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Institutional Review Board


Purpose of the IRB

Mission

Pepperdine University Institutional Review Boards (IRB) aims to provide a full circle of protection for research participants and researchers by:

  • Promoting and facilitating the protection of rights, welfare, and dignity of human research participants;
  • Helping ensure compliance with federal regulations, state laws, and University policies and national standards for research involving human research participants;
  • Providing timely and directed high quality education, review, and monitoring for human research projects;
  • Assist investigators in conducting ethical, sound research of the highest quality that complies with applicable regulations.

Three Units within the IRB

  1. The IRB Review Unit coordinates, reviews, and approves all human research protocols; and provides non-human subject verification for studies that do not involve human participants directly. The IRB Review Unit consults with investigators and guides them to support more efficient applications, and also coordinates cross-institutional research projects and works with external IRBs to approve and monitor research projects.
  2. The Education and Training Unit is responsible for providing and coordinating targeted education and training initiatives of the Pepperdine community, including investigators, research participants, and IRB Board Members.
  3. The Quality Improvement Unit reviews and manages reports of unanticipated problems, protocol violations and incidents, and conducts internal audits of ongoing studies to ensure that all activities are up to the standards set forth by federal, state, and university-wide policies. Quality Improvement Unit also monitors and measures the effectiveness and quality of the IRB.

When is an application necessary?

When a faculty member, student, and/or employee of Pepperdine University wishes to conduct research, her or his research proposal must be reviewed by one of the following IRBs:

Policies

It is the policy of Pepperdine University that all research involving human participants must be conducted in accordance with accepted ethical, federal, and professional standards for research and that all such research must be approved by one of the university's IRBs. In the review and conduct of research, Pepperdine University is guided by the ethical principles set forth in the Belmont Report.

In addition, all human subjects research conducted by or under the auspices of Pepperdine University will be performed in accordance with the U.S. Code of Federal Regulations, DHHS (CFR), Title 45 Part 46 (45 CFR 46), entitled Protection of Human Research Subjects, and Parts 160 and 164, entitled Standards for Privacy of Individually Identifiable Health Information and the California Protection of Human Subjects in Medical Experimentation Act. Where applicable, FDA regulations on human subjects research will be followed (CFR Title 21 Parts 50 and 56, Protection of Human Subjects and Institutional Review Boards).

Furthermore, research conducted with human subjects must be performed in accordance with the accepted ethical principles established by professional organizations or societies that are applicable to the area of investigation. The actions of Pepperdine University will also conform to all other applicable federal, state, and local laws and regulations. Pepperdine University has assured the Office of Human Research Protections (OHRP) of the DHHS that all human subjects research will be conducted in accordance with 45 CFR 46 and has been issued Federal Wide Assurance by the OHRP.

Please Note: Prior to initiating any research project that seeks to obtain data from human participants, the investigator must obtain written approval from the appropriate Pepperdine IRB.

 

IRB Consult Service

The GPS IRB team offers a consultation service to support you each step of the way. Please email us at gpsirb@pepperdine.edu with the subject line “Consultation Request” to set up an appointment. 


Six Steps to Completing an IRB Application

 Introduction

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 so that we can make sure to guide you through the application and approval process. The Pepperdine IRB Manual can be found here.

Research activities include:

  • Collecting and Analyzing Data
  • Analyzing Existing Data
  • Conducting a Program Review
  • Meta-Analysis or Critical Review of the Literature

NOTE TO DOCTORAL STUDENTS: Please consult with your dissertation chair and/or thesis advisor for specific guidance on your IRB application. Review these six steps with them, look over the timelines and resources provided in this guide, and ensure that the appropriate faculty and student investigator checklists are completed. It is crucial that you work with your chair and/or advisor on this and the following steps to ensure a complete IRB application that will be efficient, accurate, and allow for a timely review and approval by the IRB.

Depending on your program, you will be submitting your IRB application shortly before or immediately after your Dissertation Proposal Meeting. Please check with your chair/advisor and/or your department for timelines.

In addition, 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 Methods Review Committee or the Psychology Division Methods Review Committee before submitting the IRB applications to the GPS IRB Office. Further, all students from Graziadio Business School interested in receiving additional guidance can submit their research proposals to the DBA or MSOD Program Committee Review faculty before submitting the IRB application to the GPS IRB Office. Please consult your dissertation chair for guidance on this process.

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.

Graziadio Business School's DBA Program Committee Review:
Contact Dr. John Mooney at john.mooney@pepperdine.edu or by phone at 949.223.2538.

Graziadio Business School's MSOD Program Committee Review:
Contact Dr. Gary Mangiofico at gary.mangiofico@pepperdine.edu or by phone at 949.351.3700.


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 One: Determine Level of Review and Type of Application

First, you must determine which type of application you will submit, 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. Please find a video tutorial covering the purpose of the IRB and the application timeline here.


Decision Tool: Am I Doing Human Subjects Research?

The National Institutes of Health (NIH) Office of Extramural Research (OER) has developed a quick decision tool that should assist you with determining if your research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research. This tool should not be used as the sole determination of exemption.

