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Human Subjects - Institutional Review Board (IRB)

OUR NEW SOFTWARE IS LIVE.  PLEASE SUBMIT ALL PROPOSALS AT:   

https://pacific.cayuse424.com

If you have not completed a prior application with the IRB pre-cayuse please fill out the Cayuse Access Request Form:  https://cwrasdadsa.wufoo.com/forms/zto3f5m0l4uutd/   

Cayuse tutorial: Cayuse Research Suite

Interim IRB policy
Ver. 03/20/2020
Like everyone else affected, the COVID-19 crisis is forcing adjustments to the Institutional Review Board for Human Subjects Protection (IRB) current daily routines.
We first hope you all are taking proper care and wish health and wellness for all in the coming days and weeks. We also have to provide guidance on how you can navigate and move forward with your research.
To minimize risk and to protect research participants and investigators while following the Governor’s stay at home order, the University of the Pacific is requiring all investigators to put all human-subjects research on hold unless the research can be done remotely. If you are unsure whether or not you can conduct your research, please contact us at irb@pacific.edu.
If you already have provisions within your protocol for gathering remote information, you may continue your protocol as is. If you do not have that provision however, please submit a revised protocol form to include remote access. You can access the revision form on the ORSP: https://www.pacific.edu/academics/research-and-scholarship/office-of-research-and-sponsored-programs/human-subjects.html
Due to delays in research you may need to file a revised protocol form to extend the project beyond the original approved date.
We ask for your understanding as we navigate the COVID-19 outbreak and are grateful for your continued support and partnership.
Please feel free to direct any questions to irb@pacific.edu.


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) 946-3903 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: https://www.citiprogram.org/.

Submitting Your IRB Research Application

Upcoming Meeting           Materials completed in Cayuse by:
July 19 July 5
August 16 August 2
Fall meetings to be determined  
 

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


Amending your Protocol

 Amending your Protocol will now be completed through the Cayuse Software going forward.  If you have an older study you may input your study into the new software if you would like, but old forms will be acceptable for amendments.

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@Pacific.edu . To report noncompliance anonymously, you may complete and submit the Report of Non-Compliance form to ethics@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?
See our Frequently Asked Questions

IRB Forms

IRB Resource Material


[Required in supplement with all research applications involving surveys]


Exempt Review Protocol (Research using Surveys)