At Granite State College, research involving human subjects requires prior review by the IRB and receipt of written, unconditional approval from the IRB, regardless of discipline.

Federal regulations define research as:

Research: “A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The regulations state that following activities are not deemed research: (1) Scholarly and journalistic activities that focus directly on the specific individuals about whom the information is collected; (2) Public health surveillance activities conducted, supported, requested, ordered, required, or authorized by a public health authority; (3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes; or (4) Authorized operational activities in support of intelligence, homeland security, defense, or other national security missions.” [45 CFR 46.102(l)].

Federal regulations define human subject as:

Human Subject: “Human subject means a living individual about whom an investigator(whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.” [45 CFR 46.102(e)(1)].

Using this definition of human subjects, all research activities involving the prospective collection of information about individuals via intervention/interaction are considered using human subjects and thus require Granite State College IRB approval before commencing.

When studies involve the use of secondary/existing data (data/information that exist(s) at the time the research project begins [e.g., previously collected survey data, school records, medical records]) and if the secondary/existing data do not contain private information, GSC IRB approval is NOT needed to use such data for research purposes.

Some common examples of secondary/existing data that are not considered private information include, but are not limited to:

• Some information on the internet – comments on TripAdvisor; content of public tweets and blogs; information on public Facebook pages; census information; freely-available datasets (whether or not anonymous)
• Archives – identifiable information about individuals in a public archive
• Datasets – anonymous datasets, whether privately held or publicly available

Researchers should be aware that not all information on the internet is considered publicly available and not all datasets that are characterized as anonymous actually are. Examples include, but are not limited to:

• Comments on a non-public chatroom or listserv
• Restricted-access datasets
• Privately held datasets where individuals may be identified, either directly through a code associated with a name or through a combination of variables

Does Your Project Need an IRB Review?