The NPS IRB has jurisdiction over all research involving human subjects. A human subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. No human subject research in any form can take place without proper review and approval by the NPS IRB and NPS President. The NPS IRB is authorized to review, recommend approval to the NPS President, require modifications in, or withhold approval or suspend approval of research involving human participants. For a list of specific human research protection instructions and regulations reference NAVPGSCOL Instruction 3900.4A (authentication required).
Temporary Office Hours
Mon: 1100 - 1700
Tue-Fri: 0830 - 1500
Rikki Nguyen is out of the office and will return 1 DEC.
send questions and submissions to
IRB@nps.edu or contact Norma Reyes.
"About What" and "About Whom"
When determining if an individual is a human subject the IRB considers if the information being collected is "about what" or "about whom." "About what" information is usually collected when the focus of the research is not a person but a thing such as a system, policy, process, etc. "About whom" data is usually collected when the focus of the research is how something affects or affected a person such as their reactions, feelings, opinions, etc.
Here is an 'about whom' example. We are asked to evaluate a system by examining the cognitive workload of an operator. We collect cognitive workload data (e.g., NASA-TLX). The system is the stimulus that creates the workload but the data we are collecting is the cognitive workload of the operator. The cognitive workload is the subject of the research and therefore this data collection activity would be considered 'about whom.' Alternatively, if we ask an operator about the workload required by two different systems based on their designs, that is more likely to be an "about what" question. We are not collecting workload data on the person to whom the question is asked.
Is Your Interview or Survey Research "About Whom"?
One component of the definition of "human subject research" is that the study must involve the collection of information about one or more living individuals. That is, the study must be entirely or partly "about whom," as opposed to being solely "about what." If the study is wholly "about what," it is not human subject research, and it does not require IRB review.
See the NPS IRB Interview and Survey Guidance Sheet for more information.
The IRB stores its records as required by 32 CFR 219.115. These records include the IRB protocol files, policies and procedures, review agreements, etc. Storage of records produced during the research, including signed consent forms, data, and research notes is the Principal Investigator (PI) responsibility. Effective 1 JUL 13, the NPS Office of Human Research Protections (OHRP) will no longer collect and store these records on behalf of the PI.
DON Records Management Program requires that all research records be stored as "project case files" for 10 years after completion and then be forwarded to a Federal Records Center. For additional information please see page III-3-55, paragraph 5 Project Case Files of SECNAV M-5210.01.
|IRB review and approval is not required.
If you are unsure if human subjects are involved submit a determination request form.
|Complete a determination request, attached research proposal and any data collection tools (ex: survey questions).
The IRB will determine if human subjects are involved and notify you.
|Complete an IRB application package.
Research activities may not begin until IRB and NPS President approval is provided.
For information about the IRB review and submission process or to submit a IRB application contact Mrs. Rikki Nguyen, HRPP Specialist, at 831-656-2998, email@example.com. All other questions can be addressed to Dr. Larry Shattuck, (831) 656-2473, firstname.lastname@example.org.