Researchers use study protocols to provide specific details about the study, including background, purpose, study design, safety assessments and analysis plan.  If a formal protocol does not exist, the IRB may require the UI investigator to supply one (e.g., an investigator initiated study or a complex study)  The UI IRB recommends using an NIH Protocol  Outline Template for Phase I, Phase II-III, or Behavioral and Social Science Research (BSSR) Involving Humans.  The NIH and FDA provide a Protocol Template tool for creating a Protocol.   Information described in the HawkIRB application must be consistent with the corresponding protocol.  

Please refer to the UI Operations Manual,  UI IRB Standard Operating Procedures & Researcher Guide  (Section II Part 1.A, Part 18.A., and Part 19.A.), and The Point for assistance in aligning the protocol with the institutional guidelines.  

Phase 1 or non-Clinical Trial:  For studies that involves a Phase 1 clinical or therapeutic intervention, see  Protocol Outline template. 

Phase II-III Clinical Trials:  For the FDA/NIH draft protocol template for Phase II through III trials, use the Phase 2 and 3 Clinical Trials that Require FDA-IND or IDE Application.  

Behavioral and Social Science Research (BSSR) Involving Humans Protocol Template:  Template for  behavioral and social science researchers prepare research protocols for human studies measuring a social or behavioral outcome or testing a behavioral or social science-based intervention, use the Behavioral and Social Science Research (BSSR) Involving Humans protocol recommended by NIH.