DSIC Workspace Face-to-Face Meeting

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					                       DSIC WORKSPACE FACE-TO-FACE MEETING
                                  January 22-23, 2008
                              Philadelphia, Pennsylvania

For further information, please see the presentations and related materials available here.
Thank you to Thomas Jefferson University for hosting the meeting and for their ongoing
support of and contributions to the caBIG™ program.

                                Day 1: Tuesday, January 22, 2008


DSIC WORKSPACE UPDATE:
Where we were, Where we are, Where we are going

Wendy Patterson, J.D., NCI Facilitator for the Data Sharing and Intellectual Capital (DSIC)
Workspace and Senior Advisor with the NCI Technology Transfer Center, reviewed the
progress of the DSIC Workspace since the previous face-to-face (F2F) meeting in May 2007 and
provided an overview of the tasks remaining in the current DSIC Workplan (March 2007-March
2008). Wendy reviewed the core caBIG™ principles – open source, open access, open
development, and federation – and rearticulated the mission of the DSIC Workspace, which is
to facilitate data sharing between and among caBIG™ participants by addressing legal,
regulatory, policy, proprietary, contractual, ethical and socio-cultural barriers to data exchange.
Wendy also highlighted the diverse membership of the DSIC Workspace, which currently
includes biomedical researchers, clinicians, technology transfer experts, intellectual property
and regulatory attorneys, policy specialists, patient advocates, bioethicists, and
bioinformaticists.

Wendy also addressed several of the data sharing challenges faced by the caBIG™ community,
including the varying obligations under federal and state privacy and security laws and
standards, oversight of human subjects research by institutional review boards, academic
considerations such as the need to secure grants and publish results in peer reviewed literature,
concerns regarding the protection of intellectual property, and public perceptions regarding
privacy and security of electronic health data. Wendy also explained the roles of the special
interest groups (SIGs) encompassed in DSIC – the Regulatory SIG and the Proprietary SIG.

Wendy then gave a high level overview of the Data Sharing and Security Framework (DSSF or
Framework), designed as a decision support tool to facilitate data sharing by caBIG™
participants. To complement the DSSF, DSIC will continue to develop a “tool kit” of products
and services, known as the DSSF Bundle, which will help researchers work with their
institutions to gain approval to share data via the caBIG infrastructure.

BUILDING OUT THE DATA SHARING AND SECURITY FRAMEWORK (DSSF): ANALYSIS OF LEGAL
AND REGULATORY RESTRICTIONS ON DATA SHARING

Rachel Nosowsky, J.D., Assistant General Counsel in the Office of the Vice President and
General Counsel at the University of Michigan, and Marsha Young, J.D., DSIC Workspace
Coordinator, Booz Allen Hamilton, reviewed and gathered suggestions for refining, extending



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and implementing the DSSF and laid out a strategy for adoption of the Framework and metrics
for assessing success.

Rachel and Marsha gave a general overview of the DSSF Bundle, which, when fully developed,
will consist of tools such as policies, procedures, decision tools, recommendations for best
practices, and model documents that researchers and stakeholders at their institutions can use
to implement the DSSF. An update was given about the tools currently ready for pilot testing
(the DSSF, Guidelines for Preparing Data Sharing Plans, Security Policies for Non-Sensitive
Data, the Level 1 NCI-caGrid Host Agreement, and the Researcher Questionnaire), the tools
next up for testing (Model Informed Consent Document and Security Policies for Moderately
Sensitive Data), and the tools in development (Guidelines for De-identifying Data, Standardized
Data Use Agreements for Medium and High Sensitivity Data, and Data Access Authorization
Policies for Medium to High Sensitivity Data).

Rachel then spoke of the practical application of the Framework, the foundational tool in the
DSSF Bundle. The DSSF is designed to provide the decision logic for analyzing sensitivity of
data to determine the appropriate type of data sharing mechanisms to employ and the proper
levels of security and data access controls to apply to the data. Rachel emphasized that the
data-providing institution makes the determination regarding which data can be shared and
identifies necessary access and data security controls. She gave an overview of the
considerations and issues related to privacy based restrictions and research policy restrictions,
and discussed how the DSSF Bundle tools may be helpful in converting data that can currently
be exchanged only in the yellow or orange lanes to data that can be exchanged in the green or
yellow lanes.

