About the IRB
Function of the Institutional Review Board (IRB)
An institutional review board (IRB), also known as an independent ethics committee (IEC) or ethical review board (ERB), is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.
In the United States, IRBs are governed by Title 45 CFR (Code of Federal Regulations) Part 46. These regulations implement provisions of the National Research Act of 1974, for example defining IRBs and requiring them for all research that receives support, directly or indirectly, from what was the Department of Health, Education, and Welfare at the time, and is now the Department of Health and Human Services (HHS). IRBs are themselves regulated by the Office for Human Research Protections (OHRP) within HHS. IRBs were developed in direct response to research abuses earlier in the twentieth century.
Research is an investigation or experimentation aimed at the demonstration, discovery, or interpretation of new facts, revision of accepted theories or laws in light of new facts, or practical application of new or revised theories or laws. Research includes, but is not limited to, investigations conducted by faculty members, College associates, and graduate and undergraduate students, and include collaboration with researchers outside the College. So called “pilot studies” are defined as research.
A principal investigator is the individual in charge of a research project. The principal investigator must assume the responsibility for compliance with all ethical guidelines for research with human subjects.
Any person who is studied in any research investigation is considered to be a human subject. Subjects may include, but are not limited to, classroom participants or voluntary participants in behavioral studies or oral or written interviews, donors of fluid and tissues, or participants in a clinical setting. “Human subject” also includes any living individual about whom an investigator obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. “Intervention” includes both physical procedures by which specimens are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. “Interaction” includes communication or interpersonal contact between investigator and subject. “Private information” includes information about behavior that occurs in a context in which an individual can reasonably expect no observation or recording to be taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.
Categories of IRB Review
Exempt research at TCC is limited to research conducted by students solely for a class project. Exempt research is usually not reviewed by the Institutional Review Board. However, if such student research may be reasonably foreseen to involve any risk to human subjects, the instructor must submit the project for review.
“Minimal Risk” Research
Research in which the risks of harm anticipated are not greater, probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. No research involving any item listed as being "at risk" can be determined to be minimal risk. The IRB may determine that a research proposal submitted, in the judgment of the principal investigator as "minimal risk," is actually "AT RISK."
“At Risk" Research
"A subject is considered to be 'at risk' if he/she is exposed to the possibility of harm‑-physical, psychological, sociological, or other--as a consequence of any activity that goes beyond the application of those established and accepted methods necessary to meet his/her needs. The determination of when an individual is 'at risk' requires application of sound professional judgment of the activity in question and the ethical principles contained herein. Responsibility for this determination resides at all levels of institutional and departmental review. (The Institutional Guide to DHEW Policy on Protection of Human Subjects, Washington, D.C., 1971, p.2.)”
An illustrative, but not inclusive, list of "at risk" procedures would include experiments involving any aspect, degree, quality, or amount of any of the following: deception, mental stress, including subjection to public embarrassment, humiliation, discomfort, irritation, or harassment, hypnosis, sensory deprivation, sleep deprivation, normally ingested or inhaled materials in excess or less than normal amounts, injection, ingestion or inhalation of toxic materials, including all drugs, alcohol or placebos; strenuous physical exertion; use of physical stimuli in abnormal amounts (e.g., noise, vibration, shock, heat, magnetic fields, radiation); violation of anonymity or confidentiality of subjects and data; observations recorded about the individual which, if they became known outside the research, could make the subject liable to criminal or civil action or damage the subject'sfinancial or employment status; or abrogation of any civil right.