- 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)
- Health Research Ethics Board (HREB)
- 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).
- 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);
The next step in the MCHP Data Access Process is Step 9 - Project Reporting and Annual Renewal Requirements
Page Last Updated: March 3, 2020