Each Wednesday, UNMC Today features an informational article about changes affecting UNMC’s Institutional Review Board (IRB) and the research community. Today’s topic will cover the research involving the use of biological materials.
What is the difference between excess and extra biological materials?
In biological material research, these terms help to determine the IRB review requirements as well as let the investigator know which IRB application needs to be completed. To help explain the difference:
- Excess Biological Materials:The biological material was collected for the primary purpose of a clinical or diagnostic procedure. It was not collected for research purposes. All clinical diagnostic procedures (surgical pathology, microbiology, etc.) have been performed and the remaining “excess” biological material is requested for the purposes of research. In all cases, clinical diagnostic requirements take precedence over research objectives.
The IRB application “Research Involving Left-Over (Excess) Human Biological Material” should be used for research that will use excess biological materials.
- Extra Biological Materials:Additional biological material is collected solely for the purpose of research. For instance, a patient has blood drawn for diagnostic purposes and the investigator requests that an additional vial of blood be drawn at the same time for research purposes. This is considered “extra” biological material.
The IRB application for “Biomedical Research” must be completed for research using extra biological materials. Informed consent is required.
What is “existing” biological material?
The human biological material has already been obtained and only these samples will be used in the research. The biological material must exist at the time of initial submission of the IRB application.
What is “prospective collection” of biological material?
The human biological material is collected after submission of the IRB application.