Investigator Resources
Start with the Six Steps to Completing an IRB Application
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. 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:
Graziadio Business School's DBA Program Committee Review:
Contact Dr. Nelson Granados at nelson.granados@pepperdine.edu or by phone at 949.923.9871.
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.
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 |
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.
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:
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
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.
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.
Policies and Procedures
IRB Manual
What is HIPAA? HIPAA is the Health Insurance Portability and Accountability Act of 1996. In the IRB context, HIPAA refers to the part of that law dealing with privacy of health and mental health care information and the regulations that the Department of Health and Human Services has issued to implement the law.
Please review the HIPAA Policies, Procedures, and Forms Manual for additional information.
Resources
Guidance on Data Collection via Zoom
Exempt Categories New Common Rule Handout
Expedited Categories New Common Rule Handout
Minimal Risk vs. Greater than Minimal Risk
Establishing Inclusion and Exclusion Criteria
Principal Investigator (PI) Checklist
All PIs should use this to check off necessary steps before IRB application submission.
All Faculty Chairs and Sponsors should use this to check off chair responsibilities before IRB application submission.