A question was raised regarding the applicability and scope of the tools in the DSSF Bundle. It
was noted that the tools are intended to facilitate the assessment of data sensitivity, a
determination which ultimately rests with the institution. Comments were made regarding the
impact of IRB interpretations of research regulation requirements on obtaining informed
consent and it was noted that while institutional IRBs have the final say in such matters, OHRP
guidance is an excellent reference.

Suggested Next Steps:

   1. Develop “best practices” to assist users in determining when data belongs in the green,
      yellow, or orange lane
   2. Expose and familiarize Workspace participants with Data Sharing Plan Guidelines
   3. Refine preliminary drafts of the Model Informed Consent and HIPAA Authorization
      documents
   4. Attempt to clarify definitional issues, perhaps via a caBIG™ or DSIC glossary

IMPLEMENTING THE DSSF

Rachel and Marsha utilized a case study in order to facilitate understanding of how to apply the
Framework. The case study involved applying the DSSF to data generated from The Cancer
Genome Atlas (TCGA) initiative to identify legal and regulatory barriers to sharing data. For
the sake of illustration and brevity, the presenters acknowledged they were acting under the


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assumptions that the data were not subject to any sponsor restrictions, IP concerns were
minimal, and that the data set was static.

A participant raised concern about single nucleotide polymorphisms (SNPs) and their potential
to be considered individually identifiable health information and thus considered protected
health information (PHI) as defined by the HIPAA Privacy Rule. It was noted that while SNPs
are currently not considered PHI, the TCGA policies are conservative and treat SNPs as such. A
comment was made that, in the interest of clarity and assuaging unfounded fears, a real effort
needs to be made to combat false notions about what information is, and is not, “dangerous” in
terms of potential privacy implications.

A participant commented on the static state of the data and noted that many data sets are in fact
dynamic and will require complex data use agreements. It was noted that more discussion is
required to craft a data use agreement that addresses dynamic data sets. An agreement that
incorporates routine reconfirmation and acceptance of terms and policies concerning the current
state of the data set may be one way to address this problem.

A participant remarked that valid reasons exist for restricting access to data. It was noted that
one goal of caBIG™ is to facilitate data sharing to the greatest extent possible and a
complementary goal is to gain consensus in the community about what data really needs to be
in the yellow and orange lanes versus what is perceived to belong there. It was acknowledged
that some people use perceived regulatory barriers as ways to avoid sharing data and a
dialogue needs to be had in the research community to address sensitive issues such as this.

A participant was concerned about the potential for a data set to be misinterpreted because of
the recipient’s lack of familiarity with the data. The need to specifically identify and address
this concern was noted.

Suggested Next Steps:

   1. Develop model data use agreements that will address dynamic data sets
   2. Need to clarify and provide examples regarding what kind of data would appropriately
      be in the “yellow” versus “orange” lane
   3. Identify barriers, real and perceived, to sharing data
   4. Address concern that others may misinterpret a data set and discuss how PIs may
      reserve the right to “explain” their data to others

UPDATE FROM THE NCI-CAGRID SECURITY WORKING GROUP (SWG)

Frank Manion, M.S., Chief Technology Officer and Senior Director, Information Science and
Technology, Fox Chase Cancer Center, and Bill Weems, Ph.D., Assistant Vice President,
Academic Technology, Associate Dean of Information Technology, University of Texas Medical
School, summarized the work accomplished by the SWG since the May DSIC F2F and presented
the major issues to be addressed by the SWG in the coming months.

