NOHSP Definitions - E

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

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Emergency Use: The use of a Test Article upon an individual patient when all of the following preconditions are met:

• The individual has a life-threatening / severely debilitating condition for which no standard acceptable treatment is available;
• There is no available, approved protocol;
• The Test Article may, in the opinion of the treating physician may be beneficial to the individual;
• The Test Article is available through the sponsor or manufacturer;
• There is insufficient time to obtain FDA and IRB approval. (HSP#034)

Emergency Use Exemption:
The use of a Test Article upon an individual patient in a life threatening, or severely debilitating situation when there is no standard acceptable treatment is available when all of the preconditions described in the Checklist for Emergency Use of an Investigational Article are met.

“Engaged” in Research: An institution becomes “engaged” in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes. (HSP#016)

Enrollment: An individual is “enrolled” in a research study upon the documentation of parental permission, minor’s assent, or adult informed consent (as applicable) and is considered to be enrolled until the individual’s participation is terminated either voluntarily, by the researcher, by death, or by formal closure of the study.(HSP#004)

Equipoise: Genuine uncertainty among medical experts about the comparative therapeutic merits of each arm of a clinical trial or the relative merits of standard of care and the research intervention. (HSP#025)

Equitable selection of participants: Fairness in the distribution of risks and benefits among research participants and the population groups who may benefit by the research. (HSP#023)

Exception: See Protocol Exception

Exempt Research: Categories of research that, according to Federal regulations, do not require IRB review or approval. However, the regulations give each Institution the right to determine review requirements for these categories. All research involving human participants at Nemours requires prospective IRB review and approval. (HSP-061)

Expedited review: Review of research by the expedited procedure is an alternative to review by the convened IRB for a limited class of research. The regulatory requirements for review by the expedited procedure are otherwise identical to review by a convened IRB. (HSP#029)

Experienced reviewer: An IRB member who has no less than one year of IRB experience, is current with IRB training requirements, and has demonstrated competence as a primary reviewer for similar research and is so designated by the IRB Chair. (HSP#020)

Expiration Date / Renewal Date:
The last date that an approved protocol can be conducted. This is the date before the anniversary date, or the last day of any shorter interval, of IRB approval. For example: Research approved for one year on 01/10/2006 would expire on 01/09/2007. Research approved for a 6 month interval on 01/10/2006 would expire on 07/09/2006. (HSP#007)