 11 AFFILIATE MEMBERS 08/07/2020 rd-alliance. org @resdatall | @RDA_US 5

RDA COVID-19 Response • Call to action by European Commission to fast track Working Group aimed at developing a system for data sharing in public health emergencies, specifically COVID-19 • Recommendations and guidelines: o detailed guidelines to help researchers and data stewards follow best practices to maximise the efficiency of their work, and to act as a blueprint for future emergencies; o recommendations to help policymakers and funders to maximise timely, quality data sharing and appropriate responses in such health emergencies. 08/07/2020 rd-alliance. org @resdatall | @RDA_US 6

Community Effort • • • 600+ RDA members and newcomers registered for the different groups 165 active contributors to the documents Experts in different fields as group moderators – 6 from US region Regular calls, writing sprints, and iterations Weekly webinars, requests for comments 5 releases produced (April – May 2020) 08/07/2020 rd-alliance. org RDA’s guiding principles: ✔ ✔ ✔ Openness Consensus Balance Harmonization Community-driven Non-profit and technology-neutral @resdatall | @RDA_US 7

4 Research Areas: 1. Clinical 2. Omics 3. Epidemiology 4. Social Sciences 4 Cross-cutting Areas: 1. Community 2. Indigenous Data 3. Legal & Ethical 4. Research Software

Overarching Challenges ✔ Rapid sharing of research efforts, findings, and data ✔ Timeliness versus precision ✔ Lack of “pre-approved” data sharing agreements ✔ No universal standard / system for COVID-19 research outputs ✔ Cross-disciplinary reusability ✔ Contextualisation, licensing, documentation ✔ Ad-hoc Research software 08/07/2020 rd-alliance. org @resdatall | @RDA_US 9

Overarching Recommendations ✔ Coordinated, cross-jurisdictional efforts to foster global Open Science ✔ Infrastructure Investment & Economies of Scale ✔ FAIR and Timely outputs ✔ Early & frequently updated Data Management Planning ✔ Metadata essential for cross-disciplinary access ✔ Documentation of methodologies ✔ Use of Trusted Data Repositories (TDRs) ✔ Expedited Publications / Data Publications ✔ Ethical and legal considerations ✔ Legal frameworks 08/07/2020 rd-alliance. org @resdatall | @RDA_US 10

Cross cutting theme highlights Cross cutting themes Clinical Recommendations for funders/policy makers Guidelines for researchers Standardised clinical Promotion of clinical data terminologies should be used sharing is important due to and a fair balance achieved many studies and trials being between timely data sharing and performed under enormous protecting privacy and time pressure confidentiality Measures should be taken in order to organise the sharing of data and trial documents in a suitable, trustworthy and secure data repository Omics An increased need of rapid openness for omics data to gain early insights into molecular biology of the processes at cellular level Omics research should be a Promote use of domaincollaborative effort to learn the specific repositories to enable genetic determinants of COVIDstandardisation of terms and 19 susceptibility, severity and enforce metadata standards outcomes Epidemiology Data and models are frequently incomplete, provisional, and subject to correction under changing conditions Data models must include clinical Incentivise the publication of data, disease milestones, situational data, analytical indicators and reporting data, models, scientific findings, contact tracing and personal risk and reports used in decisionfactors making Social Sciences 08/07/2020 Challenges Need equal inclusion of social Promote interoperable crossand economic issues with disciplinary and cross-cultural medical information to enable data use and collaboration for evidence-based decision managing social science data making during pandemics rd-alliance. org Robust funding streams for social science research for understanding and managing the behavioural, and economic aspects @resdatall | @RDA_US 11

Cross cutting theme highlights Cross cutting themes Challenges Community Need specific guidelines for enabling citizen scientists undertaking research to contribute to a common body of knowledge Encourage public and patient Balance between timely testing involvement (PPI) throughout and contact tracing, emergency the data management lifecycle response, community safety and from research question to final individual privacy concerns data sharing and usage Indigenous data rights, Indigenous governance of data priorities and interests must collection, ownership, sharing Indigenous Data be recognised in all COVID-19 and use priorities is the central Guidelines research and surveillance principle of Indigenous data activities sovereignty Ethical instruments should be Achieve a balance between interpreted with the law, and Legal and Ethical rights of people and interests can guide the interpretation of Considerations of researchers and the law if the law does not policymakers address a particular issue Need systems in place for It is critical for software that is sharing of research software used in data analysis to produce Research Software and accelerated and results that can, if necessary, be reproducible research during reproduced a pandemic 08/07/2020 rd-alliance. org Recommendations for funders/policy makers Guidelines for researchers CARE Principles of Indigenous Data Governance set minimum standard for collectors, users and stewards of data. During a pandemic, ethical review and approval for legally sharing data should be expedited. Funders must allocate financial resources to support the development and maintenance of new research software @resdatall | @RDA_US 12

