Photo of a form, a computer, and a pair of glasses

Research Ethics Board (REB) Forms

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 

The TCPS 2: CORE Tutorial consists of eight modules that will take between 3 and 5 hours to complete in total. 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 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:

Guidance in Applying TCPS-2 (2018):

Privacy for Researchers Tutorial

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 10 minutes to complete. (Please note that this tutorial uses Chrome or Firefox browsers only. Currently the certificate does not print. At the end of the Tutorial, please click on "Print", type in your name, and take a screenshot to submit with your application.)

Research Privacy Guidance:

Initial Submissions

Access this section for new research submissions, clinical audits, or service evaluations

Application and Guidance Documents

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. Please use this document as a guide to assist you in developing your protocol.

When your research involves enrollment of participants, you must include an informed consent form. The following document identifies the items you must include in your consent form. 

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 found in PolicyTech. Please submit this with your completed TAHSN Application.

Contracts

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)

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

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

Clinical Audit or Service Evaluation Form

 

Ongoing Submissions

Ongoing Submissions

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.

Please use this form if your research has been completed 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.

Please 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)

Please review this process map for a better understanding of the steps involved to add a new RPTM to your research project.

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. 

Was this page helpful?