Federal regulation charges the IRB with the responsibility of reviewing and monitoring research with human subjects. Foremost in determining whether you need to obtain approval from the IRB is to understand what federal regulation defines as research and who qualify as human subjects.
The amount of risk posed to potential research subjects determines the level or category of IRB review. A risk is a potential harm or injury that a subject could incur as a result of participating in a research activity. Risk could include any discomfort, burden, or inconvenience a subject may experience as a result of the research procedure. It is important that researchers—including students—understand the concept of risk that can occur to subjects participating in your study. Risks associated with research are categorized as “less than minimal,” “minimal,” and “more than minimal.”
Research putting subjects as “less than minimal” or “minimal” risk generally require Exempt or Expedited review by the IRB. Studies that are deemed “more than minimal” risk call for a full-board meeting of the IRB.
Federal regulations also require the IRB to ensure that appropriate safeguards are in place to protect the rights and welfare of subjects likely to be vulnerable to coercion or undue influence. Potentially vulnerable subjects include children, prisoners, mentally disabled persons, economically or educationally disadvantaged persons, pregnant women, fetuses and neonates.
Depending on the research, other subjects may be deemed as vulnerable as well. Before submitting an application to the IRB, you should understand the protections you must employ in your research protocol to protect these groups of people.
Federal regulations mandate other safeguards to protect human subjects when research involves: confidential records and/or pathological/diagnostic specimens, previously collected data, research subjects are being audio and/or videotaped, ethnographic research, or international studies.
Student research projects will be reviewed the same as any other human subjects research conducted by UNK faculty or staff. Students should consult with their faculty advisors, and obtain approval from the IRB prior to any research activity or study procedures. There is no retroactive approval for data previously collected for the current study. Failure to seek approval for thesis or dissertation research may invalidate the study and/or result in a delayed graduation.