Approval Process

There are three levels of approval that are required before a research study can begin at the Royal Victoria Regional Health Centre (RVH):

Departmental Approval

Ethics

Approval

Contracts 

Approval

Departmental Approval

For studies involving contact with or observation of human study participants, the Principal Investigator is responsible for obtaining the approval(s) of the Medical and Operational Director(s) of each impacted department prior to submitting their application to the RVH Research Ethics Board (REB).  Additional approvals may be required at the discretion of the RVH Research Manager.

Approvals must be acquired on a single Research Impact Form found HERE. Investigators should complete each applicable section of the form, including providing a brief summary of how the study impacts each department. The Study Protocol and proposed Budget must accompany the Research Impact Form when being reviewed by the Medical and Operational Director(s). For assistance identifying specific Directors, please contact the RVH Research Institute at research@rvh.on.ca.

 

The Principal Investigator should be amenable to any reasonable study modifications proposed by Medical and Operational Directors.

 

Ethics Approval

All research that involves human subjects requires review and approval by an REB, also known as an Institutional Review Board (IRB) or Research Ethics Committee (REC).

 

The RVH REB must review and approve research that meets any of the following criteria:

  • The research involves living human participants at RVH;

  • The research involves the collection, storage, or transport of human biological materials at RVH (e.g., blood, urine, human embryos, fetuses, fetal tissue, reproductive materials, and stem cells). This applies to materials derived from living and deceased individuals;

  • The research is conducted fully or partially on RVH property;

  • The research involves testing an experimental drug or medical device at RVH;

  • The research involves reviewing patient medical records; and/or

  • The research utilizes RVH resources, including, but not limited to:

    • Electronic medical records (e.g., Meditech, ARIA);

    • Imaging or diagnostic services;

    • Laboratory services;

    • Pharmacy services;

    • Surgical services;

    • Emergency services; and/or

    • Other departmental services

 

If you are uncertain as to whether REB review is required, please contact the RVH REB to obtain the written opinion of the REB Chair.

Researchers can find detailed information about how to submit a research application to the RVH REB HERE.

 

Contracts Approval

The RVH Research Office reviews, negotiates, and executes all research contracts, amendments, and memoranda of understanding on behalf of RVH.

Research contracts may include, but are not limited to, Clinical Trial Agreements, Collaboration Agreements, Confidentiality/Non-Disclosure Agreements, Data Sharing/Transfer Agreements, Material Transfer Agreements, Sponsored Research Agreements, Research Funding Agreements.

 

A research contract or agreement is required when:

  • any resources and/or funds will be received from sources external to RVH;

  • any information (e.g., data including video or audio) or biological materials (e.g., bodily fluids, tissues) will be sent outside of RVH and/or will be received by RVH;

  • any external partner wishes to conduct research at RVH

If you are an RVH employee or professional staff member who has been contacted by an outside organization to complete a research contract, please send the contract to the Research Office at research@rvh.on.ca for review. The Research Office is also able to provide suitable contract templates for your research partnership needs.

 
  • White Instagram Icon

Contact Us

Address

© Copyright 2016 - 2020

Royal Victoria Regional Health Centre 

All Rights Reserved

Tel: 705-728-9090

Email: research@rvh.on.ca

Royal Victoria Regional Health Centre

Centre for Education & Research

201 Georgian Drive

Barrie, ON L4M 6M2