Non-Human Subjects Research: If you believe your project does not constitute human subjects research, per Pepperdine University Institutional Review Board (IRB) guidelines, please review and complete the Non-Human Subjects Notification Form and submit to the Interim IRB manager.

Exempt and Expedited Research: The most common applications are Exempt and Expedited. You can determine which application to submit by reviewing the one-page handout entitled Exempt-Expedited Decision Tree. For more details on each type of application, check out the Exempt Research Guide and the Expedited Research Guide.

The IRB will route any Expedited protocols that actually require Full Review after your initial submission.

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

 Step Two: Complete Human Subjects Training

 

Human subjects' training is required for all faculty, staff, and students conducting research involving human subjects at Pepperdine University. Proof of completion is required for your IRB application submission. Human subject training must be updated every 3 years from date of training completion (if there is no expiration date noted on your CITI certificate) or by the date of expiration on your existing human subject training certificate.

The CITI Program Human Subjects training is free for all Pepperdine students, staff, and faculty. Please follow these instructions to register for and complete the appropriate human subjects training course listed below.

Special human subjects training pathways in CITI are required for the following:

  • GSEP Education Students - Please select "GSEP Education Division - Social-Behavioral-Educational (SBE)"
  • GSEP Psychology Students - Please select "Graduate & Professional Schools Psychology Division Human Subjects Training"
  • Business DBA and MSOD Students - Please select "Business, Law, and Public Policy Students Human Subjects Training"
  • Public Policy and Law Students - Please select "Graduate & Professional Schools - Business Law and Public Policy Students Human Subjects Training"
  • GPS Faculty and Staff - Please select "Graduate & Professional Schools - Faculty Human Subjects Training"
  • GPS IRB Members and Reviewers - Please select "Graduate & Professional Schools IRB Members and Reviewers" (note that this will supersede other training requirements based on your affiliation)
  • Seaver IRB Members and Reviewers - Please select "Seaver Undergraduate IRB Members" (note that this will supersede other training requirements based on your affiliation)
  • Seaver Students, Faculty, and Staff - Please select the one appropriate to your type of research below:
    • "Seaver Undergraduate Biomedical Research Investigators" for biomedical studies that require expedited or full review
    • "Seaver Undergraduate Social & Behavioral Research Investigators" for social and behavioral studies that require expedited or full review
    • "Seaver Undergraduate Students, Faculty, and Staff (Conducting Minimal Risk Research)" for all studies that are designed exempt review or minimal risk
  • Optional Training for All Students, Faculty, and Staff: Please select "Revised Common Rule" for the latest IRB policy changes

*Note that if you are serving as an IRB member or reviewer, you don't also need to complete training based on your affiliation (e.g., GSEP Faculty) as long as you complete the appropriate training for IRB members and reviewers.

 

 Step Three: Familiarize Yourself with eProtocol


All new IRB applications must be submitted using the eProtocol IRB system at https://irb.pepperdine.edu. Please view a detailed video tutorial covering the eProtocol IRB application process.

Prior to submitting an application, please review the relevant User Guide and the eProtocol FAQ:

  1. Faculty and Staff
  2. Students
  3. eProtocol FAQs including technical support

 Step Four: 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 (numbers 1-5 below):

  1. Investigator Resources - Including Training Videos, Consent Form Guides, and Helpful FAQ
  2. Forms and Templates - Must be used with your specific study information filled in and then uploaded to eProtocol
  3. Review Checklist - A good way to check through and make sure your application meets standards for reviewer

 Step Five: Consult IRB (if necessary)


After proceeding through steps 1-4 above and working with your chair/advisor, if you still have questions about the application process, please email the GPS IRB team at gpsirb@pepperdine.edu with the subject line “Consultation Request” to set up an appointment. We can answer questions ranging on how to navigate eProtocol, the determination of exempt v. expedited v. full board reviews, selection and preparation of necessary forms and templates, and any other questions about the application process.

For additional questions regarding eProtocol, the determination of expedited vs. exempt application, and selection and preparation of necessary forms and template; please contact our IRB manager at andrea.quintero@pepperdine.edu or email us at gpsirb@pepperdine.edu.

For more advanced questions regarding a complicated Expedited or Full Application, please contact the appropriate IRB chairperson.

 Step Six: Submit Your Application


All applications must 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.

eProtocol Step-By-Step


Frequently Asked Questions

Find answers to frequently asked questions about Pepperdine IRB processes, forms, guidelines, and more.

 


Pepperdine University IRB Administrative Personnel

Dr. Jay Brewster Provost 310.506.4261
Dr. Lila McDowell Carlsen  Interim Vice Provost
Authorized Institutional Official
Signatory Official
310.506.4310
Mrs. Katy Carr Associate Provost
Human Protections Administrator
310.506.6084
Dr. Lee Kats Interim Dean, Seaver College
Research Integrity Officer
310.506.4280
Mr. Greyson Orellana Pepperdine Interim HIPAA Privacy Official Chair 310.506.4190
Dr. Judy Ho Chairperson, GPS IRB 310.568.5604
Dr. Susan Helm Chairperson, Seaver College IRB 310.506.4325
Ms. Andrea Quintero IRB Manager 310.568.2305