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):
- 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). 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 firstname.lastname@example.org.
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