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IRB Review
IRB Process Overview
IRB Review Types
Avoid Common Mistakes
Informed Consent
Informed Consent Waivers
Reporting Requirements

Do I Need an IRB Review

Research involving human subjects must be conducted in accordance with federal regulations, state laws, local policies, and established ethical principles. The Chaminade University of Honolulu (CUH) IRB ensures that all research performed by CUH-affiliated researchers meets the applicable regulations and criteria for approval. Projects that meet the definitions of research and human subject must be submitted to the IRB for review and approval.

You may find the OHRP decision trees helpful in deciding if you need IRB review and at what level. If you have any questions, please contact the Office of Sponsored Programs and Research Integrity/IRB.

NOTE: All research involving human subjects—or activities that may be human subjects research—should be submitted to the IRB via eProtocol for an official determination.

Whether or not you require review and approval through the Office of Sponsored Programs and Research Integrity/IRB depends upon the answers to two questions:

  • Are you conducting research as defined in the Federal regulations, and
  • Does that research involve human subjects?

Under the revised regulations, which became effective on January 21, 2019:
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

The following activities are deemed not to be research under federal regulations (45 CFR 46.102):

Category

Description

Scholarly & Journalistic Activities

Activities like oral history, journalism, biography, literary criticism, legal research, and historical scholarship that focus directly on specific individuals.

Public Health Surveillance

Data collection and testing conducted or authorized by a public health authority for identifying, monitoring, or investigating public health issues (e.g., outbreaks, health signals).

Criminal Justice Activities

Collection and analysis of data or biospecimens by or for a criminal justice agency for purposes permitted by law or court order, solely for criminal justice or investigative functions.

National Security Activities

Operational activities authorized in support of intelligence, homeland security, defense, or other national security missions.

Under the revised regulations, which became effective on January 21, 2019:
A Human Subject is defined as a living individual about whom an investigator (whether professional or student) is conducting research:

  1. Obtains information or biospecimens through interventions or interaction with the individual, and, uses, studies, or analyzes the information or biospecimens; OR
  2. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Overview of IRB Process

Applying to the Chaminade IRB

Submitting to the IRB involves two main steps:

  1. Complete CITI Training: All study personnel must complete human subjects protection training and be certified.
  2. Submit Application: The Principal Investigator (PI) submits the IRB application along with all required documents in eProtocol.

NOTE: All research involving human subjects must receive IRB approval or exemption before any data collection begins. Retroactive approval is not allowed, and failure to obtain approval may result in data being unusable and possible institutional sanctions.

Who Can Be a Principal Investigator?

Only eligible Chaminade personnel may serve as PI. This role involves overseeing the study, ensuring compliance, and maintaining long-term accountability for the research and its data.

Eligible to Serve as PI

Conditions

Faculty (non-adjunct)

Must be approved by their School to submit sponsored research proposals.

Staff

Must be qualified to conduct research and have supervisor approval.

Graduate Students

May serve as PI for their own projects with a faculty mentor listed on the application.

NOTE: Adjunct faculty, lecturers, and instructors may not serve as PI or Faculty Mentor, but may be co-investigators. However, for DNP students submitting QI/EBP protocols, adjunct faculty may serve as the Faculty Sponsor. Undergraduate students may not serve as PIs, but may be co-investigators.

Chaminade IRB Application Process

These are key steps involved in the IRB process.

STEP 1: Complete Required CTI Training
All faculty, staff, and students conducting human subjects research must complete CITI Program training in human subjects protections.

  • Use your Chaminade email and affiliate with Chaminade University of Honolulu when registering.
  • Student investigators must have faculty sponsors with current training on file.
  • CITI training must be completed before submitting an IRB application.
  • Note: For DNP students and their Faculty Sponsors/ Chairpersons conducting Quality Improvement (QI) or Evidence-Based Practice (EBP) projects, the Biomedical Research – Basic/Refresher CITI course is required. The PI and all Key Personnel must complete this course and upload their certificates in the Attachments section of eProtocol.

For more information, visit the CITI Training Instructions page.

STEP 2: Develop Your Research Plan
Develop a detailed research plan before beginning the IRB application. This should include:

  • Research goals and procedures
  • Study population
  • Consent/recruitment processes
  • Data collection methods and tools

Students must work closely with a faculty sponsor. Both faculty and staff investigators should determine whether the project qualifies as Exempt, Expedited, or Full Board review. If your activity may not involve human subjects or qualify as research, you may request a formal “Not Human Subjects Research” determination through Protocol.

NOTE: Your selection of the application type in eProtocol will be reviewed and confirmed by the IRB Chair/ Vice-Chair for an official determination.

