Research at University Health Network
 
Technology Transfer
Menu Level 3  
   

UHN-REB Home

 

Guidance & Standards Maintained by the UHN-REB
UHN-REB ensures that studies subject to its review conform to the ethical principles of ethical considerations outlined in the following requirements, as applicable to the study under review:

  • The Tri-Council Policy Statement: Guidelines on Research  Involving Human Subjects (TCPS-2)
  • The International Conference on Harmonization: Good Clinical Practice (ICH:E6)
  • Health Canada's Food & Drug Regulations
  • Personal Health Information Protection Act (PHIPA) 2002
  • Personal Information Protection and Electronic Documents Act (PIPEDA) 2004
  • US Department of Health and Human Services: Office for Human Research Protections (OHRP) 2007
  • US Department of Health and Human Services FDA Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRB (2009)

UHN-REB Mission Statement
In the context of the TCPS-2, UHN-REB subscribes to the following ethical principles that are held and valued by diverse research disciplines:

    CTO seal
  • Respect for human dignity
  • Respect for free and informed consent
  • Respect for vulnerable persons
  • Respect for privacy and confidentiality
  • Respect for justice and inclusiveness
  • Balancing harms and benefits

 

 

What's New
April 24, 2013

New Educational Presentation Available

Overview of Amendment, Renewal, and File Closure Submissions to the REB: Click Here

February 1, 2013

Updated Consent Form Guidance Document

Click Here

August 1, 2012

New Amendment and Administrative Change Requirements

Please note that the UHN REB has overhauled its guidance and forms related to the submission of amendments and administrative changes.

The changes include substantially revised guidance and forms, and the introduction of a new Administrative Change Form.

The REB will start accepting submissions on the new forms effective immediately, but a grace-period will apply for reports submitted on older reporting forms. These new requirements will become mandatory as of September 24th, 2012.

August 1, 2012

Changes to REB Application Process for Prospective Studies

Please note that as of September 24th, 2012, the UHN REB will retire the paper copy of the TAHSN application form and its associated guidance documents. Effective September 24th, 2012 all new studies must be submitted through the CAPCR process and electronic system. The CAPCR electronic system incorporates the TAHSN application form questions, among other questions from a number of other reviewing departments, services and committees.

May 1, 2012

Changes to REB Application Process for Retrospective Studies

Please note that as of May 1st, 2012, the UHN REB has retired its "Retrospective Data Studies" and "Retrospective Tissue Studies" application forms and their associated guidance documents. Effective May 1st, 2012 all retrospective studies (irrespective of whether they involve data, biospecimens, or both) must be submitted through the CAPCR process and electronic system.

Later this year, UHN will require that all studies be submitted through the CAPCR process and electronic system. In the meantime, the UHN REB highly encourages researchers to submit all new studies via CAPCR.

For new prospective studies, if you are not submitting via CAPCR or are submitting to the UHN REB's Rehabilitation Medicine and Science Review Panel (formerly "TRI REB"), please see the Application Forms page for the appropriate versions of the TAHSN form to complete and submit.

November 23, 2011

New Unanticipated Problem Reporting Requirements

Please note that the UHN REB has overhauled the process for the reporting of unanticipated problems, including adverse events and protocol deviations.

The UHN REB has prepared a guidance document to explain the new reporting requirements, as well as a new form. These documents are intended to provide a new, consolidated framework for reporting unanticipated problems to the UHN REB.

Additionally, a "Letter to Sponsors" from the UHN REB Co-Chairs is now available for use by UHN sites in informing Sponsors of the new REB requirements.

These reporting requirements are now mandatory. We thank all of those who attended presentations at the UHN sites for their constructive feedback and carefully considered

questions.

 

 

 

 


   
 
 
 
Home Researchers Facilities Support Services Programs Commercialization Ethics News About UHN Institutes OCI Techna TGRI TRI TWRI hyperlink to UHNResearchnews Facebook page hyperlink to UHNResearch Twitter feed