
Steps to Prepare IRB Application
1. Review the IRB Approval Requirement
All researchers are required to obtain approval from the GCU’s Institutional Review Board (IRB) in accordance with GCU policy on ethical research standards as well as U.S. federal regulations.
Failure to obtain IRB approval is a violation of GCU policy and is a Code of Conduct violation for students/doctoral learners with serious implications which may include starting over with a new research study. Please review the GCU University Handbook for additional information on this requirement.
2. Get Started with IRB and Video Tutorials
Begin by familiarizing yourself with the IRB Document Checklists, and General Information about the IRB. Review the IRB Handbook, Responsibilities of the Principal Investigator, FAQs, IRB Glossary of Terms. Then review the instructional videos and training resources for submitting an IRB application in iRIS.
IRB Document Checklist
General Information about the IRB
IRB Handbook
Responsibilities of the Principal Investigator
IRB Glossary of Terms
IRIS Instructional Videos
How to Start Your IRB Application in IRIS
FAQs
3. Complete CITI Training
GCU requires all researchers to successfully complete research ethics training prior to applying for IRB approval. The CITI (Collaborative Institution Training Initiative) training program is web-based instruction in the ethics of research with human subjects. CITI Training is free to GCU faculty, staff, and students and requires approximately 15-20 hours to complete. Researchers must submit completion reports for the Human Subjects Research-Basic Course and the Responsible Conduct of Research (RCR) Course as part of the IRB application. Training certification is valid for five years. Click on the links below to register and begin this training.
Please note: CITI Training records will automatically load into your iRIS IRB Submission Packet. You do not need to upload copies into your iRIS Submission Packet. You must enter your GCU email address ([email protected]) when prompted for Institutional Email Address on the CITI registration site. Please follow the steps in the documents below to ensure successful .
4. Obtain Site Authorization From Selected Research Site
General Procedures and Guidelines for Obtaining Site Authorization to Conduct Research
As part of the IRB application, researchers must provide official documentation they are authorized to collect data at their selected research site(s). Click on the link below to access site authorization guidelines and letter templates.
Obtaining GCU Site Authorization
Changes to GCU Site Authorization:
Effective January 2019, GCU will only consider site authorization requests from doctoral learners who 1) have a clear affiliation with GCU as a full-time or adjunct faculty member; 2) work for GCU in another full-time capacity; and 3) have approval from administrative leadership. Please contact the IRB at [email protected] for questions or clarification.
Please Note:
- Learners who are affiliated with GCU per above can apply through CIRT.
- Learners who have previously submitted a site authorization application in January or February 2019 may be considered.
- Learners who already have an approved GCU site authorization are grandfathered in, and the approval will remain in effect through completion of the study.
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Current Procedure:
Faculty and staff researchers and doctoral learners with GCU faculty/staff affiliation who wish to be considered for approval to use GCU as their research site must submit a GCU Site Authorization Application. Applications are reviewed based on the following:
- Does the research protocol meets ethical research standards?
- Does the study fit within GCU’s institutional or specified college research agenda?
- Does the comply with administrative guidelines for data collection involving GCU students, faculty and staff?
- Is the proposed study design valid?
- What are the operational implications of the research study?
Please note the following:
- GCU approves a limited number of site authorization applications
- GCU will not approve studies that involve release of confidential student or faculty information
- Site approval is not guaranteed for learners or faculty
- GCU site authorization approval does not constitute IRB approval
Procedures and Guidelines for Site Authorization
Site Authorization Letter Template
Social Media Guidelines for PIs
Apply for Site Authorization
5. Determine Review Category – Exempt, Expedited or Full Review
When applying for IRB approval, researchers must apply under a particular category of research that delineates the type of IRB review. The three categories– exempt, expedited, and full– are defined by the federal government and are based upon risk to subjects. Review the Decision Matrix and the Procedures for Exempt, Expedited, and Full Review to determine the likely review category your research belongs in. Please note the IRB reserves the right to re-categorize the study upon review of the application materials.
Exempt Review Procedure
Expedited Review Procedure
Full Review Procedure
6. Create Informed Consent and Recruiting Documents
Research volunteers have a special set of rights that apply when participating in research. Researchers are obligated to follow the Office of Human Research Protections (OHRP) policies and procedures for obtaining informed consent from study participants. Below are links to resources and templates needed for recruiting research volunteers and creating the proper informed consent document(s) for your study.
Templates for Informed Consent
Informed Consent – Greater Than Minimal Risk – Parental Consent Template
7. Prepare IRB Documents
Additional documents that may be necessary for the IRB review process can be found by accessing the link for IRB Forms and Templates. Remember to review the appropriate IRB Checklist based your position with the university. Doctoral learners are required to have their chair review/approve all required documents. Please note the IRB application is web-based in the iRIS system. Additionally the iRIS system will prompt the researcher to attach additional supporting documents based on the information entered into the application, and will also automatically load the researchers CITI Training completion reports.
8. Submit Application in iRIS – Instruction and Videos
iRIS is GCU’s new research protocol management system. Effective January 19, 2018, IRB applications must be submitted in iRIS and reviewed within this system. Once you have completed the steps above, Review the Instructions and Videos – Get Started in iRIS. Then click on iRIS link below to complete your online IRB application and attach the supporting documents
How to Start Your Applicatio in iRIS
iRIS Instructions and Videos
Connect to iRIS