STRATEGIC OPPORTUNITIES FUND
Program Guidelines
Published Version 2.6. June 8, 2012
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STRATEGIC OPPORTUNITIES FUND
Program Guidelines
Contents
Introduction and Background .............................................................................. 3 Genome British Columbia ................................................................................ 3 Applying Genome Sciences and Technology to the Future of British Columbia ................. 3 Strategic Opportunities Fund (SOF) .................................................................... 3 Eligibility ................................................................................................... 4 Submission and Review Process ........................................................................... 5 Applications ................................................................................................ 5 Application Submission ................................................................................ 5 Application Review ..................................................................................... 5 Outcome of Application Review...................................................................... 6 Administration Following Notice of Funding ............................................................. 7 Genome British Columbia Contact ........................................................................ 7 Appendix 1. Evaluation Criteria and Guidelines ....................................................... 8 Outcomes ................................................................................................... 8 Research Excellence Based in Genomics or Related Life Science, Social Science or
Humanities Disciplines ................................................................................... 8 Investigator Expertise and Commitment .............................................................. 9 Management and Financial Feasibility, including Co-Funding ..................................... 9 Appendix 2. Financial Guidelines ........................................................................ 11 Eligible Costs .............................................................................................. 11 Co-Funding ................................................................................................ 12 Eligible Co-Funding.................................................................................... 12 Appendix 3. Administration Following Notice of Funding ........................................... 14 Conditions for Release of Genome BC Funds ........................................................ 14 Project Readiness ........................................................................................ 14 Management of Funding ................................................................................. 14 Accountability and Reporting .......................................................................... 15 Final Reports .............................................................................................. 15 Appendix 4. Genome BC’s Data Protection & Release Guidelines ................................. 16 Published Version 2.6. June 8, 2012
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INTRODUCTION AND BACKGROUND
Genome British Columbia
Genome British Columbia (Genome BC) is a catalyst for the life sciences cluster on Canada’s
West Coast, and manages a cumulative portfolio of over $550M in technology platforms and
research projects. Working with governments, academia and industry across sectors such as
forestry, fisheries, agriculture, environment, bioenergy, mining and human health, the goal of
the organization is to generate social and economic benefits for British Columbia and Canada.
Please view www.genomebc.ca for more information.
Applying Genome Sciences and Technology to the Future of British Columbia
The genome sciences 1 hold great potential to address many of the critical challenges facing
British Columbians today, from the health of our environment and citizens to the growth of
our economy. Genome BC has established several ‘Applied Genomics’ initiatives 2 of strategic
importance to the province to expand our existing capabilities in translating discovery science
to everyday life.
Genome BC continues to work towards expanding the scope of the genome sciences in BC’s
life sciences sectors and understanding its implications for society. The main thrust of
existing and recently introduced initiatives is to facilitate the translation of discovery
knowledge into practice. However, Genome BC also recognizes the need for a source of
modest, one-time funding to facilitate the early development of unique, strategic
opportunities based in genomics and related life science, social science or humanities
disciplines. This initiative is driven by the office of the Chief Scientific Officer (CSO) and has
a mandate to catalyze or seed new programs and initiatives for discovery or applied research,
infrastructure, pre- and seed-stage commercialization or applied social science and
humanities research related to genomics that could then be supported through other Genome
BC programs and other funding mechanisms. Proposed research in the area(s) of applied social
sciences and humanities will identify projected outcomes that have the potential to support
the development of genomics research and/or the associated practices.
Note that Genome BC expects a return on its investment, such as access to residuals and
rights arising from commercialization of the research. Genome BC will negotiate and agree to
such rights with each lead organization.
Strategic Opportunities Fund (SOF)
Genome BC initially launched the Strategic Opportunities Fund (SOF) as part of its previous
Strategic Plan (2005-2010). The program, with funding provided by the government of BC and
others, aims to catalyze or seed new projects and initiatives of strategic importance to BC’s
life sciences sectors.
1
Genome sciences contribute towards the understanding of biological systems at a molecular level and collectively
includes genomics (the study of the complete genome of an organism, i.e. all hereditary information encoded in
the DNA), proteomics (the study of the full or partial set of proteins encoded by a genome), metabolomics (the
study of the metabolite pools of an organism) and related areas of research.
2
These include the Applied Genomics Consortium Program, the Applied Genomics Innovation Program, the
Translational Program for Applied Health, and the Proof-of-Concept Program.
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The SOF program’s goals include:
• Increasing access for BC researchers to emerging genomic and life sciencetechnologies being developed nationally or internationally, in order to maintain their
competitiveness;
• Fostering partnerships with national and international stakeholders in genomics;
• Engaging social scientists and humanists in research that contributes to developments
in genomics and related knowledge translation practices and applications; and,
• Facilitating new and innovative means of interactions with industry or other users of
genomics, related life sciences, or applied social science or humanities disciplines.
Some example areas of possible funding include: cutting edge and potentially non-mainstream
genomics or related life science research, training 3 and social science and humanities
research applicable to genomics.
The SOF program fills a much-needed funding gap with up to three intakes planned over
approximately three years and an investment of $6M, half of which is provided by Genome
BC. The remaining funds are to be provided on a 1:1 co-funding basis through sources
identified by the applicants; however, Genome BC is prepared to work with interested
applicants to identify potential sources of co-funding. The program is expected to support
modest endeavors typically in the range of $25,000-$200,000. Genome BC will provide no
more than $200,000 one-time funding per project.
