In addition, the Principal Investigator must keep the IRB informed of any adverse events during the term of the project. The Principal Investigator must complete a final report. Each protocol is reviewed in depth by two primary reviewers who are provided with all of the internal forms as well as the full protocol, consent form, and Drug Brochure, if available. These reviewers present a detailed review of the protocol at the IRB meeting and provide a written review for the administrator as well. All other Board members receive the internal forms, detailed abstract and a consent form.
All members contribute comments on the protocol if they have any.
All comments are collated and a letter is sent to the investigator with all of the changes required. Include both a medical title and a lay title. Explain research purpose and design in lay terms. Use study design section to describe all procedures. Add a comprehensive risk profile and pregnancy addendum when applicable.