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Research Ethics

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.

For more details on protocol submission and requirements, visit Human Subjects (IRB) and Animal Subjects (IACUC). For research ethics training, read about the CITI Program and see additional resources on our Training page. See the Research Misconduct page for important information on inappropriate practices or behavior in research and their consequences.

Human Subjects (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.

Definition of Research with Human Subjects

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):

  1. The project involves obtaining data from a living human subject through intervention or interaction with the individual, or identifiable private information AND
  2. The project is an intentional and systematic investigation using the prevailing methodologies in the discipline, including research development, testing, and evaluation AND
  3. 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.

IRB Handbook

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). The IRB Handbook is updated regularly 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.

For more information regarding the IRB Handbook, contact IRB coordinator Martha Bellin at (626) 815-2036 or [email protected].

CITI Training

The Collaborative Institutional Training Initiative (CITI) provides research education content to academic institutions, government agencies, and others. APU has a full subscription, so all faculty and students may utilize the helpful CITI curriculum at no cost to support ethical research with human and animal subjects. All APU investigators submitting IRB protocols are required to complete CITI certification. Users have the option of completing a set of modules in Social and Behavioral Research - Basic or in Biomedical Research - Basic, whichever is most appropriate to their research.

The certification is valid for three years, at which point CITI provides a refresh option to extend certification for an additional three years. Students who are conducting low-risk research may opt to take a student training module, unless directed otherwise by their faculty. In addition, all users are strongly encouraged to utilize the Responsible Conduct of Research (RCR) and Good Clinical Practice (GPC) for Clinical Trials Course modules available through the CITI system. Questions about CITI training requirements and using the CITI training system may be directed to APU’s IRB coordinator.

IRBManager: IRB Application and Forms

To access this online program, visit My IRBManager.

For More Information

Martha Bellin, RN, BSN
IRB/IACUC Coordinator
[email protected]
(626) 815-2036

Animal Subjects (IACUC)

Azusa Pacific University fosters a growing and dynamic research and teaching environment committed to scientific and educational excellence. In compliance with federal policies concerning responsible care and use of animals in research and teaching, APU facilitates an Institutional Animal Care and Use Committee (IACUC). This committee ensures that APU’s animal care and use program meets or exceeds federal regulations. IACUC advances responsible and humane animal care by reducing the use of animal models, finding alternative methods, and employing techniques to promote the best possible animal welfare conditions.

Members of the IACUC are appointed by the institutional officer (research integrity officer) as delegated by the institution’s president. The 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 the use and care of animals at APU, read our Reporting Procedures (PDF). For more information about the use and care of animals at APU, contact Martha Bellin at (626) 815-2036 or [email protected].

Training

ORG is committed to providing faculty with the latest training initiatives and opportunities to enhance their research efforts.

Research Misconduct

Azusa Pacific University is committed to the highest ethical standards in research. Research misconduct is a serious concern with ethical and legal implications. APU has a Whistleblower Policy and an Integrity in Research Policy that address possible research misconduct. These policies are compliant with federal laws and applicable to all research. Please note that the institutional Deciding Officer (DO) and Research Integrity Officer (RIO) referred to in the Integrity in Research Policy are:

DO: Stephen P. Johnson, DMA, provost, (626) 804-2550
RIO: Donald Isaak, PhD, Executive Director, Office of Research and Grants, (626) 815-6000, Ext. 3796