Where possible, projects will use existing BC facilities, including Science and Technology
Innovation Centres (STICs), as the SOF program will not assist in the building of new physical
capacity; however, Genome BC does not require funded projects to use Genome BC funded
STICs or other BC service providers.
Work on previously collected samples and data is encouraged. Applicants proposing analysis of
samples that are subject to seasonal availability should have access to existing samples or a
plan to complete sample collection very early in the project.
Given the limited number of projects that can be funded, and the expectation that a large
number of applications will be received, only the most competitive applications will be
funded. Genome BC will fund up to 50% of approved eligible costs of a project. Funds will be
provided for up to eighteen (18) months (although it is expected that many successful
projects will finish sooner) and must be co-funded by other sources. Genome BC funding can
only be used by eligible researchers working in BC. However, national and international
collaborations are strongly encouraged.
Eligibility
The SOF is open to researchers based at one of BC’s universities or affiliated hospitals,
colleges, the BC Institute of Technology, or other BC-based research institutions, including
government laboratories. Researchers working in government laboratories must collaborate
with researchers affiliated with a BC-based academic research institution. New investigators
and researchers who study life sciences areas beyond human health are encouraged to apply.
3
Training is intended for a specialized course/capability. The program is not intended to fund undergraduate,
graduate or postgraduate programs or student fellowships.
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SUBMISSION AND REVIEW PROCESS
There will be a single-stage application submission process for each round of the SOF
program. Potential applicants are encouraged to contact Genome BC at [email protected] at
their earliest opportunity with any technical questions or clarifications. Further information
and resources are available on the Genome BC website (www.genomebc.ca).
All applications must include a commitment for at least 75% of their required co-funding with
supporting documentation. If a project is selected for funding by Genome BC, 100%
of the co-funding must be secured prior to commencement of the project.
Applications
Application Submission
Instructions for submitting your application are available in the Strategic Opportunities Fund –
Application Form, which is available on the Genome BC website (www.genomebc.ca) and
must be used. Detailed explanations of each application section are included with the form.
Applications must address the evaluation criteria described in Appendix 1 to this document.
The program will accept applications in up to three intakes over an approximate three year
period from 2012 to 2015. The application and appendices must be sent to Genome BC as a
single electronic file in PDF format. Refer to the Genome BC website (www.genomebc.ca) or
contact [email protected] for submission details. Genome BC must receive one hard copy of
the original signature pages of the application at the address below within five (5) business
days of the submission deadline:
Strategic Opportunities Fund
Genome BC
Suite 500, 555 West 8th Avenue
Vancouver, BC V5Z 1C6
[email protected]
Upon receipt, applications will be reviewed for completeness by Genome BC. Incomplete
applications and those not conforming to the form will not be reviewed further. Additional
pages beyond the maximum page limit will be destroyed by Genome BC prior to further
processing. In addition, late applications will not be accepted.
Application Review
The applications will be reviewed for strategic research excellence based in genomics,
related life science research, or applied social science or humanities research, involvement
and expertise of the investigators, anticipated outcomes and financial and managerial
feasibility, in a combined peer review/due diligence process. The review team will be
interdisciplinary, consisting of scientific, industrial, financial, social science and/or
humanities and management experts as appropriate. At the time of submission, applicants
are provided with the opportunity to identify those experts who are not appropriate reviewers
for their projects. Reviewers will sign non-disclosure agreements and will have to declare all
potential conflicts of interest. They will evaluate each application taking into consideration
the three major evaluation criteria presented below.
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Following review of the applications, Genome BC, in consultation with the reviewers, reserves
the right to request a face-to-face meeting with an applicant team to discuss the proposed
project.
Evaluation Criteria
To ensure that Genome BC’s SOF goals are met and that the proposed research is novel,
reviewers will be asked to address, consider and score applications on each of the following
three major criteria, which are regarded as equally important:
• Potential to achieve outcomes of strategic importance to BC’s life sciences sectors;
• Research excellence based in genomics or related life science, social science or
humanities disciplines, including investigator expertise and commitment; and
• Feasibility of plans for project schedule, management and financing, including cofunding.
In addition, the management plan and financial feasibility, including co-funding, of projects
will be assessed to ensure they meet Genome BC eligibility requirements. Reviewers will be
asked to interpret the evaluation criteria (especially managerial and financial) at a level
appropriate to the size of the project.
A description of each criterion can be found in Appendix 1 to this document. Financial
Guidelines are described in Appendix 2 to this document.
Each criterion will be reviewed individually, although all reviewers will not necessarily be
asked to review each criterion. Selection of reviewers will be dependent on their expertise in
the category and the subject matter of the application.
Outcome of Application Review
The reviewers will offer recommendations and advice for the applications as well as project
scores to Genome BC. Genome BC will announce funding decisions within three (3) months
from the posted date for submission of applications. Following the full review process, all
applicants, whether recommended for funding or not, will be provided with the decision of
Genome BC and a written evaluation of their application. While the decision of Genome BC
regarding any project for a given review period is final and appeals will not be considered,
applicants are eligible to reapply if they can substantively address the concerns of the
review panel. Further, applicants who are not funded on a given project are not precluded
from submitting future projects to the program.
