Centre for Addiction
and Mental Health

Research Ethics Board General Information

Research Ethics Submissions - New Studies and Amendments

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 New Protocols for Review

Each new Protocol Submission Should Include:

One original plus 9 copies (copies should be double-sided and stapled) of the entire protocol; Consent Form; One copy of investigator's curriculum vitae (Principal Investigators and Co-Investigators) unless these CVs have been submitted to the Research Ethics Office within the last year.

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.

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.

PLEASE INCLUDE IN ALL CONSENT FORMS THE FOLLOWING INFORMATION:

As part of the Research Services Quality Assurance Program, this study may be monitored and/or audited by a member of the Quality Assurance Team. Your research records and CAMH records may be reviewed during which confidentiality will be maintained as per CAMH policies and extent permitted by law".

CVs and TCPS should be sent electronically. Please do not include in the hard copy submission.

ELECTRONIC FILES:

In addition to hard copy submission, please submit an electronic copy of New Protocol, CVs and TCPS(2) to: Evelyn.Prasad@camh.ca

NOTE: Please do not merge files into 1 pdf document.

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.ca

E-mails must be sent from PI's e-mail address)

NEW: Please indicate in the covering letter that all study investigators are in agreement wih this amendment.

ANNUAL RENEWALS:

Hard copy submission:

Please submit hard copies (1 original plus 9 copies) of Annual Renewals and new Protocols to: 33 Russell Street, Room T117. Date and sign as usual and make 10 double-sided and stapled copies (original binder-clipped).

Note: Paper clips are not allowed. Please staple the copies and binder-clipped the original.

ELECTRONIC FILES:

In addition to hard copy submission, please submit an electronic copy to: Evelyn.Prasad@camh.ca

Final Reports

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. Date and sign as usual and make 10 double-sided copies (1 original plus 9 copies).

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.

Both original and copy need to have attached any supporting documentation.

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.
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@camh.ca. 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