Mandatory Research training
The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS or the Policy) is a joint policy of Canada’s three federal research agencies – the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC), or “the Agencies.”
This Policy expresses the Agencies’ continuing commitment to the people of Canada to promote the ethical conduct of research involving humans. It has been informed in part, by leading international ethics norms, all of which may help, in some measure, to guide Canadian researchers, in Canada and abroad in the conduct of research involving humans.
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018)
It is the responsibility of the primary investigator(s) to ensure that their Research Project Team Members (RPTMs) are certified in the ethical conduct of research and privacy. The TCPS 2 and Privacy Training for Research Personnel Tutorial certificates for each team member (e.g., investigators, research coordinators/assistants, study monitors, volunteers and students) must accompany the submission of a project for REB review.
MGH Researchers and MGH Research Project Team Members (RPTMs) are required to complete additional Standard Operating Procedures (SOPs) training within six weeks of REB approval. Please see iCare for more information. Researchers and RPTMs will be enrolled in iLearn by the Department of Research and Innovation at time of REB approval.
- TCPS 2 Tutorial
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The TCPS 2: CORE Tutorial consists of nine modules that will take between two to three hours to complete. The tutorial has log-on and log-off capability so that it can be completed over time. A printable certificate will be generated once the tutorial is complete. Please download and submit this certificate with your research application.
Click below to access the current version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2:
- TCPS 2 Documentation (website) UPDATED 2018 version
- TCPS 2 Documentation (pdf) UPDATED 2018 version
Guidance in Applying TCPS-2 (2018):
- How to Address Material Incidental Findings-TCPS 2 (2018) (Article 3.4)
- TCPS 2 Interpretations (June 2021)
- Privacy for Researchers Tutorial
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The Privacy Training for Research Personnel Tutorial provides education for research team members regarding research specific, privacy and security training to protect study participant’s confidential information. This tutorial will take approximately ten to fifteen minutes to complete.
- Privacy Training for Research Personnel Tutorial
(New - June 2022)
Research Privacy Guidance:
- This document outlines the recommendations to promote the effective implementation of privacy best practices in the health research community and to ensure that these best practices continue to respond to the evolving nature of health research and challenges of privacy protection.
CIHR Best Practices for Protecting Privacy in Health Research - Personal Health Information Protection Act, 2004: Ontario Law, S.O. 2004, Chapter 3, Schedule A
- The Personal Information Protection and Electronic Documents Act (PIPEDA)
- Privacy Training for Research Personnel Tutorial
Initial Submissions
Access this section for new research submissions, clinical audits, or service evaluations
- Application and Guidance Documents
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Please review this process map if you would like to better understand the steps involved in the REB review.
This checklist identifies the required items to include with an initial submission to the REB.
This document provides guidelines for completing a TAHSN Research Application and to assist researchers in determining the type of review (i.e., Full Board or Delegated).
Most research projects will require the TAHSN Full Research Application to be completed; in circumstance where your project involves only retrospective data and/or previously collected bio-specimens, please use the TAHSN Research Application to Access Retrospective Data. Please note that for your project to be considered a “retrospective” review, inclusive dates cannot go beyond the submission date of your application and you must have a specified end date.
All new research submissions to the REB must include a protocol. A Protocol Template is provided; instructions are in each section of this document. If you prefer, please use the Protocol Guidelines to assist you in developing your protocol.
When your research involves enrollment of participants, you must include a consent form. The General Consent Form Template below is a modifiable document for use in your project. When a Consent Form template has already been provided to you, please use the checklist which identifies a list of elements to be included in your Consent Form.
- General Consent Form Template
(Adapted from CTO Informed Consent Form Templates) - Research Consent Form Checklist
- Consent Template for Residents NEW
If your research is industry sponsored (e.g., pharmaceutical, biotech) an REB fee will apply.
As of January 1, 2020 TEHN implemented a new policy for the collection of research overhead fees. This policy applies to all funded nonprofit and private sector research. Please complete and submit the Research Overhead Fees Recovery form; the policy is available in PolicyTech. Please submit this form with your completed TAHSN Application.
In an effort to expedite delegated reviews, a streamlined REB review process has been implemented. Minimal risk studies eligible for delegated review are now required to complete a Research Privacy Assessment prior to project submission to the REB. Information about minimal risk studies is available on the Initial Research Submission Checklist and the TAHSN Application Guidelines above.
- General Consent Form Template
- Contracts
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Please submit all draft contracts and agreements to @email in MS Word format. Please include a copy of the current research protocol.
Please be advised that review may incur fees and will be discussed with the investigator prior to initiating the review.
- Study Cost Estimate Forms (Department Impact)
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The MGH Principal Investigator is responsible for ensuring that all MGH departments impacted by the study have been properly informed by submitting a copy of the protocol to the appropriate department Health Service/Service Delivery Unit/Corporate Support Leader. This form must be signed by both parties whether there is a cost involved or not. This ensures that REB is informed that the proposed impacted departments have been notified, have agreed, and have the resources required to carry out the study.
- For US Industry Sponsored Studies
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The Statement of Investigator, Form FDA 1572 (1572), is an agreement signed by the investigator to provide certain information to the sponsor and assure that they will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic.
- Frequently Asked Questions – Statement of Investigator (Form FDA 1572), May 2010 - Clinical Audit or Service Evaluation
Ongoing Submissions
- Ongoing Submissions
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For research projects lasting longer than one year, researchers shall submit, at minimum, an annual report with sufficient details to enable the REB to make an informed judgment about the continued ethical acceptability of the research. For research lasting less than one year, an end-of-study report may suffice.
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018)Please use this form to seek continuing REB approval for your study annually.
Please use this form if your research is completed in order to close your study.
Please use this form to submit changes to any of your REB approved research documents, or to introduce new study documents to a previously REB approved project. New or revised study documents may not be used until the REB has reviewed and approved them.
lease use this form to report Serious Adverse Events to the REB.
Please use this form to inform the REB of any changes to the study investigator(s). Notifications of changes in external administrative personnel can be done via email to @email.
Identifying and Credentialing Research Project Team Members (RPTM)
Access this section to add new study personnel to an ongoing REB approved research project.
- Qualified Principal Investigator (QPI)
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Please review this process map for a better understanding of the steps involved to add a new RPTM to your research project.
- Process Maps (Identifying, Credentialing, Onboarding)
Complete this form to add your new RPTM to a previously REB approved research project. Please use a separate form for each new RPTM being added.
Physician QPIs are responsible for the supervision of their RPTMs while onsite at MGH, and must adhere to these guidelines.
Please note: Pictures/photographs of any forms for submission to the Research Ethics Board will NOT be accepted. Please scan all required documentation with required signatures for your electronic submission.