Human and Animal Ethics Review
Azusa Pacific University is committed to providing the highest level of compliance support to investigators working with human or animal subjects. Compliance with standards for ethical treatment of human or animal subjects is a federal requirement for projects meeting the definition of research. The Office of Research and Grants provides presubmission consultations for investigator projects relevant to the Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC). These services are available to university faculty, students, and staff.
Institutional Review Board (IRB)
The purpose of the Institutional Review Board (IRB) is protection of human subjects in research projects, and to provide you with sufficient information for preparing an IRB submission that appropriately addresses protection of human subjects. Egregious violations of human rights in medical research prompted Congress to pass laws setting standards for protection of human subjects. These standards, now articulated in the Code of Federal Regulations, set criteria for IRB review of applications for research with human subjects at all institutions.
Azusa Pacific IRB members are mostly faculty with an interest in research. They grapple regularly with drafting proposals that meet guidelines and promptly gain approval for data collection. The full board meets monthly, usually the third Wednesday of each month, to review proposals that pose more than minimal risk, include vulnerable populations, or address sensitive issues. Subgroups or individual IRB members review proposals with less risk. In social and behavioral research, risks are often encountered in protecting participants’ right to privacy and confidentiality. The challenge is to balance benefit and risk in research with human subjects.
Federal Definition of Research
Investigators working with human subjects should determine whether a project qualifies for ethics review under the federal definition of research. Qualification is contingent upon meeting the following criteria (45 CFR 46):
- The project involves obtaining data from a living human subject through intervention or interaction with the individual, or identifiable private information AND
- The project is an intentional and systematic investigation using the prevailing methodologies in the discipline, including research development, testing, and evaluation AND
- The ultimate aim of the project is to generate generalizable results expected to contribute to the development of knowledge in the discipline. (The concept of generalizability is usually applied to quantitative research but applies to qualitative research as well, given the expectation for knowledge contribution.) “Contribute” may mean publication but can also mean dissemination in another venue such as conference presentation or poster session.
Additional detail is provided in the IRB Handbook. IRB submissions categorized as exempt or expedited are invited at any time. These submissions are generally reviewed within a two-week timeframe.
We suggest that people new to the IRB application process start by reviewing the FAQ at the beginning of the Institutional Review Board Handbook (PDF). We update the IRB Handbook annually to reflect new federal regulations and to clarify questions encountered by researchers. Your feedback regarding the clarity and efficiency of IRB procedures will be helpful for future investigators. The IRB Handbook also includes the application forms that will guide you through issues related to protection of research participants.
The IRB Handbook (including application forms for submission) can also be found at home.apu.edu. After logging in, go to Forms and Publications/
2013–14 Institutional Review Board Handbook.
Researchers intending to conduct research internationally may consult the federal Office for Human Research Protections (OHRP) for assistance in locating a credible host country perspective on research congruence with local cultural norms.
For more information regarding the IRB handbook, contact IRB coordinator Joanie Stude at (626) 815-2036 or firstname.lastname@example.org.
Institutional Animal Care and Use Committee (IACUC)
Azusa Pacific acknowledges and accepts responsibility for the care and use of animals involved in research and activities covered by the Animal Welfare Assurance. The Assurance complies with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. As partial fulfillment of this responsibility, APU will ensure that all individuals involved in the care and use of laboratory animals understand their individual and collective responsibilities for compliance with this Assurance, as well as all other applicable laws and regulations pertaining to animal care and use.
The members of the IACUC are appointed by the institutional officer (vice provost for graduate programs and research) as delegated by the institution’s president. IACUC has established policies and procedures that must be followed and that facilitate faculty who use laboratory animals in their research.
To report any concerns about use and care of animals at APU, please see Reporting Procedures (PDF). For more information about the use and care of animals at APU, contact IACUC coordinator Suzanne Avila at (626) 815-6000, Ext. 3344, or email@example.com.