Topic

Submit a Human Ethics Protocol

Who is this for?

Information about how to submit a human ethics protocol is for the following.

  • Professors/faculty members, postdoctoral fellows, research team members, and students who are conducting human research for submission to the Research Ethics Board (REB)
  • Course instructors and undergraduate students conducting course-based human research
  • Researchers with Toronto Academic Health Science Network (TAHSN) hospital REB approvals that involve the University of Toronto (U of T)

What do I need before I can begin?

Before submitting a human ethics protocol, you will need access to My Research Human Protocols (MRHP).  The following information will also help you understand and submit your human ethics protocol.

Submission Process

There are two routes for submitting a human ethics protocol for ethics review.

  • My Research Human Protocols (MRHP): All faculty and graduate student submissions must be made through MRHP.  Course-based research in departments without a Delegated Ethics Review Committee (DERC) must also be submitted via MRHP.
  • Delegated Ethics Review Committee: Course-based research in departments with a DERC can be submitted directly to the committee. If unsure, consult with your departmental/faculty contact. For more details, see How Human Ethics Applies to Course-Based Research.

Submission Deadlines

Delegate review deadline (for low risk research): Every Monday or first business day of the week by 4pm.

Full board review deadline (default): These deadlines are determined by the respective Research Ethics Board (REB).

See Protocol Submission Deadlines & Who to Submit To.

Protocols are first approved by the relevant department’s chair or dean before they are reviewed by the REB.

Submission Guidelines

  • Submit your protocol well in advance of the expected start date of your research to allow sufficient time for the review process. For delegated review, the review process may take 4-6 weeks from submission to first response.  This first response may be an approval or a request for additional information or changes to your ethics protocol. Full board review may take 2-3 weeks after the meeting to first response.
  • Ethics review submissions should normally not include thesis proposals or journal articles.
  • Applicants are advised to watch the Tips for Writing a Human Ethics Protocol video and refer to guidelines on various methodological and ethics related topics.
  • Other permissions in addition to REB approval may be required to conduct research. It is up to the researcher to determine what these are and obtain them.  Please see Before Engaging in Research for assistance.

Administrative Review

Toronto Academic Heath Science Network Hospital-based research that involves the University in some capacity (e.g. recruitment, administration of funds, student involvement) requires administrative review after REB approval by the hospital’s REB.

To apply for administrative review, use My Research Human Protocols (MRHP) and include the following in your application:

  • Approved TAHSN Human Subjects Research Ethics Application form
  • Approved research protocol
  • All appendices
  • REB (of record) approval letter

There are no deadlines for administrative review. The timeline to first review is 1-2 weeks.

Review Timelines

The risk matrix, section 12 on MRHP will help determine the risk level. Risk level 1 goes through delegated review, while risk levels 2 and 3 will be reviewed by a panel of the full REB at a monthly scheduled meeting.

While we try to accommodate reasonable requests, ethics review is not a quick process. The REB is responsible for conducting proportionate review (in relation to level of risk) and full board reviews are conducted according to specific deadlines and scheduled meetings. It is the responsibility of the researcher to ensure sufficient time for review, prior to the commencement of the research activity.

Researchers should make every attempt to be fair in their risk matrix assessment. If you are unsure how to correctly fill out the matrix, please consult the Human Research Ethics Program (HREP) staff. If a protocol is deemed to require full board review once it has been submitted for delegated review, you will be notified and the protocol will be reviewed at the respective REB’s next full board meeting.

VPRI Role

  • Provide guidance on how to submit an application
  • Provide consultations to develop an ethics protocol
  • Assist with technical questions for using MRHP

VPRI Contact

Staff

General Inquiries: Human Research & Ethics Program (HREP)

Research Oversight & Compliance Office (ROCO)
(416) 946-3273

Staff

Staff

Mariya Gancheva

Research Ethics Coordinator
Research Oversight & Compliance Office (ROCO)
(416) 946-3273

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