Topic

How to Amend a Protocol

red checkbox Please Note

As of Monday November 23, 2020, all face-to-face (in-person) research involving human participants, that is not COVID-19-related, must stop, until further notice. This includes all in-person recruitment of human participants; in-person data collection involving human participants for on-going research; as well as studies involving human participants that have recently received REB approval. Online and virtual research may continue as usual.

The REBs will no longer approve new protocols or amendments that involve face-to-face in-person human-participant research that is non-COVID-19 research until further notice. Amendments to pivot to online or virtual methodologies will be reviewed. Renewals and protocol completion reports will continue to be reviewed to ensure that protocols remain in good standing.

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.

What do I need before I can begin?

An approved human ethics protocol on My Research Human Protocols (MRHP).

Amendments

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

Changes that Do Not Require an Amendment

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.

VPRI Role

  • Provide guidance in how and when to submit an amendment
  • Consult on the process to amend an approved ethics protocol when circumstances require it

VPRI Contact

Staff

Daniel Gyewu

Research Ethics Manager, Health Sciences
Research Oversight & Compliance Office (ROCO)
(416) 978-3165

Staff

Dean Sharpe

Research Ethics Manager, Social Sciences, Humanities & Education
Research Oversight & Compliance Office (ROCO)
(416) 978-5585

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