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ADMINISTRATION FOLLOWING NOTICE OF FUNDING
The plan for disbursement of approved funds will be determined based on the specific needs
of the project and will include a holdback from the approved budget until a final report is
submitted by the project team, the final report is approved by Genome BC, and a final faceto-face meeting is held between the project’s representatives and Genome BC. The first
disbursement of the approved funds will flow to projects once they have met all of the
conditions for the release of funds (see Appendix 3 to this document). Genome BC reserves
the right to withdraw its funding for any approved project that is not ready to receive
funding within six (6) months from the Notice of Funding or that has not complied with the
conditions for the release of funds. The latter includes the requirement that 100% of cofunding be in place. The program targets a project start date within three (3) months of the
notice of funding.
Funded projects will be required to provide Genome BC with research and financial reports,
including co-funding, outlining project progress relative to approved milestones, issues and
delays, and project expenditures relative to the approved budget. The timeframe for
reporting will be determined based on the approved work plan of projects. Guidelines for
these reports will be provided prior to the release of funds. A review process will also be
established whereby project progress will be assessed by Genome BC. Genome BC reserves
the right to reduce, suspend, or discontinue funding for those projects that fail to provide
reports or address major issues identified at the time of project review.
Within ninety (90) days of completion, each project will be required to submit to Genome BC
a final report that describes, at a minimum, the accomplishments of the project, together
with a final financial report that reconciles actual expenditures, including co-funding, with
amounts budgeted and received, the current status of outcomes developed as a result of
Genome BC funding, a description of the utility and/or relevance of the findings to the
respective field of investigation, and a plan that outlines the activities that are to be
undertaken to further develop the project.
GENOME BRITISH COLUMBIA CONTACT
New Programs
(604) 637-4381
[email protected]
www.genomebc.ca
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APPENDIX 1. EVALUATION CRITERIA AND GUIDELINES
See the application form for a description of the required contents for each section.
Outcomes
1. Applicants must demonstrate, using specific and clearly defined and quantifiable
milestones and objectives, the proposed outcomes to be achieved through the project.
The project needs to demonstrate:
a. The project’s strategic impact to BC and how it will increase BC’s
competitiveness on the world stage.
b. The short term strategic outcomes from the proposed project (e.g. upon
completion).
c. The long term strategic outcomes that will arise following completion of the
project (e.g. 3-5 years).
d. Who will benefit from the proposed project and a description of the benefits.
e. How the project will better position the applicants for future opportunities and
describe what these opportunities might be, for example:
•
New opportunities to leverage new research funding
•
New scientific collaborations or networks, particularly at a national or
international level
•
New opportunities for follow-on research activities
•
New opportunities for interfacing with industry
Research Excellence Based in Genomics or Related Life Science, Social Science or
Humanities Disciplines
2. The project needs to demonstrate, if applicable:
a. If and how it is cutting edge research based in genomics or in a related area of
life science, social science or humanities.
b. A plan for handling the research data (data protection, release and
publication), if appropriate.
c. The possible link to new national, international and/or industrial/end user
collaborators.
d. That the research builds on existing BC strengths and expertise in genomics and
life science research or social science and humanities research rather than
being an infrastructure building project.
e. The quality of the research environment in which the work will be done.
f. Where appropriate, use of the STICs and/or other technology services chosen
to support the project and the effectiveness of the arrangements made with
STIC management or other service providers:
•
Use of Genome BC funded STICs is encouraged
(http://www.genomebc.ca/portfolio/projects/innovation-centres).
•
If the service providers to be used are not those administered by
Genome BC, applicants must include a justification for their choice of
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providers that demonstrates that the overall value of the service is at
least equivalent to similar services provided by Genome BC funded
STICs.
•
A Statement of Work (SOW) or letter from the service provider is
required, including a description of the service(s) to be provided, unit
costs, number of units required, personnel requirements, data analysis
requirements, timelines, etc.
g. If proposing analysis of samples that are subject to seasonal availability, access
to existing samples or a plan to complete sample collection very early in the
project.
3. Applicants must demonstrate that the proposed objectives, goals, milestones and
critical path are feasible and that the available resources are adequate to complete
the project on schedule. Milestones must be constructed so as to provide objective,
quantifiable measures of success and should be realistically attainable during the
proposed timeframe.
Investigator Expertise and Commitment
4. Applicants must demonstrate that the Project Leader, co-applicants, organizations and
other team members as applicable:
a. Are appropriately trained and have demonstrated leadership and research
excellence, particularly in this type of research initiative. This could include a
description of the training and/or track record of the applicant(s) for the
proposed research or the importance and originality of the recent work of the
applicant(s).
b. Have a serious commitment to the project in terms of dedicated time and the
amount of resources applied to it.
Management and Financial Feasibility, including Co-Funding
Management (as appropriate to the scale and type of application)
5. Applicants should provide the following:
a. A management plan for the project, including the administrative and
organizational management structure.
b. The communication plan for dissemination of results, including the way
research results will be made accessible, communicated and transferred to
project participants and the scientific community, without conflicting with
data protection (e.g. IP) policies.
c. The decision making plan for the project, including:
•
The mechanism for making go/no-go decisions
•
A Gantt chart of activities, linked to the proposed budget, with
milestones and go/no-go decision points clearly identified
•
The methods for addressing key challenges, roadblocks, lack of
consensus and scientific progress (e.g. adherence to milestones)
•
The individual ultimately responsible for the decisions
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6. Dependent on the scale and scope of the application, applicants may consider the
value of seeking external input from peers and experts and integrate the seeking
process into their decision making structure.
