PROCEDURE
Submission of Proposals for Research
Ethics Review
Policy Mgmt #: Information Management
Services will Input.
Version:
1.00
Date Approved:
April 8, 2015
GENERAL INFORMATION
Content Summary
Covers
Procedure for submission of proposals for research ethics review
Subject
Provides an overview of the procedure for submission and review of
proposals for TPH Research Ethics Review
Superseded
Policy for Evaluation and Other Research Endeavours (2000)
Documents
Dates
Date of
Publication
Effective Date
Reviewed Date
Next Review
Date
People
Issued by
Owner
Contact
Information
May 22, 2015
April 17, 2015
April 8, 2015
April 8, 2018
Healthy Public Policy
Jan Fordham
Manager, Healthy Public Policy
Toronto Public Health
277 Victoria Street, 7th floor
Toronto, ON M5B 1W2
416-338-7443, Fordham@toronto.ca
Karen Wade
Supervisor, Healthy Public Policy
Toronto Public Health
277 Victoria Street, 7th floor
Toronto, ON M5B 1W2
416-338-0912, kwade@toronto.ca
Revision History
Version #
Version
Date
Issued by
Approvals/ Approval process
Dept/Role
Name
Director, HPP
Monica Campbell
Changes in Document
Signatures
Approved by E-mail
Approval Date
April 8, 2015
Title
Submission of Proposals for Research
Ethics Review
Effective Date
April 17, 2015
1. PURPOSE
This document describes the five step procedure (see TPH Research Ethics Review
Policy, Appendix 1: Steps in the TPH Research Ethics Review Process) for TPH
research ethics review. The procedure applies to all research proposals undergoing TPH
Research Ethics Review, including those that have or will receive research ethics review
by another research ethics board (REB).
2. RELATED POLICY DOCUMENTS
TPH Research Ethics Review Policy
3. PROCEDURE
1. STEP 1: Pre-Screening Assessment
Prior to the submission of a research application, all potential research projects will be
screened to determine if they meet the following three criteria for research ethics review.
1. The project meets the definition of research as set out in the TPH Research Ethics
Review Policy (4.32); and
2. The project involves human participants (including but not limited to, biological
samples) or data related to human participants; and
3. The project involves or relates to TPH in at least one of the following ways
regardless of who initiates the project (internal, external, collaborative, student):
a. The project involves TPH staff or clients as project participants
b. The project uses TPH provided information about individuals/their biological
materials which is not anonymous
c. The project involves 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)
The Project Lead or Principal Investigator may be asked to complete a Project Summary
Form and submit it to erreview@toronto.ca.The Research Coordinator/designate, in
consultation with the Project Lead and/or Principal Investigator and/or the REB Chair as
necessary, will determine if the project requires TPH Research Ethics Review.
If the project meets the criteria for TPH research ethics review, the Research
Coordinator will ask the Principal Investigator to complete a TPH Research Ethics
Review Application and submit it to erreview@toronto.ca.
2. STEP 2: Organizational Assessment
Research projects meeting the criteria for TPH research ethics review require several
organizational approvals prior to being reviewed by the TPH REB. The organizational
approvals usually take between one to four weeks depending on the scope and
complexity of the project, whether or not the project has previously been assessed for
scientific merit, and the time it takes for the researchers to respond to requests for
additional information and/or reviewers' comments.
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Ethics Review
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Relevance and Feasibility
The Research Coordinator/designate will send the TPH Research Ethics Review
Application, the Director's Assessment of Relevance and Feasibility of the Proposed
Project Form to the Director of the TPH program area most relevant to the research. If
the research involves multiple Directorates, the Research Coordinator will send the
application and forms to the Medical Officer of Health (MOH). The Director(s) and the
MOH may choose to delegate the assessments but are accountable for the final
decisions. The Director/MOH/designate may contact the Principal Investigator for
clarification or to request revisions to the application. The Director/MOH/designate will
send the completed assessment forms and (revised) application to erreview@toronto.ca.
Scientific Merit
TPH will generally not duplicate previously conducted reviews for scientific merit.
Principal Investigator(s) will be required to provide documentation of the results of any
previous reviews for scientific merit.
