NDSU IRB review (or determination of exemption) is required when faculty, staff, students, or other representatives of NDSU become engaged in research that will involve human subjects/participants. IRB review is required regardless of funding source.  Collaborative projects require NDSU IRB review when an agent or employee of NDSU will be involved (e.g., receiving funding, project planning/design, participant recruitment, obtaining informed consent, data collection, or handling of identifiable human data). In addition, it is important to note that IRB review would also be required if a project or activity conducted for other purposes (e.g., program evaluation, quality improvement, education), will also involve a research component. IRB approval must be obtained prior to initiating any research involving human subjects.

Human subjects research projects are not limited to the medical, social, or behavioral science fields, but may be conducted in many different disciplines. It is important to consider the regulatory definitions of research and human subjects.

Research

The Department of Health and Human Services (45 CFR 46) defines research:

a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

The IRB provides guidance to investigators, and retains the final authority in the classification of projects as 'research', or 'not research'. In general, a contribution to generalizable knowledge could include a journal publication, conference presentation, or dissertation, although this is not the sole factor in making the determination. Further definition and examples can be found in the Standard Operating Procedures.

Human subjects

The HHS defines a human subject as "...a living individual about whom an investigator (whether professional or student) conducting research obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens." 

The FDA defines human subject as "an individual who is or becomes a participant in research, either as a recipient of a test article, or as a control,  A subject may be either a healthy human or a patient."

Some examples:

• Surveys, interviews, focus groups (even if information will be recorded anonymously)
• Educational tests (i.e. cognitive, aptitude, achievement, etc.)
• Observation of public behavior
• Gathering data (academic records, or other data) from students to evaluate educational or other programs
• Obtaining data from individuals to evaluate computer software programs
• Collection of (or use of pre-existing) human blood, tissues, specimens, etc.
• Use of existing medical, educational or other records or data that is not publicly available
• Collection of data through non-invasive procedures (i.e, X-ray, EEG, eye exam, etc.)
• Exercise, strength testing
• Collection of data from human voice, video, or image recordings
• Taste and food quality evaluations
• Gathering data from individuals to evaluate electrical, electronic, or other devices or instruments
• Clinical studies of drugs or medical devices

* NOTE: Some types of projects may also require prior approval from the Food and Drug Administration. It should be noted that the definition for 'medical device' used by the FDA includes anything that will be used for diagnosis, cure, treatment, prevention of disease or other conditions, as well as anything that will affect the structure/function of the body of man or other animals.