Financial (also see Appendix 2 - Financial Guidelines)
7. Include the budget for the project using the template provided by Genome BC. The
budget will be assessed on the basis of the following questions:
a. Is the project financing plan reasonable and feasible?
b. Do the budgeted costs comply with the Financial Guidelines (Appendix 2)?
c. Are the budgeted costs aligned with the proposed research plan and activities?
d. Is there a clear relationship between the costs and proposed benefits of the
project?
e. How effective are the financial and budgetary control processes?
f. Do the documentation and principal financial assumptions support the proposed
budget?
g. Does the co-funding plan fully comply with the eligible co-funding guidelines
(see Appendix 2)?
h. Is there a firm commitment for 75% of the co-funding (i.e. a signed letter from
an independent party confirming the dollar amount and timing of co-funding to
be provided)?
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APPENDIX 2. FINANCIAL GUIDELINES
Eligible Costs
Eligible costs are defined as reasonable, new and incremental costs for items that directly
support the objectives of the Genome BC approved project. No overhead costs will be paid
by Genome BC, nor can overhead be used as eligible co-funding. Budgets must NOT include
items for which funding has already been approved from other sources, unless the request for
funding was specifically made to support the Genome BC project and meets all other
eligibility criteria.
Eligible costs may include the following:
1. Salaries:
• Salaries and benefits for researchers, trainees, technicians and management
(e.g. project managers). Note that salaries of researchers or senior
management who are currently funded by their respective organizations are
not considered eligible costs
• The actual cost of release time from teaching or clinical work, if supported by
a letter from the host organization
• Payments to persons based outside BC, for example investigator’s salaries, are
not considered eligible costs for direct Genome BC funding although they can
be covered by co-funding. However, external costs that are incurred based on
a reasonable fee-for-service arrangement or contract are considered eligible
2. Reasonable and limited operating costs (i.e. day-to-day expenses incurred in
conducting the research) such as laboratory supplies (e.g. microtitre plates, pipette
tips), administrative supplies (e.g. paper, photocopying) and other consumables
3. Costs related to the general maintenance of research infrastructure to be used for
carrying out the proposed research
4. Costs for the project’s communications and public outreach activities, including costs
associated with ensuring open access to the findings (e.g. costs of publishing in an
open access journal or making a journal article open access)
5. Costs related to the development of the plan to realize benefits for BC, including
intellectual property evaluation costs, patent registration, filing, and maintenance
costs incurred during the term of the project, and costs associated with advancing the
development of products and technology toward the proof of concept stage
6. Cost of equipment, specimens, scientific collections, computer hardware or software,
information databases and communications linkages. The opportunity cost of using
existing infrastructure may not be included as an eligible cost
7. Reasonable and low administrative costs directly linked to undertaking the project.
Administrative costs must not exceed five percent (5%) of the non-administrative costs
of the project budget (calculated as total budget less administration costs)
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Co-Funding
Co-funding means the portion of eligible project costs not borne by Genome BC. For the SOF
program, Genome BC requires that at least 50% of the approved funding (co-funding) for eligible
project costs be obtained through funding from other sources.
Co-funding must be quantifiable and auditable.
The application must include details outlining a commitment for at least 75% of the co-funding
and supporting documentation. If a project is selected for funding by Genome BC, 100% of the cofunding must be secured prior to commencement of the project.
Eligible Co-Funding
1. Co-funding must be applied for on or after the date that is eighteen (18) months prior to
receipt of application to be eligible for costs specifically requested in the Genome BC
budget. Eligible expenses will only be recognized up to six (6) months prior to Genome BC’s
Notice of Funding.
2. Genome BC considers any of the following possible co-funding sources, which may be
Canadian or foreign, as acceptable:
a. Institutional funds, trust funds, or foundations
b. Departments and agencies of the federal government, including NSERC, SSHRC
and CIHR
c. Departments and agencies of provincial and municipal governments
d. Firms and corporations
e. Voluntary or charitable organizations
f. Individuals
g. Venture capital or other investment funds
3. All co-funding must be supported by appropriate documentation. This would include:
a. Written confirmation (e.g. a letter or a legal agreement) from the co-funding
source that commits the funds and provides detail of the amount and date of
funding, and acknowledgement of the use of these funds to co-fund the
Genome BC project.
b. For co-funding from a funding agency, a copy of the full application, project
summary, detailed budget and notice of funding (if applicable). Note that
documentation must clearly demonstrate that funding is being used for eligible
costs included in the budget of the Genome BC approved project. Written
confirmation from the funding agency that they acknowledge use of these
funds to co-fund the Genome BC project is also required.
c. Co-funding from an industry source:
o For smaller and privately held companies, a copy of a Board resolution
specifying the company’s level and terms of commitment
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o For larger companies, a letter from the Vice-President of Research or
someone with similar signing authority, specifying the company’s level
and terms of commitment
o Documentation provided to support the financial viability of the
company and its ability to fulfill its commitment to the project,
including recent financial statements accompanied by other
information, such cash flow projections, audited financial statements,
press releases announcing significant new funding, etc.
