How to Submit an Application

Applications will not be considered until all relevant information for the review is complete. A complete application includes the application form, protocol, consent form(s) (as necessary), all supplemental material (e.g., questionnaires and other assessment tools), the most recent investigators brochure for clinical trials, the allocated budget and any other relevant correspondence. In addition, other supplemental material necessary for the decision process should be provided before the review. Such supplemental material may include advertisements for recruitment, preclinical information from animal studies depending on the phase of the clinical trial, and any correspondence from other sources that might be pertinent to the review (such as the details from any other ethical reviews that have been carried out by other Boards). The primary cause of delay in ethics approval is incomplete information.

E-mailing Submissions to the REB

Please note that the REB will start accepting all types of submissions via e-mail on August 10, 2011. We hope to fully transition to receiving submissions via e-mail by the end the year. 

While you still have the option to submit in hard copy, we encourage you to make use of this mode of submission. In addition, to avoid confusion and delays in processing your submission, we ask that you adhere to only one method of submission (e-mail OR hard copy) for each of your submissions.

If you would like to take advantage of this change and choose to e-mail submissions to our office we request that you follow these steps (depending on the nature of your submission):

Where to Submit

All submission should be sent to

• If the e-mail submission is too large and your mail client refuses to send the submission, please attach documents to the UHN Research File Portal
  (Please note that this option is only available to you if you have access to the UHN Intranet)

What to Submit

For detailed information on what to submit (documents, application forms, etc.) consult the relevant pages for the different types of submission. Initial submission requirements are listed below. If submitting via e-mail, only one e-mail with one copy of each of the documents listed is required.

How to Submit via E-mail

Please see below for specific instructions on how to  e-mail us the different types of submission:

- Initial Review Submissions (New Applications)

- Continuing Review Submissions (Amendments, Renewals, Terminations, Unanticipated Problem Reports, Informational [DSMB reports, etc.], Responses to REB review)

Initial Review Submissions (New Applications)

• Please include the type of submission in the SUBJECT Line of your e-mail (e.g. — Full Board TAHSN, Delegated TAHSN, Chart Review, or Tissue Submission). 
  
  
• Attach all required documents to your e-mail software (e.g. — Microsoft Outlook, Mozilla Thunderbird). Please include in the body of your e-mail a list of the documents you have attached. 
  
  
  • Ensure that a scanned copy of the application form that contains signatures of the PI (unless PI is submitting), Department Head, and Co-Is (if applicable) is attached. 
    
    
• Please note that the REB WILL NOT accept new study applications under any of the following situations: 
  
  
  • PI of the study is not a UHN PI
    
    
  • PI signature is missing from the submitted application form 
    
    
  • Protocol is missing from submission

Continuing Review Submissions (Amendments, Renewals, Terminations, Unanticipated Problem Reports, Informational [DSMB reports, etc], or Responses to REB Reviews)

• Please include the type of submission in the SUBJECT Line of your e-mail submission e.g. — Amendment, Renewal, Termination, Unanticipated Problem Report, Informational [DSMB, etc.], or Responses to REB Reviews).
  

• Ensure that the REB # of your study is included in the SUBJECT line of the e-mail e.g. —
  01-0001-B_Amendent. 
  
  

• Failure to do the above will result in the REB office returning the e-mail back to you for the inclusion of the REB #
  

• Attach all required documents to your e-mail software (e.g. — Microsoft Outlook, Mozilla Thunderbird). Please include in the body of your e-mail a list of the documents you have attached.
  
  
• Submissions can be e-mailed by either the PI or any member of the study team:
  
  
  • the PI may submit using his/her UHN e-mail address (PI signature not required in this case)
    
    
  • Study team may submit a scanned, signed PDF copy with all supporting documents if the PI is unable to submit using his/her UHN e-mail address

What should I include with my application?

Full Board Review:

Submit 6 collated hard copies of the research submission of the TAHSN application form including the original copy with signatures. Each of the 6 complete submissions should include:

• Application form with appropriate signatures
• Study protocol
• Consent form(s) (if applicable)
• Study budget
• 4 copies of the most recent Investigator Brochure, Product Monograph, or Device Manual (if relevant)
• All supplemental material (e.g., questionnaires and other assessment tools)
• Any other relevant correspondence.

Delegated Review:

Submit 2 collated hard copies of the research submission of the TAHSN application form including the original copy with signatures. Each of the 2 complete submissions should include:

• Application form with appropriate signatures
• Study protocol
• Consent form(s) (if applicable)
• Study budget
• 2 copies of the most recent Investigator Brochure, Product Monograph, or Device Manual (if relevant)
• All supplemental material (e.g., questionnaires and other assessment tools)
• Any other relevant correspondence.

Delegated Review for Access to Retrospective Patient Data: Research Requests - Multidisciplinary (Non-Oncology)

Submit 1 hard copy of the Application for REB Approval to Access Retrospective Data for Research Purposes or Access for Administrative Purposes form with original signatures and 1 copy of the application directly to the REB office for review. Include all relevant documents with the submission (e.g. — data collection forms, budget, study summary).

Delegated Review for Access to Retrospective Patient Data: Research Requests - Oncology

Oncology Research requests must be submitted to the PMH Cancer Registry Data Access Committee (CRDAC) for approval prior to review by the UHN REB. Once CRDAC has approved the application, CRDAC will notify the Principal Investigator of the approval and will forward the PI a notification of approval letter. CRDAC will notify the REB of approval and will forward the original application to the REB office for review. Once approved by the REB, an REB notification of approval letter will be mailed to the PI.

Please contact CRDAC for more information.

Where can I get help?

For general inquiries please contact the REB administrative office at 416-581-7849.

I want to start my research project ASAP. What can I do?

Note that the primary cause of delay in ethics approval is incomplete information. Be sure to provide copies of all supplemental material necessary for the decision process: e.g. — advertisements for recruitment, preclinical information from animal studies (depending on the phase of the clinical trial), and any correspondence from other sources that might be pertinent to the review.

All e-mail submissions should be forwarded to:

All hard copy submissions should be forwarded to:

UHN Research Ethics Board Office
Hydro Building, 700 University Avenue
10th Floor North, Room 1056
Toronto, Ontario
M5G 1Z6