Personal Profile Requirements
The following outlines the requirements for establishing a User Profile in Harmony:
CORE Training
The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd edition (TCPS 2) is the official policy for human research ethics recognized by the Canadian federal granting agencies.
All individuals involved in research projects with human participants must complete the TCPS 2: Course on Research Ethics through the Government of Canada and upload their certificate of completion to the Certifications tab in their User Profile in Harmony.
PHIA Training
The Personal Health Information Act (PHIA) is designed to provide individuals with a right to examine and receive personal health information about themselves and to protect individuals from unauthorized use, disclosure or destruction of personal health information maintained by a trustee.
All personnel listed in the project Research Personnel table are required to have completed PHIA training program within the last 3 years. Your most recent completion certificate must be uploaded to the Certifications tab in your User Profile in RITHIM-Harmony.
If you do not have a PHIA certificate, or it has been more than 3 years since your last certification, evidence of training will be required prior to submitting an application.
Please confirm with your home organization and the relevant data trustee(s) for your project, which PHIA training program is required. If a specific training program is not mandated by your organization, you can complete the Manitoba Health Indirect PHI Version at https://trainingtodo.com/mbhealth/secure/phia-for-individuals.asp
Curriculum Vitae
The Harmony Curriculum Vitae (CV) Template must be completed by the Principal Investigator (PI). Retain a copy of the PI full CV in your study file should RITHIM require more detail on your qualifications.
Signature Authorities
A Signature Authority is a role within Harmony that permits the PI to designate another individual on the project team to execute activities in Harmony on their behalf. There may only be one Signature Authority, in addition to the PI, designated per project.
The PI is ultimately responsible for all aspects of their research, including the information included and submissions that are made in RITHIM-Harmony. All Initial Applications must be submitted by the PI. However, the PI will be able to assign the role of Signature Authority to another individual on the project team at the time of initial application. This authority can be used for follow-on submissions when appropriate justification is provided. The PI will be copied on all submissions made by their Signature Authority. The PI may revoke or re-assign Signature Authority at any time through a Personnel Change.
Signature Authority functions can be used in the following situations:
- The PI has passed away and the Signature Authority must submit a Personnel Change to assign a new PI; or
- The PI is unable to submit a follow-on form during a limited period of time due to:
- Absence where access to the RITHIM-Harmony system is not possible; or
- Incapacity due to illness or injury;
- AND there is a time sensitive submission during this period requiring action from the PI or authorized delegate.
In all instances, the Signature Authority will need to provide justification in RITHIM-Harmony for invoking their authority. The justification will be reviewed and if it does not align with the requirements outlined in this document, the submission will be rejected. Submissions received from a Signature Authority will only be considered when there are well justified circumstances that prevent PIs from executing their responsibilities within RITHIM-Harmony.
Additional Requirement for Regulated Projects
If the project is regulated under the Health Canada Food and Drug regulations, the additional Signature Authority must be a Co-Investigator who would meet the criteria for PI for the project. For this reason, the additional Signature Authority for regulated projects is required to adhere to the same CV requirements as the PI.
Additional Requirement for Advisors/Supervisors
If the project has a Student PI, their Advisor/Supervisor must oversee and sign-off on their RITHIM-Harmony submissions. For this reason, the Advisor/Supervisor for student-led projects is required to adhere to the same CV requirements as the PI.