STEP 3: Submit via eProtocol
All new IRB submissions must be submitted via the Chaminade eProtocol system. Required documents include:

  • CITI Training Certificate for PI
  • CITI Training Certificate(s) for other participant(s)
  • Conflict of Interest information (i.e., Form VI COI Disclosure Form) for all Key Personnel
  • Consent/assent forms
  • Recruitment materials
  • Survey/interview questions or study instruments (i.e., debriefing scripts, letters of agreement from cooperating organizations)
  • Dissertation approval (if the protocol is for the student’s thesis)
  • Any other study documents

Students: Your faculty sponsor must review and electronically sign your application in the system (under “Obligations).

For more information, visit the eProtocol page.

STEP 4: Await Review
Once your protocol receives an initial review from the IRB Administrator and official determination by the IRB Chair or Vice-Chair, it will be assigned to the IRB Panel. You’ll receive an automated email from eProtocol (Key Solutions). IRB members will be assigned based on the review type. After review, feedback will either be discussed at a Full Board meeting or sent directly to you for revisions. This cycle repeats until the protocol is approved. Once approved, you’ll receive another automated email, and the approval letter will be available under “Event History” in eProtocol.

NOTE: The status of your submitted protocol can be viewed any time in the “Protocol Event” column.

STEP 5: After IRB Approval
Once approved, you must:

  • Conduct the study exactly as described in the approved protocol
  • Submit amendments in eProtocol before making any changes (e.g., to consent forms, procedures, or research team)
  • Report any adverse events or unanticipated problems in eProtocol immediately (Protocols starting with “CUH” may email a Form V to the IRB Chair)
  • Complete an annual report if required in eProtocol (for Full Board or Expedited protocols) (Protocols starting with “CUH” may email a Form IV to the IRB Chair)
  • Submit a final report upon study completion in eProtocol (Protocols starting with “CUH” may email a Form IV to the IRB Chair)

Download required forms and templates from the IRB Forms & Templates page.

Types of IRB Review (Exempt, Expedited, Full Board)

Determination; Initial Submission

Purpose:

Used to assess whether the proposed work constitutes Human Subject research or not. If not, then there is no IRB review required.

Process:

Must be qualified to conduct research and have supervisor approval.

Requires a Full Committee Review/IRB Meeting?

No

Exempt

Purpose:

Used to assess Human Subjects Research that fall under one or more of the Federally-designated Exemption Categories

Process:

IRB Chair or IRB Vice-Chair will review & inform PI of decision.

Requires a Full Committee Review/IRB Meeting?

No

Expedited

Purpose:

Used to assess Human Subjects Research that does not fall under one or more of the Federally-designated Exemption Categories & has minimal risk.

Process:

2 IRB members review; IRB Chair or IRB Vice-Chair inform PI of decision.

Requires a Full Committee Review/IRB Meeting?

No

Limited Activity Determination

Purpose:

Involves studies that normally would be classified as expedited or NHSR but because of the focus or instrumentation used in the study needs full review by the IRB.

Process:

2 IRB members forward protocol to the full IRB for review; IRB Chair or IRB Vice-Chair will review & inform PI of decision.

Requires a Full Committee Review/IRB Meeting?

Yes

Full Board

Purpose:

Review of non-exempt research or review of any application that includes a vulnerable population (e.g. minors, prisoners) & has more than minimal risk.

Process:

At least 2 IRB members review; Requires quorum & a majority vote by those present; IRB Chair or IRB Vice-Chair will review & inform PI of decision.

Requires a Full Committee Review/IRB Meeting?

Yes

Continuing Review

  • All Expedited and Full-board revies are approved for a period of three years. However, PIs must submit a Human Subjects Annual Report/Final Report in eProtocol annually.
  • Automated notifications will be sent to the PI and Faculty mentor ahead of protocol expiration.
  • After protocol approval, there will be an option for the PI to make amendments or request an extension.

Guidance for DNP Students Submitting QI/EBP Protocols

  • CITI Training – For DNP students and their Faculty Sponsors/ Chairpersons conducting Quality Improvement (QI) or Evidence-Based Practice (EBP) projects, the Biomedical Research – Basic/Refresher CITI course is required. The PI and all Key Personnel must complete this course and upload their certificates in the Attachments section of eProtocol.
  • Application Type Checklist in eProtocol – In the Application Type Checklist section of eProtocol, select “QI/EBP or Full Board.” This allows review of HIPAA, instruments, and consent (when applicable), even if the project is not human subjects research under federal definitions.
  • PI Eligibility – The CUH IRB typically limits PI eligibility to full-time faculty.  However, for DNP students completing QI/EBP protocols, adjunct faculty may serve as the faculty sponsor in eProtocol. This exception applies only to these projects. 
  • Letter of Support – In the Procedures section of eProtocol, please indicate that securing MOUs from clinical sites is handled through a separate Nursing Department process. Briefly describe that process and include an estimated timeframe. If there is any documentation associated with this process that contains approvals, please upload this to the Attachments section in eProtocol.
  • For additional guidance, please refer to the QI/EBP decision tree or email the IRB Chair at [email protected].

