Institutional Research Board

Q1: Are services from the Institutional Research Board (IRB) available?

A1: The IRB office remains fully functional from remote locations. Dr. Larry Shattuck (x2473), Mr. Bryan Hudgens (x2039), Ms. Rikki Nguyen (x2998) and Mr. Scott Ramos (x2043) are available to assist vis telephone, or to meet virtually through Zoom, MS Teams and/or Collaborate. 

Q2: What guidance is applicable to all IRB protocols regardless of status or type? 

A2: Investigators should follow the procedures specified in the approved protocol (or the protocol that will be approved).

If procedures cannot be followed, contact the IRB before modifying the approvals for instructions on how to proceed.

Investigators are authorized to modify procedures if the approved procedures would, for any reason, place a participant at risk of harm.

Per IRB policy, investigators must report unanticipated problems involving risks to subjects or others (UPIRTSOs) promptly. This includes any UPIRTSOs related to the COVID-19 crisis. Any problems or risks resulting from the COVID-19 crisis and impacting protocols that do not formally address the COVID-19 crisis are, by definition, unanticipated under that protocol.

Q3: What guidance is applicable to IRB protocols using online surveys or pre-collected data/secondary information? 

A3: In general, protocols continue as planned. Researchers should follow the data transfer and data storage procedures specified in the approved protocol.

Q4: What guidance is applicable to IRB protocols involving face-to-face interaction with participants? 

A4: In addition to obtaining approval from the NPS IRB, approval for conducting human subjects research involving face-to-face interaction must also be obtained from the Provost. Researchers are expected to comply with guidance disseminated by the Provost, NPS President, DON, and DOD.

Recommendation: when possible, change physical face-to-face interactions to virtual interactions, which do not require prior approval from the Provost. For those without a waiver of documented consent, ask participants to sign a consent form or submit an amendment to the IRB for a waiver.

Rules and requirements include:

• Screening participants prior to the study, which does not need IRB approval.  To be enrolled in a study, all potential participants must confirm that they do not have flu-like symptoms, fever or a cough; and have not been in contact with anyone, including healthcare workers, suspected of or confirmed to have contracted COVID-19.
• All equipment used must be thoroughly sanitized before and after use.
• Social distancing rules apply as well as the current limitations on the number of people in a group. 

Q5: What impact will this have on my thesis?

A5: If student research is impacted and a thesis cannot be completed due to restrictions, discuss with thesis advisors on how to complete and/or modify the thesis plan, and contact the IRB for guidance.