Research Ethics Board General Information

IMPORTANT NOTE: Researchers who are external to the Centre for Addiction and Mental Health (CAMH), and who wish to collaborate on human research projects associated with CAMH, are advised that it is a CAMH policy that all members of research teams must provide evidence of the successful completion of the Tri-Council Policy Statement Tutorial (TCPS-2). The tutorial is available at:
http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/

Submitting Protocols for Review (hard copy and electronic)

Hard copy submission:
Please submit hard copies (1 original plus 9 copies) of Annual Renewals and new Protocols to 33 Russell Street, Room T117. CVs and TCPS should be sent electronically. Please do not include in the hard copy submission.

Final Reports Submission:
Researchers are asked to fill out Final Report forms only when data have been analyzed and a summary of results can be submitted. Prior to this stage, the study should be renewed annually. If you are no longer running subjects, or never were running subjects (e.g. study was a chart review) but have not yet completed the study, please check the appropriate box on the Annual Renewal of Ethics Approval Form and fill out the first and last page.

Final Reports should be submitted in paper form (1 original + 1 copy - signed). We recommend that you submit double-sided copies of Final Reports and any supporting documentation. These should be sent to the attention of Susan Pilon.

In addition to hard copy submission for Annual Renewals and New Protocols:
Please submit Annual Renewals, new Protocols, CVs and Checklists and TCPS electronically to Evelyn_Prasad@camh.net.

NEW: Electronic submission. Files should be sent individually and not scanned into one PDF document.

OTHER INFORMATION - NEW SUBMISSION
Please provide one original and 9 copies of the Human Subjects Research Application Form and the CAMH General Checklist.

1a: Human Subjects Research Application Form (TAHSN)

1b: Human Subjects Research Guidelines (TAHSN)

2: Human Subjects Research Application Form: Required Checklist & Guidance Materials (CAMH). Includes Consent Form Guidelines and Consent Form Sample.

The deadline for new submissions is the first business day of each month. Early submissions are appreciated.
Please note that all future Protocol forms submitted to the Research Ethics Office MUST be the most recent version of the Protocol Form.
Two-sided copies are appreciated, and all forms must be typed.
Handwritten and/or lengthy submissions will not be reviewed.
Each submission should include:
- One original and 9 copies of the entire protocol.
- One (1) copy of each investigator's curriculum vitae (Principal Investigators and Co-Investigators), unless these have been submitted to the Research Ethics Office within the last year. Electronic versions of investigator CVs are required.

Expedited Review

The following items are usually considered eligible for expedited review by the REB Chair with consultation as required:

Amendments to already approved protocols where there is no increase in risks to human subjects.
Chart reviews, where individual identifiers will not be maintained as part of research data. See PHIPA Requirement of Research Plan. Please refer to link.
Adverse events reported in the course of an on-going approved study.
Studies already approved by another established REB.
Studies involving secondary analysis.

The Chair can always decide to have the full Board review the submission.

Applications for expedited review require the same materials as for full review but 1 (one) paper copy and an electronic copy sent to Susan Pilon (Susan_Pilon@camh.net). There is no deadline for applications for expedited review.

Protocol submissions for review by the Centre for Addiction and Mental Health Research Ethics Board may be sent to:

Centre for Addiction and Mental Health
33 Russell Street, Room T116
TORONTO ON M5S 2S1
Attention: Ms. Susan Pilon

Submitting Amendments for Review

Please e-mail your Amendment requests to the Research Ethics Office.

Follow these steps:

Create a cover letter with the following information:
- Investigator name(s)
- Project title
- Most recent CAMH protocol reference number
- Date of most recent CAMH REB approval
- Description of proposed changes (to protocol and/or consent form(s), etc.)
Revise applicable materials (e.g. protocol, consent form, questionnaire) with changes highlighted (e.g. bold, italicize, underline)
Scan any material not available electronically (e.g. Instruments)
Separate and name documents for easy identification by reviewer.
E-mail cover letter with rationale for amendment and revised materials attached to:Susan_Pilon@camh.net . E-mails must be sent from PI's e-mail address.

General Information

Effective May 3, 2004, all applications for approval by the CAMH Research Ethics Board of protocols, amendments or renewals must be accompanied by evidence of successful completion of the Tri-Council Policy Statement (TCPS-2) tutorial which can be accessed through http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/ Researchers who have already completed the NIH course may also wish to take the new TCPS-2 course but this is not mandatory. EACH member of the research team must complete the course and supply to CAMH Research Ethics Office a certificate of completion. This requirement applies independent of source of study funding, although applicants for NIH funds must, in addition, take the NIH course.
Investigators must fill out the CAMH "Final Report for the Research Ethics Board" form and provide it to the CAMH Research Ethics Office upon completion of each study approved by the CAMH REB. If the study has NOT been completed or terminated, and needs to be renewed, please fill out the CAMH Annual Renewal of Ethics Approval form.
If a study is to be conducted only with external grant funding, the protocol will not be reviewed until the investigator indicates that the funding application has been successful and funds have been awarded. Investigators are free to submit their protocols prior to notice of funding but they will not be reviewed until funding has been confirmed.
If your study will be externally funded, please submit three (3) copies of your contract OR grant, including the budget, with this protocol form.
If your study will be internally funded, please submit three (3) copies of the budget with this protocol form.

Each new submission should include:

One original and 9 copies (copies double-sided and stapled and original binder-clipped) of the entire protocol.
One (1) copy of each investigator's curriculum vitae (Principal Investigators AND Co-Investigators), unless these have been submitted to the Research Ethics Office within the last year. Electronic versions of investigator CVs are required.
- If the protocol involves any type of advertising, the REB requires 10 copies of the advertisement. No specific dollar amount of payment to subjects should be listed in the advertisement.
Please note that the REB requires these items for ethical, scientific and legal reasons and will treat this information as confidential.
Dr. Padraig Darby, Chair, Research Ethics Board, Centre for Addiction and Mental Health, may be contacted by research subjects to discuss their rights. Dr. Darby may be reached by telephone at 416-535-8501 ext. 6876. This information should be included on all CAMH consent forms.
If the study involves positron emission tomography (PET), refer to the "PET Centre Guidelines for Informed Consent Statements" available at: For studies involving PET (PDF only).