Because of guidance updates from federal regulatory agencies and the Institutional Review Board (IRB) accreditation process, UNMC’s IRB is making many changes to the process of human subject protection at UNMC, The Nebraska Medical Center and the University of Nebraska at Omaha (UNO). Continuing education of the research community is an important part of the IRB accreditation process. As a result, UNMC Today features an informational article each Wednesday about changes affecting UNMC’s IRB and the research community. In today’s article, you’ll learn how to determine if a project requires IRB approval.
Does my project require IRB approval?
All research must receive IRB approval before you can start the project. This includes all research conducted by UNMC, The Nebraska Medical Center, and UNO faculty, students, staff or others under the authority of the UNMC IRB, even if the research is conducted someplace else. Additionally, if a representative from another institution is conducting research on the campus of UNO, UNMC or The Nebraska Medical Center, the research must be reviewed by the UNMC IRB before it is started.
Federal regulations define research as “any systematic investigation involving human subjects which is designed (in whole or in part) to develop or contribute to generalizable knowledge.” Very generally, if you intend to gather data by any means (including using someone else’s collected data), analyze the data, and publish or present the results at a meeting or gathering of any kind, the activity is considered research.
Projects performed solely as part of a class project typically have not been viewed as research. The project becomes research when the results are presented outside the classroom or institution.
If there is no intent to present or publish the findings, quality improvement and utilization review projects do not require IRB approval. Additionally, single case studies do not fall under the classification of “research.”
Is IRB approval required for UNO thesis research?
Yes, if it meets the above definition of research. In most cases, the research probably qualifies as exempt. The IRB will make this determination. You will need to file the IRB Application for Exempt Educational, Behavioral, and Social Science Research (found on the IRB Web site.)
I was told by my advisor that I did not need IRB approval and I’ve already collected the data, analyzed it, and am ready to present or publish. Now someone told me I needed IRB approval. What can I do?
While the IRB greatly sympathizes with individuals in this situation, federal regulations do not allow the IRB to grant approval of research “after the fact,” even if it could have been classified as exempt.
I don’t know if I need IRB approval. Who do I ask?
Call the UNMC IRB at 559-6463 anytime for assistance. It is important to remember to ask before you start collecting data or information.