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.
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.
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.
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.
Hawai’i Pacific University IRB Committee Members and Contact Information
Hawai’i Pacific University IRB Research Proposal Review and Meeting Schedule, 2012
- Sample IRB Project Application Form (Appendix A)
- Download IRB Project Application Form (Appendix A)
- Sample Informed Consent Form (Appendix B)
- Download Informed Consent Form (Appendix B)
- Sample Amendment/Modification/Renewal Form (Appendix C)
- Download Amendment/Modification/Renewal Form (Appendix C)
- Sample Debriefing Form
- Sample Brief Summary of a Research Project
- Checklist and Decision Trees (for help deciding what type of review is most appropriate)
- Human Subjects: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html
- Informed Consent: http://www.hhs.gov/ohrp/policy/consentckls.html
- Office for Human Research Protections: http://www.hhs.gov/ohrp/
- IRB Guidebook: http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm
- IRB Common Rule: http://www.hhs.gov/ohrp/humansubjects/commonrule/index.html
- HPU IRB Policies and Procedures for Research with Human Subjects
- 45 CFR 46: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
- Belmont Report: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
- Health and Human Services Policy & Guidance Index: http://www.hhs.gov/ohrp/policy/index/index.html