Overview of Process for GSEP Students GPS IRB Overview of Process for GSEP Students

Purpose of IRB 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. 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). 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.

When to submit to IRB? Research include: 1) Collecting and Analyzing Data; 2) Analyzing Existing Data; 3) Conducting a Program Review; 4) Meta-Analysis or Critical Review of the Literature 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.

Step 1: Determine Level of Review and Type of Application First, you must determine which type of application you will submit (which involve different documentation and forms), which then corresponds to differing levels of risk, review processes, and timelines for obtaining IRB approval. Note that most applications go through at least one request for revisions or modifications, so please budget your time accordingly.

DECISION POINT: Exempt or Expedited Application? Potential Risk No more than minimal risk such as : Possible breach of confidentiality and identity. Minimal to Moderate risk such as: quasi protected population, vulnerable subjects, subjects under the age of 18 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

If Expedited: Submit research proposals to the Education Division or the Psychology Division You must first submit their research proposals to the Education Division Methods Review Committee or the Psychology Division Methods Review Committee before submitting the IRB applications to the GPS IRB Office. Psychology Division’s Methods Review Education Division’s Methods Review Dr. Cary Mitchell at cary.mitchell@pepperdine.edu or by phone at (818) 501-1641.  Dr. Kay Davis at kay.davis@pepperdine.edu or by phone at (310) 568-5660.

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 (attach certificate in e-Protocol). Update training every 3 years. Go to https://www.citiprogram.org

Step 3: Familiarize Yourself with e-Protocol protocol IRB system : https://irb.pepperdine.edu ( Examples available) 1. Faculty and Staff: https://community.pepperdine.edu/irb/content/eproto col/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/epr otocol/faqs.pdf

Examples

Exempt Criteria Protocol Title: Developing a supplemental resource for Trauma-Focused Cognitive Behavioral Therapists working with African American youth

Expedited Criteria Protocol Title: Focus Group Research in Loneliness

Procedures: Expedited

Purpose Study Procedures

2.c

Subject Population Number of participants etc, inclusion criteria/exclusion criteria of participants

Risks

Benefits/Alternatives

There is no direct benefits to participants in study The alternative is to not participate in the study and subjects may opt out at any time for any reason. Store: Electronic data/Hardcopy

Funding section – no funding

Informed Consent

Assent

Attachments

Step4: Gather necessary materials for submission  Faculty and Staff Checklist:  https://community.pepperdine.edu/irb/conte nt/eprotocol/faculty-staff-checklist.pdf  Student Checklist:  https://community.pepperdine.edu/irb/conte nt/eprotocol/student-checklist.pdf  List of Forms and Templates:  https://community.pepperdine.edu/irb/gps- irb-forms/ To ensure the submission of a complete application, please review the relevant

Step4: Sponsors Sponsors need to check, submit their CITI training certificate for upload in e-Protocol, Sponsors need to Review Sponsor checklist to make sure all portions of iRB app are reviewed prior to student submission

Step 5: Consult IRB (if needed after completion of step1-4) Set up an appointment at gpsirb@pepperdine.edu. For more advanced questions contact the GPS IRB Chair, Dr. Judy Ho at judy.ho@pepperdine.edu.

Last Checks! Check in with your Chair/Sponsor They need to complete CITI Training and you need to upload their certificate to the application They should review the Sponsor/Chair checklist to ensure they’ve reviewed your entire application before you submit They need to check the necessary box in e-Protocol (see screenshot)

Step 6: Submit Your Application All applications should be submitted at https://irb.pepperdine.edu. The system will save your progress if you are unable to complete the entire submission in one sitting. 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.

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, MA, MBA; andrea.quintero@pepperdine.edu IRB GA – Tristan Meier, MA Candidate Tristan.meier@pepperdine.edu IRB GA- Awrad Alostath, MA Candidate; Awrad.alostath@pepperdine.edu