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Ethics Review Process: Research Ethics Committees

Review by a Research Ethics Committee

Pursuant to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) (Articles 6.1 to 6.12), ethics review by the full Research Ethics Board (REB) is the default requirement for research involving human participants.  However, the REB can authorize the delegation of ethics review to an individual or individuals for research of minimal risk.

According to the TCPS2 (Chapter 2,Section B) minimal risk is defined as "the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research then the research can be regarded as within the range of minimal risk".  Research that poses "greater than minimal risk" to participants must be reviewed by the full REB.

At UW, each application for ethics review of human research is reviewed by the Director or a Manager of the Office of Research Ethics (ORE). However, certain projects will be referred to a Research Ethics Committee for ethics review and clearance.  UW has two Research Ethics Committees:  the Human Research Ethics Committee (HREC) and the Clinical Research Ethics Committee (CREC).   For further guidance on the ethics review mandate of the committees see the guidance document.

The Human Research Ethics Committee reviews research ethics applications that involve:

The Clinical Research Ethics Committee reviews clinical research ethics applications.  A clinical research ethics application reviewed by the CREC involves

Applications for studies that include an investigational drug, investigational natural health product, or investigational medical device are reviewed by full committee as required by Health Canada.  Investigational includes "off-label use" and "new-indication".

Researchers may also clarify whether or not their project meets the criteria for full Committee review by contacting the ORE.  The ORE receives over 850 applications per year; approximately 8% of the applications submitted to the ORE are reviewed by a full committee or a sub-committee, while the remaining 92% are reviewed by the Director or a Manager.

Researchers will be notified via phone call or email if a decision is made to refer their project for full Committee review.

 

Terms of Reference

The Human Research Ethics Committee (HREC) is comprised of 16 members with membership determined by the terms of reference for the Committee.

The Clinical Research Ethics Committee (CREC) is comprised of 8 members with membership determined by the terms of reference for the committee.

 

Meeting Dates, Submission Deadlines, and Process

Each Committee meets once a month except in the month of August. Submission of applications for review by a REC are to be received by the ORE 3 weeks prior to its meeting date. An email notification will be sent by the ORE to researchers whose projects will be reviewed by either the HREC or CREC.

Researchers are to provide the copies of their application** if their project is to be reviewed by a REC, however they first submit the standard 2 copies to the ORE.   Usually, an application that will go to Committee undergoes a screening by the ORE, hence researchers should not make the copies of their application for full committee until the ORE has advised them to do so.   Revisions or additional materials may be required due to the initial review.  The number of copies to be provided by the researcher is 16 for HREC and 8 for the CREC.

Copies of the applications are to be double-sided (within sections as listed below) and delivered to the ORE 9 days prior to the meeting day.  Researchers are to ensure that all copies of the application are complete.

**The term "application" is defined as:

The application package should be assembled in the following order:

HREC MEETING DATES APPLICATION DEADLINES
Thursday September 22, 2011 Thursday September 1, 2011
Thursday October 20, 2011 Thursday, September 29, 2011
Thursday November 17, 2011 Thursday October 27, 2011
Thursday December 15, 2011 Thursday November 24, 2011
Thursday January 19, 2012 Wednesday December 23, 2011
Thursday February 16, 2012  Thursday January 26, 2012
Thursday March 22, 2012 Thursday March 1, 2012
Thursday April 19, 2012 Thursday March 29, 2012
Thursday May 17, 2012 Thursday April 26, 20112
Thursday June 21, 2012  Thursday May 31, 2012
Thursday July 19, 2012 Thursday June 28, 2012

Note: No meeting in August

 

CREC MEETING DATES APPLICATION DEADLINES
Tuesday September 6, 2011 Tuesday August 16, 2011
Tuesday October 4, 2011 Tuesday September 13, 2011
Tuesday November 8, 20101 Tuesday October 18, 2011
Tuesday December 6, 2011 Tuesday November 15, 2011
Tuesday January  10, 2012 Tuesday December 20, 2011
Tuesday February 7, 2012 Tuesday January 17, 2012
Tuesday March 6, 2012 Tuesday February 14, 2012
Tuesday April 10, 2012 Tuesday March 20, 2012
Tuesday May 1, 2012 Tuesday April 10, 2012
Tuesday June 5, 2012 Tuesday May 15, 2012
Tuesday July 10, 2012 Tuesday June 19, 2012

Note: No meeting in August

 

REC Access to Standard Operating Procedures

Standard operating procedures (SOPs) for various research procedures have been developed.  Some are available on the website while others are accessible by CREC and HREC members on the sharepoint site.

 

 

Last updated on January 25, 2012