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FAQs

Application Deadline

When is the application deadline for full-board and delegated studies?

Budgets
Whom can I contact for guidance on developing a budget for a research study?

Case Reports
Does a case report require REB approval?

Clinical Trials Ontario
Who is the Institutional Representative?

Contracts and Agreements
How do I know when a contract or agreement is required for a research study?

Data Retention/Storage
How long do I have to keep study-related records after the study is completed?

Electronic Files
How do I know if my documents/folders/files are on the secure server versus my desktop (i.e. my computer, network places)

Grants
For funding applications to the Canadian Institutes for Health Research, who should sign for the president or principal of the institution, and the dean of faculty or the director of the institution?

Health Canada

  1. When is a clinical trial application (CTA) required to be filed to Health Canada? *Updated October 2012
  2. For investigator-initiated clinical trials, what is the submission order when you have a clinical trial application (CTA) to Health Canada and a research ethics board application? *Updated October 2016
  3. For investigator-initiated clinical trials, who is the "contact person for sponsor" on the Clinical Trial Site Information (CTSI) form (items 13 to 18)? *Updated October 2016
  4. For an investigator-initiated clinical trial application (CTA), who signs as the senior executive officer? *Updated October 2016
  5. My study is regulated under an Investigational Testing Authorization (ITA) and I submitted an amendment to the Research Ethics Board. How do I know when Health Canada approval is also required?
  6. For CTA/ITA studies, I know when a new No Objection Letter (NOL) is required, but when is an updated ITA required?

Health Canada Authorization

Does the REB require a copy of the Health Canada authorization (e.g. NOL, NOA, ITA)?

Health Data Resources

1. Once I obtain ethics approval for my retrospective chart review study, how can I obtain the paper charts or access the electronic personal records? *Updated November 2012
2. Is there a cost associated with chart retrieval and refilling for research?
3. What is the cost of photocopying?

Informed Consent Form
1. How can I check the language level of an informed consent form to ensure that it is a suitable reading level? *Updated November 2012
2. Where do I file signed informed consent forms? *Updated November 2012
3. How can I get my informed consent form on Sunnybrook letterhead?
4. Who can approach or make initial contact with potential research participants during recruitment?
5. Who can obtain informed consent from research participants?
6. Do I need to obtain consent for a survey research study?

Laboratory Services
How can I get a copy of the laboratory license at Sunnybrook for the regulatory files of a study?

Legal
What is the appropriate legal entity to be used for regulatory or other official documentation related to a research study?

Protocols
What is a protocol and tips for protocol development?

Is your project QI or Research?

REB Applications
1. For investigator-initiated clinical trials, what is the submission order when you have a clinical trial application (CTA) to Health Canada and a research ethics board application? *Updated October 2016
2. Who can I contact for guidance when completing an research ethics board application?
3. What other types of identifying information that may be collected, used or disclosed during a research study have to be listed on the research ethics board application?
4. Can residents or fellows be local principal investigators at Sunnybrook?
5. Why did the Sunnybrook research ethics board change from expedited review to delegated review?
6. What happens to a research ethics board application after it is submitted to the research ethics office?
7. For Practiced Based Research (PBR) Award Recipients, who is the most appropriate person to sign the REB application? 

REB Fees
What are the fees for submitting to the REB?

REB Review types

Full Board vs. Delegated review\

Research results and medical records

Can research data/results be included in a patient’s medical record?

        Trial Registration
        1. How do I register my clinical study on ClinicalTrials.gov?
        2. How do I know when registration is required for a research study?

          Regulations
          What regulations are investigators required to follow with respect to responsible conduct of research? 

          Research Equipment
          What is the approval process for bringing equipment into the hospital for research purposes? 

          Secondary Use of Data
          When do you need REB approval for "secondary use of data"?

          Study Closure

          How do I know if I should close my study with the REB?

            Terminology
            1. What is the difference between a principal investigator, co-investigator and sub-investigator?
            2. Online Resources
            3. Alphabet Soup: The Acronyms Used in Human-Subjects Research Ethics in Canada