J

Joint Commission on the Accreditation of Healthcare Organizations (JCAHO)

An independent, not-for-profit organization, the Joint Commission accredits and certifies health care organizations and programs in the US. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards. Their mission is to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.

Justice

An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.

K

Key Personnel

Persons considered of primary importance to the successful conduct of a research project. The term usually applies to the senior members of the project staff; however, sponsors may have differing definitions of Key Personnel.

L

Lactation

The period of time during which a woman is providing her breast milk to an infant or child.

Lead Researcher

The person with primary responsibility for meeting all ethical, scientific, and regulatory requirements for conduct of a study protocol, whether or not acting as the Principal Investigator for the award that funds the study.

Leftover / Remnant Specimen

Remaining portion of a specimen obtained for clinical purposes that is no longer needed for its original purpose and that would otherwise be discarded.

Legally Authorized Representative (LAR)

1. Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. (FDA)
2. A person authorized either by statute or by court appointment to make legal decisions on behalf of another person. In human subject research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

Lethal Dose

That quantity of an agent that will or may be sufficient to cause death.

Life Threatening Event

The subject's life was endangered by the event. (FDA) A life threatening event is considered Grade IV using NCI/CTC Common Toxicity Criteria (see also Severity).

Life-threatening

Refers to diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; also diseases or conditions with potentially fatal outcomes.

Limitation of Cost

A mandatory clause for cost-reimbursement type contracts. Under the clause, the sponsor is not obligated to reimburse the contractor for costs in excess of the stated amount. The contractor, however, is not obligated to continue performance once expenses reach the stated amount.

Limited Data Set

Health information that excludes certain direct identifiers, but may include city, state, and ZIP code; elements of date; and other numbers, characteristics, or codes that cannot be used to identify an individual or the individual's relatives, employers, or household members. Limited data sets may be used or disclosed for purposes of research with a data use agreement as described by the HIPAA Privacy Rule at 45 CFR 164. For more information, including the list of identifiers that must be removed from health information in a limited data set, see HIPAA and Human Subjects Research.

Local Event / UM Event

An event which occurs in a study under the supervision of the UM IRBMED and whose principal investigator is a UM faculty or staff member. The event is a UM Event when it occurs at UM (including any UMHHC, or other facility) or any other site where the UM PI has oversight, even when the PI is physically in another location. It does not matter where the subject experiences or is treated for the adverse event. If interventions take place at several different UM locations, please specify at which location the event occurred.

Longitudinal Study

A study designed to follow subjects forward through time.