4. In-kind contributions 4 will be considered on a case-by-case basis. For all potential inkind contributions:
a. A clear rationale and calculation of how the value was determined is required,
supported by documentation (e.g. assumptions, price lists, quotes from
suppliers, letters supporting same, etc.)
b. Salaries must be readily auditable
c. The expenditure represents an item that would otherwise have to be acquired
with cash; however, this excludes the cost of pre-existing facilities or
equipment (i.e. budgets cannot include the opportunity cost of space or
equipment)
d. Supplier discounts, including arrangements in which a supplier/purchaser
relationship exists, are not acceptable sources of co-funding
e. The reviewers may determine that only a portion of proposed in-kind
contribution is eligible
5. The value of previously existing IP transferred to a project is not eligible co-funding
unless it is a contribution by a supplier of IP (e.g. software license that would
otherwise have to be acquired from a third party supplier). Such items must be
supported by appropriate documentation from the supplier’s head office.
4
Defined as non-cash eligible budget items which can be given a cash value.
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APPENDIX 3. ADMINISTRATION FOLLOWING NOTICE OF FUNDING
Conditions for Release of Genome BC Funds
The Terms and Conditions of Funding will be issued subsequent to project approval by
Genome BC. The following are the minimum requirements to allow for the disbursement of
Genome BC’s contributions:
1. Signed affiliation and/or collaborative research agreements between Genome BC, the
lead organizations (private, government, and academic), the researchers and the cofunders that establish the resolution of major areas and the roles and responsibilities
of each party, such as contributions, IP ownership and management, data protection
and release, a commercialization process, project management, the role of the
scientific advisory committee, funding term, termination policy, accountability and
reporting, progress reviews, management of funds, financial policies, etc. Note that
Genome BC expects a return on its investment, such as access to residuals and rights
arising from commercialization of the research. Genome BC will negotiate and agree
such rights with each host organization.
2. Approved budget and milestones and their compliance with funding eligibility criteria,
in accordance with the recommendations of the reviewers as approved by Genome BC.
3. Appropriate certification for research involving human subjects, human stem cells,
animals, biohazards, radioactive materials, or possible effects on the environment.
4. A clearly defined policy and plan for data protection, data release, sharing of
resources created by the project and publication of results.
5. 100% of the co-funding for eligible costs secured, with documentation as described in
Appendix 2 (Eligible Co-Funding, point 3).
Project Readiness
All applicants must demonstrate that they will be in a position to receive Genome BC funding
within six (6) months from the Notice of Funding. Genome BC reserves the right to withdraw
its funding for any approved project that is not ready to receive funding, or for which signed
agreements as described above, have not been secured, within six (6) months from the
announcement of funding results. The program targets a launch date within three (3) months
of the Notice of Funding.
Management of Funding
1. The plan for disbursement of approved funds will be determined based on the needs of
the project and may include a retainer of 10% of the approved budget until a final
report is submitted by the projects. The first disbursement of the approved funds will
flow to projects once they have met all of the conditions for the release of funds.
2. The financial status of co-funding must be reported to Genome BC on a predetermined
basis; an agreement to comply will be a condition of launch.
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Accountability and Reporting
All approved projects are required to maintain information necessary to enable Genome BC to
assess the ongoing performance of the projects and their activities. Genome BC will put in
place mechanisms to assess the ongoing performance of all funded projects in order to
determine from time to time whether funding should be continued, reduced, suspended, or
cancelled:
1. All funded projects will be required to provide Genome BC with scientific and financial
reports, including co-funding, outlining project progress, issues and delays and actual
results as compared to budget. The timeframe for reporting will be determined based
on the approved work plan of the project. Guidelines for these reports will be
provided prior to the release of funds. Genome BC reserves the right to reduce,
suspend, or discontinue funding for those projects that fail to provide reports or
address major issues identified at the time of project review.
2. A review process will also be established whereby project progress will be assessed by
Genome BC. This process may include peer review or other consultation to evaluate
the progress of the research and the progress toward ensuring the strategic benefits to
BC’s life science sectors are realized.
It is the responsibility of the investigators leading the projects to ensure that sufficient
records and supporting documentation are maintained and are available for review and audit
for a period of three years after the completion of the project.
Final Reports
Within ninety (90) days of the completion of the work, each project will be required to
submit to Genome BC a final report that describes, at a minimum, the accomplishments of
the project, a final financial report that reconciles actual expenditures (including co-funding)
with amounts budgeted and received, the current state of any outcome developed as a result
of Genome BC funding and a plan that outlines the activities that could be undertaken to
further develop the application within a two year time frame.
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APPENDIX 4. GENOME BC’S DATA PROTECTION & RELEASE GUIDELINES
Contents
Data Sharing ................................................................................................. 17 Goals of Data Sharing ...................................................................................... 17 Applicability of Genome BC Data Protection & Release Guidelines ................................ 17 Implementation ............................................................................................. 18 Timeliness of Data Sharing ................................................................................ 18 Human Subjects and Privacy Issues ...................................................................... 18 Proprietary Data ............................................................................................ 19 Methods for Data Sharing .................................................................................. 20 Resource Sharing ............................................................................................ 20 Data Documentation........................................................................................ 21 International Data Repositories .......................................................................... 21 Funds for Data Sharing ..................................................................................... 22 Definitions ................................................................................................... 23 Published Version 2.6. June 8, 2012
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Data Protection & Release Guidelines
DATA SHARING
It is the policy of Genome BC that data produced with its funds and support will be freely
shared and made widely available, thereby enabling the effortless stream of data within and
between fields. Data will be shared in a manner adhering to applicable laws, the policies of
other project funders and with full and proper attribution to the data provider. Genome BC
recognizes that in some instances the data will include proprietary information and/or knowhow which may be desirable to protect, in a reasonable period of time, prior to mandatory
public dissemination of the data.
