Investigators are reminded that obtaining blood samples or other biological specimens for research, whether from a patient, an employee or colleague, or other normal volunteer, requires IRB approval and written informed consent. This includes drawing blood as “controls” for in vitro assays, for use now or in the future, unless those assays are performed solely for clinical purposes (and usually in a CLIA certified laboratory).
The IRB is happy to work with you to develop protocols that encompass a number of different activities involving collection of samples from human subjects, and to discuss further. Please email IRBORA@unmc.edu.
Conducting human subject research without IRB approval and informed consent, including obtaining blood or other biospecimens for any research purpose, is serious non-compliance and may be reported to HHS, FDA, NIH, or other Federal authorities.