According to Title 45 Code of Federal Regulations Part 46 (45 CFR 46), (a-j), research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes.”
National American University's (NAU) Institutional Review Board (IRB) is an authoritative body to ensure the protection of human subjects through the review, approval, modification, or disapproval of research applications submitted by faculty, staff, student, and/or external investigators. Therefore, any research project involving human subjects which is conducted by NAU faculty, staff, students, or external persons (or that takes place on any NAU campus or as a part of an academic affiliation agreement) is subject to review and approval by the NAU IRB. The IRB is further responsible for communication, recordkeeping, reporting, monitoring, education of the university community about ethical issues, and oversight of all research activities involving human subjects. The IRB is guided by ethical principles outlined in the Belmont Report (1979), the Declaration of Helsinki, and the Nuremberg Code. and legal mandates outlined in the Title 45 Code of Federal Regulations Part 46 (45 CFR 46), (2017).
NAU's Institutional Review Board (IRB) is guided by National Institutes of Health Regulations and Ethical Guidelines and underlying principles established by Title 45 Code of Federal Regulations Part 46 (45 CFR 46), the Belmont Report, the Declaration of Helsinki, and the Nuremberg Code. NAU's IRB will review all research proposals in accordance with the policies and procedures outlined in the NAU Institutional Review Board Procedures Manual.
There are two questions you must answer prior to moving forward on the decision of if you will need IRB approval: Is it research and is the research on human subjects?
1. Is it research? According to 45 CFR 46.102 (a-j), research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes.”
a. Are you conducting an investigation, an inquiry to gather facts, an experiment, or an examination of a specific phenomenon?
b. Is it systematic, involving a method, system, or plan that will be used consistently throughout data collection?
c. Will your results be presented as representing a larger population than the sample you recruited?
d.Will your findings be presented beyond a class setting such as presenting at a conference, publishing in a peer-reviewed journal, or used in a graduate-level thesis or dissertation?
If you answered NO to EVERY question, you are not doing research. However, if you answer YES to ANY question 1a-d, you are conducting research.
2. Is human subject research? According to 45 CFR 46.102 (f), “Human subject” means a living individual about whom an investigator (whether professional, faculty, or student) is conducting research to obtain data through intervention or interaction with the individual or collects identifiable private information.
a. Does the research involve human subjects or said another way, does your research involve living human individuals in any way, even previously collected data from any source on a living human?
NO? If you can answer no to question 2.a. IRB approval is not necessary.
YES? You need an IRB review.