Who is this for?
All researchers and students at the University of Toronto (U of T) who have an approved ethics protocol requiring a change.
Any proposed changes to an approved research project requires submission of an amendment on My Research Human Protocols (MRHP). Visit MRHP for detailed instructions.
An ‘amendment’ is a written description of (a) change(s) to an ongoing, currently approved protocol. Amendments include any change to the study documents that affect scholarly intent, study design or human participant protection. Rationale for this/these change (s) should also be provided.
Amendments may include (but are not limited to) changes to any of the following.
- Study title
- Recruitment methods or materials
- Research team members
- Location of the research
- Length of study or intervention
- Participant population, inclusion or exclusion criteria
- Procedures, including interaction of intervention with participants
- Privacy of personal information or participant confidentiality
- Data management plan – change in storage, retention or destruction – physical and electronic safeguards or personnel with access
- Informed consent documents or scripts (unless only minor wording to correct grammar or spelling)
- Information that could impact free and informed consent of participants
- Compensation type or amount
- Conflicts of interests
- Funding source(s)
- Change(s) of other institutional Research Ethics Board (REB) or administration approval, including additions or removals
Minor variations to protocols (e.g. grammatical changes to consent forms) are acceptable without the need for submission of an amendment.
Contact the Human Research Ethics Unit (HREU) staff, listed in the contact section below, with any questions regarding whether a proposed change requires submission of an amendment.
- Provide guidance in how and when to submit an amendment
- Consult on the process to amend an approved ethics protocol when circumstances require it