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). The tutorial is available at: http://www.pre.ethics.gc.ca/english/tutorial

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Submitting Protocols for Review

Please provide one original and 17 copies of the Human Subjects Research Application Form PLUS 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 C/F 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 17 copies of the entire protocol, together with one (1) copy of each investigator's curriculum vitae (Principal Investigators AND Co-Investigators), unless these CVs have been submitted to the Research Ethics Office within the last year.
  • Electronic versions of investigator CVs are preferred; single copies can be e-mailed to Loretta_Wong@camh.net

PHIPA Requirement of Research Plan

Under PHIPA privacy legislation, any investigator who is proposing to conduct research without explicit patient consent must provide a research plan as outlined below, unless all items are covered by the completed TAHSN protocol form. A research plan must include:

• The affiliation of each person involved in the research.
• The nature and the objectives of the research and the public or scientific benefit of the research that the researcher anticipates.
• A description of the research proposed to be conducted and the duration of the research.
• A description of the personal health information required and the potential sources.
• A description of how the personal health information will be used in the research, and if it will be linked to other information, a description of the other information as well as how the linkage will be done.
• An explanation as to why the research cannot reasonably be accomplished without the personal health information and, if it is to be linked to other information, an explanation as to why this linkage is required.
• An explanation as to why consent to the disclosure of the personal health information is not being sought from the individuals to whom the information relates.
• A description of the reasonably foreseeable harms and benefits that may arise from the use of the personal health information and how the researchers intend to address those harms.
• A description of all persons who will have access to the information, why their access is necessary, their roles in relation to the research, and their related qualifications.
• The safeguards that the researcher will impose to protect the confidentiality and security of the personal health information, including an estimate of how long information will be retained in an identifiable form and why.
• Information as to how and when the personal health information will be disposed of or returned to the health information custodian.
• The funding source of the research.
• Whether the researcher has applied for the approval of another research ethics board and, if so the response to or status of the application.
• Whether the researcher's interest in the disclosure of the personal health information or the performance of the research would likely result in an actual or perceived conflict of interest with other duties of the researcher.

 

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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 CAH 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:

Susan_Pilon@camh.net (CC Loretta_Wong@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) tutorial which can be accessed through http://www.pre.ethics.gc.ca/english/tutorial. Researchers who have already completed the NIH course may also wish to take the new TCPS course but this is not mandatory. EACH member of the research team must complete the course and supply the CAMH Research Ethics Office with a copy of their 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 grant application has been successful and funds have been awarded.  Investigators are free to submit their protocols prior to notice of grant 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 submission should include:

• • One original and 17 copies of the entire protocol, together with one (1) copy of each investigator's curriculum vitae (Principal Investigators AND Co-Investigators), unless these CVs have been submitted to the Research Ethics Office within the last year.
  • Electronic versions of investigator CVs are preferred; single copies can be e-mailed to Loretta_Wong@camh.net
  • If the protocol involves any type of advertising, the REB requires 18 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. Many thanks for your assistance with this matter.  
• 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).  

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