If review for scientific merit is required, the Research Coordinator/designate will send the
TPH Research Ethics Review Application and the Director's Assessment of Scientific
Merit of the Proposed Project Form to the Director of the TPH program area most
relevant to the research. If the research involves multiple Directorates, the Research
Coordinator will send the application and form to the Medical Officer of Health (MOH).
The Director(s) and the MOH have three options: (a) perform the review for scientific
merit, (b) delegate the review within their program area, or (c) ask the Research
Coordinator to have the review completed by a TPH staff member who is designated as
a scientific reviewer or by a reviewer external to TPH.
If the Director/MOH conducts the assessment or delegates the assessment within their
program area the Director/MOH is accountable for the final decision. The Director/MOH
may contact the Principal Investigator for clarification or request revisions to the
application. The scientific reviewer will remain blind to the Principal Investigator. The
Director/MOH/designate will send the completed assessment form and (revised)
application form to erreview@toronto.ca
If the Director/MOH asks the Research Coordinator to have review completed the
Research Coordinator is accountable for the final decision. The Research Coordinator
may contact the Principal Investigator for clarification or request revisions to the
application. The scientific reviewer will remain blind to the Principal Investigator. The
Research Coordinator/scientific reviewer will send the completed assessment form and
(revised) application form to erreview@toronto.ca
Information Management (Privacy)
The Research Coordinator/designate will also send research applications to the TPH
Privacy and Information Management Liaison Officer who will assess compliance with:
PHIPA, PHIPA Regulation 329/04, MFIPPA, MFIPPA Regulation 823, as well as any
other relevant privacy and information management requirements using the TPH
Privacy and Information Management Assessment Form. Some research projects
involve the disclosure of personal health information to a researcher. The MOH, who is
the Health Information Custodian, decides whether or not the personal health
information can be disclosed and if there are conditions to that disclosure.
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Ethics Review
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The Privacy and Information Management Liaison Officer may contact the Principal
Investigator for clarification or request revisions to the application.
The Privacy and Information Management Liaison Officer will sign send the completed
form and (revised) application to erreview@toronto.ca.
Research Agreement(s)
Some research projects will require a TPH Research Agreement to ensure that they are
carried out in accordance with the approved research application and that they meet
legislative requirements for use, security, disclosure, and return or disposal of personal
health information or other data.
The Privacy and Information Management Liaison Officer, the relevant Director(s, and
the Research Coordinator will contribute to the identification of research projects
requiring the completion of a TPH Research Agreement(s). The Research Coordinator
will facilitate the completion of the TPH Research Agreement.
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Ethics Review
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3. STEP 3: Research Ethics Review
The TPH REB will meet monthly, as necessary. Dates for REB meetings will be posted
on the TPH website annually.
The Research Coordinator/designate, in consultation with the Principal Investigator and
REB Chair as necessary, will use a proportionate assessment approach to research
ethics review to determine if the research proposal will receive a delegated REB review
or a full review.
Delegated REB Review
Minimal risk research proposals receive delegated reviews. The Research Coordinator
usually selects two reviewers from the REB membership who do not have a conflict of
interest and who have knowledge and skills relevant to the proposal. The Reviewers
independently assess the proposal using the Research Ethics Review Form and forward
the results of the assessment to erreview@toronto.ca.
Full REB Review
Research proposals which are more than minimal risk receive a full REB review at a
REB meeting where quorum is maintained for items requiring a decision. Two REB
Members who do not have a conflict of interest with the proposed research are selected
to be Primary and Secondary Reviewers. Both Reviewers conduct an in-depth
assessment using the Research Ethics Review Form in advance of the REB meeting.
The Secondary Reviewer will focus particular attention on informed consent. All other
REB members read the proposal. The Primary reviewer leads the discussion and the
remaining REB Members contribute to the review.
The REB decides whether or not to approve the research proposal and indicates any
conditions or requirements associated with their decision. The Primary and Secondary
Reviewers revise the assessments based on the REB discussion and forward them to
erreview@toronto.ca .
REB Initial Decision Notification
The REB Chair will send the Principal Investigator a letter containing the initial REB
decision and the REB comments. The letter indicates that the:
1. Research proposal is approved (go to Review Outcome Final Notification)
2. Research proposal has been reviewed; modifications are required
The letter, signed by the REB Chair, will set out the expected timelines and process for
communication between the REB and the Principal Investigator. The Principal
Investigator will be asked to respond to the issues identified by the REB in writing
highlighting revisions in the revised research proposal, including appendices, and submit
them to the REB through erreview@toronto.ca. The Research Coordinator will facilitate
communication about the modifications and/or requests for information, where
necessary.
