Human Subjects


Federal regulations require that all proposed research involving human subjects undergo review by an Institutional Review Board (IRB). IRB's are responsible for reviewing all human subjects research and ensuring compliance with federal regulations; their primary role is to protect the safety and welfare of human subjects. There are two IRB's at the University of Virginia:

  • The Institutional Review Board for Health Sciences Research (IRB-HSR) is responsible for reviewing all health sciences research for the University of Virginia. Faculty and graduate students in the School of Education and Human Development's Kinesiology program are most likely to have their research reviewed by this IRB.
  • The Institutional Review Board for Social and Behavioral Sciences (IRB-SBS) is responsible for reviewing all non-medical behavioral human research. Faculty and graduate students in all other School of Education and Human Development programs are most likely to have their research that includes human subjects reviewed by this IRB.

If you are not sure which IRB should review your research, the Vice President for Research and Graduate Studies has developed a very handy decision-making chart for your use.

In years past it was typical for sponsors to require that an IRB approval be in place at time of proposal submission. Recognizing that this resulted in many protocol reviews of research that was never funded or undertaken and represented an inefficient use of sometimes strained resources, most sponsors moved to a 'just-in-time' process requiring that your IRB approval be in place at time of award. Therefore, if you have good reason to believe that you are going to be funded and your research involves human subjects you should immediately initiate the protocol review and approval process.

Even if you do not have to have an IRB approval in place at time of submission, your sponsor will probably still want you to include a human subjects protection section/narrative in your Research Plan. The extent of the information to be included in this section will be dictated by the sponsor, but if you are in doubt as to what to include, the NIH guidelines provide a good model.