Activities Requiring IRB Review
At VCU, investigators are responsible for determining whether an activity requires IRB review. The VCU IRB provides ethical oversight to all activities that meet the criteria of "research involving a human subject", meaning that any activity meeting both of the following definitions requires IRB review.
If an activity does not meet the research criterion, no IRB review is required. Similarly, if an activity is research, but it does not involve human subjects as defined above, the research does not require IRB review.
Refer to a Decision Chart provided by the Office of Human Research Protections (OHRP) to help determine whether an activity requires IRB review in most situations.
There may be some instances where it appears an activity does not meet the definition of research with human subjects that do require IRB review, such as when VCU receives a direct federal award that involves human subjects research in some capacity (i.e., at subaward / collaborating institutions). See guidance on Engagement in Research from the Office of Human Research Protections (OHRP) for more information.
Is it Research?
- Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration).
- Systematic investigation involves a predetermined system, method or plan for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing theory. A systematic approach includes the collection of information and/or biospecimens, and analysis, either quantitative or qualitative.
- Generalizable knowledge is information that is collected or gathered to draw general conclusions or generalize outcomes beyond the specific group, entity, or institution.
Examples of activities that generally do not meet the research definition:
- Student projects conducted for a credit class assignment where there is no intent to contribute to knowledge in the field of study.
- Medical case studies involving no more than two patients are not considered systematic investigations.
- Quality improvement activities where the data will only be used internally and there is no intent to publish or present the outcome.
Does it involve Human Subjects?
- Human subject: a living individual about whom an investigator conducting research obtains data through an intervention or interaction with the individual or identifiable private information.
- Intervention includes both physical procedures by which data are gathered (e.g., drawing blood) 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., medical record information).
Examples of activities that generally do not involve human subjects:
- Research only using data about deceased individuals; however, research using Protected Health Information about decedents does require submission of a Research with Decedents form (see forms page).
- Data that are obtained by the investigator in a completely de-identified state when the investigator will have no access to the ability to re-identify individuals. See the Research Involving Private Information or Biological Specimens decision chart.
Quality Improvement vs. Research
Determining if an activity is Research and/or Quality Improvement can be challenging. Federal regulations require human subject research to reviewed and approved by the IRB, while strictly QI activities do not require IRB oversight. However, some QI activities may also be research and therefore need IRB approval. Please review the following guidance and use the following REDCap decision tool to determine if your activity likely needs IRB approval PRIOR to beginning the activity.
Then, to help you further make a decision of whether or not your project requires IRB approval, please fill out the following RedCap Survey. The determination of a project is considered human subject research and need IRB approval, is ultimately up to the PI. We are unable to give a concrete determination without a full IRB submission, however, this tool should help guide your determination, if answered accurately.
Once you've used these determination tools, if you have questions about whether your project needs IRB approval, please contact Meghan Wright at email@example.com.
If still in doubt about whether an activity requires IRB review, please submit information about the activity to ORSP@vcu.edu explaining how the activity meets the definitions above.
Once you have determined that IRB review is required, the next step is to assess what type of review is required: Exempt, Expedited, Full Board, or Administrative Grant Review.