Research Methods at UF: Orientation to Library Literature: IRB

Researchers struggle with ethical concerns when using humans as research subjects, for example when developing vaccines for human diseases.  Modern cases of unethical treatment of humans as research subjects led to laws that require voluntary consent of the human subjects in research.

Beecher (1966) article "Ethics and clinical research" elucidated unethical treatment of human research subjects even at some of the most prestigious institutions and publications in the U.S.

According to the federal regulations (45 CFR 46 102.f) a Human Subject means a living individual about whom an investigator conducting research obtains:

1. Data through intervention or interaction with individual
2. Identifiable private information

• A person who becomes a participant in research – either as a recipient of a test article or as a control. A subject may be either a healthy individual or a patient.
• data obtained from medical records – even if the data is recorded without identifiers.
• tissue used in research that possesses or is linked* to any kind of identifiable information.
• data obtained from surveys – even if the data is recorded without identifiers.
• data obtained from observation – even if the data is recorded without identifiers.
• data obtained from third parties – collecting information about family members makes them subjects.