All research that involves the use of humans (e.g., survey, experimental, evaluation, and biomedical research) must be approved by the Institutional Review Board (IRB), according to the university’s Assurance of Compliance Agreement with the U.S. Department of Health and Human Services and Mississippi State law.
The Institutional Review Board is responsible for maintaining institutional compliance with the U.S. Office for Human Research Protections (OHRP) regulations regarding the use of human subjects in research.
Human subject is defined by the Code of Federal Regulations (CFR) as “a living individual about whom an investigator obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.” The regulations extend to the use of human organs, tissue, and body fluids from individually identifiable human subjects as well as to graphic, written, or recorded information derived from individually identifiable human subjects. The use of autopsy materials is governed by applicable state and local law and is not directly regulated by the federal human subject regulations.
Research is defined in the CFR as “a systematic investigation designed to develop and contribute to generalizable knowledge.”
Examples of activities that constitute research include:
- senior and Honors College theses, masters theses and dissertations
- any study intended to result in publication or public presentation;
- any activity resulting in publication or public presentation, even though it involves only review of existing data that was collected with no intent to publish;
- any use of an investigational drug or device;
- any use of human subjects in pilot studies or development and planning for subsequent studies to be published or presented;
- survey and interview research, as well as evaluation studies.
An example of an activity that is not research would be any evaluation of an employee, course, program, or service in which such evaluation is not designed to lead to generalizable knowledge. If an activity does not involve research, it does not require approval or review by the IRB. If the investigator has any doubt as to whether an activity constitutes research, he or she should contact the IRB Coordinator in the Division of Research Integrity and Compliance (DRIC), a division of the Office of Research and Sponsored Programs (ORSP).
For all funded and unfunded research involving human subjects, the investigator — whether an administrator, faculty member, staff member, or student — must file an application with the IRB. The IRB must approve the application prior to the recruitment of any research participants or collection of any data or research information from participants.
IRB Application Forms can be downloaded from the ORSP IRB Forms page. Researchers should allow up to four weeks for IRB approval or longer, if modifications are requested by the IRB. Projects that require review by a convened meeting of the Full Board must be submitted two weeks in advance of scheduled monthly meetings.
The Human Subjects Research pages on the ORSP website contain useful information, resources and links. These pages include the IRB Meeting Schedule and Guidelines, as well as tips on preparing a protocol for review.
University policy requires that all students, faculty and staff who have contact with human subjects during a research project must complete an educational course in the protection of human research subjects before they can have any contact with subjects (with one narrow exception). More information about the education program is available on theHuman Subjects Research pages of the ORSP website.
Note: The human subjects research assurance agreements apply to all research involving human subjects, whether funded or not and whether conducted by administrators, faculty, staff, or students.