FAQs: Human Research Protection and the IRB

The IRB is an autonomous administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities.

A human subject is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102(f)(1),(2)) ​

Faculty or staff members qualified by experience and or training may serve as principal investigators. Students may serve as a student PI on student initiated studies but will still be required to have a faculty member serve as PI. Students must also be in good academic standing to participate in scholarly activity..​

Federal regulations define research as “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”. (45 cfr 46.102(d))

Exempt research are studies with human subjects that present no more than minimal risk to subjects and fit into one or more of the exempt categories of research described in the regulations at 45 cfr 46.104. Note: exempt research still undergoes a review process to determine whether exemption applies. The review process must be completed through the electronic IRB management system.

Expedited research are studies with human subjects that present no more than minimal risk to subjects and fit into one or more of the expedited categories of research described in the Federal Regulations at 45 cfr 46.110 ​

A waiver of documentation of consent may be requested when the following are true 1) the research involves no more than minimal risk 2) the waiver of informed consent will not adversely affect the rights and welfare of the subjects; and 3) it is not practicable to conduct the research without the waiver; 4) whenever appropriate, the subjects will be provided with additional pertinent information after participation. (45 cfr 46.116(c)) ​

IRB applications are submitted via PNWU’s electronic submission and tracking software:

• Internal PNWU employees and students: https://shib.axiommentor.com/pages/irb/info.cfm​
• External Partners: https://www.axiommentor.com/pages/home.cfm​
• Institution ID: PNWU

You may request assistance with your application by emailing the IRB Administrator at research@pnwu.edu or osa@pnwu.edu ​

PNWU requires completion of an appropriate level of Collaborative Institutional Training Initiative Training (CITI) in human research protections. The level of training will depend on the type of research that will be conducted. Most training is valid for four years from the date of certification and must remain current throughout the period of the study.  Note: Investigators with certain types of funding have additional training requirements. These could include financial conflict of interest training, responsible conduct of research training that includes at least 8 hours of face-to-face training, and Good Clinical Practice training if the study is a qualifying clinical trial as defined by NIH.​

All members of the study team who will interact with study participants or have access to identifiable data or coded data that can be re-identified need to complete training in human research protections. ​

Principal Investigators are required to keep the IRB informed about their research. This includes submission of a study closure request when the study is completed.

Studies should closed when one of the following are true: ​

• All research/clinical investigation activities, including data analysis and reporting are complete ​
• The Principal Investigator never initiated the study ​
• The Principal Investigator plans to leave the University and intends to continue the research at another institution ​

Studies cannot be closed if one of the following are still occurring: ​

• Subjects are still being followed up with ​
• Identifiable data (including data with codes or links to identifiers) are still being analyzed

Studies that undergo a Full Board Review are required to submit continuing review. Studies that undergo Expedited Review may or may not be required to submit continuing review. Expedited studies that are not required to submit continuing review, and Exempt studies will be required to submit an Annual Check in form to the IRB.

Principal Investigators are required to keep the IRB informed about their research.  This includes any changes made to the research regardless of the review level (Full Board, Expedited, or Exempt) ​