GPS IRB SIX STEPS Updated 05.2018

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!

Doctoral Students and Grant Awardees NOTE TO DOCTORAL STUDENTS: Depending on your program, you will be submitting your IRB application shortly before or immediately after your Dissertation Proposal Meeting. Please consult with your dissertation chair for exact timelines and specific guidance. NOTE TO GRANT APPLICANTS AND AWARDEES: Because many funding agencies require proof of IRB approval prior to the award of grants, investigators should submit their IRB applications concurrently with submissions for funding. Doctoral Students and Grant Awardees

Special Note to GSEP Students All students from the Graduate School of Education and Psychology (GSEP) submitting Expedited or Full Review IRB applications must first submit their research proposals to the Education Division or the Psychology Division Education Division’s Methods Review – Contact Dr. Kay Davis at kay.davis@pepperdine.edu or by phone at (310) 568-5660.  Psychology Division’s Methods Review – Contact Dr. Cary Mitchell at cary.mitchell@pepperdine.edu or by phone at (818) 501-1641.  Special Note to GSEP Students

Step 1: Determine Level of Review First, you must determine which type of application you will submit: Exempt, Expedite or Full Review. The most common applications are Exempt and Expedited. See the Exempt Expedited Decision Tree (handout 1). 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 FULL Potential Risk No more than minimal  (see handout 1) Minimal to Moderate   Moderate to Substantial (determined by IRB) Submission Process e-Protocol Review Process At least 1 reviewer At least 2 reviewers Full Board Review Timeline for Receipt of Initial Review 11-15 business days 15-20 business days 30-40 business days, dependent on Board Meeting  (see calendar 2) 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 Assistant Director and 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.  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 Interim IRB Manager – Andrea Quintero, MA, MBA; andrea.quintero@pepperdine.edu IRB Coordinator – Keisha Lee, Ed.D. keisha.lee@pepperdine.edu  IRB GA – Awrad Alostath awrad.alostath@pepperdine.edu Thank you!