Human Subjects - Institutional Review Board (IRB)
In accordance with federal regulations, Pacific assumes the responsibility for the protection of the rights and welfare of human subjects who participate in research and other projects conducted by, or under the supervision of, University faculty, staff, or students. In addition, the IRB is responsible for reviewing protocols for projects to be conducted on any of the three campuses by outside individuals.
Determining Whether the Project Needs to be Reviewed
All research projects, whether funded or unfunded, directed or co-directed by the University's faculty, students, or staff in which human subjects participate, are subject to the federal regulations governing such research, and to the policies and procedures outlined in the IRB Manual.
"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. "Intervention" includes both physical procedures by which data are gathered (ex: venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. "Interaction" includes communication or interpersonal contact between investigator and subject (ex: surveys, interviews, and observations).
CITI training is required for all investigators (faculty, students, and staff ) submitting new protocols, revisions, continuation reports, etc. will be required to complete this training every three years. All personnel involved in human subject research, including assistants and thesis/dissertation committee members, advisors and unit reviewers are also required to complete this training every three years.
Certification is active for three years, upon which a refresher course will be required as well as in year six. After nine years the full course must be completed if you are still engaged in research involving human subjects. Certification is tracked by the administrator online, however final scores should be submitted to the IRB administrator for proof of completion.
Note that there are required modules within the course, and several optional modules. The IRB reserves the right to request any researcher to take one or more of the optional modules, if the IRB feels that the module is pertinent to the researcher's project.
Create an account and complete the training here: https://www.citiprogram.org/
Submitting your application
IRB Review Category Timeline
|Review Category||Duration Review|
Review categories are ultimately decided by the IRB. To determine which category your research falls under, please refer to page 24 in the IRB Manual.
Report of Noncompliance
Noncompliance is the failure to comply with, or a deviation from, an approved IRB Human Subjects Activity Review Form or other approved IRB protocols, institutional policies, laws, and federal regulations regarding the Protection of Human Subjects found in Title 45 Code of Federal Regulation Part 46. Questions, please contact Valerie Andeola, IRB administrator 209-946-7716. The noncompliance form can be accessed on our Policies and Forms page.
If you wish to remain anonymous and report noncompliance, please complete the noncompliance form, print and send via campus mail to Research & Graduate Studies, attn: IRB Administrator.
In order to avoid duplication of effort, cooperative research between Pacific and other universities or institutions will be reviewed by the lead institution's authorized IRB. The lead institution is normally the primary grantee or contractor for funded projects and/or home institution of the principal investigator. Pacific will accept documented review and approval by another institution's IRB when appropriate. The Cooperative Research Agreement form should be completed for any research that has been approved by another IRB and submitted with the approved IRB protocol to Pacific's IRB Administrator.