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).
Who can decide if an activity involves human subjects?
Per SECNAVINST 3900.39D, only the NPS IRB Chair and Vice Chairs can determine if an activity involves human subjects. Faculty, students, and staff cannot make this determination. If the activity involves any of the following an IRB determination should be requested.
- Administer a questionnaire or survey.
- Conduct interviews or focus groups.
- Observe human performance directly or indirectly (e.g., online, through analysis of info systems, crowdsourcing, etc.) with or without individuals’ knowledge.
- Audio or video record activities of humans.
- Use pre-collected data that contains any information about humans.
- Test any equipment in which humans will serve as users.
"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"?
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.
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, firstname.lastname@example.org. All other questions can be addressed to Dr. Larry Shattuck, (831) 656-2473, email@example.com.