GOALS OF DATA SHARING
Data sharing and data documentation allow scientists to facilitate the translation of research
results into knowledge, products, procedures and measurable outcomes related to Genome
BC’s contracts and initiatives.
There are many reasons to share data. Sharing data facilitates open scientific inquiry,
encourages diversity of analysis and opinion; promotes new research; makes possible the
testing of new or alternative hypotheses and methods of analysis; supports studies on data
collection methods and measurement; facilitates the education of new researchers; enables
the exploration of topics not envisioned by the initial investigators; permits the creation of
new datasets for new applications when data from multiple sources are combined; and
enables open inquiry about the impact of project activities.
In short, data sharing maximizes the value of each project’s outputs. Genome BC-funded
projects must follow the data release and resource sharing principles of a “community
resource project”, defined as a research project specifically devised and implemented to
create a set of data, reagents or other material whose primary utility will be as a resource for
the broad scientific community.
APPLICABILITY OF GENOME BC DATA PROTECTION & RELEASE GUIDELINES
The Genome BC Data Protection & Release Guidelines apply to:
• The sharing of research data for not-for-profit research and charitable purposes,
• Final research data, and the basic research, laboratory studies, field surveys, and other
types of research supported by Genome BC (Note: It is especially important to share
unique data that cannot be readily replicated), and
• Projects that transform or link pre-existing datasets (as opposed to producing new data).
(Note: If there are limitations associated with a data sharing agreement of the original
data that preclude subsequent sharing, then the principal investigator should explain this
in the project application.)
Genome BC also understands that data distribution regulations vary by country. Investigators
collecting data in non-Canadian countries should familiarize themselves with the policies and
laws governing data sharing in the country(s) in which they plan to work and address specific
limitations in their data-sharing strategy.
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Even if Genome BC support is sought to transform or link datasets (as opposed to producing a
new set of data), the investigator should still include a data-sharing agreement for the
original data that precludes subsequent sharing and the applicant should explain this in the
application.
IMPLEMENTATION
Given the variety of projects that Genome BC supports, neither the precise content for the
data documentation, nor the formatting, presentation, or transport mode for data is
stipulated. What works for one field or one study may not work for others.
However, principal investigators must plan for data sharing, and be aware of the current
state of data sharing activities and data-management best practices within their disciplines
and fields. This means the principal investigator is expected to participate in and contribute
to the creation of environments that support data sharing by seeking out relevant data
sharing activities and networking with others within their discipline. These activities address
areas such as:
•
•
•
•
•
relevant online data repositories (e.g., Genbank) and data federations,
procedures for data documentation,
data formatting and data exchange standards,
software (or online data services) that conform to data format and exchange standards,
procedures for quantifying the demand (use) for the data (i.e., number and rate of users
and records per data repository and/or data federation per year), and
• procedures for the data owner, or provider of the datasets, to receive feedback about the
quality of the data.
Familiarity with these subjects will allow the principal investigator to better estimate the
costs and benefits associated with their data sharing strategy and implementation plan.
TIMELINESS OF DATA SHARING
Recognizing that the value of data often depends on timeliness of access, data sharing should
occur in a timely fashion. Genome BC expects the timely release and sharing of data to be no
later than the acceptance for publication of the main findings from the final dataset. The
specific time will be influenced by the nature of the data collected. Data from small studies
can be analyzed and submitted for publication relatively quickly. If data from large
epidemiologic or longitudinal studies are collected over several discrete time periods or
waves, it is reasonable to expect that the data would be released in waves as data become
available or main findings from waves of the data are published. Genome BC recognizes that
the investigators who collected the data have a legitimate interest in benefiting from their
investment of time and effort. Genome BC continues to expect that the initial investigators
may benefit from first and continuing use but not necessarily from prolonged exclusive use.
HUMAN SUBJECTS AND PRIVACY ISSUES
The rights and privacy of human subjects who participate in Genome BC-sponsored research
must be protected at all times. It is the responsibility of the investigators, their Institutional
Review Board (IRB), and their institution to protect the rights of subjects, the consent terms
under which the data was first obtained and the confidentiality of the data. Prior to sharing,
data should be redacted to strip all identifiers, and effective strategies should be adopted to
minimize risks of unauthorized disclosure of personal identifiers. Stripping a dataset of items
that could identify individual participants is referred to by several different terms, such as
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"data redaction," "de-identification of data," and anonymizing data. In addition to removing
direct identifiers, e.g., name, address, telephone numbers, and social insurance numbers,
researchers should consider removing indirect identifiers and other information that could
lead to "deductive disclosure" of participants' identities. Deductive disclosure of individual
subjects becomes more likely when there are unusual characteristics of the joint occurrence
of several unusual variables. Samples drawn from small geographic areas, rare populations,
and linked datasets can present particular challenges to the protection of subjects' identities.
Also, if research participants are promised that their data will not be shared with other
researchers, the application should explain the reasons for such promises. Such promises
should not be made routinely and without adequate justification. For the most part, it is not
appropriate for the initial investigator to place limits on the research questions or methods
other investigators might pursue with the data. It is also not appropriate for the investigator
who produced the data to require co-authorship as a condition for sharing the data.
Investigators may use different methods to reduce the risk of subject identification. One
possible approach is to withhold some part of the data. Another approach is to statistically
alter the data in ways that will not compromise secondary analyses but will protect individual
subjects' identities. Alternatively, an investigator may restrict access to the data at a
controlled site, sometimes referred to as a data enclave. Some investigators may employ
hybrid methods, such as releasing a highly redacted dataset for general use but providing
access to more sensitive data with stricter controls through a data enclave.
