The VCU IRB provides ethical oversight to all activities that meet the regulatory definitions 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 regulatory definition of “research,” no IRB review is required. Similarly, if an activity is research, but it does not involve human subjects (as defined below), the research does not require IRB review. Failure to meet either definition means that the activity is not human subjects research.
If you need documentation from the IRB that your activity is not research or does not involve human subjects, use RAMS-IRB to submit a request for a determination. Learn how on our blog.
RESEARCH (Systematic investigation designed to develop or contribute to generalizable knowledge) + HUMAN SUBJECT (Research about a living individual either through interaction or intervention OR use of identifiable private information) = IRB Review [View Image]
Scholarly and journalistic activities
These activities include the collection and use of information that focus directly on the specific individuals about whom the information is collected (e.g., oral history, journalism, biography, literary criticism, legal research and historical scholarship).
The focus of these scholarly and journalistic activities should not be on generalizing to other individuals. Whenever the focus is on understanding the beliefs, customs and practices of the studied community or group, and not just to the individuals from whom the information was obtained, the activity would meet the definition of research and might require IRB review.
Public health surveillance activities
These activities must be conducted, supported, requested, ordered, required or authorized by a public health authority. They should be limited to only 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.
Public health surveillance refers to collecting, analyzing and using data to target public health and disease prevention. Surveillance uses data from a variety of sources, including mandatory reporting of certain conditions, routine monitoring, vital records, medical billing records and public health investigations.
Public health surveillance activities can include (but are not limited to) the following:
A public health authority is an agency or authority of the United States that is responsible for public health matters as part of its official mandate. A public health authority might be an agency of a state, territory, a political subdivision of a state or territory, an Indian tribe, a foreign government. It might also be a person or entity acting under a grant of authority from or a contract with such public agency.
Examples of public health surveillance activities that WOULD NOT be research:
Examples of activities related to public health that WOULD meet the definition of research because the purposes, context or nature of these activities is to create generalizable knowledge:
Criminal justice activities
The scope of these activities is the collection and analysis of information, biospecimens, or records by or for a criminal justice agency. They must be authorized by law or court order and done solely for criminal justice or criminal investigative purposes. These activities are ones necessary for the operation and implementation of the criminal justice system.
Examples of authorized criminal justice activities that WOULD NOT be research:
Examples of activities related to criminal justice that WOULD meet the definition of research:
Authorized operational activities in support of national security missions
These activities would involve only authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense or other national security missions.
Quality improvement activities
Determining if an activity is research and/or quality improvement can be challenging. Most quality improvement efforts do not meet the definition of research because they are not designed to be generalizable. However, in some cases quality improvement activities are designed to accomplish a research purpose, as well as the purpose of improving quality, and in these cases, IRB review would be required.
The intent to publish is an insufficient criterion for determining whether a quality improvement activity involves research. Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of “research” because people seek to publish descriptions of non-research activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results.
Examples of other activities that generally do not meet the definition of research:
Human subject: a living individual about whom an investigator conducting research:
Research only using data about deceased individuals
Investigators accessing or using protected health information about decedents for research purposes must submit a HIPAA Research on PHI of Decedents Certification Form.
Secondary data that are obtained by the investigator in a completely anonymous state when the investigator will have no access to the ability to re-identify individuals.
Secondary research involving non-identifiable newborn screening blood spots is not considered research involving human participants.
The Newborn Screening Saves Lives Reauthorization Act of 2014 will no longer be effective following the effective date of the Revisions to the Common Rule, given that its changes applied only until changes to the Common Rule were promulgated.
The VCU IRB must approve all research involving human subjects in which VCU is considered to be engaged. The university is engaged in research when one or more of the following apply:
VCU faculty, staff or students are “engaged” in the conduct of human subjects research when interacting or intervening with a living individual for research purposes or when using identifiable private information or biospecimens about a living individual for research purposes.
VCU receives a direct federal award to conduct human subjects research, even when all activities involving human subjects are carried out by a subcontractor or collaborator.
The following clinical activities are not research, but FDA regulations require that they are reviewed by the IRB.
Investigational drugs, biologics and devices are sometimes used for treatment of serious or life-threatening conditions either for a single subject or for a group of subjects:
A humanitarian use device is a medical device that has been given a special type of FDA marketing approval with certain profit and use restrictions because it has potential therapeutic benefit for a small population of patients but has not been proven effective:
At VCU, investigators are responsible for determining whether an activity requires IRB review. However, investigators may submit their project to the IRB if they wish the IRB to make an official determination.
(The project is or might be “research involving a human subject" and VCU is engaged.)
If you have determined that IRB review is required, the next steps are to assess the project’s level of risk and what type of review is appropriate, exempt, expedited or full board, and then to submit the study to the IRB electronically using RAMS-IRB. The IRB’s review decision will be sent in a letter to the principal investigator.
If a determination cannot clearly be made, submit the project to the VCU IRB using RAMS-IRB, and the IRB will make an official determination. If the activity is submitted to the IRB, the review decision will be sent in a letter to the principal investigator.
(The project is not “research involving a human subject" or it is “research involving a human subject,” but VCU is not engaged.)
The project does not need to be submitted to the IRB. When an individual makes the determination that an activity does not constitute human subject research, the VCU IRB recommends that it be documented in writing (e.g., write a memo or note to file that explains how you think the definitions of research and/or human subject are not met). Then, request an acknowledgment/counter-signature from your department chairperson (or designee) to document that they concurred with your rationale. These records should be retained with other activity records.
If an official determination letter from the IRB is required, submit the project to the VCU IRB using RAMS-IRB, and the review decision will be sent in a letter to the principal investigator.
Refer to a decision chart provided by the Office of Human Research Protections to help determine whether an activity requires IRB review in most situations: