The Chapman University Institutional Review Board (IRB) operates under policies and procedures mandated by the U.S. Department of Health and Human Services and the Office for Human Research Protections. These policies are available for review at www.hhs.gov/ohrp/. The following documents are meant to serve both as policy statements for the Chapman University IRB and as guidelines for investigators involving human subjects in their research.
Broad Considerations Across the Study Lifecycle
General Procedures Manual
Provides an overview of the institution’s expectations for researchers, including standards of conduct, research integrity expectations, and compliance requirements across all research activities.
General Procedures Manual
Date of current version: Sept. 9, 2025
Conflict of Interest
Explains researcher obligations for disclosing financial or personal conflicts that may influence study design, conduct, or reporting.
Conflict of Interest
Date of current version: Apr. 10, 2022
Integrity in Research
Summarizes the standards for ethical behavior in research, including expectations for honesty, accuracy, objectivity, and responsible management of research data.
Integrity in Research
Date of current version: Mar. 28, 2016
Initial Review
Initial Review of Human Subject Research
Outlines criteria and requirements for studies that need IRB evaluation before beginning, including risk assessment, protocol components, and review pathways.
Initial Review of Human Subject Research
Date of current version: Apr. 5, 2024
Guidelines for Student Classroom Projects and Research Involving Human Subjects
Clarifies when student projects require IRB oversight versus when involvement of the IRB is not required by regulations.
Guidelines for Student Classroom Projects and Research Involving Human Subjects
Date of current version: Aug. 22, 2022
Guidelines for International Research
Provides considerations for conducting research outside the U.S., including local permissions, cultural norms, and international compliance requirements.
Guidelines for International Research
Date of current version: May 9, 2023
Device Checklist Guidance
Explains documentation and regulatory considerations for studies involving medical or non-medical devices.
Device Checklist Guidance
Date of current version: Oct. 9, 2025
Research Involving Deception or Incomplete Disclosure
Describes the ethical and regulatory requirements for using deception in research, including justification, consent modifications, and debriefing procedures.
Research Involving Deception or Incomplete Disclosure
Date of current version: May 9, 2023
Recruitment & Consenting
Recruitment of Research Participants
Summarizes standards for appropriate recruitment methods, ethical communication, and safeguarding against coercion or undue influence.
Recruitment of Research Participants
Date of current version: May 13, 2024
Participant Recruitment Pools
Explains the types of pools available for participant recruitment and the rules governing their use.
Participant Recruitment Pools
Date of current version: Oct. 7, 2024
Vulnerable Populations in Research
Outlines additional protections and review considerations for populations with diminished autonomy, including minors, prisoners, and individuals with impaired consent capacity.
Vulnerable Populations in Research
Date of current version: Jun 17, 2022
Use of Raffles/Drawings in Research
Provides guidance on using raffles or drawings as incentives, including regulatory and institutional restrictions.
Use of Raffles/Drawings in Research
Date of current version: Mar. 25, 2025
Informed Consent
Explains the elements of informed consent, documentation requirements, and when alternatives
(e.g., waiver or alteration) may be permitted.
Informed Consent
Date of current version: Dec. 15, 2025
Research Using Data Collection on Social Media and Online Communities
Covers ethical challenges, privacy considerations, and consent expectations when collecting data from online platforms.
Research Using Data Collection on Social Media and Online Communities
Date of current version: May 13, 2024
Privacy & Data Protections
Privacy and Confidentiality
Defines key concepts, provides expectations for protecting participant privacy, and describes methods for maintaining confidentiality of data.
Privacy and Confidentiality
Date of current version: Aug. 6, 2025
Accessing Health Data Including Protected Health Information (PHI)
Explains when PHI can be accessed, required authorizations or waivers, and HIPAA compliance obligations.
Accessing Health Data Including Protected Health Information (PHI)
Date of current version: Apr. 24, 2024
Audio, Video, or Digital Recordings
Details consent requirements, secure storage expectations, and limitations on using identifiable recordings.
Audio, Video, or Digital Recordings
Date of current version: July 16, 2021
Post-Approval Oversight
IRB Review of Modifications
Explains which types of protocol changes require IRB approval and how to submit a modification.
IRB Review of Modifications
Date of current version: Mar. 4, 2024
Renewals of Research Involving Human Participants
Outlines requirements for annual or continuing review for studies that are not exempt.
Renewals of Research Involving Human Participants
Date of current version: May 9, 2023
Data and Safety Monitoring Plan
Provides guidance on when a DSMP is required, recommended components, and ongoing monitoring expectations.
Data and Safety Monitoring Plan
Date of current version: May 15, 2023
Post-Approval Monitoring
Describes routine IRB monitoring activities, what investigators should expect, and how compliance is evaluated.
Post-Approval Monitoring
Date of current version: May 9, 2023
Compliance & Reporting
Incidents and Research Noncompliance Reports
Explains the institutional process for submitting reports and how the IRB reviews
and categorizes incidents.
Incident Reports
Date of current version: Aug. 9, 2022
Research Noncompliance
Date of current version: Jun. 17, 2022
Suspension and Termination of Research
Summarizes circumstances under which a study may be suspended or terminated and the
procedures that follow.
Suspension and Termination of Research
Date of current version: Jun. 17, 2022
Reporting to Regulatory Agencies and Sponsors Regarding Research Involving Human Participants
Describes when the IRB must report to federal agencies, sponsors, or other regulatory bodies, and what triggers those reports.
Reporting to Regulatory Agencies and Sponsors Regarding Research Involving Human Participants
Date of current version: May 12, 2023
Study Closure
Study Closure
Explains when and how to close a study, what documentation must be submitted, and ongoing data responsibilities after closure.
Study Closure
Date of current version: Oct. 4, 2023
Other
Site Permissions
Site Permissions
Date of current version: Dec. 8, 2025
For more detailed information on changes to the guidelines, please click here.