NOHSP Definitions - C

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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Capacity: A clinical judgment that an adult has the ability to understand the nature of the research participation; appreciate the consequences of such participation; to deliberate on alternatives, including the alternative not to participate in the research; and to make a reasoned choice. (HSP#054) (see Limited Capacity)

Case report: A report of observations on one or two patients retrieved in a retrospective manner for medical and/or educational purposes. (HSP#032)

CITI: Acronym for the Collaborative IRB Training Initiative (CITI). The CITI Program (http://www.citiprogram.org) includes “Basic” and “Refresher” courses in the Protection of Human Research Subjects for Biomedical as well as for Social / Behavioral Research. (HSP#005)

Child: Persons (who may or may not be minors) who have not attained the legal status to consent to treatments or procedures involved in research (clinical investigations), under the applicable law of the jurisdiction in which the research will be conducted. (HSP#027)

Clinical Hold: An order issued by the FDA to delay a proposed clinical investigation or to suspend an ongoing investigation. (HSP-076)

Clinical investigation:  Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the FDA, or is not subject to requirements for prior submission to the FDA but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit. (HSP-076)

Complaint: A concern, from any source, that might result in a negative consequence regarding the rights and / or safety of one or more research participants. (HSP#066)

Concealment: A designed component of a research plan in which the investigator intentionally does not reveal initially to the participant all details of the protocol (not the whole truth). (HSP#053)

Confidentiality:

Abiding by a commitment to an individual to limit disclosure of control over information about that individual.

 Note the difference between Privacy and Confidentiality:

• Privacy is about people. Confidentiality is about data.
• Privacy interests of individuals are protected.

Confidentiality commitments about data are maintained. (HSP#082 Conflict of Interest

Conflict of Interest:
Occurs when a member of the Research Team or his/her Family Member engages in an activity or has a relationship which is or could be perceived as inappropriately influencing the judgment, research conclusions, medical decision making, or business decisions made by the individual, especially when there is a financial or other material benefit to the Individual or his/her Family Member. Occurs when any member of the research team engages in an activity or relationship that may inappropriately influence the validity of the research or the protection of human subjects. (HSP-082)

Consultant: An individual that is not an IRB member who provides specific expertise and perspective no available in the membership. (HSP#009)

Continuing Noncompliance: More than one incident of noncompliance occurring within a proximate timeframe, whether similar in nature or not, that may indicate a pattern of noncompliant behavior requiring further examination. (HSP-058)

Continuing Review / Renewal: The process whereby the IRB reviews all active human subjects research studies on an annual (or more frequent) basis in order to assure that the rights and safety of subjects are being appropriately protected. (HSP#007)

Continuing Review Date: Continuing review and re-approval of research must occur on or before the date when IRB approval expires (no greater than one year of approval, e.g., 365 days, or sooner as specified by the IRB).

The new approval date is the date of re-approval by the convened IRB or the date of final re-approval of the IRB Chair or designee by expedited procedure. (HSP#006)

Convened IRB: A scheduled meeting of the IRB with sufficient members in attendance to attain a quorum. A meeting may be convened by telephone conference call or videoconference. The Florida and the Oncology IRBs routinely conduct meetings using videoconference. (HSP#029)

CRRC: Nemours Clinical Research Review Committee (HSP#024)