Indigenous Peoples Data Stephanie Russo Carroll, Ph. D, MPH RDA COVID-19 WG - International Indigenous Data Sovereignty IG Chair Associate Director, Native Nations Institute, University of Arizona 08/07/2020 rd-alliance. org @resdatall | @RDA_US 13

Indigenous Data GIDA-RDA COVID-19 Guidelines for Data Sharing Respecting Indigenous Data Sovereignty ○ Reflect and support Indigenous Data Sovereignty (see www. GIDAglobal. org) and are underpinned by the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP). ○ Framed around the CARE Principles for Indigenous Data Governance -Collective benefit, Authority to control, Responsibility, Ethics -- (www. gidaglobal. org/care) that set forth critical considerations for Indigenous rights and interests in data. ○ Available in English and Spanish (www. gida-global. org/resources). ○ Lay Policy Brief in production to be available in up to 6 -8 languages. ○ Scholarly manuscript in production. 08/07/2020 rd-alliance. org @resdatall | @RDA_US 14

Indigenous Data COVID-19 Data Challenges ○ Data for Governance ■ No data ■ Limited data access ■ Misclassification ■ Ethics/Weaponization 08/07/2020 rd-alliance. org @resdatall | @RDA_US 15

Indigenous Data To enhance Indigenous data governance and improve the flow of information for effective public health response 1. 2. 3. 4. 08/07/2020 Proactive investment in Indigenous community-controlled data infrastructures to support community capacity and resilience Data access and sharing protocols between Indigenous Peoples and other governments and data holders Collection of Indigenous/ethnic status and/or tribal affiliation Training and capacity building to involve more Indigenous people in order to enhance Indigenous data governance and improve the flow of information for effective public health response. rd-alliance. org @resdatall | @RDA_US 16

Clinical Dawei Lin, Ph. D RDA COVID-19 Clinical Group Moderator Associate Director for Bioinformatics and Senior Advisor to the Director, Division of Allergy, Immunology, & Transplantation National Institute of Allergy and Infectious Diseases Rockville, MD 08/07/2020 rd-alliance. org @resdatall | @RDA_US 17

RDA-COVID 19 clinical sub-group Clinical Sub-group Co-chair Clinical Sub-group Moderators Clinical Andrea Jackson-Dipina, NIH Sergio Bonini, CNR Dawei Lin, NIH Christian Ohmann, ECRIN rd-alliance. org @resdatall 18

SWOT Analysis of RDA Clinical Subgroup Strengths • Broad perspectives and expertise. • Strong enthusiasm and commitment. Weaknesses • Challenges to work together (Time zone, geolocations, technologies, cultures). • Work is volunteered Opportunities • Cross-cutting recommendations, which can be the basis for long term development • Creating or enhancing the interdisciplinary connections. Threats • Work is not sustainable • Not able to reach consensus (priorities, level of details) rd-alliance. org @resdatall 19

The Outputs of RDA Clinical Subgroup Strengths • Broad perspectives and expertise. • Strong enthusiasm and commitment. Clinicians, policy makers, data researchers, standard developers, community organizers. Opportunities • Cross-cutting recommendations, which can be the • basis for long term development Creating or enhancing the interdisciplinary connections. Leveraging Trustworthy data repositories Imaging and immunology, heath related data and standards, such as ISO/TS 17975: 2015 Health informatics rd-alliance. org Weaknesses • Challenges to work together (Time zone, • geolocations, technologies, cultures). Work is volunteered Participants were mainly from European, US. Quality is high based on positive feedbacks from the public. Threats • Work is not sustainable • Not able to reach consensus (priorities, level of details) Activities decreased after the working group finished. How to measure impact is in discussion. @resdatall 20

