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

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

3. There are three streams of delegated review:

1. 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 Application Form for Prospective Studies involving Low Risk to Families or Staff .
2. Retrospective chart reviews/secondary use of clinical data.  The Application Form for Retrospective Chart Review and Secondary Use of Clinical Data must be submitted.
3. Databases.  The Application Form for Databases Analyses must be submitted.

4.  Please submit the original and one copy 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 each document stapled individually and then black-clipped or bound in elastics in collated packages.  Only complete applications will be accepted.

 

 

 

 

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Guidance With Respect To The Distinction Between Quality Assurance And Research.

 

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.

 

 

 

 

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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