FAQs - Research
Frequently Asked Questions
Answer: The Federal Regulations definitions:
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for this policy.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
(1) data through intervention or interaction with the individual, or
(2) identifiable private information.
If your research involves any of the following you are strongly recommended to obtain an official IRB determination.
- Administer a questionnaire or survey
- Conduct focus groups or interviews
- Observe human performance directly or indirectly (e.g. online, crowdsourcing, or through analysis of information systems)
- Audio or video record activities of humans
- Use of secondary information or biospecimens that contains any information about individuals and that is not available to the general public (i.e., cannot be obtained via a Google search)
- Test any equipment in which humans serve as users
Per SECNAVINST 3900.39E only the NPS IRB Chair and Vice Chairs can determine if an activity involves human subject research.
Answer: That depends on the nature of your study and the characteristics of the people you intend to recruit. Allow two weeks to prepare your IRB application package. Below is a list of the estimated time to complete IRB review and NPS President approval.
- Minimal risk research – 3 weeks
- Greater than minimal risk or special populations – 6 weeks
- International research – 10 weeks
Answer: You must receive written approval from the IRB and NPS President before beginning subject recruitment, data collection, or data analysis. A package including the approved protocol and an approval letter will be sent to you via e-mail.
Answer: No. IRB review and approval is required for all human subject research meeting an exempt category. Only the IRB Chair has the authority to make exemption determinations.
Answer: In general, yes, but there are some limited exceptions. The IRB has the authority to waive some or all of the Federal requirements for informed consent in certain extenuating circumstances. The NPS IRB is responsible for ensuring that basic ethical principles are abided by in all research. The expectation that the informed consent of research participants be obtained is based upon the Belmont Principle of respect for persons, and regarded as extremely important in conducting ethical research.
Answer: Not always. In certain situations (all involving no more than minimal risk) the IRB can waive the requirement that you obtain the participant's signature on the consent form. An example is if you are conducting a online survey or a phone interview. Requests for a waiver of documented consent are submitted with the IRB application package.
Answer: Yes. NPS IRB and NPS President approval is required to conduct human subject research regardless of where the research takes place. You should also be aware that your project may need IRB approvals in addition to NPS if the research is being conducted in another location.
Answer: Yes. All research involving human subjects conducted by NPS personnel requires NPS IRB and NPS President approval.
Answer: Something that is truly anonymous has no known name or identity or known source. For research to be considered anonymous, no identifiers of any kind (e.g. name, code number, etc.) are used that can link the data or information to the individual who provided it. In contrast, research data that contains identifiers that link individual participants with their information, need to have appropriate provisions that protect confidentiality. The researcher has been entrusted with private information and is responsible for addressing how sensitive information will be protected.
Answer: For protocols that do not full board require review (i.e., exempt and expedited protocols), there is no specific deadline for submission. These protocols are reviewed as they are received.
Answer: Any changes to the protocol, including consent forms, questionnaires, research personnel, number of participants recruited, additional research sites, must be submitted to the IRB for review and approval before implementation. To request modifications, revise your initial protocol submission by completing parts 1 and 3.