Procedures
Researchers must describe their proposed research to the Institutional Review Board (IRB) in enough detail that the potential adverse effects and benefits to human subjects can be evaluated. The Institutional Review Board (IRB) forms and procedures provide a means for researchers, subjects, the University, and community to communicate clearly and responsibly about the risks and benefits of research involving human subjects. Copies of all Institutional Review Board (IRB) forms and corresponding documentation will be available in the Office of Research and Graduate Studies or can be downloaded from here.
Three principles guide the review process:
- Subjects must give their informed consent to participate in research;
- Researchers must provide and protect subject confidentiality;
- Potential risks to subjects must be balanced by potential benefits of the research.
The review process uses the concept of minimal risk to decide the extent to which subject interests warrant formal and extensive review of research proposals. Minimum risk is defined as “the risks anticipated in the proposed activity, are not greater than those ordinarily encountered in daily life or during performance of routine physical or psychological tests.” Risks to subjects are minimized (1) by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk, and (2) whenever appropriate, using procedures already being performed on subjects for diagnostic purposes.
The Institutional Review Board (IRB) classifies research into three categories based on the need to ensure that research conforms to the above principles. These categories are:
- Full Review - A Full Review occurs when the Institutional Review Board (IRB) reviews the proposed research and meets with the principal investigators to discuss and evaluate the impact on human subjects. After review, Institutional Review Board (IRB) members vote to approve or disapprove the proposal. Full Reviews are conducted for proposed research that involves more than minimal risk or where very careful evaluation or risks and benefits is appropriate, minors or vulnerable populations are subjects, or where adverse impact on subjects may occur due to research activities. For example, research exposing subjects to threats to dignity, physical or emotional injury or discomfort, legal liability or arrest, damage to financial or social standing, or procedures in which subjects experience stress or have their behavior, attitudes or beliefs manipulated by researchers must undergo Full Review. Approval is by majority vote in all cases.
- Expedited Review – An Expedited Review occurs when at least two members of the Institutional Review Board (IRB), designated by the chairperson, review the proposal and independently indicate their approval or disapproval. Researchers are not required to meet with reviewers. Reviewers frequently give written comments advising the researcher on ways to enhance the protection of human subjects. Reviewers may ask for more information or require changes in procedures to enhance the provisions for informed consent, confidentiality and risk/benefit balance. Expedited research involves minimal risk to subjects but involves procedures with potential impact on subjects; such as the collection of body samples or physiological data, video or voice recordings, or studies involving vulnerable populations or sensitive issues.
- Exemption from Review - A Request for Exemption from Review may be submitted to the Institutional Review Board (IRB) by the researchers. Exempted research involves research on effectiveness of or the comparison among instructional techniques, curricula, or management methods, the use of educational tests, or the study of existing data.
