Skip to content
  • Print
return to Research and Scholarship

CONTACT US

Human Subjects (IRB)
(209) 946-3903
irb@pacific.edu
Knoles Hall, 2nd Floor, Room 204

Valerie Andeola
IRB Administrator
Gilbert Ojeda
IRB Program Specialist

Human Subjects - Institutional Review Board (IRB)


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 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))  

Complete the Human Subject Research Worksheet- This worksheet is designed to help you determine and record whether your research project constitutes research involving human subjects pursuant to federal regulations. You may not conduct research involving human subjects without IRB approval. Submit completed worksheet to IRB@pacific.edu for formal determination.

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 and complete the training here: https://www.citiprogram.org/.

Submitting Your IRB Research Application

  • Complete Human Subjects Research Worksheet to obtain a formal determination ( IRB forms can be found here)
  • Review the IRB Manual 
  • Complete the CITI training 
  • Complete IRB Application and submit to IRB@pacific.edu

IRB Review Category Timeline
EXEMPT REVIEW: "Exempt Review" refers to research activities that meet very specific criteria established by DHHS as human subject research exempt from certain regulatory requirements. The research activities may be eligible for Exempt Review if there is minimal risk to research subjects and the only involvement of human subjects falls into one of the specific Exempt Categories (pursuant to 45 CFR § 46.104). Exempt Review does not mean that the investigator is exempt from filing the documentation necessary for the IRB to review and document the research.

Duration of Review: 1-3 weeks

EXPEDITED REVIEW: Research projects not eligible for Exempt Review may be eligible for Expedited Review if the research involves minimal risk. DHHS has established a list of categories of research deemed to involve minimal risk that may be reviewed by the IRB through Expedited Review, unless the review determines the research involves more than minimal risk. The full list of categories of research that may be expedited are listed in the IRB Investigators Manual. Unless determined otherwise by the reviewer, the IRB will use the Expedited Review process: (1) if some or all of the research falls into one or more of the categories below and involves no more than minimal risk to subjects; (2) for minor changes in previously approved research during the period for which IRB approval is authorized; and (3) for Limited Review of exempt research activities.
Duration of Review: 3-4- weeks

Full Review: Research which involves more than minimal risk to the human subjects is not eligible for Exempt or Expedited Review, and will require Full Review by the IRB. Any research which involves children, prisoners, individuals with impaired decision-making ability, or economically or educationally disadvantaged persons or individuals who may be subject to high risk must be provided Full Review of the IRB at a regular IRB Committee Meeting. Any research involving more than minimal risk to children requires Full Review.

Duration of Review: 4+ weeks

Note: Review categories are ultimately decided by the IRB. Duration of review will be extended if modifications to application are requested.

Amending your Protocol
Complete Protocol Revision Form and submit to IRB@pacific.edu.  Any changes made to a study must first be approved by the IRB prior to implementing any change.  Failure to notify the IRB of changes or implementing a change before the IRB grants approval is considered noncompliance and will be handled pursuant to the IRB Noncompliance Policy.

Event Reporting/Non Compliance 
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. Complete the Report of Noncompliance form and submit to IRB Administrator at vandeola@pacific.edu

Cooperative Research
In order to avoid duplication of effort the University of the Pacific will accept documented review and approval by another institution's IRB when appropriate, through satisfactory completion of the Cooperative Research Agreement.  The lead institution's authorized Institutional Review Board will review cooperative research between the University of the Pacific and other universities or research institutions.  The lead institution is generally the primary grantee or contractor for funded projects and/or home institution for one or more of the principal investigators.  Complete and submit the Cooperative Agreement form to IRB@pacific.edu after obtaining the necessary signatures from the lead institution, along with necessary documentation of review/approval from lead institution.  Required documentation includes, completed cooperative agreement form, approval letter from lead institution, original approved protocol and copies of CITI training.

Questions?
Email inquiries to irb@pacific.edu. Access our IRB Newsletter here!


Attend one of our Human Subjects Research, IRB Workshops:
Friday, September 29th 12-1PM - DUC 211 A&B
Thursday, October 26th 2-3PM- DUC 211 A&B
Thursday, November 16th 10-11AM- Dugoni 214-2B
Thursday, December 14th 2-3PM- DUC 211 A&B
Thursday, January 18th 10:30-11:30AM- McGeorge HR Training Room
Thursday, March 15th 3-4PM- DUC 211 A&B

RSVP to IRB@Pacific.edu  

Not able to attend one of our scheduled workshops? Request a classroom or department training by sending request to IRB@pacific.edu.  One-on-one training is also provided as requested!