Appendix A

GCU Institutional Review Board (IRB)

The IRB at Grand Canyon University is registered with The Department of Health and Human Services, Office of Human Research Protections, and has gained the status of Federal-wide Assurance, which assures that the GCU community of researchers abides by the Code of Federal Regulations, Title 45, Part 46 (45.CRF.46).

The Institutional Review Board (IRB) ensures that all research conducted under the purview of Grand Canyon University meets the highest ethical standards, complies with the federal regulations for the protection of human participants in research (45.CFR.46) The IRB provides timely and efficient processing, review, monitoring, tracking, and reporting of all research protocols and IRB activities, and ensures that all research conducted by researchers within the GCU community meets the following requirements:

• Protects human participants
• Develops and sustains an ethical research environment
• Assures that researchers are qualified
• Assures that research has the potential to add value to the academic community and society

All researchers within the GCU community who wish to conduct research at GCU must submit their request to the IRB using the appropriate form. Guidelines for GCU researchers are provided in the Institutional Review Board Handbook. Researchers are encouraged to read the IRB Handbook carefully to ensure proper classification of their research. IRB requests and questions should be forwarded to [email protected].

The GCU Institutional Review Board Handbook is intended to provide guidelines to researchers affiliated with Grand Canyon University who conduct research involving the use of human subjects.

The Handbook is designed to assist institutional review board (IRB) members, researchers and institutional administrators in fulfilling their responsibilities for protecting the rights and welfare of human subjects as defined in the Department of Health and Human Services regulations ("Protection of Human Subjects;" 45 CFR 46).

GCU Institutional Review Board guidelines are adopted from those guidelines detailed in the IRB guidebook by the Department of Health and Human Service, Office for Human Research Protection.

The Code of Federal Regulations, Title 45, Part 46, also referred to as the “Federal Policy” or the “Common Rule,” takes precedence over the contents of this handbook.

National Research Act:

The National Research Act, passed by Congress in 1974, established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The purpose of the Commission is to ensure that the rights and well-being of human subjects involved in research are protected. Therefore, any institution that engages in or supports research must establish an Institutional Review Board (IRB) for the purpose of approving and monitoring research according to Federal Policy such that human subjects are protected during all phases of the research process.

The Belmont Report:

The Belmont Report, published by the Commission in 1974, is a statement of fundamental ethical principles and/or guidelines for investigators who conduct research using human participants or subjects. The Belmont Report distinguishes between practice and research, defines basic ethical principles (the Belmont Principles) as they apply to research involving human subjects, and provides guidelines in the application of those ethical principles. There are many instances in which practice and research overlap. External and objective review of protocols is required only when human subjects are used in some aspect of research. The IRB at GCU bases all decisions on approval of research protocols according to the Belmont Principles.

• Respect for Persons. The ability of an individual to make personal decisions must be acknowledged, and additional protection is required for those who have diminished ability to make personal decisions or are vulnerable to coercion or manipulation when making a decision.
• Beneficence. Research should not harm an individual, and any risk of harm should be minimized while any benefit to the human subject is maximized.
• Justice. Provision of benefit to which an individual is entitled cannot be denied without good reason and undue burden cannot be imposed on a human subject. Equals should be treated as such with regard to share, individual need, individual effort, individual societal contribution or individual merit.

Application of the Belmont Principles:

• Informed Consent. Providing opportunity for individuals to choose what shall or shall not happen to them; upholds the principle of respect for persons.
• Risk/Benefit Analysis. A balance between the risk to a human subject and the benefit gained from the research; establishes the beneficence of research on human subjects.
• Selection of Subjects. Researchers must exhibit fairness by avoiding preference among individuals or social biases in support of justice in human subject-based research.