Chaminade University of Honolulu

Policies and Regulations

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IRB Charter
Office for Human Research Protections
Operating Principles
Compliance with Changes to the Common Rule

IRB Charter

Institutional Review Board (IRB) Charter Overview

The Chaminade University Institutional Review Board (IRB) is charged with ensuring the protection of the rights, welfare, and well-being of human subjects involved in research conducted by Chaminade faculty, staff, and students.

This IRB Charter outlines the authority, scope, and responsibilities of the IRB in alignment with federal regulations, institutional policy, and ethical principles outlined in the Belmont Report.

The IRB operates under the authority of the University President and is administered through the Office of Sponsored Programs and Research Integrity. It is registered with the U.S. Department of Health & Human Services (HHS) and functions in compliance with:

  • Review all human subjects research for compliance with federal and ethical standards
  • Ensure appropriate informed consent processes
  • Assess risks and potential benefits to participants
  • Monitor ongoing protocols, including continuing reviews and amendments
  • Review and address unanticipated problems, adverse events, and noncompliance
  • Maintain IRB records per 45 CFR 46.115

The IRB includes members with varied backgrounds in accordance with 45 CFR 46.107, including:

  • Scientific and nonscientific members
  • At least one member unaffiliated with the University
  • IRB Chair and Vice Chair
  • IRB Administrator 

Research is reviewed using one of the following federal categories:

Review type is based on study risk level and design.

All protocols are submitted through eProtocol—Chaminade’s online platform for protocol submission, review, and tracking. The system supports:

  • Initial submissions
  • Amendments
  • Annual reports (status reports)
  • Final reports
  • Adverse or unanticipated event reporting

This Charter is reviewed annually and revised as necessary to reflect changes in federal regulations or institutional policies.

Checklist of Required Documents (retain for 3 years post-closure):

  • Final approved protocol
  • Consent forms or Waiver of Consent documentation 
    • NOTE: Please ensure that your approved protocol includes a clear plan for obtaining informed consent.
    • NOTE: Depending on the nature of your study or funding requirements (e.g., longitudinal or biomedical research), signed consent forms may be required to be retained for a minimum of three years following the conclusion of the study.
  • Final versions of instruments (e.g., questionnaires, interview guides)
  • Approved recruitment materials (e.g., flyers, emails)
  • IRB approval letter
  • CITI and COI documentation for all research team members
  • De-identified data
    • NOTE: This refers to data collected during the research study that has been cleaned of any personal or identifying details, such as names or contact information, so that participants cannot be linked to their responses. These data are considered part of the official research records and must be retained for a minimum of three years following the conclusion of the study.
  • Annual or final status reports

NOTE: All research records listed above must be retained for a minimum of three years following the conclusion of the study and stored on a secure, campus-based drive at Chaminade University. If the Principal Investigator (PI) is not a faculty or staff member of Chaminade (e.g., a graduate student), they are required to provide these records to their faculty mentor/ program coordinator, who will be responsible for storing them securely on the approved campus-based drive.

Need Help?
Contact the IRB Chair or Administrator: [email protected]

Office for Human Research Protections (OHRP) Guidance

The Office for Human Research Protections (OHRP) is the federal agency within the U.S. Department of Health & Human Services responsible for protecting the rights and welfare of participants in research conducted or supported by HHS.

Chaminade University’s IRB follows OHRP regulations and guidance to ensure that all human subjects research conducted by our faculty, staff, and students is compliant with federal law and grounded in the highest ethical standards.

Key OHRP Resources

Below are direct links to official OHRP guidance documents and tools that support the ethical design, review, and conduct of human subjects research. Chaminade researchers are encouraged to consult these resources during the planning stages of their research and when preparing IRB submissions. The IRB reviews all studies in accordance with these federal guidelines.

Questions?
Contact the IRB Chair or Administrator: [email protected]

Operating Principles

Ethical Principles Guiding Human Subjects Research at Chaminade

The Chaminade University IRB is guided by the fundamental ethical principles outlined in the Belmont Report: Respect for Persons, Beneficence, and Justice. These principles were established by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research on April 18, 1979, and form the foundation of all human subjects research oversight at Chaminade.

In alignment with federal regulations and institutional values, the following ethical and procedural standards apply to all research involving human participants, including student projects:

Core Principles for Research Involving Human Subjects at Chaminade

All research must be supervised by individuals qualified in the relevant discipline. If the research involves medical procedures or interventions, oversight by licensed healthcare professionals is required.

Participants’ legal rights must be respected, and their rights to privacy, dignity, and personal comfort must be considered throughout the review and conduct of research.

Risks to participants must be minimized and must be reasonable in relation to any potential benefits to the individual and the importance of the knowledge expected from the study.

Research protocols must include adequate provisions for facilities, procedures, and professional oversight to protect the health, safety, and well-being of all participants.

Recruitment practices should ensure fair representation across gender and racial/ethnic backgrounds unless scientific justification for exclusion is clearly provided.

Participation must be fully voluntary, with individuals free to withdraw at any time without penalty. Consent materials must be clear, appropriate, and written in lay language that is understandable to the participant population.

All human subjects research must be reviewed and approved by the IRB prior to initiation, including any proposed changes to an approved study.

Approved research is subject to continuing review at intervals not less than once per year, or more frequently if required based on risk level.

These standards help ensure that all research conducted under the auspices of Chaminade University adheres to the highest ethical and professional norms, fostering trust and safeguarding the dignity and welfare of research participants.

Compliance with Changes to the Common Rule

Updates to the Federal Common Rule and Chaminade IRB Procedures

As of January 21, 2019, major revisions to the Federal Policy for the Protection of Human Subjects (Common Rule)—published by the U.S. Department of Health & Human Services (HHS)—are in full effect.

These regulatory updates affect how IRBs review and approve certain types of human subjects research. Chaminade University’s IRB has updated its policies, application forms, and guidance materials to align with these changes.

What Has Changed and What It Means for Researchers at Chaminade

The revised Common Rule applies to all new IRB submissions on or after January 21, 2019.

  • Studies approved or submitted before that date continue to follow the pre-2018 Common Rule unless voluntarily transitioned under IRB guidance.
  • No action is required for older studies unless requested by the IRB.

OHRP Guidance: Transition Provisions and Guidance

The revisions provide expanded and clarified categories of exempt research, including certain types of benign behavioral interventions and secondary research using identifiable private information.

  • eProtocol applications reflect these updated categories.
  • Investigators should review the CUH IRB Charter for guidance or reach out to the IRB Chair to determine whether their study qualifies.

OHRP Guidance:Exempt Research Determination Tool

The revised rule enhances transparency in the informed consent process:

  • A new “Key Information” section must appear at the beginning of the consent document. This section should summarize the most important information a prospective participant needs to make an informed decision.
  • Consent forms must be organized in a way that facilitates comprehension.

OHRP Guidance: Informed Consent FAQs

Under the revised Common Rule:

  • Certain minimal risk studies no longer require annual continuing review.
  • However, Chaminade University still requires an annual status report (submitted via eProtocol) for all approved protocols. This is required for record-keeping, adverse event tracking, and protocol closure, even for studies granted exemption from full continuing review.

OHRP Guidance: Continuing Review Requirements

Questions?

Please contact the IRB Chair or Administrator at [email protected] if you have any questions.