Institutional Review Board
- Purpose of the Institutional Review Board (IRB)
- The Six Steps to IRB Success (Applicants Start Here)
- Pepperdine University IRB Administrative Personnel
Purpose of the IRB
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
- 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.
- 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.
- 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:
- Graduate and Professional Schools (GPS) IRB: Responsible for reviewing research applications of investigators from the Graduate School of Education and Psychology, Graziadio Business School, Caruso School of Law, and School of Public Policy.
- Seaver College IRB: Responsible for reviewing applications of investigators from any division/department within Seaver College. Staff members or employees of Pepperdine who do not have a faculty appointment, but who are conducting research investigations should also submit IRB applications to the Seaver College IRB.
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.
Investigators START HERE
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.
Please consult your dissertation chair for guidance on this process.
Education Division's Methods Review:
- Contact Dr. Kay Davis at email@example.com or by phone at 310.568.5660.
Psychology Division's Methods Review:
- Contact Dr. Cary Mitchell at firstname.lastname@example.org or by phone at 818.501.1641.
Graziadio Business School's DBA Program Committee Review:
- Contact Dr. John Mooney at email@example.com or by phone at 949.223.2538.
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 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 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 2: 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.
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 - Social-Behavioral-Educational Human Subjects Training
- Faculty/Staff - Faculty/Staff Human Subjects Training
- MSOD - Graduate & Professional Schools - Business/Public Policy/Law Student Human Subjects Training
- DBA - Graduate & Professional Schools - Business/Public Policy/Law Student Human Subjects Training
- GSEP Psychology Students - Psychology Human Subjects Training
- Business/Public Policy/Law Students - Graduate & Professional School Human Subjects Training
STEP 3: Familiarize Yourself with eProtocol
All new IRB applications must be submitted using the eProtocol IRB system at https://irb.pepperdine.edu.
Prior to submitting an application, please review the relevant User Guide and the eProtocol FAQ:
- Faculty and Staff
- eProtocol FAQs including technical support
- eProtocol Tutorial video (11 minutes)
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 (numbers 1-5 below):
- Investigator Resources (Including Training Videos, Consent Form Guides, and Helpful FAQ)
- Forms and Templates (Must be used with your specific study information filled in and then uploaded to eProtocol)
- Review Checklist (A good way to check through and make sure your application meets standards for reviewer)
STEP 5: 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 reach out to our IRB manager and/or the appropriate IRB chairperson for assistance prior to submitting your application. We will gladly help you in advance to ensure a smooth application submission and review.
For additional questions regarding eProtocol, the determination of expedited vs. exempt application, and selection and preparation of necessary forms and template; please contact our Interim IRB manager at firstname.lastname@example.org or email us at email@example.com.
For more advanced questions regarding a complicated Expedited or Full Application, please contact the appropriate IRB chairperson.
STEP 6: 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.
|Dr. Rick Marrs||Provost||310.506.4261|
|Dr. Lee Kats||Vice Provost
Authorized Institutional Official
|Mrs. Katy Carr||Assistant Provost for Research
Human Protections Administrator
|Dr. Helen Williams||Graduate School of Education and Psychology
Research Integrity Officer
|Mrs. Kim Miller||Pepperdine HIPAA Privacy Official Chair||310.506.6464|
|Dr. Judy Ho||Chairperson, GPS IRB||310.568.5604|
|Dr. Susan Helm||Chairperson, Seaver College IRB||310.506.4325|
|Ms. Andrea Quintero||Interim IRB Manager||310.568.2305|