Chapman University Institutional Review Board (IRB) uses Cayuse IRB, an online system that allows processing of human subject research studies in accordance with institutional, federal, ethical, and regulatory standards. Visit the IRB Application System page to log into Cayuse IRB and learn how to begin an IRB submission.
» Forms
Non-Research Determination
The federal regulations include a very specific definition for what constitutes “research” (see 45 CFR 46.102(d)) and for what is meant by a “human subject” (see 45 CFR 46.102(f)). A formal determination from the IRB can be made if their project either is not research and/or does not involve human subjects (e.g., as may be required by a student’s doctoral dissertation committee, a funding agency, or a journal editor). 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 NHSD form and request a formal written determination prior to the project initiation. IRB can issue a formal written determination of a project as non-human subject research. However, IRB will not provide retroactive review and approval for projects deemed human subject research.
If you are unsure whether your project meets this criteria, contact the IRB staff before submitting your application for review.
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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-Research Determination Form should be used only if a formal determination is required by a university entity (e.g., dissertation committee) or by an external agency.
Conflict of Interest
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.
California Experimental Subject’s Bill of Rights
California Experimental Subject’s Bill of Rights
The California Protection of Human Subjects in Medical Experimentation Act (Section 24170-24179.5) requires all medical experimentation to be “undertaken with due respect for human life and the right of individuals to determine what is done to their own bodies”. All participants in medical experiments must be provided a written “Experimental Subject's Bill of Rights” in addition to informed consent.
A medical experiment is defined under section 24174 of the California Health and Safety Code as follows:
- The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject;
- The investigational use of a drug or device as provided in Sections 111590 and 111595;
- Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.
As defined in Section 109925
- “Drug” means any of the following:
- An article recognized in an official compendium.
- An article used or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or any other animal.
- An article other than food, that is used or intended to affect the structure or any function of the body of human beings or any other animal.
- An article used or intended for use as a component of an article designated in paragraphs (1) to (3), inclusive.
- The term “drug” does not include any device.
- Any food for which a claim (as described in Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(3) (21 U.S.C. Sec. 343(r)(3)) or Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(5)(D) (21 U.S.C. Sec. 343(r)(5)(D)) of the federal act), is made in accordance with the requirements set forth in Section 403(r) (21 U.S.C. Sec. 343(r)) of the federal act, is not a drug under subdivision (b) solely because the label or labeling contains such a claim.
- Cannabis product, including any cannabis product intended for external use, is not a drug.
As defined in Section 109920, a device means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is any of the following:
- Recognized in the official National Formulary or the United States Pharmacopoeia, or any supplement to them.
- Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in humans or any other animal.
- Intended to affect the structure or any function of the body of humans or any other animal and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and that is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
The Cayuse IRB Application will prompt researchers if certain study procedures meet the requirement for the Experimental Subject’s Bill of Rights form. If any of the following categories apply, please note them in the submission, and ensure the Form is provided to participants.
- Use of a device (e.g., electromyography [EMG], electroencephalography [EEG], inertial sensor, motion capture systems, smartphone apps, electrical stimulation systems, sphygmomanometers and other physiological monitoring devices, and in-vitro testing kits or reagents)
- Use of ingestible substances other than drugs or food
- Invasive medical procedures (e.g., severance, penetration, or damaging of human tissue)
- Withholding medical treatment
- Applying hot or cold to participants
- Electromagnetic radiation
- Other medical experiments as defined under the California Protection of Human Subjects in Medical Experimentation Act
California law requires that the Experimental Subject’s Bill of Rights should remain a separate document from the informed consent form. It must be attached to the front of the informed consent form. In addition, the copy is to be dated and signed by the research participant or the participant’s legally authorized representative. The participant or the participant’s legally authorized representative is given a copy of the Experimental Subject’s Bill of Rights before giving consent to participate in any medical experiment.
The California Experimental Subject’s Bill of Rights must be provided to the participant or the participant’s legally authorized representative in his or her language during the consent process. This also applies when a Short Form is used in the consent process. If you have any questions regarding the use of the form, please contact the IRB Office for additional information.
Protected Health Information
Consent forms and related documents
Researchers are strongly encouraged to use the templates below in order to facilitate a smooth review by the IRB:
- Information sheet for exempt studies (Aug. 13, 2024)– 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 (Oct. 21, 2024)– 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.
- Recruitment Pool Consent (Oct. 21, 2024) – 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 (Mar. 4, 2024)– 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 (Mar. 4, 2024)
- 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).
Research Collaborations
- Local Context Form – to be used when another institution will be relying on Chapman’s IRB.
- Fillable MS Word:
- 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.
Other Templates and Forms
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 (Mar. 4, 2024)
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.