Researchers who seek access to individual level data are typically required to enter into a
data-sharing agreement. Data-sharing agreements, which come by many terms, including
"license agreements," and "data distribution agreements," generally include requirements to
protect participants' privacy and data confidentiality. They may prohibit the recipient from
transferring the data to other users or require that the data be used for research purposes
only, among other provisions, and they may stipulate penalties for violations. For further
information on these alternative mechanisms to share data while protecting participant
confidentiality, see also the section concerning "Methods for Data Sharing." In most instances,
sharing and archiving of data is possible without compromising confidentiality and privacy
rights. The procedures adopted to share data while protecting privacy should be individually
tailored to the specific dataset.
Investigators seeking Genome BC support for clinical trials may wish to consider several
factors as they develop their data-sharing plan. Researchers who are planning clinical trials
and intend to share the resulting data should think carefully about the study design, the
informed consent documents, and the structure of the resulting dataset prior to the initiation
of the study. For example, many early phase clinical trials use small samples, which make it
difficult to protect the privacy of the participants. Furthermore, some study designs afford
greater privacy protection to subjects than others. For example, longitudinal research poses
challenges because the need to retain identifiers in order to link individual-specific data
collected at different time points.
Many research efforts supported by Genome BC do not include human subjects. Final research
datasets from studies that do not include human subjects generally should not be constrained
by the limitations deemed necessary and appropriate for human subjects.
PROPRIETARY DATA
Issues related to proprietary data also can arise with corresponding constraints on public
disclosure. Genome BC recognizes the need to protect patentable and other proprietary data.
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Any restrictions on data sharing due to a need for protection of arising data and ensuing
discoveries should be discussed in the data-sharing plan section of an application and will be
considered by program staff. While Genome BC understands that an institution's desire to
exercise its intellectual property rights may justify a need to delay disclosure of research
findings, a delay of thirty (30) to ninety (90) days is generally viewed as a reasonable period
for such activity, unless there are extenuating circumstances that are openly disclosed to and
agreed upon by all parties concerned.
METHODS FOR DATA SHARING
There are many ways to share data.
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•
•
•
•
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Publishing
Patents
Researcher’s publicly and freely accessible sources (e.g. website)
Data Archives (e.g. GenBank, EMBL, etc.)
Open Source Archives (sourceforge.net)
Depositing into Strain Collections (e.g. ATCC)
When making data available, researchers cannot place limits on questions posed, methods
used, nor require co-authorship as a condition for receiving data, although we recognize that
certain end users will have special needs.
There are several mechanisms for data sharing that investigators can use. For example,
investigators sharing under their own auspices should consider using a data-sharing
agreement to impose appropriate limitations on users. Such an agreement usually indicates
the criteria for data access, whether or not there are any conditions for research use, and can
incorporate privacy and confidentiality standards to ensure data security at the recipient site
and prohibit manipulation of data for the purposes of identifying subjects.
The method for sharing that an investigator selects is likely to depend on several factors,
including the sensitivity of the data, the size and complexity of the dataset, and the volume
of requests anticipated. Investigators sharing under their own auspices may simply mail a CD
with the data to the requestor, or post the data on their institutional or personal website.
Although not a condition for data access, some investigators sharing under their own auspices
may form collaborations with other investigators seeking their data in order to pursue
research of mutual interest. Others may simply share the data by transferring them to a data
archive facility to distribute more widely to interested users, to maintain associated
documentation, and to meet reporting requirements. Data archives can be particularly
attractive for investigators concerned about a large volume of requests, vetting frivolous or
inappropriate requests, or providing technical assistance for users seeking help with analyses.
Datasets that cannot be distributed to the general public, for example, because of participant
confidentiality concerns, third-party licensing or use agreements that prohibit redistribution,
or national security considerations, can be accessed through a data enclave. A data enclave
provides a controlled, secure environment in which eligible researchers can perform analyses
using restricted data resources.
RESOURCE SHARING
Projects funded by Genome BC must also address sharing of resources generated by projects
such as unique biological specimens and computer programs designed to analyze datasets.
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Biological reagents such as unique strains should be deposited into repositories such as ATCC
and computer programs designed to analyze large datasets should be made available to others
through the use of license agreements that adhere to “open source” principles (see for
example, http://www.opensource.org/).
DATA DOCUMENTATION
Regardless of the mechanism used to share data, each dataset will require documentation.
(Some fields refer to data documentation by other terms, such as metadata or codebooks.)
Proper documentation is needed to ensure that others can use the dataset and to prevent
misuse, misinterpretation, and confusion. Documentation provides information about the
methodology and procedures used to collect the data, details about codes, definitions of
variables, variable field locations, frequencies, and the like. The precise content of
documentation will vary by scientific area, study design, the type of data collected, and
characteristics of the dataset.
It is appropriate for scientific authors to acknowledge the source of data upon which their
manuscript is based. Many investigators include this information in the methods and/or
reference sections of their manuscripts. Journals generally include an acknowledgement
section, in which the authors can recognize people who helped them gain access to the data.
Authors using shared data should check the policies of the journal to which they plan to
submit to determine the precise location in the manuscript for such acknowledgement.
