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The federal regulations include a very specific definition for what constitutes “research” (see 45 CFR 46.102(l)) and for what is meant by a “human subject” (see 45 CFR 46.102(e)). Conducting a non-human subject and/or non-research activity does not require a formal written determination. However, when in doubt whether the project requires IRB oversight, PIs should submit the NHSRD form to the IRB and request the IRB’s formal written determination prior to the project initiation. The IRB will not provide retroactive review and approval for projects deemed human subject research.

If you are unsure whether your project constitutes human subject research, contact the IRB staff before submitting your application for review.

· The federal research regulations [45 CFR 46] do not require the IRB to make a formal determination that projects are not research, or do not involve human subjects. Thus, this Non-Human-Subject-Research Determination Form should be used only if a formal determination is required by a university entity (e.g., dissertation committee), funding agency, or a journal editor.

All researchers who are engaged in the design, analysis, conduct, or reporting of the results of research under an IRB protocol must disclose whether they have a financial interest in or other relationship that may have an impact on the project. 

• Human Subjects COI Disclosure Form

• California Experimental Participant's Bill of Rights

Please refer to the accordian header "California Experimental Participant's Bill of Rights" under the page "Informed Consent Process" for more information.

• Authorization to the Use or Disclosure (Release) of Protected Health Information for Research Purposes (.docx)
• Representations Form for Research Involving only Decedents’ Information

Researchers are strongly encouraged to use the templates below in order to facilitate a smooth review by the IRB:

• Information sheet for exempt studies (Dec. 11, 2025)– The IRB may request use of this template for minimal risk studies that undergo exempt review when only a brief consent process is possible (e.g., online studies). This template may be used for exempt studies involving audio or visual recordings.
• Adult/Surrogate Informed Consent Form (August 4, 2026)– use this template for most studies with adult participants. This form is also to be used in obtaining consent from parents or Legally Authorized Representatives (LARs) for individuals who do not have the maturity (e.g., children) or ability to decide for themselves (e.g., medically or cognitively impaired adults). This consent form is needed when there are plans to request the study participants’ permission for their private identifiable information (to be stored by the research team in a recruitment pool) so that the participants can be invited to join other studies.
• Abbreviated Oral Short Consent (August 4, 2026) – use this template when only oral consenting is possible (e.g., phone surveys) and documentation of informed consent is requested to be waived.
• Recruitment Pool Consent (Jan. 6, 2026) – use this template when individuals other than those currently on an IRB-approved study, will be invited to share private identifiable information so that such individuals can be invited to join upcoming studies.
• Additional Elements of Consent (Jan. 8, 2026) – this document provides consent language for studies involving electroencephalogram (EEG), Transcranial direct current stimulation (tDCS), collection of biospecimens (e.g., saliva collection, blood draws), certificates of confidentiality, and when clinical trial studies will be registered on ClinicalTrials.gov.
• Assent Template (Sept. 3, 2024) –  use this template for studies involving minors between ages 7-17, or any adults who are not able to provide legal consent (e.g., cognitively or medically impaired adults)
• Debriefing Form Template (Feb. 9, 2026)
• GDPR Notice and Consent - must be used for studies that include collecting data from participants located in a country that belongs to the European Union (EU) or in the European Economic Area (EEA).

• Local Context Form – to be used when another institution will be relying on Chapman’s IRB.
  • Fillable MS Word:
    • With MS Office signature field
    • No MS Office signature field
  • Fillable PDF
• Individual Investigator Agreement (IIA) – to be used when an investigator not affiliated with Chapman University would like to join Chapman’s research team.
• IRB Authorization Agreement (IAA) – also called “Reliance Agreement”; to be used when Chapman will serve as the IRB of Record for other institutions.

Research studies may involve other study materials such as permission letters, advertisements, and scripts. Although researchers are not required to use the templates below, the IRB provides the following examples:

• Research Site Permission Letter Template (.docx)
• Advertisement Template (Mar. 4, 2024)
• Flyer Template (Mar. 4, 2024)
• Recruitment, Verbal Script, Follow-up, and Reminder Templates (Sept. 9, 2025)

The Translation Certification Guidance and Form is to be used when any document(s) related to an IRB-approved study will be translated from English to other languages or other languages to English.

• Translation Certification Guidance and Form