Frank and Bill noted that the basic technical infrastructure (caGrid GAARDS infrastructure) is
in place and that the SWG has decided to leverage the extensive OMB/NIST e-authentication


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federated infrastructure. The SWG has developed a Level 1 Host Agreement as well as OMB
LOA1 and LOA2 Certificate Practice Statements. Among the key tasks on the SWG short term
agenda are to:
    Describe a governance model that creates and manages policies, procedures and
       administers caBIG™ federated activities and systems
    Operationalize minimum risk level data security policies and procedures and to proceed
       with plans to provide interested parties with OMB LOA1 credentials
    Map security policy project recommendations to SWG agenda to ensure all are
       considered and addressed
    Develop policies and procedures for low to medium sensitivity data regarding
       authentication/identify management issues and authorization/privilege management
       issues
    Determine a privilege management infrastructure for authorization including study and
       definition of required workflows.

Frank and Bill also provided an overview of the current SWG working sub-groups and their
respective activities. The considerations and drivers underlying security issues were also
elaborated upon.

Bill then gave an overview of identify management issues and how to authenticate an
individuals identity. Bill discussed the federal e-authentication initiative and gave an overview
of the requirements of the various levels of assurance. He also discussed the GAARDS Security
Infrastructure and the inter-federation project between NIH and the University of Texas
Identify Management (IdM) Federation, which are working together to develop an inter-
federation agreement at LOA2.

A participant asked if there will be global caBIG™ policies and procedures surrounding
instances when data is breached or inappropriately disclosed and, if so, what type of liability
will the person who inappropriately disclosed or used the data potentially face. Currently there
is no caBIG™ policy surrounding data breaches or misuse of data but due to the wide variation
among state standards, the SWG may explore developing overarching best practices. The
questioner was also referred to HHS standards and NIST guidance.

Suggested Next Steps

   1. Develop inter-federation agreement at LOA2
   2. Develop/explore possibility of developing caBIG™ policies or procedures for response
      to data breach and misuse of data

EFFORTS TO STANDARDIZE AND SIMPLIFY THE INFORMED CONSENT PROCESS

Moderated by Rachel Nosowsky, the purpose of this session was three-fold: (i) to identify and
discuss major impediments to data sharing impacted by informed consent forms and processes;
(ii) to educate DSIC Workspace members about various efforts underway nationally, with focus
on the patient perspective; and (iii) roll out prototype “living” documents for use by researchers
using the caBIG infrastructure.



                                                4
Sarah Greene, M.P.H., Research Associate, Group Health Center for Health Studies, gave a
presentation on the PRISM Toolkit, a strategy for improving consent form readability and also
gave an overview on health literacy and its role in the informed consent process. The PRISM
Toolkit focuses on improving the readability of documents, with an emphasis on a
conversational writing style, short simple sentences and paragraphs, and organization and
presentation based on the needs of the reader.

Deborah Collyar, Patient Advocates in Research, and Mary Lou Smith, J.D., M.B.A., Research
Advocacy Network, gave a presentation on simplifying the informed consent process from the
patient/participant perspective. They stressed the importance of recognizing participant
expectations and operating in a culture of transparency and ongoing communication.

Lynn Dressler, Dr. P.H., Assistant Professor, Division of Pharmaceutical Outcomes, and Policy
Associate Director for Policy and Ethics, Institute of Pharmacogenomics and Individualized
Therapy, University of North Carolina School of Pharmacy, discussed issues surrounding the
sharing of genomic data and informed consent. Lynn spoke of how the issue of data sharing
should be addressed in the informed consent document, and explored the challenge of
addressing interests and meeting expectations of various stakeholders while conducting
research within a responsible and ethical framework.

A participant commented on the lack of incentive that IRBs at smaller institutions with limited
staff and resources have to simplify informed consent documents and the overall process.
Another participant pointed out the importance of recognizing the difference between legal and
ethical requirements.

Suggested Next Steps:

   1. Identify how to standardize the language of patient/research participant “choices”
      informed consent documents and how to ensure that informed consent and HIPAA
      regulatory requirements are reflected in these “choices”
   2. Identify how the goal and the meaning of data sharing can best be communicated in an
      informed consent document, including the benefits and potential risks


UPDATE ON CABIG™ ENTERPRISE SUPPORT NETWORK (ESN)

Leslie Derr, Ph.D., Director of Community Alliances and Support, NCI Center for Biomedical
Informatics and Information Technology (CBIIT), presented on the structure of the ESN and the
expected role of the DSIC Workspace. Leslie articulated the purposes of the ESN, which are to
facilitate the widespread adoption of caBIG™ standards, tools and infrastructure and to expand
the support structure for end users beyond the Workspaces, caBIG™ Program Staff and NCI
CBIIT. Leslie identified and explained the components of the ESN – the caBIG™ Knowledge
Centers, the caBIG™ Service Providers, and the caBIG™ Program Offices – and the caBIG
program management requirements and expectations related to each component.