Common Mistakes to Avoid

Mistake: Collecting data (even pilot data) before receiving formal IRB approval or exemption.

Why it matters: This violates federal regulations and Chaminade policy. Retroactive approval is not permitted, and data collected without IRB oversight may not be used.

Mistake: Failing to include all required materials such as consent forms, instruments, recruitment scripts, or incomplete responses in the protocol.

Why it matters: Incomplete submissions delay the review process and may result in administrative return.

Mistake: Submitting an application before all research team members have completed required CITI training.

Why it matters: The IRB cannot approve studies without documentation of current human subjects protections training for all investigators.

Mistake: Using overly technical language, omitting required elements, or failing to include version dates.

Why it matters: Consent documents must be understandable and meet federal requirements for informed consent.

Mistake: Assuming a project is exempt or “not research” without consulting the IRB.

Why it matters: Only the IRB can make formal determinations about exemption or non-reviewability. The PI will select an application type in eProtocol, but this can be corrected by the IRB Administrator or IRB Chair, if needed.

Mistake: Implementing changes to procedures, staff, instruments, or consent forms before submitting an amendment to the IRB.

Why it matters: All changes must be reviewed and approved before they are implemented.

Mistake: Failing to submit annual reports (status reports), final reports, or adverse event reports.

Why it matters: Noncompliance can lead to study suspension or future restrictions on IRB submissions.

Mistake: Listing a student or outside investigator as PI when institutional policy requires a Chaminade faculty or staff PI.

Why it matters: The PI must be institutionally accountable for study oversight and data management. An outside investigator can be added to the study as “Other Personnel”.

Mistake: Students submitting protocols without close review and involvement of their faculty sponsor.

Why it matters: Faculty sponsors are responsible for mentoring and ensuring student compliance with IRB requirements.

Mistake: Guessing on regulatory requirements or assuming the IRB will approve a non-standard approach.

Why it matters: Early communication prevents unnecessary delays and ensures compliance.

Informed Consent

Informed consent is a core ethical and regulatory requirement for research involving human participants. It ensures individuals voluntarily participate with a clear understanding of the study’s purpose, procedures, risks, benefits, and their rights. Principal Investigators (PIs) are responsible for obtaining informed consent, typically through a signed document.

Consent forms must comply with the 2018 Common Rule (45 CFR 46.116) and include:

  1. Purpose of the research
  2. Procedures involved
  3. Duration of participation
  4. Risks or discomforts
  5. Potential benefits
  6. Confidentiality measures
  7. Voluntary participation
  8. Right to withdraw at any time
  9. Contact information (PI and IRB)
  10. Compensation or incentives (if any)
  11. Participant costs (if any)
  12. Assurance of no penalty for declining or withdrawing

If applicable:

  • Compensation and treatment for injury (if more than minimal risk)
  • Audio/video recording
  • Use of de-identified data or biospecimens in future research
  • Potential commercial use or profit sharing
  • Waivers of Consent/Documentation: May be requested under specific conditions (per 45 CFR 46.116/117). Find more information here. Download PDF here.
  • Non-English Speakers: Translations and interpreter access must be provided.
  • Children/Vulnerable Populations: Include assent and additional protections.

Informed Consent: IRB Waivers of Informed Consent

Under federal regulations (45 CFR 46.116), the IRB may approve:

  • A waiver of informed consent or parental permission (i.e., consent is not required), or
  • An alteration of informed consent (i.e., some elements are omitted or modified)

These options may apply when full informed consent is not practicable, and the study still meets ethical and regulatory criteria.

Examples Include:

  • Studies on natural behavior where informing participants could bias results.
  • Research where disclosing the full purpose would compromise data integrity.

In such cases, IRBs can approve waivers or alterations if all regulatory conditions are met.

The IRB must document that:

  1. The research poses no more than minimal risk to participants.
  2. The waiver or alteration will not adversely affect participants’ rights and welfare.
  3. The research could not practicably be carried out without the waiver or alteration.
  4. When appropriate, participants are provided additional information after participation.

An alternative waiver may apply to government-conducted or -approved public benefit/service programs, under specific conditions (see 45 CFR 46.116(e)).

NOTE: These requirements do not override any applicable federal, state, or local laws requiring additional disclosure, nor do they limit emergency medical care under law.

To request a waiver or alteration:

  1. Navigate to the Consent Information page in eProtocol
  2. Upload a “Request for Waiver of Informed Consent” form that clearly explains how your study meets the applicable federal criteria listed above as an attachment under “Informed Consent”.

