IRB approval is required when conducting research involving human subjects.
Human Subject
A human subject is a living individual from whom a researcher obtains information or biospecimens through interaction, intervention, or identifiable private information.
- 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.
- 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.
To meet the definition of a ‘human subject’, all the following must apply:
- The ‘subjects’ are currently alive,
- The information to be collected is about the ‘subjects’ (e.g. personal information about the individuals)
- Information/biospecimens are collected by:
- an intervention (physical procedures and manipulations of the subject or the subject’s environment for research purposes) OR an interaction (communication or interpersonal contact between investigator and subject) AND
- the Investigator uses, studies or analyzes the information/biospecimens, OR generates identifiable private information or identifiable biospecimens.
Research
Research is a systematic investigation designed to develop or contribute to generalizable knowledge.
- Systematic investigation: Planned data collection and analysis to answer a research question
- Attempts to answer research questions (for example, a hypothesis),
- Is methodologically driven (data/information are collected in an organized/consistent way), and
- Conclusions are drawn from the results.
- Generalizable knowledge: Findings intended to inform broader conclusions, policies, publications, or presentations beyond a single case or internal program
- The information gained contributes to a theoretical framework of established knowledge,
- Results are intended to be generalized to a larger population beyond the site of data collection or population studied, and
- Results are intended to be replicated in other settings.
The following activities are NOT considered research:
- A case study of one, two, or three clinical cases. (more than three cases is considered research).
- 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).
- Quality Improvement (QI) projects are typically aimed at improving internal processes, patient care, or operational efficiency and are not intended to produce generalizable knowledge.
- Program evaluation that is routine or part of standard operating procedures, is internal and intended only to provide feedback to the program, does not involve experimental or non-standard intervention and is not designed to contribute to generalizable knowledge.
Obtaining IRB Approval
If your project meets both definitions of “research” and “human subjects,” you will need to submit the project for IRB review.
If you are not sure if your project requires IRB review, please contact Janice Hicks at Janice.hicks@vdh.virginia.gov