Frequently Asked Questions
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All projects meeting the TPH Research Ethics Review Criteria need to be submitted for review.
If you are not sure if your project requires review please complete a Project Summary Form and submit it to firstname.lastname@example.org prior to submitting a Research Ethics Review Application. The Research Coordinator/designate will review the project summary to determine if your project requires ethics review.
All projects meeting the TPH Research Ethics Review Criteria need to be submitted for review even if they have received approval from another REB.
You need to submit your proposal for TPH Research Ethics Review if:
- it involves human participants/data related to human participants and
- it involves or relates to TPH. This means that it needs to:
- involve TPH staff/clients as project participants and/or
- use TPH provided information about individuals/their biological materials which is not anonymous and/or
- involve TPH staff, students, or others as delegated, including contract service providers, as Principal Investigator(s) or Investigator(s), as part of their TPH role, accessing participants and/or data related to individuals/their biological materials outside of TPH (if the data/biological materials are not anonymous).
Please Note: If TPH staff member(s), student(s), or others as delegated, including contract service providers, are member(s) of the Research Team as part of their TPH role, but not the Principal Investigator(s) or Investigator(s), please notify email@example.com. Please provide the name of the project, a brief description of the project, and list all members of the Research Team. Please describe the role of all TPH staff members (s), student(s), or others as delegated, including contract service providers who are members of the Research Team.
You need to obtain a TPH Research Ethics Review Application Form from firstname.lastname@example.org and submit it and all attachments (e.g., copies of relevant REB approvals, documentation of previous scientific review (if applicable), informed consent checklist, information forms which will be read to/by potential participants, data collection/extraction/debriefing instruments) to email@example.com.
Step 1: TPH Organizational Approval
Research projects require several organizational approvals prior to being reviewed by the TPH Research Ethics Board (REB).
TPH Directors assess the application to ensure that the research:
TPH will generally not duplicate previously conducted scientific reviews
The TPH Privacy and Information Management Liaison Officer assesses the application to determine if it is compliant with: PHIPA, PHIPA Regulation 329/04, MFIPPA, MFIPPA Regulation 823, and any other relevant privacy and information management requirements.
Step 2: REB Review and Approval
Once organizational requirements are met, minimal risk research proposals receive a Delegated REB review. Research proposals which are more than minimal risk receive a Full REB review at a REB meeting. Following REB review the REB Chair sends the Principal Investigator a letter containing the initial REB decision and any comments.
Research proposals should not require more than three rounds of revisions before a final REB decision is made. Before a final decision is made to reject a proposal, the proposal will be reviewed by the full REB (even if determined as a result of the proportionate assessment to be minimal risk). Principal Investigators may ask that the REB reconsider its decision to reject a research proposal and subsequently appeal the REB decision to reject a proposal following reconsideration on certain grounds.
Step 3: Signed TPH Research Agreements
Some research projects will require a TPH Research Agreement before the project can start to ensure that they are carried out in accordance with the approved research proposal and that they meet legislative requirements for use, security, disclosure, and return or disposal of personal health information or other data.
You will need a TPH Research Agreement if you are an external researcher and you are requesting records containing personal health information, personal information or other types of data from TPH.
The Privacy and Information Management Liaison Officer, in consultation with TPH Directors, City Legal, and the Research Coordinator, will provide guidance on the need for and content of the Research Agreement(s).
The length of time required to review your application varies depending on the organizational approvals required, the type of REB review required (Delegated REB Review or Full REB Review) and on how quickly the Principal Investigator can respond to suggested and/or required modifications required at the organizational level or by the TPH REB.
Research projects are approved for one year from the date on the REB approval letter. Projects which extend beyond one year will require Annual Renewal until completion.
The Principal Investigator, as the leader of the Research Team, has primary responsibility and accountability for the scientific and ethical conduct of the research project, including ensuring that the actions of all members of the Research Team are consistent with the approved research application. The Principal Investigator also has primary responsibility and accountability for legal and administrative aspects of the project. This includes but is not limited to:
- Signing off on the completed research application and responses to REB requests for information/clarification/changes to the original application
- Obtaining written TPH REB ethics approval
- Ensuring that a Research Agreement is completed and signed, if required, prior to starting the research project
- Ensuring that all members of the Research Team carry out sound ethical research consistent with the research proposal approved by the TPH REB
- Informing the TPH REB of amendments or modifications to the approved research proposal by completing and sending a Research Project Amendment Form to firstname.lastname@example.org and receiving approval when necessary
- Reporting unanticipated issues/events that may increase participants’ risk or have other ethical implications that may affect their welfare to the TPH REB immediately by completing and sending an Unanticipated Issue or Event Form to email@example.com.
- Complying with all written TPH REB notifications
- Ensuring that progress reports, requests for continuing review, and final reports are submitted to the TPH REB
- Complying with TPH REB mandated monitoring and auditing processes
- Obtaining approval from the TPH REB before withdrawing a project after approval
Substantive changes to previously approved research proposals that affect participants at any stage of the process (e.g., changes to research team membership/roles, changes to consent forms, interventions, and/or measures to protect privacy and confidentiality) must be reported to the TPH REB through firstname.lastname@example.org in a timely manner using the Research Project Amendment Form. Substantive changes should not be implemented without documented TPH REB approval, except when necessary to eliminate an immediate risk to participants.
Minor deviations (e.g., slight wording changes to a survey/interview guide; slight increase in time for completion of a survey/interview) can be summarized in the Continuing Research Renewal Form and do not require immediate reporting.
Some research projects (e.g., qualitative studies utilizing emergent design) usually involve adjustments. Such adjustments need to be reported to the TPH REB if they alter the level of participants’ risk or have other ethical implications.
Principal Investigator(s) who are unsure about the potential implications of changes on participants’ risk levels should consult with the Research Coordinator at email@example.com.