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Designing excellent clinical research takes experience and a good mentor is always helpful. However, a great place to start is to follow the guidelines laid out by the CONSORT and STROBE statements.
Submit any materials that will eventually go to the UW IRB to Lisa Flint (206-543-7817; email@example.com) for departmental review and approval. Dr. Domino assigns faculty reviewers and reviews all materials and responses.
Research is reviewed according to the potential level of risk to subjects and federal regulatory guidelines.
If anything needs to change - complete and submit a "Modification Form" to the IRB. Approval must be received before the change is implemented.
If there are any problems with the research, inform the IRB using a "Problem Report Form" as soon as possible (in some cases, this must be done within a specific time frame).
Once approved by the IRB, the research must be reviewed at least annually.* This involves the preparation and submission to HSD of a "Status Report Form" at least 6-weeks before the anniversary of the last IRB approval.
*The IRB can require review more frequently where there are specific concerns. Exempt research does not need to undergo continuing review.
Please remember to keep the Department informed of all active IRBs, renewals, and when terminated.
If all research-related activities with human subjects have been completed, and all data collection and analysis of identifiable private information described in the IRB-approved research plan have been finished, then the human subjects research study has been completed.
When a human subjects research study has been completed, the investigators no longer are required to obtain continuing review and approval of that study by the IRB. UW researchers should inform the IRB that a study has ended by selecting "CLOSE IRB Application" on the "Status Report Form" that is submitted following the end of the study.
Once a study has been completed, investigators may keep the data they collected, including identifiable private data, if consistent with the IRB-approved research plan. Investigators should continue to honor any confidentiality protections of the data, as well as any other commitments that were agreed to as part of the approved research (e.g., providing information about the study results to research subjects, or honoring commitments for compensation for research participation).