Glossary | Human Research Protections

Legally Authorized Representative (LAR):

A person authorized either by statute or by court appointment to make 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. There are several considerations that must be addressed when the inclusion of an LAR is proposed, such as, whether periodic re-consenting is warranted, and whether the probability of benefit is greater than the probability of harm.

Life-Threatening:

Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and diseases or conditions with potentially fatal outcomes,where the end point of clinical trial analysis is survival.

Limited Capacity:

A person who is able to make independently some but not all of the decisions necessary for the person's own care and the management of the person's property; and the person is not a minor.

Limited Data Set:

A limited data set could include the following (potentially identifying) information:

Admission, discharge, and service dates;
Dates of birth and, if applicable, death;
Age (including age 90 or over); and
Five-digit zip code or any other geographic subdivision, such as state, county, city, precinct and their equivalent geocodes (except street addresses).

Covered entities must condition the disclosure of the limited data set on execution of a "data use agreement," which

establishes the permitted uses and disclosures of such information by the recipient, consistent with the purposes of research, public health, or health care operations;
limits who can use or receive the data; and
requires the recipient to agree not to re-identify the data or contact the individuals.

In addition, the data use agreement must contain adequate assurances that the recipient will use appropriate physical, technical and administrative safeguards to prevent use or disclosure of the limited data set other than as permitted by HIPAA and the data use agreement, or as required by law.