An important part of training future researchers is allowing them to conduct studies of their own. Students at the University of Virginia are encouraged to develop projects and research studies that will enhance their educational experience and progress to a career of pursuing knowledge. An important part of the research experience is learning how to navigate research committees such as the IRB-SBS. This section provides guidance for Student Researchers as well as Faculty Sponsors. For additional orientation sections, see IRB-SBS 101 and Getting Started.
Students often ask when it is appropriate for them to submit a protocol to the IRB. The first determination that the IRB-SBS makes is whether your project meets the federal definition of human subject research. This is important because the University of Virginia has committed to the Office of Human Research Protection (Department of Health and Human Services) through signing a Federal Wide Assurance (FWA) that all such research will comply with the requirements set forth in the regulations as well as the terms of the assurance.
- Are you collecting individualized and/or identifiable data about living people?
- Is the collection of data occurring systematically and according to research methodologies used in your field?
- Will the project result in knowledge that is generalizable?
The key for most student projects is whether the information produced will be generalizable knowledge or not. The Board considers anything that will be published or disseminated in a public manner to meet the federal definition. If you are writing a master’s thesis or doctoral dissertation, you need to have IRB approval. If you are writing an undergraduate honors thesis and it will be archived in a University of Virginia library or other public location, then you will need to have IRB approval. If you will receive funding to conduct your study, such as a grant, award (i.e. Harrison award, Center for Global Health award), etc, you need to have IRB approval.
One gray area for student researchers is class projects. In most methodology courses, etc, students are required to complete projects that include collecting data from individuals. Class projects do not usually meet the federal definition of human subject research. However, these projects may lead to studies, such as a dissertation, which does require IRB approval.* When making a decision about the need for submitting to the IRB, please keep in mind the following: The Board cannot retroactively approve data that was collected prior to their approval if the original project meets the federal definition of human subject research. The federal regulations do allow the Board to approve data that was collected under a project that originally did not meet the federal definition, which would apply in the case of a class project. However, if the data was not collected according to the Board’s standards, the Board may decide that you may not use the data for research purposes beyond your class project. So, if you are developing a class project that may turn into a study, at minimum make sure that you are following IRB rules and regulations. You may be asked to contact your participants and re-consent them regarding the use of their data. The Board will review class projects, so if you think that you will use your data for research, you may want to consider submitting a protocol prior to collecting your data, or at least contact our office for further recommendations.
If you are a graduate or undergraduate student, we recommend that you consider going through any review process required by your department, such review by thesis and dissertation committees. The Board wants to see projects that are in their final stage with all changes from other committees already implemented. In addition, you will be required to have a UVa faculty sponsor’s signature in order to submit, which verifies that your faculty sponsor approves of the materials you submitted.
*Some class projects are initiated by the professor as part of the professor’s research. In this case, it is the professor’s responsibility to obtain IRB approval to collect data. Individual students are considered research assistants and not the primary investigator in these cases. If you have questions, ask your professor if he or she has IRB approval and/ or contact our office.