                                               5
Leslie also highlighted the Pilot Enterprise Adopter (EA) Program, which is a short term
program to assist IT administrators and application end users in integrating caBIG™ tools and
infrastructure in support of their research efforts.

Participants raised questions regarding the timeframe associated with the launch of the ESN
and the level of support that would be available throughout the effort. Participants also raised
questions about the selection and training of service providers. It was noted that the RFPs will
be released soon and it will take a few months to launch the knowledge centers . Also, Leslie
clarified that service providers are expected to bring their own expertise to the program, and
noted that cross institutional efforts are encouraged.

Suggested Next Steps:

   1. Keep Workspace participants abreast of ESN developments


QUESTIONS FROM REPRESENTATIVES OF “GETTING CONNECTED” CENTERS AND NCCCP
CENTERS

The purpose of this session was to address the questions/comments of newcomers to the
caBIG™ DSIC Workspace.

In regards to a model informed consent document, a participant suggested a summary of salient
information for decision making as a preamble of sorts for the actual regulatory consent form.
Another participant queried the consequences of and obligations stemming from the
aggregation of data. Specifically, if the findings that come out of a study identify risk to a
particular participant, is there any kind of obligation to inform said patient about this risk? The
response noted that the appropriate action is dependent on the policies and procedures
implemented by the researchers and/or institution involved in the study.

                              Day 2: Wednesday, January 23, 2008

KEYNOTE ADDRESS
Ken Buetow, Ph.D., NCI Associate Director for Biomedical Informatics and Information
Technology; Director, NCI CBIIT

Dr. Buetow presented the caBIG™ program management’s perspective on achievements and
vision for the program in Enterprise Year 2 and beyond and updated the charge to the DSIC
Workspace in the coming year. He articulated the mission and goals of caBIG™ and provided
an overview of the caBIG™ Pilot Phase activities and accomplishments. Dr. Buetow identified
immediate priorities of the caBIG™ program, including deploying caBIG™ throughout the
NCI-designated cancer center community and reaching out to the broader NCI family to bring
them into the caBIG™ framework. He described the stages involved in “Getting Connected
with caBIG™” and provided an overview of the caBIG™ Bundles. Dr. Buetow also highlighted
various NCI initiatives, including the NCI Community Cancer Centers Program, and provided
an overview of the FDA Amendments Act.




                                                6
Dr. Buetow spoke to the future of caBIG™ as we continue in the Enterprise Phase. The vision
for 2010 is to have all comprehensive community cancer centers connected and sharing data, to
have all multi-center clinical cancer trials connected electronically to each other and to the FDA
for reporting, and for institutions to be collaborating and publishing studies with data they are
sharing through caBIG™. The DSIC Workspace’s charge continues to be disambiguating social,
legal and technology issues pertaining to data sharing.

Suggested Next Steps:

   1. Develop “adopt/adapt” versions for negotiating transactions involving the generation
      and transfer of sensitive information
   2. Articulate a clear set of rules/expectations as to when different kinds of data can be
      shared and rebut traditional arguments for not sharing
   3. Resolve researcher issues surrounding data sharing
   4. Contribute actively in demonstration projects that establish the validity of using the
      caBIG™ infrastructure in researching, developing and resolving ethical, legal and social
      issues


UPDATE FROM THE OTHER CABIG™ WORKSPACES:
What are the agendas of the other caBIG™ Workspaces in the coming year? How can the DSIC
Workspace support the needs of the other caBIG™ Workspaces?

