To determine if an activity is human subjects research we ask three questions:Is it research?
Is it generalizable knowledge?
Does the research involve human subjects?
Research is defined as a systematic investigation, including research development, testing, and evaluation that is designed to develop or contribute to generalizable knowledge. Research generally is described in a protocol that sets forth explicit objectives and formal procedures designed to investigate those objectives. More information
Quantitative and qualitative research methods are acceptable research methods that contribute to generalizable knowledge. The question many times is not if the study is research but if the study contributes to generalizable knowledge
Generalizable Knowledge is knowledge that is "expressed in theories, principles, and statements of relationships" that can be widely applied to our experiences. The information is collected to share with other people within a discipline and is created to make a broad statement about a group of people, procedures, programs, etc.
Generalizable knowledge includes one or more of the following concepts:
- The information contributes to a theoretical framework of an established body of knowledge
- The primary beneficiaries of research are other researchers, scholars, and practitioners in the field of study
- Publication, presentation, or other distribution of the results is intended to inform the field of study
- The results are intended to be replicated in other settings
- The knowledge is a web-based publication for professional purposed
(Used with permission from Michigan State University's IRB)
Human subjects are defined as "living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information."
If you are not using living human subjects in research, you do not need to submit to the IRB
However, research involving the secondary analysis of existing data must be reviewed by the IRB to ensure that the original data was properly and ethically obtained and that the objectives of the secondary analysis are aligned with those for which consent was obtained.
ALL human subject research, as explained above, regardless of whether or not identifying information is collected must be reviewed by the IRB. The research, including the recruitment of research participants, cannot begin until the application has been reviewed and approved.
Please contact the IRB Administrator for further guidance.
For more seasoned researchers here are some Human Subject Regulations Decision Charts.