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Lead Clinical Research Associate

Individual who manages the study protocol (i.e. consenting, IRB applications, scheduling patients, monitor visits, data entry, query resolution, etc.)

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.

Limited Data Set (LDS)

A HIPAA-specific term, denoting a dataset that contains PHI with only indirect HIPAA identifiers. Specifically, the following types of HIPAA identifiers may be included:

  • Geographic subdivisions smaller than a state.
  • All elements of dates (except year) for dates that are directly related to an individual; and all ages over 89 and all elements of dates (including year) indicative of such age
  • Any other unique identifying number, characteristic, or code

See Research A-Z webpage Limited Data Sets for guidance on the requirements for using or disclosing an LDS.

Related Terms: HIPAA, Protected Health Information (PHI), HIPAA identifiers

Limited IRB Review

A "Limited IRB review" is required under the 2018 Revised Common Rule for certain Exempt human subjects research categories. Its purpose is to ensure privacy/confidentiality protections are in place with exempt research that involves the collection of sensitive, identifiable data (categories 2(iii) and 3(i)(C)).

The "Limited IRB reviewer" must determine that, per 45 CFR 46.111(a)(7), "When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data."

Related Terms: Exempt Review, Expedited Review

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.