Research


Our Vision for Research and Data Sharing

Trillium Gift of Life Network (TGLN) is committed to ensuring its resources are adding value to the current and continually developing research initiatives across the province, within Canada, and internationally, while at the same time maintaining a direct focus on the mission mandated to us by the Government of Ontario – saving and enhancing more lives through the gift of organ and tissue donation and transplantation.

Like all patient-focused organizations, TGLN cannot afford to merely sustain current practices. To do so would risk a plateau. We need to innovate – in registration, consent, donation, and transplantation. It is only through participation in scientifically founded and evidence-based research, combined with an agility to mobilize and implement knowledge transfer that TGLN will further progress on achieving its mission.

In addition, continued data sharing with our external partners will support education for health care professionals and facilitate both promotion and advancement of donation and transplantation best practices in Ontario.

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Data/Research Request Form
Healthcare Professionals and Hospitals
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FAQs
Donor Families
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Current and Recently Completed Research
Individuals in the community
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Data/Research Request Process Overview
Recipients

Submitting Data/Research Requests

If you would like to submit a data or research request, please ensure the following requirements are met:

  • Requests must belong to one of the following categories: clinical trials requesting donated organs or tissues related to donation and transplant research, knowledge translation, interventional studies, basic research, epidemiology, health outcomes, quality of life studies or data validation and quality assurance
  • Requests should support the  potential to increase registration and consent rates; increase organ and tissue donor numbers; increase the number transplants; improve transplant outcomes; or ensure data quality/validation that supports donation and/or transplant clinical practice
  • Requestor/Principle Investigator must be working or training at an academic centre, non-profit institution, or public hospital
  • Requestor/Principle Investigator must take responsibility for obtaining funding (if applicable)
  • Requestor/Principle Investigator must take responsibility for Research Ethics Board approval (if applicable)
  • Requestor/Principle Investigator must complete the Data/Research Request Form and submit the request electronically to research@giftoflife.on.ca

If your request does not meet the above requirements you may still be able to submit a data request to TGLN:


Additional Guidelines for Submitting Research Requests

  • Research proposals should be innovative, and involve the novel implementation of interventions in Ontario.
  • The successful Requestor/Principle Investigator must provide evidence of appropriate Research Ethics Board approval, along with consent forms where human subjects are involved in the study before data is released.
  • The amount of each project budget will include direct costs (labour and study costs), study drug costs (if applicable), and indirect costs (publication, and software license fees).
  • TGLN’s institutional costs will also be considered (see below).  A description of anticipated requirements of TGLN staff (protocol development, data acquisition, statistical analysis, manuscript preparation and review) is required.
  • The Requestor/Principle Investigator will include letters of funding, research ethics board approval, and a free form copy of their curriculum vitae (CV).


Notice of Acceptance

Depending on the nature of the request, applications will be reviewed and assessed by TGLN’s Research Advisory Group, where appropriate.  Notice of Acceptance or Notice of Application Status (e.g. if more information is required) will be within a maximum of four (4) weeks from the date the application is submitted. Requests will be evaluated based on the following criteria:

  • Project appropriateness and feasibility
  • Project impact and timelines
  • Project’s requirement for and return on TGLN resources (see Cost Recovery considerations below)


Cost Recovery Considerations

To ensure that TGLN’s ability to support its research partners is sustainable, a cost recovery model is in place to recoup incremental costs. The cost recovery model outlined below was developed in accordance with the following principles: simple to administer; fair, reasonable, and transparent.

At the time of receiving Notice of Acceptance, TGLN will inform successful Requestors/Principle Investigators of the fee associated with their request.  Where a grant or other funding source (e.g. a public hospital or academic institution) is already in place to support the initiative, payment of the flat fee is to be forwarded to TGLN by the Requestor/Principle Investigator upon receiving TGLN’s Notice of Acceptance.  Where a grant or other funding source has not yet been approved, TGLN will withhold formal Notice of Acceptance until the funding is approved.

Breakdown of Cost Recovery Fees

1.    Type A Request – No Cost/In-Kind
        •    Aggregate or simple data request
        •    No Data Sharing Agreement or Terms of Use Agreement required

2.    Type B Request – $1,000 one-time
        •    Simple data requests that require a Terms of Use Agreement only
        •    Limited data manipulation and analysis by TGLN
 
3.    Type C Request – $5,000 one-time
        •    Clinical trials, no data required
        •    May require legal consultation regarding consent and Research Ethics Board
        •    Coordination and education of multiple TGLN staff to implement a process that is not associated with the donation and
              recovery process for the purpose of organ transplantation.

4.    Type D Request – $10,000 one-time
        •    Clinical trials, data required 
        •    Complex Data Sharing Agreement
        •    Coordination and education of multiple TGLN staff to implement a process that is not associated with the donation and
              recovery process for the purpose of organ transplantation.
        •    Large complex data requests that require analysis and numerous data validation points.

If you have any questions about the cost recovery model, including which category your request falls under, please contact the Program Manager, Research at Research@GiftOfLife.ca.


Requirements of Successful Requestors/Principle Investigators

Requestors/Principle Investigators will be required to:

  • Provide TGLN with progress reports, where applicable.
  • Comply with the Personal Health Information Protection Act, the Freedom of Information and Protection of Privacy Act, the Trillium Gift of Life Network Act, and TGLN’s privacy and legal requirements, including but not limited to acknowledging that data and records requested may contain personal health information including potentially identifiable information such as dates, diagnoses, names of patients, and hospitals.
  • Conform to TGLN’s Privacy Terms of Use Agreements and/or Data Sharing Agreements, where applicable.
  • Securely destroy or return the data at the end of the approved period of use, in accordance with TGLN specifications as outlined in the Privacy Terms of Use Agreements or Data Sharing Agreements.
  • Provide TGLN with the opportunity to review the final manuscript prior to submission for publication.
  • Share a copy of proposed publications with TGLN upon submission for publication or other public disclosure.
  • Acknowledge collaboration or partnership with TGLN.
  • Submit Research Ethics Board approval.
  • Provide education to TGLN staff, as applicable.


Authorship/Non-Author Contributions

Acknowledgement of TGLN’s time and resources for all requests is appropriate. A discussion about authorship should occur for all requests that require more from TGLN than simple data acquisition. TGLN encourages Requestors/Principle Investigators to follow the International Committee of Medical Journal Editors (ICMJE)recommendations for defining the role of authors and contributors.

The ICMJE recommends the following four criteria be used to determine authorship:

  • Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
  • Drafting the work or revising it critically for important intellectual content; AND
  • Final approval of the version to be published; AND
  • Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Further, though contributors who do not meet all of the above criteria should not be listed as authors, they should be acknowledged. [1]

Suggested statements for acknowledgement include:

  • “This research/presentation/initiative was supported by the Trillium Gift of Life Network”; or
  • “This research/presentation/initiative research was supported by Trillium Gift of Life Network; however, the conclusions do not necessarily represent the views of the organization.”




[1] International Committee of Medical Journal Editors. 2017. “Defining the Role of Authors and Contributors.” Accessed February 23, 2017. http://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-authors-and-contributors.html.

 




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