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Ethics Review
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4. STEP 4: REB Review Outcome- Final Notification
The number of steps between the initial REB decision and final decision will vary
depending on how quickly the Principal Investigator can respond to required
modifications. 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 (if determined as a result of the
proportionate assessment to be minimal risk).
Approved
The REB approves a research proposal if it is found to be ethically acceptable, with a
favourable balance between protection of participants and/or their data and the benefits
of the research. No project can start without TPH REB approval.
When the REB approves a research proposal, the REB Approval Letter, signed by the
REB Chair, is sent to the Principal Investigator(s), outlining the approval conditions (e.g.,
length of the approval; requirement to notify the REB of changes to the proposal or
unanticipated events, and the need for a TPH Research Agreement). The Principal
Investigator(s) must comply, at all times, with any REB conditions.
The Principal Investigator will work with the Privacy and Information Management
Liaison Officer, TPH Legal, the data holder, and the Research Coordinator to ensure that
the TPH Research Agreement(s) has been completed and signed, when required.
A project cannot begin until the Research Agreement(s) has been signed by the
Principal Investigator and the Medical Officer of Health (MOH) and received by the REB
through erreview@toronto.ca.
Rejected
If the REB does not approve the research proposal, the REB Rejection Letter, signed by
the REB Chair, will inform the Principal Investigator that the REB has made a final
decision not to approve the proposal.
Research cannot be conducted at TPH without TPH REB approval.
Appeal
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 if they believe they have grounds to assert that:
 there were REB procedural irregularities (i.e., the established research ethics review
process was not followed)
 elements of the REB decision were not supported by the Tri-Council Policy
Statement: Ethical Conduct for Research Involving Humans (TCPS2) 2014
The Principal Investigator must submit a Request for Reconsideration letter, justifying
the grounds for reconsideration, to the REB at erreview@toronto.ca within 30 days of
receiving the rejection letter. The REB will reconsider the proposal at the next scheduled
REB meeting. The Principal Investigator may be asked to attend the meeting but will not
be present for the REB deliberation and decision making. Following reconsideration the
REB Chair will advise the Principal Investigator in writing of the REB decision to approve
or reject the proposal.
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Ethics Review
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The Principal Investigator may appeal the rejection of the proposal by submitting an
Appeal of the REB Reconsideration Decision letter, justifying the grounds for appeal, to
the REB at erreview@toronto.ca within 30 days of receiving the rejection of
reconsideration letter.
The appeal will be considered by an adhoc Appeal Committee comprised of at least:
 one community member who is not affiliated with TPH
 one member who is knowledgeable in research ethics
 two members who have expertise in the methods or areas of the research
 one member who is knowledgeable in considering privacy issues
REB members whose decision is under appeal can not sit on the Appeal Committee.
The Appeal Committee shall meet within 30 days of the REB receiving the Appeal of the
REB Reconsideration Decision letter. The Principal Investigator and a representative of
the REB will be provided with the opportunity to address the Appeal Committee, but will
not be present when the committee deliberates and makes a decision. The Appeal
Committee will advise the Principal Investigator and the TPH REB Chair in writing of its
decision which is final.
5. STEP 5: Ethics Monitoring & Completion
The TPH REB will monitor all projects it approves until completion ( i.e., data collection,
data analysis, and contact with project participants is finished and/or use of their data is
no longer required and an End of Research Project Reporting Form has been submitted
to the REB at erreview@toronto.ca by the Principal Investigator). The results of the
project cannot be disseminated until the End of Research Project Reporting Form and
final report of the project have been submitted to the REB at erreview@toronto.ca.
The nature and frequency of continuing ethics review (monitoring) is determined by the
REB and is related to the project's level of risk. The Principal Investigator is required to
report on projects which involve no or minimal risk to participants annually at the time of
renewal. The Principal Investigator may be required to report on projects which are
assessed to be more than minimum risk more frequently. A specific Standard Operating
Procedure will be developed for clinical trials, which have unique monitoring
requirements.
Early Termination
The Principal Investigator must request REB approval to end a previously approved
research project early, even if the project never began, by submitting an Early
Termination Request Form to the REB at erreview@toronto.ca.
