1.    Protocols that present only minimal or very low risk to subjects are reviewed by the Chair or a subcommittee of the Board.  Low risk is ordinarily taken to mean those risks normally encountered in everyday life by the average individual.

2.     The turn-around time upon receipt of completed submissions that receive expedited review is generally within three (3) weeks. Submissions that are incomplete or require modifications will necessarily delay this process. 

3.      There are two streams of expedited review:  

• Retrospective chart reviews/secondary use of clinical data and databases.  No authorizing signatures are required other than those of the CHEO investigator(s).  The Research Ethics Board Application For Retrospective Chart Review and Secondary Use of Clinical Data and Databases must be submitted. (See page 37).

• Research projects involving minimal risk that proposes a prospective collection of data involving families or staff.  The appropriate authorization from the manager responsible for the staff or the clinical population involved in the study is required.  Please use the application form Research Ethics Board Application for Prospective Studies involving Low Risk to Families or Staff (see page 39).

4.    Please submit the original and two copies of the application, protocol and applicable documents for review.  Please ensure that all questions are answered in full.  Materials should be double-sided and pages numbered consecutively; collated in complete packages, and stapled or black-clipped in complete packages (not paper-clipped).  Only complete applications will be accepted.

The Distinction between Quality Assurance and Research

The REB overseas all human research conducted at or through the hospital.  In defining its scope, the REB adheres to Tri-Council definition of research as a systematic investigation to establish facts, principles, and generalized knowledge.  This is distinct from quality assurance activities that are intended to assess the performance of an organization or its staff, within the mandate of the organization.  Recognizing that there can be overlap between these two concepts, the REB should be consulted to determine whether or not a specific activity constitutes research.

The Interagency Advisory Panel on Research Ethics PRE has provided guidance on the distinction between quality assurance and research.  The Panel states that quality assurance studies may share characteristics with research and in fact, may use scientific methods.  In quality assurance, however, the data are used to advance the needs and functioning of the organization.  By contrast, in research, data are used to answer a scientific question.  The primary distinction between research and quality assurance is therefore, in their respective objectives, rather than the methods used.  Studies that intend to disseminate their findings beyond the organization are more typically categorized as research.  This is because it is difficult to assert that the data will only serve the internal purposes of the organization when there is a clear intent to disseminate the results.

Definition of Secondary Analyses of Clinical Data

The secondary use of data refers to the use in research of clinical data generally contained in health records and collected in the provision of care.  Common examples are patient records or biological specimens, originally obtained or produced for therapeutic purposes, but subsequently used to address scientific questions. The ethical obligation to respect privacy and confidentiality requires that researchers and REB’s exercise caution in the secondary use of clinical data toward research ends. The Provincial Personal Health Information Protection Act of Ontario (PHIPA) sets forth the following requirements in this regard:

• The scientific question being asked is valuable and justifiable

• Appropriate measures are being taken to protect the privacy of the individuals, to ensure the confidentiality of the data, and to minimize harm to subjects;

• The patients regarding whom the data refer will not be directly contacted by the researchers without their prior express and informed consent

• Identifying information will not be released to researchers outside the hospital without the patient’s express and informed consent  

•  Individuals to whom the data refers have not previously objected to such secondary use

 Procedures for Database Analysis Projects

Database Analysis refers to the use in research of data contained in a previously created data set, whether it is retrospective or prospective. Database projects often use the same data set to answer a different research question. In these circumstances the REB would request that the following procedures be used when submitting a Database Analysis study.

• Are to be submitted using the Retrospective Chart Review application.

• An authorization is required from the appropriate division head from which the database information would be extracted.

 The data abstraction form or the list of data fields to be collected should be appended to this form. The CHEO unique number rather than the patient's name should be retained for subject identification.  This allows projects to fall into compliance with the existing hospital privacy policies. The data if lost or stolen would therefore, be de-identified. 

Databases are often used to produce multiple publications.  In view of this, the REB now requires that investigators submit a general description of the project including all the elements specified above (study rationale, identifiers to be retained, etc.).  The overall database project is then approved and each publication or sub-study is treated as an additional component that must be described by investigators in an addendum to the application.  For instance, in a database looking at job satisfaction of REB staff (protocol number 000X), a study looking at the quality of life of REB chairs would be treated as a sub-study (protocol 000Xa).  In this example, the quality of life study would be described in a one-page summary submitted to the Board for approval.