Research Requiring Ethics Review
 

University of Manitoba's Commitment to Tri-Council Statement

The Tri-Council Policy Statement 2:  Ethical Conduct for Research Involving Humans (TCPS) describes the policies of the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSCERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC).  The joint Policy expresses the three Agencies continuing commitment to the people of Canada to promote the ethical conduct of research involving human subjects.

The University of Manitoba is committed to complying with the intent of the TCPS 2 with respect to ethic and ethical conduct for research involving human subjects.


When is Research Ethics Approval Required?

In accordance with the University of Manitoba policies, any undertaking in which a university affiliated faculty, staff or student investigates and/or collects data on human subjects for research purposes must be approved by a University of Manitoba Research Ethics Board (REB) prior to implementation.  This includes research carried out on University premises or conducted elsewhere.

If you are a Winnipeg Regional Health Authority (WRHA) researcher who is either (i) employed by the WRHA or have a written contract for service with the WRHA; or (ii) have privileges under the WRHA's Medical Staff By-Laws and are conducting your research at facilities owned by or operated by the WRHA or under the direction of the WRHA you may also submit or in some cases be required by WRHA to submit your research to a University of Manitoba REB.

How is Research defined?

The definition as per University of Manitoba Policy 1406 used in determining if an activity needs prior REB approval is as follows:

Human Research refers to any project that involves the collection of specimens, data or information from persons, through intervention or otherwise.  Included are procedures that have a low degree of invasiveness (e.g. survey, interviews, naturalistic observations, exercise or psychometric testing, examination of patient records) as well as more invasive procedures (e.g. blood sampling, insertion of a cannula, administration of a substance).

This includes all types of research conducted with human subjects.  Specifically, prior ethics review and approval is required when research data are derived from, but not exclusively restricted to:

  1. information collected through intervention or interaction with a living individual(s);
  2. identifiable private information about individuals;
  3. human organs, tissues, body fluids and/or
  4. written or recorded information derived from individually identifiable human subjects.  In addition, ethics review is required for the following categories of research that may be overlooked or raise questions about the necessity for such a review:
  • Pilot studies and feasibility studies, even those involving only one human subject require the same scrutiny as full-scale research projects involving many subjects.
  • Projects that involve the secondary use of data on human subjects gathered in earlier projects.
  • Research conducted by administrative and academic units that involves the collection of survey replies or the use of records as correlates of survey replies from human subjects, e.g. students, staff and/or faculty members.
  • Research projects in which the researcher is a consultant unless the researcher has a strict consulting relationship which: (a) the researcher is hired on his or her own time, (b) the researcher holds no rights in the work; and (c) neither the researcher nor the University retains any data.  If any one of these criteria is not met, prior ethics review and approval is required.
  • All graduate and undergraduate independent student research projects conducted in partial fulfillment of degree requirements.


When is Research Not Subject to REB Review?

Prior ethics review and approval from an REB will not normally be required for:

  • A limited type of research most often found within the humanities, fine arts, and in some historical research which involves: (a) a public database where aggregated data that cannot be associated with any individual are obtained; and/or (b) information already in the public domain (e.g. autobiographies, biographies or public archives).  Nevertheless, it is the responsibility of the researcher to ascertain that any information used from these sources is presented in an accurate fashion.
  • Archival analysis of records by University departments normally engaged in the collection, maintenance and analysis of such records.  Nevertheless, it is incumbent on such units to ensure that the anonymity of individuals and confidentiality of their records are maintained.
  • Class research projects which involve human subjects and which are conducted by students on other members of the class as exercises to learn how to conduct research.
  • Per article 1.1. (d) of the TCPS, quality assurance-type evaluations or internal audits conducted within the domain of the custodians of the data being evaluated do not need to undergo REB review.  However, if the project has an element of research or if the project involves an issue that is sensitive in nature, it may need to be submitted to the REB.  Many research journals will require evidence of ethics approval for such studies and such can be submitted to the board.
  • The researcher should seek the written approval of the REB Chair that ethics approval is not required.
     
TRI-COUNCIL POLICY STATEMENT 2-Ethical Conduct for Research Involving Humans      
University of Manitoba Policy 1406 - 
Ethics of Research Involving Human Subjects
           
UNCERTAIN IF ETHICS APPROVAL IS REQUIRED 
The researcher must seek the written opinon of the REB Chair by sending  a one page summary of the proposal to the REB office.  
WILL THE REB GRANT RETROACTIVE APPROVAL FOR QA or CHART REVIEW STUDIES?
Retroactive approval will NOT be granted in any circumstances.  If there is any possibility that the data generated may be interesting enough to consider publishing, the recommendation is that REB approval be obtained BEFORE the project is initiated.                                     
ADDITIONAL REQUIREMENTS FOR INTERNATIONAL RESEARCH
If you are planning to conduct research with human participants outside of Canada, the Tri-Council Policy Statement (Article 1.14) requires ethics approval at your institution and by an ethics board, where such exsists, in the country where the research will be conducted.  To find out more about this requirement, get in touch with REB staff.  

Remember to factor in extra time for obtaining ethics approval from international ethics bodies often known a Institutional Review Boards (IRBs) or Research Ethics Committees (RECs).