Research Terms/Definitions – E

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Emergency Use:  A life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval.

Ethics:  There are three major ethical codes that provide general ethical guidelines for the responsible conduct of research in the United States and which provide the basis for the HHS/FDA regulations on the protection of human research participants. Most institutions use the Belmont Report, Declaration of Helsinki and the Nuremberg Code.

Belmont Report: A report consisting of ethical principles and guidelines for protection of human research participants in research. It was issued April 18, 1979, by the National Commission for the Protection of Human Research participants of Biomedical and Behavioral Research.

Declaration of Helsinki: An international ethical code first issued in 1964 by the 18thWorld Medical Assembly in Helsinki, Finland. The Declaration contains 12 basic principles which are similar to the Nuremberg Code but represent an expansion of what constitutes acceptable research and the ethical responsibilities of investigators. Unlike the Nuremberg Code, the Declaration of Helsinki addresses the need for peer review (i.e., IRB review). It is interesting to note that the FDA will not accept foreign data unless the studies in which such data are generated are conducted in compliance with the Declaration of Helsinki (21 CFR 312.20, 46 Fed Reg 8953, Tuesday, January 17, 1981).

Nuremberg Code: An international ethical code published in 1947 which established standards for the conduct of research involving human beings. It arose out of the Nuremberg War Crimes Trial, where 23 Nazis were charged with crimes against humanity that involved murderous pseudo medical experimentation. Twenty of the individuals charged were physicians.

Exempt:  The project is exempt from all Federal Regulations but since it is still human subject research it must be submitted to ORI for a determination that the research is exempt and approval. An Exempt study must meet one of the minimal risk categories listed in 45CFR46.104 and can be approved by the ORI Director, IRB Chair or a designated IRB member.

Expedited Review:  This means the project is minimal risk and must receive review by the IRB chair or an experienced voting member or group of experienced voting members designated by the IRB chair rather than the entire IRB. An Expedited study must meet one of the categories listed in 45CFR46.110.

Expired Protocols:  If the IRB has not re-approved a research study by the study’s current expiration date, the research is no longer approved. All research activities must stop, including recruitment, enrollment, interventions, interactions, and data analysis.  If an investigator believes that currently enrolled participants will be harmed by stopping interventions, the investigator must provide a list of such subjects and the reasons why participation in the research should continue.  The IRB chair, and in the case of VA research the IRB chair in consultation with the VA Medical Director, will determine which participants may continue because of an over-riding safety concern or ethical issue involved such that it was in the best interests of the individual participant to continue participating in the research interventions or interactions. Under no circumstances will investigators be allowed to enroll new participants into expired research.  The expiration will be lifted when and if the protocol is re-approved by the IRB.