Does my Project Need IRB Review?
Any project that meets the Department of Health and Human Services (DHHS) federal regulatory agency definition 45 CFR 46 of Human Subjects Research (HSR) requires IRB review. The requirement for IRB review extends to HSR conducted by any UNF faculty, staff, or student. Student research includes but is not limited to all honors theses, master’s theses, and doctoral dissertations.
There are two central steps to determine if your project is HSR. First, you must determine if the project meets the federal definition of research. If the answer is yes, then the second step is to determine if it involves human subjects. Please see the UNF IRB Decision Chart for determining if project is HSR for additional guidance.
Step One: What is Research?
The DHHS Common Rule defines "research" as:
a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
What do each of these terms mean?
Systematic Investigation
A "systematic investigation" is an examination that uses a prospectively identified approach to studying a specific topic and incorporates data collection, either quantitative or qualitative, data analysis to answer a specific question(s), testing a specific hypothesis(es), or developing theory based on a system, method, or plan. Systematic investigations include observational studies, interviews or surveys, group comparison studies, or intervention studies.
Generalizable knowledge
Developing or contributing to "generalizable knowledge" means that the information derived from the study is expected to expand the knowledge base of a scholarly field of study or discipline. This includes:
- Results that are applicable or expected to be generalized to a larger population beyond the site of data collection or the specific participants studied.
- Results that are intended to be replicated in other settings.
- Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.
- Results that contribute to a theoretical framework of an established body of knowledge.
- The primary beneficiaries of the research are other researchers, scholars, and practitioners in the field of study.
Special Cases: Activities may be considered research even if they are also program evaluation, quality improvement, public health surveillance, preliminary work, pilot studies, or demonstration and service programs, depending on design and intent. Contact Research Integrity IRB Staff staff for guidance.
Step Two: What is a Human Subject?
The DHHS Common Rule defines “human subject” as:
a living individual about whom an investigator conducting research obtains (1) information through intervention or interaction with the individual, or (2) identifiable private information
What do each of these terms mean?
Intervention
Intervention includes both physical procedures by which information is gathered (i.e. blood draw, surveys) and physical, psychological and environmental manipulations performed for research purposes.
Interaction
Interaction includes communication or interpersonal contact between investigator and subject. This includes electronic, virtual and face-to-face communication, including remote interactions like internet or email surveys.
Private Information
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. For example, medical records, school records, or observation of private behavior.
Identifiable Private Information
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. For example, a dataset that includes name, DOB, address and the like, or an audio- or video-recorded interview.
Based on these definitions, if you find your project is HSR, submit it in IRBNet for UNF IRB review.