IRB Human Subjects Applications and Forms

The Cayuse Institutional Review Board (IRB) module is a human subjects application management system for electronically preparing, submitting, and routing studies for IRB approval. All information is stored in the cloud and can be accessed securely from any location, making it simple for multiple simultaneous users to view and share documents. Users receive electronic notifications whenever an action is required on their part, allowing the study to proceed smoothly through each step of the process from study creation to final approval.

Instructions - CSUSB faculty have direct access to the Cayuse IRB system through MyCoyote (Single-Sign-On). Student's must submit their coyote email address and full name to the Research Compliance Officer (RCO) at mgillesp@csusb.edu to be entered into the Cayuse IRB system. The student record takes 24 to 48 hours to be updated in the system before a student user can begin theIRB application process. You need to include your CSUSB faculty advisors name as the Co-PI in the application.

Once you have logged in through MyCoyote sign on page to the right you will see two software links. Please select Cayuse IRB (Human Studies Compliance). See print screen for an example in PDF Cayuse IRB Example.

If you are a student or faculty member in the Social Work and Psychology department's and submitting under exempt (administrative) or expedtied review you can must submit the hard copy version to the Social Work and Psychology IRB Sub-committees. However, if you require full board review all application for full board review must be submitted through the Cayuse IRB system. All other departments besides the Social Work and Psychology department's will need to submit their applications for administrative (exempt), expedited, and full bord review to the main IRB commitee through the Cayuse IRB application system. See the user support instructions below.

External Investigators will NOT have access to the Cayuse IRB Online Submission system and must complete either the External Investigator Agreement or Cooperative Research Agreement forms below.

 

CAYUSE IRB USER GUIDE (help user guide for faculty and student investigators)

Cayuse IRB User/Help Support - Assistance and instructions for faculty, student, and other investigators to help navigate and submit your IRB application through the Cayuse IRB System.

IRB Policies and Procedures PDF  

CAYUSE IRB COMMITTEE MEMBER GUIDE (help user guide for IRB committee members)

Cayuse IRB User/Help Support - Assistance and instructions for IRB committee members to help navigate and review IRB applications through the Cayuse IRB System.

IRB Policies and Procedures PDF  

User Access Issues: The most common user access issue is when student's have both a coyote.csusb.edu and csusb.edu email since you work as a student assistant on campus. When you attempt to log-in the system will give you an error message. Sent me a print screen of the error message you receive at mgillesp@csusb.edu and I may be able to help you with this access issue. If the problem persists you would need to contact user Cayuse support at ResearchSuiteSupport@evisions.com to assist you with this access problem.

 

IRB Human Subjects Research Application Form (Hard Copy) -

Please note faculty, student's, staff, and administrators must use the New IRB Cayuse Application Submission System - Hard Copies of IRB Application's will not be accepted without permission from IRB Research Compliance Officer, Mr. Michael Gillespie, mgillesp@csusb.edu. See instructions for faculty and students above.

IRB Application for Human Subjects Research Word Document

 

IRB POLICIES AND PROCEDURES IRB Policies and Procedures Word Document IRB Policies and Procedures PDF

AERA Publications - Standards for Reporting on Empirical Social Scienc Research - Provides an excellent advanced overview (which you can simplify for an IRB protocol) in organizing a human participants study protocol and includes topics such as Problem Formulation, Design and Logic, Sources of Evidence, Measurement and Calculation, Analysis and Interpretation, Quantitative and Qualitative Methods, Generalization, and Title Abstracts and Headings.

(American Educational Research Association, 2009). Retrieved from http://www.aera.net/Publications/StandardsforResearchConduct/tabid/15746/Default.aspx

  IRB Policies and Procedures PDF
IRB Powerpoint Presentation - IRB History and Application Requirements PPT  

IRB Certification of Data Sets Form

IRB Renewal Form Word Document  

IRB Renewal/Continuing Review Form

Please include new informed consent documents and recruitment advertisements/fylers

IRB Renewal Form Word Document  

IRB Protocol Change/Modification/Amendment

Please include the proposed change to your study, new surveys instruments (new or modified) and additional documentation as needed.

IRB Protocol Change Form Word Document  

IRB Adverse or Unanticipated Event Reporting

IRB Adverse Event Form Word Document

IRB External Investigator Agreement

IRB Adverse Event Form Word Document

IRB Cooperative Research Agreement Form

IRB Adverse Event Form Word Document

External Investigator and Cooperative Research Guidance

IRB Adverse Event Form Word Document

Sample Forms

Informed Consent Informed Consent (Type II) Word Document  
Child Assent Example Informed Consent (Type II) Word Document  
Debriefing Statement Debriefing Statement Word Document Debriefing Statement PDF
Video/Audio/Photograph Consent Video/Audio/Photograph Consent Word Document Video/Audio/Photograph Consent PDF

Administrative and Expedited Examples of IRB Reviewed Applications

Sample Student Group Project (Courtesy of CSUSB Department of Criminal Justice)   Video/Audio/Photograph Consent PDF
Sample Student Group Project (Courtesy of CSUSB Department of Criminal Justice)   Video/Audio/Photograph Consent PDF
Sample Faculty Classroom Student Project (Courtesy of CSUSB Department of Criminal Justice)   Video/Audio/Photograph Consent PDF
Sample Faculty Classroom Project (Courtesy of CSUSB Department of Criminal Justice)   Video/Audio/Photograph Consent PDF
Sample Faculty Analysis of Secondary Data (Courtesy of CSUSB Department of Criminal Justice)   Video/Audio/Photograph Consent PDF

Full Board Examples of IRB Reviewed Applications

Full Board Review Application - Dr. Courtney Doussett   Video/Audio/Photograph Consent PDF
Full Board Review Application - Ms. Krystal Howard and Mrs. Caryn Kruse   Video/Audio/Photograph Consent PDF

More Information on Informed Consent

OHRP Informed Consent Checklist
OHRP Tips on Informed Consent
OHRP Informed Consent for Non-English Speakers
OHRP Legally Effective and Prospectively Obtained
OHRP Exculpatory Language (Language You CANNOT Use) in Informed Consent
OHRP Informed Consent Use in Emergency Research