What Needs Review
IRB review is required for all projects involving human subjects conducted by Clemson University employees or students, regardless of the funding support or site location.
Two initial questions researchers should consider are:
(1) Does my project meet the definition of research?
According to the federal regulations governing research with human subjects [45 CFR 46.102(l)], research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
A project is considered to be “contributing to generalizable knowledge” if the outcomes will be generalized for other organizations, programs or services, designed to draw conclusions, inform policy, or use to support future funding proposals.
The following activities are deemed not to be research:
- a) Scholarly and journalistic activities (g.,oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
- b) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
- c) 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.
- d) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Class assignments that are conducted to satisfy a course or graduation requirement and the results will not be shared externally, do not require IRB review.
Projects using oral history methods: The IRB office uses the Oral History Association’s (OHA) definition of oral history at https://www.oralhistory.org/about/do-oral-history/ to determine if an IRB application is required for research studies using oral history methods. If the research involves collecting and using information about individuals for the purpose of drawing generalizations about such individuals or a population of which they are members, then the research may require IRB review.
Program evaluations: Evaluations conducted for internal purposes only do not require IRB review. Evaluations designed to draw conclusions, inform policy or generalize findings and will be shared publicly may require IRB review.
Contact the IRB office for assistance in determining whether or not a project constitutes research involving human subjects.
(2) Does my project involve human subjects?
According to the regulations [45 CFR 46.102(e)], human subject means a living individual about whom an investigator (whether professional or student) conducting research:
- a) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- b) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.