Human Subjects
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 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 (available for download in the Manuals and Forms table below).
Human Subject - "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).
Training
Pacific requires Human Subjects Training for all individuals on all three campuses who wish to use Human Subjects in their projects. You can receive training through an 
on-line tutorial offered by the National Institutes of Health (NIH).
Principle Investigators Association CD-Roms for loan:
- IRB Boards and Qualitative Research: Insider Guidance for IRB Forms, Informed Consent
- Research, Safety, and Ethical Issues Involving Children and Adolescents
If you are interested in checking-out a CD-Rom, please contact Leah Vargas, lvargas@pacific.edu.
Submitting your application
It is preferred that protocol be signed and scanned as PDF documents, then emailed to Leah Vargas, IRB Administrator. If paper copies are submitted, only one copy is needed for all protocol.
Manual and Forms
IRB Manual |
|
Human Subjects Activity Review Form |
|
Informed Consent Template |
|
Protocol Revision Form |
|
Continuation/Final Report Form |
|
Cooperative Agreement Form |
|
PDF
Word
IRB Category Review Timeline
Category |
Duration of Review* |
Exempt |
1-2 weeks |
Expedited |
2-4 weeks |
Full
|
4+ weeks or more |
*Review categories are ultimately decided by the IRB.
To determine which category your research falls under, please refer to page 22 in the IRB Manual available above. For interviews please refer to Expedited number 6 to determine whether your research is Exempt or Expedited.
IRB Newsletters
Fall 2011 |
|
Spring 2012 |
|
Cooperative Agreements
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, avaialble above, 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.