Title 45 Part 46 - Protection of Human Subjects. Submit the completed form together with written documentation of prior external IRB review and approval. Submit the completed forms together with all pertinent documentation. If, after expedited review, the Chair determines that a project does not qualify for exempt status, the principal investigator will be required to complete all pages of the protocol and resubmit it together with any pertinent documentation for full Board review. Submit the completed forms together with all pertinent documentation.
Informed consent is an essential element in almost all human subjects research.
It is the principal investigator's responsibility to ensure that the subject has been given sufficient information to decide whether or not to participate in the research, that the subject has a clear understanding of the proposed research, and that the consent to participate is voluntary. Completed forms must be signed by the principal investigator. Protocols should be sufficiently self-explanatory so that IRB members have adequate information to form a clear understanding of the proposed research.