Overview

Applying to the Chaminade IRB has two stages. Principal investigators and all personnel working on the study must complete human subjects training, for which they receive certification. Once certified, the principal investigator submits an application form to the IRB with required supporting documentation.

Who may submit an application? Only certain personnel at Chaminade may act as principal investigators on IRB protocols. Because PI responsibilities involve direct interaction and supervision of the research team, the PI must be a current employee or student of the University who is operating within their University role to oversee the conduct of the study. Because IRB studies require long term storage and availability of data resulting from the study, and accountability for long term follow-up (including adverse event reporting) by participants, the position of PI is not compatible with an adjunct appointment due to its temporary nature. The following individuals may serve as PI:

Faculty members: All categories of faculty members may serve as PI if their School allows them to serve as Principal Investigator on applications for sponsored funding administered through the University. Adjunct faculty of the University, including lecturers and instructors, are not permitted to serve as a PI or Faculty Mentor but may serve as co-investigator.

 Staff: Other University staff may serve in this role if they have appropriate qualifications to conduct the research and if they have obtained approval to conduct the research from their immediate supervisor.

 Students: Students may serve as principal investigators for their own research projects and are responsible for submitting the IRB application. However, when a student is listed as the PI, a faculty mentor must be listed on the protocol submission. Note: The IRB reviews and holds student research projects to the same standards as human subject research conducted by faculty or staff. IRB approval or exemption must be obtained prior to initiating any research activity under IRB oversight. “Retroactive” IRB approval or exemption is not permitted under federal regulations and University policy. Failure to obtain IRB approval for research with human subjects may preclude the use of the previously collected data and could result in other institutional sanctions.

FAQ

 I’m not sure if my research constitutes Human Subjects Research. What should I do?

Check the Guidance Document on examples of IRB-reviewable and non-reviewable research. Fill out Form I and submit it for Determination. Note that only an IRB can make this determination, Federal regulations and the CUH IRB Charter state that the individual investigator may not. This means that if you intend to do human research at Chaminade, you must submit Form I to the IRB. You may not determine whether your research requires IRB approval yourself.

My research would be exempt but it includes minors. What should I do?

Use Form III. There are no exemptions for work that include vulnerable populations.

What does Exemption mean?

It’s a common misperception that exemption refers to the project not requiring IRB approval. This is not the case. It simply refers to the project being ‘exempt’ from the full review process, which is more time consuming and in depth. Exempt research still cannot proceed without an IRB approval letter. Guidance on Exemption Categories and the criteria for Expedited Review can be found here and here.

What does it mean if my research is not determined to be Human Subjects Research?

You may go ahead without IRB approval. If your protocol changes such that new activities are added that constitute research, you must fill in Form II or III and gain approval before starting.