Does My Research Require IRB Review?
The Regulations
Federal regulations require that research projects involving human subjects be reviewed by an Institutional Review Board (IRB). The IRB must approve or determine the project to be exempt prior to the start of any research activities. The IRB cannot provide approval or determinations for research that has already been concluded. In light of the mission to protect human subjects, and the potential regulatory consequences of not obtaining IRB review and approval, the investigator should choose to err on the side of caution and consult the IRB when s/he is uncertain whether the study is human subjects research or not.
IRB review and approval is required for projects that:
1. meet the federal definition of research; and
2. involve human subjects
What is Research?
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
A systematic investigation follows a predetermined plan for studying a specific topic, testing a hypothesis or research question, or developing a new theory. A systematic investigation:
- Attempts to answer one or more research questions
- Collects data or information in an organized and consistent way
- Analyzes data or information in some way (quantitative, qualitative)
- Draws conclusions from the results
Examples of conducting a systematic investigation include:
- Administering surveys and questionnaires
- Conducting interviews and focus groups
- Analyzing existing data or biological specimens
- Evaluating social or educational programs
- Conducting medical chart reviews
Contribute to generalizable knowledge means that the purpose or intent of the project is to test or to develop scientific theories or hypotheses or to draw conclusions that are intended to be applicable and/or shared beyond the populations or situations being studied. Generalizable knowledge applies to research projects in which:
- Publication, presentation, or other distribution of the results outside the College is intended to inform or contribute to general knowledge in the field
- Results are expected to be generalized to a larger population beyond the population studied
- Results are intended to be replicated in other settings or by other researchers
- The primary beneficiaries of the research are other researchers, scholars and practitioners in the field of study
Research does not include:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship) that focus directly on the specific individuals about whom information are collected
- Public health surveillance activities (collecting, analyzing, and using data to target public health and disease prevention)
- Data collection and analysis that enables the conduct of certain activities carried out as part of the criminal justice system
- Authorized operations in support of national security
- Studies for internal management purposes such as program evaluation, quality assurance, quality improvement, fiscal or program audits, marketing studies or contracted-for services
If the project does not meet the definition of research (i.e. is not a systematic investigation or does not contribute to generalizable knowledge), as described above, then the project does not require IRB review, and an IRB application is not required.
Does it Involve Human Subjects?
Human subjects is defined as "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."
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.
If your project meets the definition of research but does not involve human subjects as defined in the regulations, then the project does not require IRB review, and an IRB application is not required.