       Clinical Trials Management Systems (CTMS) Workspace Update

John Speakman, Associate Director, Clinical Trials Products and Programs, NCI CBIIT,
provided the CTMS Workspace update. John highlighted the Clinical Trial Lifecycle Process
Architecture Framework as it now exists and identified priorities for 2008. John also gave an
overview of the tools in the caBIG™ Clinical Trials Suite.

In terms of how the DSIC Workspace can support the needs of the CTMS Workspace, John
identified the following opportunities:

      FDAAA - guidance regarding requirements for reporting outcomes and adverse events
      caXchange – strategies for getting lab data from the clinical side, including best practices
       for sheparding data through an IRB
      Credentialing and authentication
      Creating a “map” of the contract landscape (how widespread, how varied, how much
       sponsor trial data is retained by centers) and perhaps develop a canon of “successful
       language”
      Investigate restrictive data use contracts signed with pharmaceutical company sponsors
      Assist CTMS in identifying what can be proactively and retroactively done to free up
       information
      Map the investigator mindscape regarding data sharing and see if there is room for
       consensus
      Identify whether there is a need for a post publication embargo period
      Assemble pro-sharing talking points


                                                7
       Tissue Banks and Pathology Tools (TBPT) Workspace Update

Ian Fore, D. Phil., Associate Director, Biorepository and Pathology Informatics, NCI CBIIT,
provided the TBPT Workspace update. Ian articulated the TBPT agenda for Enterprise Year 2
and highlighted planned activities of the NCI Office of Biorepositories and Biospecimen
Research (OBBR) for FY 08.

In terms of how the DSIC Workspace can support the needs of the TBPT Workspace, Ian
identified the following opportunities:

      Lead IRBs through the “issues”
      Facilitate information sharing between IRBs
      Educate domain Workspaces and help to understand the “real” issues and dispel myths
      Data sharing – establish models for incentives for sharing and engage in debate in key
       scientific forums
      Do the cost-benefit analysis
      Research data sharing best practices from other industries, such as banking and
       insurance


       Integrative Cancer Research (ICR) Workspace Update

Elaine Freund, Ph.D., ICR Workspace Coordinator, Booz Allen Hamilton/3rd Millennium
provided the ICR Workspace update. Elaine outlined proposed Enterprise Year 2 ICR activities
and outlined the components of participation and implementation.

In terms of how the DSIC Workspace can support the needs of the ICR Workspace, Elaine
identified the following opportunities:

      Define use case
      Specifications and requirements (permissioning/security functional requirements)
      Coding/testing/technical implementation
      Focus on interoperability
      Lessons learned (gather feedback on data sharing issues and concerns)

       In Vivo Imaging (IMAG) Workspace Update

Eliot Siegel, M.D., IMAG Workspace Facilitator, Professor and Vice Chairman, Department of
Diagnostic Radiology, University of Maryland Medical Center provided the IMAG Workspace
update. Eliot highlighted the goals of the IMAG Workspace and gave an overview of the IMAG
Workspace “products”.

In terms of how the DSIC Workspace can support the needs of the IMAG Workspace, Eliot
identified the following opportunities:

      Assist in facilitating the culture of sharing information


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      Obtaining IRB approval for adoption of caBIG tools developed through the IMAG WS
      Assessing local IT policies for security/privacy including HIPAA challenges

       Vocabulary and Common Data Elements (VCDE)/Architecture (ARCH) Workspace
       Update

Mike Keller, Ph.D., ARCH Workspace Coordinator, Booz Allen Hamilton, provided the VCDE
and ARCH Workspace updates. Mike first gave an overview of the ARCH and VCDE
Workspaces roles and responsibilities. He then addressed the evolution of the ARCH and
VCDE Workspaces in the context of the expanding caBIG™ community and the resulting
impact on technology. Mike then articulated the ARCH and VCDE Workspace goals and
highlighted the ongoing collaboration of DSIC with ARCH and VCDE via the Security Working
Group (SWG), which is tasked with creating and implementing security policies to enable data
sharing across caBIG™ using the NCI-caGrid.

