Human Subject Research Protocol Submissions
Project Review and Approval Requirements
When a principal investigator (PI) plans to conduct research that uses human subjects and/or data about human subjects, he or she must obtain (1) permission to perform that planned work from the PI's chain of command, (2) an approval recommendation from the Naval Academy's IRB, and (3) an approved decision from the Academy's Superintendent before any research participants can be recruited, any informed consent forms can be distributed, any data collection or data analysis can begin, etc. These requirements apply to all projects and studies that directly or indirectly involve human subjects and/or the data about them. Questions as to the applicability of these requirements should be addressed to the Academy's HRPP office.
Quality assurance, process improvement and assessment activities, including surveys, interviews and focus groups, undertaken to evaluate the strengths and weaknesses of a program, to identify "best practices", to evaluate educational endeavors and/or to monitor success in achieving the goals of a project may or may not meet the definitions of "research" and "human subject research" provided in federal regulations, adhered to by the Department of the Navy, and incorporated into the Academy's HRPP policies and procedures. Questions as to the applicability of these policies and procedures should be addressed to the Academy's HRPP office.
All proposed human subject research projects, regardless of the level of risk, must be approved by the Academy's Superintendent prior to the selection of participants for the project, the distribution of informed consent forms, the collection of any human subject data, and/or the analysis of any datasets.
Protocol Submission and Review Process
The initial entry point for obtaining an approval recommendation of the proposed project via the Academy's IRB process, and an approved decision on the project by the Superintendent to perform the planned work is via a protocol submission to the Academy's IRB. Detailed information on the components of a protocol submission is available from the Academy's HRPP office.
After a complete protocol submission has been received by the Academy's HRPP office, the Academy's IRB review process will commence.
- Projects that appear to involve negligible or low risk to the human subjects and the data about them (i.e., the "Exempt" category in the human subject research classification system) and projects that appear to involve minimal risks to the human subjects and the data about them (i.e., the "Expedited" category in the human subject research classification system), can be reviewed by the Chair or Vice Chair of the Academy's IRB, outside of a convened meeting of the IRB.
- Projects that involve or may involve greater than minimal risk to the human subjects and the data about them (i.e., the "Full" category in the human subject research classification system) must be reviewed during a convened meeting of the Academy's IRB.
Protocol Submission Information
Please contact the Academy's HRPP office at HRPPoffice@usna.edu.