Examples of Activities That Do and Do Not Require IRB–HSR Review
Examples of When an Activity Does Require IRB Review
- Use of existing specimens that were collected either for research or for clinical reasons that are identifiable, or you have access to a code which identifies the donor (e.g., pathology number), or if the investigator has knowledge of the subject's identity (e.g., patient's surgeon is also an investigator on the study)
- Use of data from medical records for non-clinical or non-quality improvement (QI) reasons
- A review of your own patients' clinical records (i.e. medical records, x-rays, laboratory values and/or reports) in order to answer a research question.
- Calling patients for follow-up information for purposes of research
- Establishment of a database protocol when the primary purpose of the database is to collect data for future research.
- Thesis or dissertation projects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval.
- The investigator obtains specimens or data through intervention or interaction with a living individual (e.g. interviews, surveys, physical procedures, manipulations of the subject’s environment, private or limited access internet sites, or any other direct contact or communication with the subject.
- The investigator is obtaining identifiable private information about living individuals (e.g. chart review, lab studies on tissues or specimens, information from data or tissue repository).
- The data or specimens are received by or provided to the investigator with identifiable private information
- The data or specimens are coded and the investigator has access to a link that would allow the data or samples to be identified.
- The activity involves one or more individuals who are or become participants in research, either as a recipient of the test article (e.g. drug, biologic, medical device or other article subject to regulations under the Food, Drug & Cosmetic Act) or as a control
- The activity involves one or more individuals who participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.
- The activity is a clinical investigation involving a project regulated by the FDA (e.g. drug, device or biologic)
- The activity involves the use of a drug, excluding an FDA approved drug in the course of medical practice, in one or more human subjects.
- The activity involves the use of a medical device, excluding an FDA approved device in the course of medical practice, in one or more human subjects.
- The results of the project are required to be submitted to or held for inspection by the FDA
- The activity involves the testing of a medical device using tissue specimens from one or more human subjects and the results are being submitted to the FDA for approval of the device.
- The activity involves one of the activities listed above, however you are NOT performing the work as an AGENT of UVa. You may be considered to NOT be working as an agent of UVa if either of the following situations exit.
You were NOT involved in the design of the research.
A UVa IRB has NOT approved the research.
Funding to conduct the research will NOT come from UVa.
You have other reasons for traveling to the outside institution besides working on research
Working on this research is NOT required for your degree program.
- you are a student, employee and/or faculty member of the University of Virginia.
- the project has or will have IRB approval from the outside institution and you will be listed on their application as personnel conducting the study.
- your work on this project will be overseen by the Principal Investigator and the IRB at the outside institution.
- You will communicate with the IRB and the Contracts Office, to determine what approvals may be needed, prior to receiving any data from the outside institution.
You designed this research. You are a student at UVa but employed by another institution. All subjects will be enrolled at the outside institution. The research will be overseen by their IRB. There is no funding for this study. You will notify the outside IRB that an UVa IRB will not be overseeing your work.
Type of Submission Required
- If your activity meets one of the examples above and you are NOT working as an agent of UVa submit the Determination of UVa Agent Form to the IRB-HSR.
- If your activity meets one of the examples above and you ARE considered to be working as an agent of UVa, proceed to Protocol Builder to submit your project to the IRB-HSR.
Examples of When an Activity Does Not Require IRB-HSR Review
Version Date: 09/16/14
See the Determination of Human Subjects Research Form for examples of activities that do NOT require review by the IRB-HSR.