Hawai'i Pacific University Institutional Review Board

Hawaii Pacific University Institutional Review Board

Research on human subjects serves to advance the study of human thought, behavior, and physical make up and ultimately the knowledge base of science. The purpose of the Institutional Review Board (IRB) is to evaluate all research proposals, to determine what risks may be present for subjects, and to assess how these balance against benefits to subjects and the advancement of knowledge. Hawaii Pacific University’s human subjects policy was developed in accordance with the Federal Policy for the Protection of Human Subjects, published in the Federal Register on June 18, 1991, as a final common rule for participating federal agencies (Institutional Review Board Guidebook and Belmont Report). Hawaii Pacific University's policy, like the federal policy, is designed to safeguard the rights and well being of human subjects, and to ensure that the principles of respect for persons, beneficence, and justice are met by proposed activities involving human subjects.

History of the Institutional Review Board

The modern story of human subjects protections begins with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis. The Code captures many of what are now taken to be the basic principles governing the ethical conduct of research involving human subjects. The first provision of the Code states that "the voluntary consent of the human subject is absolutely essential." Freely given consent to participation in research is thus the cornerstone of ethical experimentation involving human subjects. The Code goes on to provide the details implied by such a requirement: capacity to consent, freedom from coercion, and comprehension of the risks and benefits involved.

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Categories of Research Review: Determining Which Category Best Fits the Researcher’s Inquiry

All research involving human subjects must be submitted to the IRB. There are three categories of review: Exempt, Expedited and Full. Principle investigators will be notified in writing about IRB decisions.

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Informed Consent

Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. This assurance protects all parties, the subject, whose autonomy is respected, and the investigator, who otherwise faces legal hazards. The "proxy consent" of someone other than the subject is not the same as the subject's own consent, although it may be an acceptable substitute when a subject is unable to give informed consent.

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Training and Certification for Researchers

Collaborative Institutional Training Initiative

Link to online training course: https://www.citiprogram.org/Default.asp

National Institutes of Health Office of Extramural Research Training Course

Link to online training course: http://phrp.nihtraining.com/users/login.php


Procedure for Submitting a Research Project for Review

All research involving human subjects must be submitted to the IRB. Investigators should request the type of review most appropriate for their study using the IRB Project documents. Proposals are first reviewed by one of the IRB Chair. If there is any disagreement with the type of review requested, the investigator will be contacted, the reasons for the disagreement explained, and any additional material necessary to continue the review process will be requested by the IRB Chair.

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Hawai’i Pacific University IRB Committee Members and Contact Information

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Hawai’i Pacific University IRB Research Proposal Review and Meeting Schedule, 2012

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A-Z Glossary

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Forms, Documents and Resources