       Documentation & Training (D&T) Workspace Update

Jenny Tucker, D&T Workspace Coordinator, Booz Allen Hamilton/Otto Kroeger Associates,
provided the D&T Workspace update. Jenny first articulated the D&T Workspace mission,
which is to support the creation and dissemination of documentation and training materials for
caBIG™ projects and general training opportunities and resources. She then highlighted a D&T
product, the caBIG™ Essentials Self-Paced Training.

In terms of how the D&T Workspace can support the needs of the DSIC Workspace, Jenny
identified the following opportunities:

      Providing guidance and expertise about how and which DSIC products might benefit
       from training support tools
      Supporting training needs related to the DSSF – including education related to the
       green, yellow, and orange pathways
      Continuing to support the translation of “lessons learned” from past projects and
       community experiences into actionable guides and strategies for the future
      Collaborating with DSIC to identify emerging needs


ROUNDTABLE: ADDRESSING THE PROPRIETARY AND CONTRACTUAL RESTRICTIONS ON
CABIG™-ENABLED DATA SHARING

       Framing the Issues

The session began with a “Framing the Issues” presentation by Elaine Brock, J.D., Senior
Associate Director, Division of Research Development Administration, University of Michigan.
Elaine briefly summarized the current proprietary, legal, and policy regime related to data
sharing and the work of DSIC to date. She discussed current restrictions on data sharing and
articulated incentives to sharing data.




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       Session 1 – Experiences in the Field:
       Perspectives of caBIG™ adopters, academic researchers and participants in the discovery and
       development process for drugs, devices, and diagnostics

The purpose of this session was to articulate actual and perceived challenges that caBIG™
adopters and end users are likely to encounter in using the caBIG™ infrastructure to share
research data and specify requirements for support. The DSIC Workspace Patient Advocates,
Mary Lou Smith and Deborah Collyar, moderated the session. Panel members and audience
participants were posed a series of questions in order to stimulate discussion surrounding
proprietary and contractual restrictions on data sharing.

Participants were asked to articulate interests in and benefits of data sharing from a patient’s
perspective. Benefits included the facilitation of information exchange regarding drug toxicity
and the increased accessibility to research information beyond the geographic location of an
academic medical center (AMC). The participants also noted that if patients are well informed
they will be able to have more satisfying dialogue with their providers regarding their
treatment.

Participants were then asked to articulate the pros and cons to sharing data. Some of the pros
mentioned were that extensive data collection will facilitate effective evaluation of data and the
recognition that the core competencies required for drug development do not all reside in one
institution. Regarding cons to data sharing, participants identified IP concerns and the struggle
to balance open data sharing with the need to preserve institutional investments. Also
mentioned was industry fear of losing competitive advantage and researcher’s fear of getting
scooped by others using data generated by such researcher.

Participants were next asked for ideas on how to incentivize institutions to “give up” data
rights and further, how to encourage companies to stop imposing “gag orders” on data sharing.
Respondents identified funding as a pivotal issue and noted the importance of staying
competitive in a research environment. Also, the pressing need for academic institutions to
compete on an intellectual basis does not promote timely data sharing. Further, there is a
disparity between the public image projected by individual industry participants and their
actual practices, as reflected in the terms of clinical trial agreements they seek to impose in
relationships with AMCs.

Participants were asked to identify what data are really proprietary. Most respondents
characterized the value of the data in terms of the level of human effort it took to produce.

       Session II - Reactors’ Panel:
       Discussion and Consolidation of themes heard during Session I

The purpose of this session was to convey broad expert perspectives on approaching the issues
presented during Session I, propose pathways to solutions, both short and long term, identify
new activities for the DSIC Workspace, and to establish a logical sequence and timeline for next
steps coming out of this session.




