“Is My Project Research?” (Do I Need IRB Approval?)
All projects involving both research and human participants must be reviewed and approved by the IRB before recruitment and data collection may start. However, not all projects involving human participants are classified as research.
Projects are considered to be research if they:
1. Involve a systematic investigation, and
2. Are designed to contribute to generalizable knowledge.
Research: A systematic investigation designed to develop or contribute to generalizable knowledge.
Systematic Investigation: an approach to seeking knowledge involving a predetermined method for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing a theory.
Generalizable Knowledge: Data gathered with the intent to draw conclusions from the research which will develop or contribute to a general body of knowledge. Please note: Results that remain in the classroom or are presented within the confines of the institution (i.e., at NDNU’s Undergraduate Research Conference) are not considered generalizable. However, if the results will be published, presented at a conference off-campus, or generalized in some other way, the project will be considered generalizable and will thus be considered research.
The following are considered to be research and need IRB approval (inclusive of exempt status):
• Thesis or dissertation projects conducted to meet the requirements of a degree are considered generalizable and meet the regulatory definition of research.
• Intent to publish (although not automatically an indication of intent to do research) might signify that generalizable results are anticipated, and is taken into consideration when making a determination of research.
The following are not considered to be research and do not need IRB approval:
• Research practical or training activities: individuals who are being trained to perform a certain technique or therapy, such as art therapy, psychotherapy, interview technique.
• Classroom exercises: the objective of the activity is to teach proficiency in performing certain tasks, such as design of research, implementation, or analysis.
• Quality assurance, quality improvement, course or program evaluations: activities designed to continuously improve the quality or performance of a department or program, where the intention is not to share results beyond that department or program.
• Oral histories: activities which are solely designed to create a record of specific historical events without intent to draw conclusions or generalize findings. Please note: Some oral histories could be invasive, such as oral interviews of Japanese Americans put in camps during WWII or Vietnam Veterans, and will require IRB approval.
• Case studies: publications that are descriptive in nature, involve fewer than three cases, and are not meant to contribute to generalizable knowledge.
• Pilot studies: preliminary investigation of the feasibility of a study, usually done on a small scale (usually fewer than ten participants) and exploratory in nature. It is designed to help the investigator refine data collection procedures and instruments or prepare a better, more precise research design.