Protocol Outline [1]
Protocol Outline Template
A protocol is a detailed plan of every aspect of the research study. It outlines the following information:
- Scientific basis for the project
- Study objectives
- Subject population(s)
- Methodology (study procedures)
- How data will be managed (data security plan)
- Evaluations and analysis plan
- Safety management and regulatory issues
The IRB provides a template protocol [2]as guidance for what to include in a study protocol. The revised template includes prompts to provide specific information that will be requested in the HawkIRB New Project form.
Template Options
The Human Subjects Office Protocol Outline Template [2] can be used for Phase I or non-clinical trials
Phase II-IV clinical trials should use the FDA/NIH Clinical Trial Protocol Template [3]. There is also a Behavioral and Social Science Research protocol template on this page of the National Institutes of Health (NIH) website.
Separate Protocol Note Required
The IRB requires a separate, written protocol when the study is identified as a clinical trial. The IRB reserves the right to request other physiology or clinical trial like research submit a protocol if the study is of a complex nature. The description of the study design and procedures in the HawkIRB application in those cases would not be sufficient. Applications for IRB-01 (biomedical) and IRB-03 (VA Health Care System) have a question (Section VII.B.11) asking whether there is a study protocol. If so, it must be attached to the HawkIRB application in the appropriate attachment category. If the project is a clinical trial, the IRB may request a separate, written protocol.
The IRB-02 (social/behavioral/educational research) application does not have Section VII.B, so there is no question about a separate, written protocol. However, researchers can still attach a protocol in the Miscellaneous attachment category.