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Melissa Markey, J.D., Hall, Render, Killian, Heath & Lyman, P.C. moderated this session and
opened with a presentation on the changing landscape of medical research and the need to seek
new paradigms. Melissa outlined the current paradigm in which data is an asset which must be
protected, academic advancement is based on “publish or perish,” and commercial
viability/success is based on identifying drugs, devices and other healthcare products that are
derived from research results. In the current paradigm, the greater social good is accomplished
through protecting the intellectual property (IP) value of research results, and limited disclosure
of research results best protects the IP value. In the new paradigm:

      Data is a public utility
      Greater social good results from data sharing
      Non-identifiable data should be freely shared for the “right” purposes
      Personalized medicine and future healthcare solutions will require access and
       management of large amounts of data

In preparation for the Reactor’s Panel, a summary of the major issues from Session I was
provided. Major issues included:
    1. Timing issues surrounding publication
    2. Identifying situations in which data sharing should be restricted
    3. Economic concerns of pharmaceutical industry
    4. Academic Medical Centers confronting difficult issues regarding sharing

Participants were asked to comment on potential ways to incentivize data collection and data
sharing by research participants, researchers, funders, and archivists. A panel member
suggested that a way to incentivize academics to share data would be to tie grant support to
mandatory data sharing. Participants acknowledge that one must remain cognizant of the
source of the data as this will often determine the rules that apply in terms of sharing
information, and noted that the rules in the public versus the private sector are very different in
this respect. Also, participants recognized that the decision to share or not to share is a function
of the “levers” that are applied. These levers take many forms including, but not limited to,
brute force, competition, peer pressure, the desire to “do good”, and public opinion.

The participants were then asked to speculate on what institutions and beliefs must change to
accommodate the new paradigm. A participant stated that the tenure system is outdated and
proposed that researchers should be forced to submit research proposals and questions they are
working on to act as a “check” on their activities. Another participant expressed frustration
with how IRBs are very conscious about approving studies that may cause adverse events but
often put very little thought into the resulting delay and its effect on research.

Participants were asked to comment on what sorts of regulatory or legislative changes are
necessary to accommodate the new paradigm. Participants identified inconsistency among
policies as a major constraint and expressed the need for regulatory initiatives to be aligned so
that we do not end up with conflicting goals and regulatory schemes.

Participants were also asked to identify experiences from other disciplines and industries that
can be leveraged. Many agreed that lessons can be learned from the financial industry and



                                                11
noted that banks seem to routinely exchange very sensitive information without catastrophic
results.

Participants were asked what other solutions, tools, and initiatives can promote the changes
identified. Open source technologies, citation systems to quantify sharing, building tools for
patient communication, employing an escrow agent for data, and explicitly articulating
associated risk were all discussed in response to this query.

Participants were asked how divergent interests can be aligned in the new paradigm. One
comment addressed the need to foster trust among providers, patients, and researchers and
noted that tissue collection is particularly distrusted because there is no gold standard for
collection and preservation.

Suggested Next Steps:

   1. Identify incentives that can potentially be integrated into funding agreements to
      encourage collaboration
   2. Articulate what pre-competitive data really means
   3. Form workgroup to discuss motivations of various stakeholders in response to need to
      accurately assess and measure incentives of various parties
          a. Disincentives should also be discussed in this forum
          b. Need to address the unintended consequences of putting data on the internet
   4. Assess current regulatory and legislative scheme and identify where there could be
      further alignment and consistency
   5. Develop guidance/best practices that aim to reduce barriers regarding data sharing
   6. Eliminate smokescreens and develop guidance to facilitate understanding from multiple
      perspectives (i.e. patients, researchers, IRB members)
   7. Formalize data evaluation process and develop guidance for what kind of data should
      go in the green/yellow/orange lanes

RECALIBRATING THE DSIC WORKPLAN

The purpose of this session was to update the DSIC Workplan and agree on an implementation
process.

Over the next 12 months, the DSIC Workspace will:

   1. Continue work on building out the DSSF
   2. Reach out to other members of the community to work on incentive issues with respect
      to AMCs, sponsors, and beyond our community of stakeholders
   3. Increase focus on proprietary and contractual issues
   4. Publish peer reviewed articles
   5. Organize focused discussion groups and come up with a set of recommendations to
      circulate to larger Workspace meeting and eventually socialize to larger communities
          a. Need to further explore what it means to “tag data” and operationalize ideas
   6. Work together to develop systems that would facilitate data sharing in orange lane




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7. Work on developing best practices regarding what it means to share in the respective
   lanes




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