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Frequently Asked Questions



  1. Do I need to submit an application to the REB?

  2. What counts as research?

  3. How does the REB review protocols?

  4. What research qualifies for expedited review?

  5. Who reviews my proposal?

  6. Who decides who reviews my proposal?

  7. Where do I find specific information on the REB?

  8. Why does the REB review the study budget?

  9. How do I find out the status of my protocol application?

  10. Where is the REB located?

  11. What is the Federal Wide Assurance (FWA) number for this institution?

  12. Where can I find information about the REB fee?

  13. May I submit documents for REB review and approval via CAPCR or should they be submitted to the REB office directly?

  14. Can a participant be given new information, which may influence their current consent prior to REB approval?

  15. Why is there often more than one set of questions during a review?


 
1. Do I need to submit an application to the REB?

All research involving human subjects or confidential patient information within the University Health Network (UHN) requires approval of the UHN REB prior to the initiation of a research project.

Investigators from other institutions who wish to carry out research on UHN premises or with UHN patients or patient data must also apply to the UHN REB.

 

2. What counts as research? top

The definition of research is outlined in the Tri-Council Policy Statement . In summary, human research is considered to include any of the following, if the researcher:

  • will administer a drug, take a blood sample, do a test or perform any procedure, clinical, therapeutic, or otherwise, upon the person of himself/herself or someone else, for research rather than treatment
  • will ask people information whether by telephone, letter, survey, questionnaire or interview
  • will review information from patient charts (even their own patients' charts) for research rather than clinical purposes
  • will use material derived from people (tissue samples, blood, DNA)
  • will be using non-public records (e.g. not the telephone book) which contain identifying information about anyone either directly or indirectly
  • will use information previously gathered about anyone, even if anonymized (secondary data analysis)
  • will be observing anyone's responses or behaviour, either directly or indirectly 

If you cannot determine whether an intended investigation constitutes research (for instance, quality assurance studies do not constitute research), contact the Chair of the REB or one of the Ethics Coordinators for assistance.

 

3. How does the REB review protocols? top

In accordance with the Tri-Council Policy Statement , the UHN REB conducts a proportionate review of research protocols: that is, the scale of the review is in accordance with the type of research proposed and with the potential for harm that the research may pose.

 

4. What research qualifies for expedited review? top

Some research protocols will qualify for expedited review. The decision to expedite a research project is made by the Chair of the REB. Some of the criteria for expedited review are listed below:

  • protocols involving minimal risk or protocols where there are minimal incremental risks over standard procedures
  • minimal risk protocols where data are collected non-invasively such as questionnaires or direct/indirect observation
  • protocols primarily using previously-collected data such as chart reviews and database information
  • protocols using previously-collected tissue or other samples

 

5. Who reviews my proposal? top

There are 5 review committees. The committee to which a certain proposal is directed for review depends on the following:

  • the subject of the research proposed
  • the scientific expertise of the committee
  • and, in the case of the two equivalent General Review Committees, the current workload of each committee

The Chair of the UHN REB, or a delegate reviews proposals qualifying for expedited review.

 

6. Who decides who reviews my proposal? top

Decisions as to which committee receives each proposal are made by the Chair of the REB in consultation with REB Coordinators.

 

7. Where do I find specific information on the REB? top

The REB policy statements: Operating Procedures and Terms of Reference, are the official statements of REB policy and guidelines and may provide the information you need.

For further assistance contact the REB office at 416-581-7849 or via email at rebsubmissions@uhnresearch.ca.

 

8. Why does the REB review the study budget? top

According to the Tri-Council Policy Statement (TCPS) Article 7.3 “REBs shall examine the budgets of clinical trials to assure that ethical duties concerning conflict of interest are respected” .

The UHN REB examines the budgets of clinical trials for very specific reasons and does this from the perspective of: feasibility, coercion, and conflict of interest. For further explanation, please see the Budget Review document.

 

9. How do I find out the status of my protocol application? top

Contact the REB office at 416-581-7849 or via email at rebsubmissions@uhnresearch.ca.

 

10. Where is the REB located? top

700 Bay Street, LuCliff Place, 17th Floor 1700-1, Toronto Ontario, M5G 1Z6

 

11. What is the Federal Wide Assurance (FWA) number for this institution? top

FWA # A00000518

 

12. Where can I find information about the REB fee? top

The REB fee is neither levied by the REB nor received by the REB. It is levied and collected by Research Support Services, and is used to partially offset the costs incurred by Research Support Services in providing support to the REB. Contact the UHN Grant and Services office for further details at gcs@uhnres.utoronto.ca.

 

13. May I submit documents for REB review and approval via CAPCR or should they be submitted to the REB office directly?

Q. I understand that all initial submissions to the REB must be submitted via CAPCR. May I submit any other documents, e.g. annual, amendment, unanticipated event form etc, for REB review and approval via CAPCR or should they be submitted to the REB office directly?

A. Only initial submissions must be submitted to the REB via CAPCR. All other submissions, e.g. annual, amendment, unanticipated event form etc, must be submitted for REB review and approval to the REB office directly at rebsubmissions@uhnresearch.ca

 

14. Can a participant be given new information which may influence their current consent prior to REB approval?

Consent is an ongoing process and participants should be provided with any and all new information that may influence their consent.

New information may be provided, verbally or otherwise, to participants prior to receiving REB approval if the Principal Investigator:

  • determines it to be in the best interests of already consented participants (i.e. to eliminate or reduce any apparent immediate hazards to study participants)
  • documents the process
  • submits all new information and documentation to the REB for confirmation of agreement as soon as possible within seven days.

15. Why is there often more than one set of questions during a review?

It is the nature of research that answers often lead to more questions, and the REB review element of research is no different.

An REB review is an iterative process between the PI and the REB, which continues until such time as all elements have been satisfactorily addressed.

In the course of review, information provided by the study team may result in requests from the REB:

a) to modify elements of the study

b) for more information

At the conclusion of the review, the REB will provide one of the following decisions concerning the study:

a) Approved

b) Not Approved

c) Approval Not Required

Please see see the following webpage (only accessible to those within UHN) describing the review process: http://intranet.uhnresearch.ca/service/understanding-review-process

 


   
 

 
 
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