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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 (1) original plus 13 copies (copies should be double-sided and stapled) of the entire protocol, consent form, checklist; and 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:

  • 14 copies of the advertisement. No specific dollar amount of payment to subjects should be listed in the advertisement.

 

Dr. Robert Levitan, Chair, Research Ethics Board, Centre for Addiction and Mental Health, may be contacted by research subjects to discuss their rights.  Dr.Levitan may be reached by telephone at: 416-535-8501 ext  34020.  This information should be included on all CAMH consent forms.

Reminder:  When submitting a new study, researchers are reminded that the Principal Investigator or Co-Investigators cannot also sign as Head of Department on the TAHSN application.

 

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". 

 

Please verify if your consent forms reflect recent changes in the phone extension of the REB Chair, Dr. Robert Levitan extension 34020.  

 

NEW:

CVs and TCPS should be uploaded to RTED site.- http://portal1/sites/rted

Please do not include in the hard copy submission or send electronically.

 

ELECTRONIC FILES:

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


Note:  Submission should include identical documents as that submitted in hard copy format.  Do not merge the electronic file into 1 PDF file (send as separate documents).

 

 

 Submitting Amendments for Review

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

Follow these steps:

  1. 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.)
  2. Revise applicable materials (e.g. protocol, consent form, questionnaire) with changes highlighted (e.g. bold, italicize, underline)
  3. Scan any material not available electronically (e.g. Instruments)
  4. Separate and name documents for easy identification by reviewer.
  5. E-mail cover letter with rationale for amendment and revised materials attached to:   Gregory Staios (Gregory.Staios@camh.ca) 

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

 

ANNUAL RENEWALS: 

Hard copy submission:
Please submit hard copies (1 original plus 13 copies) of Annual Renewals and new Protocols to:  33 Russell Street, Room T1053
 

Date and sign as usual and make 14 double-sided and stapled copies (original binder-clipped).

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


 

 

 Final Reports

 

Note:  There is no monthly deadline for this report.

 
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 14 double-sided copies (1 original plus 13 copies).

Final Reports should be submitted in paper form in 2 copies (1 original + 1 copy - signed).  Both original and copy need to have supporting documentation attached.
 
We recommend that you submit double-sided copies of Final Reports and 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 Toronto area affiliated 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 (checklist included) and an electronic copy sent to Gregory Staios (Gregory.Staios@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 T1053
TORONTO ON M5S 2S1
Attention: Gregory Staios

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