What requires IRB review and approval?
Any research activity involving human subjects conducted by a member of USC’s faculty or staff or one of its students must be reviewed and approved by the IRB before it is undertaken. Research involving human subjects includes a wide variety of activities such as, but not limited to, research on medical records, collection of data through surveys or observation, research using existing pathological specimens, discarded tissue or secretions, use of investigational drugs or devices, and randomized trials.
The project must be approved by the IRB if it meets the following criteria as defined under “Research” AND “Human Subject”:
Research is defined as:
A systematic investigation, including research development, testing and evaluation, designed to develop or to contribute to generalizable knowledge.
Note: Research conducted in connection with a master’s thesis or doctoral dissertation meets the definition of research.
Human subject is defined as:
A living individual about whom an investigator (whether professional or student)
1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
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.
What does not require IRB review and approval?
Many activities have the characteristics of research or use research techniques but do not meet the definition of research for IRB review. These activities do not require review by the IRB. Examples of data collection or observation activities that do not require review include:
- Scholarly and journalistic activities (e.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.
- 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).
- 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.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
- Data collection for internal departmental or other university administrative purposes (e.g. teaching evaluations, student evaluations, and “customer service” surveys), and
- Program evaluation carried out under independent contract for an external agency that is for their internal purposes only. Examples include personnel studies, human cost benefit analysis, treatment effectiveness studies, and customer satisfaction studies.
Course related activities and/or projects (e.g. research methods instruction) that involve the use of human participants but have no connection with research beyond the instructional function do not require IRB review. Course instructors are responsible for ensuring that students understand and abide by ethical obligations in carrying out their assignments. The IRB suggests that, at a minimum, students complete the student training modules available through CITI. Additionally, instructors are responsible for reviewing student class projects to ensure that the methods and procedures are ethical and appropriate. This includes monitoring student activities during the conduct of the project to ensure that the rights and welfare of participants are adequately protected. Instructors are encouraged to consult with IRB staff if they have questions or concerns.