Clinical Data Challenges Time pressures, weakness in methodology (e. g. no control group), no review, redundancy Recommendations and Guidelines • A fair balance achieved between timely data sharing and protecting privacy and confidentiality. • Leverage existing solutions and the sharing of data and trial documents in a suitable, trustworthy and secure data repository. 3. 3. 1 Trustworthy Sources of Clinical Data 3. 4. 1 Data and Metadata Standards for Clinical Data 3. 4. 2 Clinical Trials on COVID-19 3. 4. 3 Immunological, Imaging and Healthcare Data rd-alliance. org @resdatall 21

Omics https: //www. rd-alliance. org/groups/rda-covid 19 -omics Natalie Meyers, MA, MLIS Interim Director, Navari Family Center for Digital Scholarship Hesburgh Libraries University of Notre Dame RDA COVID-19 Omics Group Co-Moderator with Natalie Meyers: natalie. meyers@nd. edu @nkmeyers 08/07/2020 Rob Hooft Program Manager Data Stewardship Dutch Techcentre for Life Sciences rd-alliance. org @resdatall | @RDA_US Rob Hooft: rob. hooft@dtls. nl | @rwwh 24

Omics https: //www. rd-alliance. org/groups/rda-covid 19 -omics 08/07/2020 rd-alliance. org @resdatall | @RDA_US 25

Data Sharing in Omics o Virus Genomics Data o Host Genomics Data o Structural Data o Metabolomics o Lipidomics 26

Omics Policy Recommendations 27

Lipidomics Example 28

4. 4. 3 Guidelines for Structural Data • 4. 4. 3. 1 Repositories o Protein Structures: ww. PDB, EBI PDBe, EMDB for Europe, RCSB PDB for USA, PDBj for Japan o GDHHI of China • 4. 4. 3. 2 Locating Existing Data o COVID-19 Molecular Structure and Therapeutics Hub by MOLSSI and Bio. Excel • 4. 4. 3. 3 Data and Metadata Standards o o o X-ray diffraction Electron Microscopy NMR Neutron Scattering Molecular Dynamics simulations Computer-aided Drug Design data 29

Data Sharing in Omics - Structural Data Example Outline • Repositories o Protein Structures: ww. PDB, EBI PDBe, EMDB for Europe, RCSB PDB for USA, PDBj for Japan o GDHHI of China • Locating Existing Data • Data and Metadata Standards o COVID-19 Molecular Structure and Therapeutics Hub by MOLSSI and Bio. Excel o o o X-ray diffraction Electron Microscopy NMR Neutron Scattering Molecular Dynamics simulations Computer-aided Drug Design data 30

Community Participation Daniel Mietchen, Ph. D RDA COVID-19 Community Participation Group Moderator Data Scientist, School of Data Science, University of Virginia, Charlottesville, VA 08/07/2020 rd-alliance. org @resdatall | @RDA_US 31

Community participation sub-group • One of the five original subgroups • Quickly reframed as a cross-cutting theme, along with o Research software o Indigenous data guidelines o Legal and ethical considerations 08/07/20

Community participation sub-group • Group site: https: //www. rd-alliance. org/groups/rda-covid 19 -communityparticipation • Co-moderators: Timea Biro, Kheeran Dharmawardena, Eva Méndez, Daniel Mietchen, Susanna Sansone, Joanne Stocks • Group membership of roughly 120 • Regular group and coordination calls • Brainstorming and several writing sprints • Survey for use cases to address • Several reiterations - with feedback via Timea Biro 08/07/20

Community participation sub-group • A cross-cutting theme - looking at data sharing within and across research communities, as well as community participation in addressing the emergency • Use cases of community generated data via apps and data challenges related to participatory disaster response strategies • Policy recommendations around transparency, community participation and data governance; encouraging inclusiveness and incremental and multidisciplinary approach, ethics & privacy • Guidelines for researchers & teams around data collection and data stewardship in particular via Timea Biro 08/07/20

Community participation sub-group via Timea Biro 08/07/20

Community participation sub-group Still lots to be done - get involved! Questions? via Timea Biro 08/07/20

