Institutional Review Board
The purpose of the Institutional Review Board (IRB) at Trinity Health West Region is to protect the rights and welfare of subjects participating in research. It is the policy of Trinity Health West Region that the involvement of human subjects and/or their data in research is not permitted until the IRB has reviewed and approved the research protocol regardless of the source of funding and including student and GME sponsored research activities. This means that no contact with subjects, including recruitment and obtaining consent, or their data can be initiated until the research has been approved. Furthermore, unless the consent process has been specifically waived by the IRB in accordance with 45 CFR 46.116, and the Health Insurance Portability and Accountability Act (HIPAA), no subjects may be included in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. All ethically minded individuals should take an interest in protecting the rights and welfare of research participants, without whom we could not advance our knowledge.
Contact Information
IRB Chair: Dr. Lisa M. Nelson
IRB Vice-Chair: Dr. Phillip Kim
IRB Specialist: Julie Bird
IRB Phone: 208-367-6350 | Fax: 208-367-6821
Address:
SAHS: 1055 N. Curtis Road, Boise, ID 83706
SAMC: 1303 E. Herndon Ave., Fresno, CA 93720
Saint Agnes FWA#: 00033057
Saint Alphonsus FWA#: 00007980
Fee Schedule
- Initial Review of a New Study – Full Board $3500
- Initial Review of a New Study - Expedited $1500
- Annual/Continuing Review – Full Board $1000
- Annual/Continuing Review – Expedited $1000
- Amendment Full Board $1000
- Amendment - Expedited $500
- Study Closure – Full Board No Fee
- Study Closure Expedited No Fee
- Resident/Student/Exempt Research No Fee
IRB Fees Waiver Request
If a PI feels the IRB review fee imposes an undue hardship, they may submit a written request to waive the fee. A waiver will be considered when funding is limited, and the fee will impede the conduct of the clinical research study. The waiver request may be approved or disapproved by the IRB. The waiver request must contain the following information for consideration:
a. A summary of the study objectives and procedures
b. The final clinical study budget summary
c. Justification for the waiver of the fees for IRB review
Schedules & Deadlines
Trinity Health West Region Institutional Review Board (IRB)
2026 MEETING DATES AND SUBMISSION DEADLINES
Meeting dates may change due to scheduling conflicts- please call the IRB office to verify meeting dates.
The IRB study submission deadlines are four weeks before the day of the scheduled IRB meeting.
IRB Contact Information
Email
Phone: 208-367-6350
All research study staff will require IRB Manager access, as each member of the study team is required to provide their electronic signature on financial conflict of interest as well as a confidentiality agreement.
How to Access IRB Manager
One Aegis – formerly called IRB Manager
The Trinity Health West Region IRB submissions platform can be accessed here.
IRBM Submission Instructions
For IRB Manager Submission Instructions, please consult the IRB Manager Handbook here
For additional information, please contact the IRB Specialist: Julie Bird.
Any submissions made to the IRB need to be made electronically. IRB submissions include:
1. New Research Application
2. Continuing Review Application
3. Amendment Request Application
4. Internal Adverse Event and Unanticipated Problem Submission Form
5. Personnel Change Request Application
6. Protocol Deviation Report
7. Non-Human Subjects Research (NHSR) Determination Request
How to Determine if Your Project is Quality Improvement or Research?
Sometimes individuals may not be sure if the project they plan to undertake is research, which does require IRB review and approval, OR, quality improvement, which does not require IRB review and approval.
Quality Improvement is the combined and unceasing efforts of everyone – health care professionals, patients and their families, researchers, administrators, payers, planners, educators – to make changes that will lead to better patient outcomes, better system performance, and better professional development.
Research is a systematic investigation in a clinical setting designed to develop or contribute to generalizable knowledge (the Common Rule definition of research).
The IRB does not have purview over quality improvement projects. It is the responsibility of the investigator to make this determination prior to initiation of their project and the IRB offers the following worksheet to facilitate this determination. Although not a requirement, its use is recommended as a means to document the determination prior to starting the project. Please that the IRB will not render a research determination decision after a project has started or been completed. The worksheet is not used for those projects that are known to meet the definition of research, such as, Clinical Trials that test the use of a test article, device or biologic in human subjects.
If upon completion of the checklist it reveals that your project is a quality/process improvement project, then you do not have to submit anything to the IRB. Retain the completed checklist within your project files for future reference. You may begin your project.
Policies and Procedures
HRPP
1. Misconduct in Research
2. The Institutional Official - Human Research Protection Program
Institutional Review Board
1. Authority of Institutional Review Board
2. Function and Operation of the Institutional Review Board
3. Institutional Review Board Membership
4. Institutional Review Board: Fees for Service
5. Initial Review of Research
6. Exempt Determinations
7. Amendments to Approved Research (under development)
8. Continuing Review of Research
9. Study Closure
10. Human Subjects Research Determinations (Under Development)
11. Conflict of Interest Management for IRB Members, Consultants, Institutional Official, and IRB Administrative Staff
12. Limited Institutional Review Board Review
13. Institutional Review Board (IRB) Reliance Agreements
14. Expedited Review
Conduct of Research
Investigators Acting as Sponsors for Research to this section with all falling under Conduct of Research
Research Collaborations with External Investigators
Investigator Qualifications & Responsibilities
Education & Training on Human Research Subject Protections
SARMC Institutional Review Board: Informed Consent Process and Documentation
SARMC Institutional Review Board: Recruitment and Subject Selection Practices
SARMC Institutional Review Board: Deviations from Protocol and/or Standard Operating Procedures
SARMC Institutional Review Board: Unanticipated Problems or Adverse Events Reporting
SARMC Institutional Review Board: Informed Consent - Waiver of Authorization
SARMC Institutional Review Board: The Privacy Rule (HIPAA) and Research
Medical Devices
Special Types of Research and Participant Populations
Humanitarian Use Devices
Expanded Access to Investigational Drugs, Biologics and Devices (under development)
SARMC Institutional Review Board: Emergency Use of a Test Article (Drug, Device, Biologic)
Planned Emergency Research (Under Development)
Vulnerable Populations: Children
Vulnerable Populations: Research Involving Prisoners
Vulnerable Populations: Pregnant Women, Human Fetuses and Neonates
SARMC Institutional Review Board: Vulnerable Populations: Decisionally Impaired and Other Potentially Vulnerable Subjects
Conflict of Interest
Promoting Objectivity in Research – Financial Interest Disclosure
Templates and Resources
Adverse Event Tracking Log
Subject Screening and Correlation Log Template
Protocol Deviation Log
Medication Log
Clinical Trial Protocol Template
Minimal Risk Protocol Template
Evidence Based Practice Proposal Template
Quality Improvement Project Template
Minimal Risk Informed Consent Template
Clinical Trial Informed Consent Template
Presentation Templates
Survey Study Poster
Meta-Analysis or Systematic Review Poster
Pictorial Essay Poster
Quality Project Poster
Educational Study Poster