Project Renewals
TPH research ethics approval is valid for one year from the date of the approval letter.
One month prior to this date, a Continuing Research Renewal Form will be sent to the
Principal Investigator if the REB has not received a Project Completion Form. The
Principal Investigator will be asked to complete the form and return it to the REB at
erreview@toronto.ca. Research projects which are not complete and which have not
deviated from the approved proposal will usually receive a Renewal of REB Approval
letter. This process will continue annually until the project is complete.
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Ethics Review
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Amendments or Modifications
The Principal Investigator(s) is responsible for notifying the REB of any amendments or
modifications to the approved research, indicating the significance of the deviation.
Amendments or modifications may be minor or substantive (major). 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 REB if they alter the level of participants' risk or
have other ethical implications. Principal Investigators who are unsure about the
potential implications of the changes on participants' risk levels should consult with the
REB.
Substantive changes to previously approved research proposals that affect participants
at any stage of the process (e.g., changes to research team memberships/roles,
changes to consent forms, interventions, and/or measures to protect privacy and
confidentiality) must be reported to the REB through erreview@toronto.ca in a timely
manner using the Research Project Amendment Form. Substantive changes should not
be implemented without documented REB approval, except when necessary to eliminate
an immediate risk to participants.
Requests for amendments or modifications may receive delegated or full board review
depending on implications of the change for risk to participants.
Following review of the amendment or modification the REB Chair/designate will send
the Principal Investigator a letter indicating whether or not the proposed amendment or
modification is approved as well as any conditions associated with the approval.
If there are significant extensive changes to the previously approved research the
Principal Investigator may be required to submit a new research proposal.
Unanticipated Issues or Events
Unanticipated issues or events may be minor or serious and may have short or long
term implications for participants. They include unexpected reactions by participants
(e.g., unintended stimulation of traumatic memories, unforeseen side effects of a drug)
and unavoidable single incidents (e.g., translator not available for an interview, failure to
follow the correct procedure for one participant), or a privacy breach.
Principal Investigators are required to report unanticipated issues or events that may
increase the level of participants' risk or have other ethical implications that may affect
participants' welfare to the REB immediately by completing and sending an
Unanticipated Issue or Event Form to erreview@toronto.ca. Changes to eliminate an
immediate risk may be implemented if needed. The REB may require changes in
procedures to prevent recurrence.
If there are immediate issues for the safety of participants the REB may withdraw ethics
approval, necessitating that the research be suspended until the issue is addressed. The
Principal Investigator may be required to submit a revised research application
depending on the modifications required.
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Ethics Review
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Complaints
All complaints received by the REB about a TPH REB approved research project will be
investigated by the Research Coordinator, in consultation with the REB Chair, as
necessary, using the TPH Complaints Management Policy and Procedure.
Auditing
Auditing of research projects may occur if the monitoring and/or complaints process
reveals that projects are not being conducted as approved.
The REB determines the nature and extent of auditing, which is in proportion to the
deviation from the previously approved research. Auditing may result in more intensive
monitoring, and /or suspension or termination of a previously approved project,
Suspension or Termination
The REB may suspend or terminate a research project for reasons including but not
limited to: change in level of risk for either participants or TPH; not being informed of
unanticipated issues or events; concerns for participant safety; insufficient protection of
personal health information and/or personal information and/or data; receiving
complaint(s) regarding the research; a change in the functioning of the Health Unit (e.g.,
during an emergency); or for any other reason that the REB deems appropriate.
4. FORMS AND/OR TEMPLATES
Continuing Research Renewal Form
Director's Assessment of Relevance and Feasibility of Proposed Research Form
Director's Assessment of Scientific Merit of Proposed Research Form
Early Termination Request Form
End of Research Project Reporting Form
Privacy and Information Management Assessment of Proposed Research Form
Project Completion Form
Project Monitoring Form
Project Summary Form
REB Letter- Research Approved
REB Letter - Research Not Approved, Modifications Required
REB Rejection Letter
REB Letter – Reconsideration Response
REB Letter- Response to Amendment/Modification
Renewal of REB Approval Letter
Research Ethics Review Application Form
Research Ethics Review Form
Research Project Amendment Form
TPH Complaint Reporting Form
Unanticipated Issue or Event Form
REFERENCES/SOURCES
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