Pacific's 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 conducted by, or under the supervision of, Pacific faculty, staff or students at any of the campuses, other academic sites, or off-campus. In addition, Pacific IRB is responsible for reviewing protocols for research projects conducted on any of the three campuses by individuals unaffiliated with Pacific. To conduct this responsibility effectively, Pacific upholds the IRB standards for all three campuses, which is the governance body authorized and competent to review research and research methods, training and other activity protocols involving human subjects and to evaluate both risk and protection against risk for those individuals. The IRB serves all Pacific faculty, staff and students, regardless of location.
Determining Whether the Project Needs to be Reviewed by the IRB
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. Pacific IRB uses the federal criteria at 45 CFR 46 to determine what requires IRB review. Therefore, the first question we ask is does the project meet the definition of human subject research.
Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The general rule is that if there is any element of research in an activity, that activity should undergo IRB review to ensure the protection of human subjects. For example, some demonstration and service programs may include research activities.
Human Subject: Living individuals about whom an investigator (whether professional or student) conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies,or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (45 CFR § 102(d)(1))
You may also call our office directly at (209) 946-2565 or e-mail irb@shorinji-kempo.net to discuss your study and any questions you may have.
Human Subject Research Training
It is Pacific policy that each individual conducting research, collecting information/biospecimens/data, working in research labs, recruiting subjects, or serving on a thesis/dissertation committee with human subjects be trained in human subjects research history, ethical principles, federal, state and local regulations, and general institutional review board procedures. This means any individual working as an assistant on a project who will be handling information/biospecimens/data or working in a research lab must also be trained as well as any faculty serving as a thesis/dissertation committee member when the student is doing research involving human subjects. It is preferred that all faculty who teach research methods courses involving human subjects also keep current with training and incorporate Pacific's IRB procedures and review timeline in class discussions. 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 by affiliating with University of the Pacific and complete the Social Behavioral or Biomedical training here: citiprogram.org.
Submitting Your IRB Research Application
- IRB Applications can be found at http://pacific.cayuse424.com
- Review the IRB Investigator's Manual (login required)
- Complete the CITI training
Note: Review categories are ultimately decided by the IRB. Duration of review will be extended if modifications to application are requested.