Additional Resources

Reporting Requirements (Templates & Forms)

All Principal Investigators (PIs) must report key study updates to the IRB via eProtocol, including Annual Reports, Final Reports, Amendments, and Adverse Events. A Conflict of Interest (COI) Disclosure form but be attached to all new protocol submissions. These forms ensure compliance with federal regulations and protection of research participants. Reporting requirements do not apply to research that have been determined as “Not Human Subjects Research” by the IRB Chair.

Purpose: To maintain IRB approval for ongoing research.

When to Submit:

  • At least 30 days before the IRB approval expires/ a status report is due
  • eProtocol sends reminders at 90, 60, and 30 days

What to Include:

  • Summary of progress
  • Enrollment to date
  • Any amendments submitted
  • Adverse events (if any)
  • Future plans for the study
  • For “CUH” protocols: Email a completed Form IV to the IRB Chair: Form IV Annual or Final Report Form

How to Submit in eProtocol:

  • Open your approved study
  • Click “Create Event” → “Annual Report”
  • Complete the required form and upload relevant documents

Purpose: To formally close the study when all human subjects activities, including data analysis of identifiable data, are complete.

When to Submit:

  • At least 30 days before the IRB approval expires, if the study is complete
  • Required even if no participants were enrolled

What to Include:

  • Total number of participants
  • Summary of results or findings
  • Description of data retention or destruction plans
  • Any final adverse events
  • For “CUH” protocols: Email a completed Form IV to the IRB Chair: Form IV Annual or Final Report Form

How to Submit in eProtocol:

  • Open your study
  • Select “Create Event” → “Final Report”
  • Complete the required form and upload relevant documents

Purpose: To obtain IRB approval before implementing any changes to the approved study.

Examples of Changes That Require an Amendment:

  • Study design or methodology
  • Recruitment materials or consent forms
  • Study personnel
  • Study sites
  • Sample size or data collection instruments

When to Submit:

  • Before implementing any changes

How to Submit in eProtocol:

  • Open your study
  • Click “Create Event” → “Amendment”
  • Describe all changes clearly
  • Upload revised documents with tracked changes or highlighted changes and clean versions
  • For “CUH” protocols: Email an amendment request to the IRB Chair.

Purpose: To report any unexpected issues that may affect participant safety or study validity.

When to Submit:

  • Within 5 business days of becoming aware of the event

What to Include:

  • Events that are unexpected, related to the study, and increase risk to participants
  • Examples: injuries, breaches of confidentiality, or protocol violations
  • For “CUH” protocols: Email a completed Form V to the IRB Chair: Form V Adverse Event Reporting Form

How to Submit in eProtocol:

  • Open your study
  • Click “Create Event” → “Adverse Event”
  • Include description, impact, and corrective actions

Purpose: To report any serious and unexpected event related to the study that results in significant harm or requires prompt action to ensure participant safety.

When to Submit:

  • Immediately, but no later than 24 hours after becoming aware of the event

What to Report:

Events that are unexpected, related to the study, and result in:

  • Death
  • Life-threatening experience
  • Inpatient hospitalization or prolongation of existing hospitalization
  • Persistent or significant disability/incapacity
  • Congenital anomaly/birth defect
  • Any event requiring intervention to prevent one of the outcomes above

Examples: drug/device reaction, serious injury, or suicide attempt
For “CUH” protocols: Email a completed Form V to the IRB Chair: Form V Adverse Event Reporting Form

How to Submit in eProtocol::

  • Open your study
  • Click “Create Event” → “Serious Adverse Event”
  • Clearly indicate in the event title or description that it is a Serious Adverse Event
  • Include a detailed description of the event, impact, actions taken, and whether the study has been paused or modified

Purpose: To disclose any financial or personal interests that could affect—or appear to affect—the integrity or objectivity of the research.

When to Submit:

  • With all new protocol submissions
  • Anytime there is a change in the financial or personal interests of the PI or research team
  • Prior to annual reports or amendments that involve new personnel or changes to study funding

What to Report:

  • Any financial interest in the sponsor, product, or service being evaluated
  • Consulting fees, honoraria, stock ownership, intellectual property rights
  • Personal or professional relationships that may influence the research
  • Upload a completed Form VI to “Attachments”: Form VI Conflict of Interest Disclosure Form

How to Submit in eProtocol:

  • Open your protocol submission
  • Upload Form IV for each study team member in the “Attachments” section
  • For continuing reviews or amendments, include any updated COI disclosures as needed

eProtocol Tips & Reminders

  • Automated emails are sent 90, 60, and 30 days before study expiration
  • You must submit a continuing review or final report to remain in compliance
  • If your study expires, all research activities must stop until the IRB re-approves it
  • There is a 60-day grace period to submit annual reports and final reports after protocol expiration
  • Save a PDF of your submission confirmation and IRB determination letter under “Event History”
  • Refer to the IRB Reviewer Checklist prior to submitting your protocol. This checklist is used by IRB members when conducting a review of protocols for completeness.

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