Social Sciences Amy Pienta, Ph. D RDA COVID-19 Social Sciences Group Moderator Research Scientist and Director, Business and Collection Development ICPSR, University of Michigan, Ann Arbor, MI 08/07/2020 rd-alliance. org @resdatall | @RDA_US 37

Social Sciences Iryna Kuchma EIFL Social Sub-group Co-chair Social Sub-group Moderator 38

Social Sciences 85 members 05/05/2020 rd-alliance. org @resdatall 39

More than a Health & Medical Crisis Scientific discourse that moves beyond demographics to also include indicators of social, economic, and political statuses • • Staying at home to social distance Closing of schools and impact of virtual learning on children Working from home, furloughs, unemployment Changing face communities, social spaces Small businesses failing and large corporations filing Impact on institutionalized populations in nursing homes, in prison Vastly growing inequalities and disparities 40

Spotlight Recommendation - Linkage Goal to Ensure Data Sources Can be Linked Data from the social sciences is shared in ways that allow for information to have impact and reuse by all domains. 05/05/2020 rd-alliance. org @resdatall 41

Spotlight Recommendation - Linkage Goal to Ensure Data Sources Can be Linked Common practice is to store data. . . without direct identifiers and replace personal identifiers with a randomly assigned identifier. Where possible, seek legal authority to retain identifiers in a separate secure file to facilitate linkage. 05/05/2020 rd-alliance. org @resdatall 42

Spotlight Recommendation - Linkage Goal to Ensure Data Sources Can be Linked Use standardized codes for places. We encourage the use of ISO-3166 for countries or administrative subdivisions, ANSI and FIPS for U. S. States and counties, and standard identifiers for organisational entities such as companies. This set of actions will facilitate linkage (and also data analysis, harmonization, visualization, and integration in applications). 05/05/2020 rd-alliance. org @resdatall 43

Spotlight Recommendation Generalizability Goal to Ensure Generalizability To ensure that data is more generalizable, researchers should provide access to information that can be used to address selection bias (e. g. , demographic characteristics, geographic variables, etc. ). 05/05/2020 rd-alliance. org @resdatall 44

Spotlight Recommendation Accessibility Goal to Ensure Accessibility Deposit COVID-19 related data, whenever possible, in a trustworthy digital repository committed to preservation. As the first choice, disciplinary repositories are recommended for maximum visibility, followed by general or institutional repositories. 05/05/2020 rd-alliance. org @resdatall 45

Panel Questions & Answers ● Please use the Q&A option to ask questions of the presenter(s). Questions will be addressed at the end of each panelist’s presentation, and also at the end of the panel. ● The Q&A option can be found at the bottom of your Go. To. Webinar screen: ● Please note that this event is being recorded, including questions and answers. 08/07/2020 rd-alliance. org @resdatall | @RDA_US 46

COVID-19 Resources ✔ Final endorsed version published as “RDA COVID-19 Recommendations and Guidelines” on 30 June 2020 - https: //doi. org/10. 15497/rda 00052 ✔ RDA COVID-19 Zotero Collection - https: //doi. org/10. 15497/rda 00051 ✔ RDA COVID-19 Infographic - https: //tinyurl. com/RDA-covid 19 -infographic ✔ RDA COVID-19 Navigation Tool(s) under development ✔ Supporting Outputs → Epidemiology, FAIRsharing, … ✔ The Value of RDA COVID-19: https: //rd-alliance. org/value-rda-covid-19 -0 08/07/2020 rd-alliance. org @resdatall | @RDA_US 47

Thank you! For more information. . . The Research Data Alliance COVID 19 Guidelines and Recommendations on Data Sharing RDA-US contacts for more information: Yolanda Meleco & Mary Uhlmansiek 08/07/2020 rd-alliance. org RDA Email - enquiries@rd-alliance. org RDA-US Office – rdaus@rda-foundation. org Web - www. rd-alliance. org Twitter - @resdatall & @RDA_US Linked. In www. linkedin. com/in/Research. Data. Alliance Video - https: //tinyurl. com/youtube-RDA Slideshare http: //www. slideshare. net/Research. Data. Alliance Yolanda Meleco, Business Director, RDA-US - melecy@rpi. edu Mary Uhlmansiek, Implementation & Outreach Director, RDA-US – mary. uhlmansiek@rda-foundation. org @resdatall | @RDA_US 48