INTERNATIONAL DATA REPOSITORIES
The following table provides examples of databases where various data types or unique
resources produced by Genome BC-funded projects may be deposited with appropriate
subject consent and conform with Genome BC’s ethical guidelines on genetic discrimination
and informed consent for biobanking, available on the Genome BC website. Note that the
following are intended as examples and this is not presented as an exhaustive, definitive list.
Data/Resource type
DNA, RNA and Protein
Sequences
EST sequences
Database
DDBJ/EMBL/GenBank
URL for submission
http://www.ncbi.nlm.nih.gov/Genbank/submit.html
DDBJ/EMBL/GenBank
STS sequences
DDBJ/EMBL/GenBank
Microarray data (eg.
gene expression and
CNV)
SNPs
Human genotype and
phenotype (GWAS)
Trace and Short Reads
from Next
Generation
Sequencers
Gene Expression
Omnibus (GEO)
http://www.ncbi.nlm.nih.gov/dbEST/how_to_submit.h
tml
http://www.ncbi.nlm.nih.gov/dbSTS/how_to_submit.h
tml
http://www.ncbi.nlm.nih.gov/geo/
dbSNP
dbGaP
http://www.ncbi.nlm.nih.gov/SNP/
http://www.ncbi.nlm.nih.gov/gap
Trace Archive and
Short Read Archive
http://www.ncbi.nlm.nih.gov/Traces/trace.cgi
http://www.ncbi.nlm.nih.gov/Traces/sra/sra.cgi
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Data/Resource type
Proteomics data*
Protein Structures
Interactions
Human gene
nomenclature
Mouse gene
nomenclature and
mouse phenotype
and expression data
Biological strains
Software Code
Database
PRoteomics
IDEntifications
database (PRIDE)
PeptideAtlas
Global Proteomics
Machine (GPM)
PDB
IntAct
HGNC
MGI
URL for submission
http://www.ebi.ac.uk/pride/
http://www.peptideatlas.org/
http://gpmdb.thegpm.org/
http://www.wwpdb.org/
http://www.ebi.ac.uk/intact
http://www.gene.ucl.ac.uk/nomenclature
http://www.informatics.jax.org/mgihome/nomen/
http://www.informatics.jax.org/submit.shtml
ATCC
http://www.atcc.org/
SourceForge.net/
http://sourceforge.net/
Bioinformatics
http://www.bioinformatics.org/
Organization
http://www.open-bio.org/
Open Bioinformatics
Foundation
Miscellaneous Data
FigShare
http://figshare.com/
http://datadryad.org/
Dryad
Publications
PubMed Central
http://pubmedcentralcanada.ca/
Canada
http://arxiv.org/
http://www.ssrn.com/
arXiv
http://www.researchgate.net/
Social Science
https://circle.ubc.ca/
Research Network
http://summit.sfu.ca/
(SSRN)
https://dspace.library.uvic.ca
ResearchGate
http://viuspace.viu.ca/
Institutional
repositories at UBC,
SFU, UVic, or VIU
*Standards in proteomics are fluid, but researchers should adopt best practices such as the ontologybased mzXML file format (http://tools.proteomecenter.org). Researchers are encouraged to deposit
their trace files in one of the three open repositories.
FUNDS FOR DATA SHARING
Genome BC recognizes that it takes time and money to prepare data for sharing. Thus,
applicants can request funds for data sharing and archiving in their project application.
Investigators who incorporate data sharing in the initial design of the study may more readily
and economically establish adequate procedures for protecting the identities of participants
and share a useful dataset with appropriate documentation.
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DEFINITIONS
Restricted Data - datasets that cannot be distributed to the general public, because of, for
example, participant confidentiality concerns, third-party licensing or use agreements, or
national security considerations.
Data – The dataset and its associated documentation.
Data Archive – A place where machine-readable data are acquired, manipulated,
documented, and distributed to others for further analysis and consumption.
Data Enclave – A controlled, secure environment in which eligible researchers can perform
analyses using restricted data resources.
Data Federation – A group of data providers working under a common charter to serve data
under uniform rules that govern data access and data use.
Data Sharing Agreement – A contract between data provider and data consumers that defines
terms of data access and use. These terms should be consistently applied.
Final Research Data – Final research data are recorded factual materials commonly accepted
in the scientific community and require documentation and validation. This data includes not
only summary statistics or tables, but also all the data on which those statistics and tables are
based. For the purposes of these guidelines, final research data do not include laboratory
notebooks; partial datasets; preliminary analyses; drafts of scientific papers; plans for future
research; peer review reports; communications with colleagues; or physical objects such as
gels.
Metadata – The information that describes the data source and the time, place, and
conditions under which the data were created. Metadata informs the consumer of who, when,
what, where, why, and how data were generated. Metadata allows the data to be traced to a
known origin and known quality.
Timeliness – In general, Genome BC considers the timely release and sharing of data to be no
later than the acceptance for publication of the main findings from the final dataset. The
Principal Investigator will notify Genome BC of any delays to the release of data beyond the
publication date or other scheduled dates for the release of data developed with Genome BC
funds, such as the need to file provisional or full patent applications or apply for copy-write
or trademark to protect intellectual property and/or know-how arising from the dataset.
Unique Data – Data that cannot be readily replicated. Examples of studies producing unique
data include: large surveys that are too expensive to replicate; studies of unique populations,
such as native or un-contacted peoples; studies conducted at unique times, such as after a
natural disaster; studies conducted over long time scales; and studies of rare phenomena.
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