• An amendment is a significant change in your original, approved research project that must go through a review and approval process.
• If any of the following project information changes, this requires that you submit an amendment, and await approval before you can proceed with the changes to your research project:
  • the years of data for your study;
  • datasets / data sources;
  • the research question(s) / objective(s);
  • the location of your data storage and / or analysis;
  • the funding source or sponsor; or
  • the investigators ** / personnel involved in your research project.

  ** The Health Information Privacy Committee (HIPC) requires notification of any changes in the original submission with respect to investigators or anyone accessing line-level data. Notification is also required if someone other than one of the investigators becomes first author on a manuscript, regardless of whether the individual has access to line-level data. If you have questions, please check with the HIPC coordinator at HIPC@gov.mb.ca for more information on other changes that require an amendment.

• If an amendment to your project is required, please email the Repository Access Unit (RAU) at MCHP_Access@cpe.umanitoba.ca with a short description of the changes you are making.  The RAU will guide you through the amendment process.

• An amendment request will need to be sent to each of the following groups for review and approval:
  • Health Information Privacy Committee (HIPC)
    • Guidelines - Guidelines for Completing a Protocol Amendment Form for the Health Information Privacy Committee
    • Amendment Form - Health Information Privacy Committee Protocol Amendment Form
  • Health Research Ethics Board (HREB)
    • Guidelines - Submission and Review Procedures for Changes to the Protocol (Amendments) 
    • Amendment Form - Request for Amendment/Changes to the Previously Approved Study Form
  • all non-Manitoba Health, Seniors and Active Living (non-MHSAL) data providers involved in your project (if applicable)
    • The MCHP Repository Access Unit (RAU) will provide you with a current template for submitting an amendment to non-MHSAL data providers. Please complete the template and return it to the MCHP RAU, who will facilitate the amendment submission. 
  • First Nations, Metis and Inuit representatives (if applicable).
    • The MCHP RAU will provide contact information for information on the current process to complete an amendment. For more information, please visit the First Nations Health and Social Secretariat of Manitoba - Health Information Research Governance Committee (HIRGC) web page.
  • Project Specific Data Providers (if applicable).
    • The MCHP Repository Access Unit (RAU) will provide you with a current template for submitting an amendment to Project Specific Data providers. Please complete the template and return it to the MCHP RAU, who will facilitate the amendment submission.

• Amendments to your proposal and the original approvals will not be accepted by MCHP during the initial proposal and approval process.
• Submitting an amendment prior to final approval being in place may lead to delays in project commencement.
• Please submit amendments after all aspects of the original proposal and initial final approval process have been completed.

The required tasks include:

• Contact the RAU with the details regarding your amendment;
• Submit a HIPC Protocol Amendment Form to HIPC;
• Submit a HREB Request for Amendment/Changes to the Previously Approved Study Form to HREB;
• Complete the template letters outlining the changes to the non-MHSAL Data Providers (if applicable). The RAU will submit these letters on your behalf; and
• Submit a letter outlining the changes to the Project Specific Data Provider (if applicable);

• Send a Copy of all Amendment Approval Documentation from HIPC, HREB, and all other data providers involved to the MCHP Repository Access Unit (RAU).

• Health Information Privacy Committee Protocol Amendment Form
• HREB - Request for Amendment/Changes to the Previously Approved Study Form

• Contact the MCHP Repository Access Unit at: MCHP_Access@cpe.umanitoba.ca
• Contact: HIPC@gov.mb.ca

The next step in the MCHP Data Access Process is Step 9 - Project Reporting and Annual Renewal Requirements