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 Request Form
Healthcare Professionals and Hospitals
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RESEARCH REQUEST FORM
Donor Families
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FAQ
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
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COST RECOVERY CONSIDERATIONS
Recipients

Data Requests

Submitting Data Requests

A Data Request is a request for data from TGLN that is not related to research.  

Please ensure that the following criteria are met:

  • Data requests should generally belong to one of the following categories: case management and/or follow-up; education; background data for general presentations related to organ donation or transplantation; review of transplant program history/trends; performance improvement; or data validation.
  • Requests should support the potential to increase registration and consent rates; increase organ and tissue donor numbers; increase the number of transplants; improve transplant outcomes; or ensure data quality/validation that supports donation and/or transplant clinical practice.
  • Requestors must be working or training at an academic centre, non-profit institution or public hospital.
  • Requestors must complete the Data 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:


Notice of Acceptance of Data Requests

Depending on the nature of the request, it may be reviewed and assessed by TGLN’s Research and Data Request Committee. The average turnaround time for simple data requests is two weeks from the date the application is submitted. More complex requests generally take longer to complete. 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 may apply to both data and research requests. Please see below for more details.


Requirements of Successful Data Requestors

Requestors will be required to:

  • 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.


Research Requests

Submitting Research Requests

A Research Request is any request related to a research project. This includes requests for data, tissue/organ/blood samples, clinical interventions or for consultations. If you would like to submit a research request, please ensure the following requirements are met:

  • Requests should generally 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.
  • Requests should support the potential to increase registration and consent rates; increase organ and tissue donor numbers; increase the number of transplants; improve transplant outcomes; or ensure data quality/validation that supports donation and/or transplant clinical practice.
  • Requestor/Principal Investigator must be working or training at an academic centre, non-profit institution, or public hospital.
  • Requestor/Principal Investigator must take responsibility for obtaining funding (if applicable).
  • Requestor/Principal Investigator must take responsibility for Research Ethics Board approval (if applicable).
  • Requestor/Principal Investigator must complete the 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/Principal 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/Principal Investigator will include letters of funding, research ethics board approval, and a free form copy of their curriculum vitae (CV).


Notice of Acceptance of Research Requests

Depending on the nature of the request, applications will be reviewed and assessed by TGLN’s Research and Data Request Committee, 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)


Requirements of Successful Research Requestors/Principal Investigators

Requestors/Principal 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 for Research Requests

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/Principal 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. [i]

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.”


Cost Recovery Considerations

Cost recovery considerations may apply to both data and research requests.

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/Principal 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/Principal 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
        •    Data request that does not require a Terms of Use or Data Sharing Agreement, AND
        •    Limited data manipulation and analysis by TGLN
              OR
        •    Brief consultation that requires a small amount of TGLN Research Program staff time

2.    Type B Request – $1,000 one-time
        •    Data request that requires a Terms of Use Agreement only, AND
        •    Data manipulation and/or analysis by TGLN
              OR
        •    Extended consultation that requires a significant amount of TGLN Research Program staff time
 
3.    Type C Request – $5,000 one-time
              EITHER
        •    Clinical trials and/or requests for organs, tissues and/or blood, no data required
              OR
        •    Large, complex data requests that require analysis and numerous data validation points
        •    May require legal consultation regarding consent and Research Ethics Board approval
              AND/OR
        •    Extensive TGLN Research Program staff time 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 and/or requests for organs, tissues and/or blood, data required 
        •    Complex Data Sharing Agreement Required
        •    Extensive TGLN Research Program staff time to implement a process that is not associated with the donation and recovery
             process for the purpose of organ transplantation

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.



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[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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