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Guidelines for delegated research protocols
 
Protocols that present only minimal or very low risk to participants 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 participant.

There is no submission deadline for delegated reviews; they can be submitted at any time. The turn-around time upon receipt of completed submissions that receive delegated review is generally within six (6) weeks. Submissions that are incomplete or require modifications will necessarily delay this process.

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. Complete the Application Form for Prospective Studies involving Minimal Risk (e.g.; Surveys, Quality of Life Questionnaires, Non-Invasive Procedures).

2. Retrospective chart reviews/secondary analysis of clinical samples. Complete the Application Form for Retrospective Chart Review and Secondary Use of Clinical Data or Biological Samples.

3. Databases. Complete the application for Prospective Studies Involving Minimal risk in Romeo.
 
4. Record Level Requests from the BORN Datasets - complete the application in Romeo.
 
5. Prescribed Entity or Prescribed Registry  - complete the application in Romeo.

Applications are to be submitted using Romeo.  If you have not received Romeo training, please email Elizabeth Gillis. To access Romeo, please use your user name and password.
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