GPS IRB SPP Updated 11.2018

The primary goal of the GPS IRB is to protect the rights and welfare of human subjects participating in research activities conducted under the auspices of Pepperdine University. Applications submitted to the GPS IRB generally encompass social, behavioral, and educational research and are usually considered medically non-invasive. The GPS IRB employs a review process in conformity with the Federal Policy for the Protection of Human Subjects (45 CFR 46) and the Federal-wide Assurance (FWA) enacted between Pepperdine University and the Office for Human Research Protections (OHRP) under the Department of Health and Human Services (DHHS). Purpose of the GPS IRB

The GPS IRB supports faculty, staff, and students from the Graduate School of Education and Psychology, the Graziadio School of Business and Management, School of Law, and the School of Public Policy.  All new IRB applications must be submitted using the new eProtocol IRB system at https://irb.pepperdine.edu. Helpful resources are available to assist with applying online and submitting an IRB application at Pepperdine University. Purpose of the GPS IRB

All Research Investigators! Obtaining IRB approval is a legal and ethical requirement before beginning research activities. It is essential that you contact the IRB before you start any research activities including recruitment of subjects. Research activities include: 1) Collecting and Analyzing Data; 2) Analyzing Existing Data; 3) Conducting a Program Review, and 4) Meta-Analysis or Critical Review of the Literature. All Research Investigators!

Step 1: Determine Level of Review First, you must determine which type of application you will submit: Exempt, Expedite, or Non-Human Subjects (NHS). The most common applications are Exempt and Expedited. See the Exempt Expedited Decision Tree (handout 1). For any NHS research please reach out to the IRB and ask for NHS Review form. Further guidance will be provided to you. Approval time is rather quickly for these type of studies (1-3 days). The IRB Board will help to route any Expedited protocols that actually require Full Review after your initial submission; or if you consulted with the IRB prior to submission, we will let you know during the submission process. Step 1: Determine Level of Review

APPLICATION  EXEMPT EXPEDITED Potential Risk No more than minimal  (see handout 1) Minimal to Moderate   Submission Process e-Protocol Review Process At least 1 reviewer At least 2 reviewers Timeline for Receipt of Initial Review 11-15 business days 15-20 business days Timeline for Receipt of Revisions and Modifications Review 6-10 business days 11-14 business days

Step 2: Complete Human Subjects Training Training is required for all faculty, staff, and students. Proof of completion is required to submit your IRB application. Update training every 3 years. Go to https://www.citiprogram.org Special human subjects training pathways in CITI · GSEP Education Students · Faculty/Staff · MSOD · GSEP Psychology Students · Business/Public Policy/Law Students Step 2: Complete Human Subjects Training

Step 3: Familiarize Yourself with e-Protocol All new IRB applications must be submitted using the new eProtocol IRB system at https://irb.pepperdine.edu. Please review the relevant User Guide and the e-Protocol FAQ: 1. Faculty and Staff: https://community.pepperdine.edu/irb/content/eprotocol/faculty-staff-checklist.pdf 2. Students: https://community.pepperdine.edu/irb/content/eprotocol/student-guide.pdf 3. All: e-Protocol FAQs including technical support  https://community.pepperdine.edu/irb/content/eprotocol/faqs.pdf Step 3: Familiarize Yourself with e-Protocol

Step 4: Gather the Necessary Materials for Submission To ensure the submission of a complete application, please review the relevant eProtocol Checklist and the specific guidance for Exempt or Expedited Consent Forms: 1. Faculty and Staff Checklist:  https://community.pepperdine.edu/irb/content/eprotocol/faculty-staff-checklist.pdf  2. Student Checklist:  https://community.pepperdine.edu/irb/content/eprotocol/student-checklist.pdf 3. Consent Forms Guide for Exempt Applications: Handout 4. Consent Forms Guide for Expedited Applications: Handout 4 5. List of Forms and Templates:  https://community.pepperdine.edu/irb/gps-irb-forms/ Step 4: Gather the Necessary Materials for Submission

Step 5: Consult IRB (if Necessary) If after proceeding through steps 1-4, you still have questions about the application process; contact our IRB Manager or IRB Chair for assistance.   For additional questions regarding e-Protocol, application type, and forms, contact our IRB staff to set up an appointment at gpsirb@pepperdine.edu. For more advanced questions regarding a complicated Expedited or Full application, contact the GPS IRB Chair, Dr. Judy Ho, at judy.ho@pepperdine.edu. Step 5: Consult IRB (if Necessary)

Step 6: Submit Your Application All applications should be submitted at https://irb.pepperdine.edu/. The system will save your progress. *Make sure to click “save” when you make any suggested changes in the application! All applications must be complete prior to being assigned reviewer(s). Any incomplete applications will be returned and requested to be resubmitted with all necessary materials.  Step 6: Submit Your Application

GPS IRB Contact Information Pepperdine University Graduate School of Education & Psychology 6100 Center Drive, Suite 500 Los Angeles, CA 90045 Phone: (310) 568-5753 Email: gpsirb@pepperdine.edu  IRB Chairperson – Dr. Judy Ho, Ph.D., ABPP, CFMHE; judy.ho@pepperdine.edu IRB Manager – Andrea Quintero, MAP, MBA; andrea.quintero@pepperdine.edu IRB GA – Tristan Meier keisha.lee@pepperdine.edu  IRB GA – Awrad Alostath awrad.alostath@pepperdine.edu Thank you!