Research Contracts

The Research Contracts Office is part of Research Operations at WCH and manages the drafting, negotiation, and signature process of agreements for research studies/projects with external institutions and partners.

Agreements are required to make sure WCH requirements are met, including adherence to relevant privacy legislation and ensuring any WCH obligations created from existing agreements are reflected, when necessary, in new agreements. In addition, agreements are required to protect researchers and WCH from risks inherent in binding legal agreements.

The Research Contracts Office manages a variety of agreements, including:

  • Data and/or Material Transfer Agreements
  • Research Collaboration Agreements
  • Inter-Institutional Agreements
  • Research Funding or Subgrant Agreements
  • Non-Disclosure or Confidentiality Agreements
  • Clinical Trial Agreements
  • Memorandum of Understanding
  • Amendments to existing research agreements

Forms

Research Contracts Information Sheet (RCIS)

FAQs

  1. Complete the Research Contracts Information Sheet (RCIS)
  2. Compile the study or project documents listed in the RCIS
  3. Email the RCIS and the applicable study/project documents to researchcontracts@wchospital.ca to request a file be opened.

Please note that an RCIS must be completed for each external organization partner for the study/project. For example, one study led by WCH with multiple study sites would require an RCIS for each study site.

An agreement is required if you answer yes to any of the questions listed below about the planned research activities?

  • Biological Materials (ex. human blood or tissue samples)
    • Does the study protocol or project plans include human biological materials being received by WCH from an external organization?
    • Does the study protocol or project plans include human biological materials being sent from WCH to an external organization?
  • Data (meaning Personal Health Information and/or Personal Information, which can be identifiable or de-identified)
    • Does the study protocol or project plans include data from an external organization being transferred to WCH and/or being accessed by WCH personnel?
    • Does the study protocol or project plans include data from WCH being transferred to an external organization and/or being accessed by non-WCH personnel?
  • Funding
    • Are you receiving funding from an external organization to support study or project activities at WCH?
    • Is there funding at WCH being sent to an external organization to support the research activities at that external organization?
  • Draft agreement received from an external organization
    • Have you received an agreement from an external organization that you want to partner with for the planned research activities?

An agreement must be completed before any biological materials, data or funding is exchanged between WCH and the external organization. Please contact the Research Contracts Office once the study protocol is developed for Ethics submission or, if it is a research project not requiring a protocol, as soon as the project plans are developed. The protocol and/or project plans are reviewed by a Research Contracts Associate to assess the type of agreement required for the study/project.

Please contact the Research Contracts Office if you are in the early stage of developing a study protocol or project plans and wish to discuss if agreements are potentially required. Email researchcontracts@wchospital.ca with the plans you have developed so far and a Research Contracts Associate will be in touch to schedule a meeting.

Please note that changes to the planned research activities could have implications on the types of agreements required. Any discussion in the development phase will need to be re-visited once the study protocol or project plan is completed and a Research Contracts Associate  re-assesses the planned research activities.

The Research Contracts email address is monitored daily and new submissions are assigned to a Research Contracts Associate. The typical process for an agreement is the following:

Preliminary Review

The Research Contracts Associate conducts a preliminary review of the materials, creates a file number in the Research Contracts Office management system, and contacts to confirm receipt of the file request.

Drafting Stage (if WCH is drafting the agreement)

The Research Contracts Associate drafts the agreement to include terms that address the planned transfer of biological materials, data, and/or funding, WCH institutional requirements and other terms reflecting the intended arrangement between WCH, the WCH Investigator, and the external organization for the study/project.

The Research Contracts Associate may also contact the WCH Investigator and/or the WCH research team with questions about the planned study/project activities, and also consult other areas of WCH, including Finance, Privacy, Legal, the Research Ethics Office, Quality Assurance, and WCH’s insurance provider.

WCH Investigator and Research Team Review

Once the agreement is drafted, the Research Contracts Associate sends it to the WCH Investigator and research team for review to confirm the agreement is consistent with the planned study/project activities. This review is particularly important for sections of the agreement related publication, ownership of data and biological samples, and intellectual property. The WCH Investigator and research team can discuss any questions or concerns about the draft agreement with the Research Contracts Associate.

Negotiation Process

If WCH drafted the agreement:

  • The Research Contracts Associate sends the draft to the study investigator or project lead at the external organization for submission to the appropriate contracts office for institutional review.
  • The external organization reviews the agreement and returns to the Research Contracts Associate any proposed revisions and comments.
  • The Research Contracts Associate  reviews the proposed changes and, as necessary, consults internally at WCH with the WCH Investigator, research team, Privacy, Legal, Finance, and others to address any questions or outstanding issues.
  • Once the external organization and the Research Contracts Office are satisfied that all the revisions and comments are addressed then the agreement is ready for signatures.

If the external organization drafted the agreement:

  • The Research Contracts Associate reviews the drafted agreement and works with the WCH Investigator and research team to confirm the agreement is consistent with the planned research activities.
  • The Research Contracts Associate may also consult other areas of WCH during the review, including Finance, Privacy, Legal, the Research Ethics Office, Quality Assurance, and WCH’s insurance provider.
  • The Research Contracts Associate revises the drafted agreement to incorporate any changes or comments that are consistent with WCH’s institutional expectations and requirements for research agreements, and then submits the revised draft back to the external organization for their review.
  • Once the external organization and the Research Contracts Office are satisfied that all the revisions and comments are addressed then the agreement is ready for signatures.

Signature Process

The Research Contracts Office initiates WCH’s institutional signature process through DocuSign for research agreements. Please note agreements must be signed by individuals with authority to legally bind WCH to the agreements.

The Research Contracts Associate contacts the WCH Investigator to sign the agreement through DocuSign once the WCH institutional signature process is completed, and then coordinates with the external organization to gather any required signatures there.

Once the agreement is fully signed, the Research Contracts Associate distributes a completed agreement to the WCH Investigator and research team. Any planned transfer of funds, biological materials, or data may proceed provided any other required institutional approvals at WCH and the external organization are also completed.

Contact

For further information please contact the Research Contracts Office:

researchcontracts@wchospital.ca