REVIEW GUIDELINES FOR INVESTIGATIONS
                   INVOLVING HUMAN SUBJECTS


PREAMBLE


Any undertaking in which an individual or agency connected with the aca-
demic programs of instruction, research and service at the University
of Kentucky performs a physical procedure or collects data on human
subjects for research, development, or demonstration purposes may be
construed as "an investigation involving human subjects. " Under such a
definition "human investigation" encompasses a broad spectrum of activ-
ities ranging from questionnaires to experimental medical procedures.
Protection of the subject from physical, psychological, sociological, or
other type of harm in addition to safeguarding his legal rights is the ethical,
moral, and legal responsibility of the University of Kentucky as well as of
the individual researcher or agency connected with the project. Protection
of the subject by the institution is maintained by means of formal review
procedures. Since the role of human subjects in research, development,
and demonstration of new ideas is necessary and vital to many university
programs, and since this function cannot be carried out in a legal or
ethical vacuum, the review procedures must be flexible. Ultimately, the
decision on approval for a given investigation must depend upon the com-
mon sense and sound professional judgment of reasonable individuals.
This document is intended as a guideline for individuals who choose to
study human subjects in the course of their investigative efforts. It is the
individual investigator's responsibility to seek the appropriate review as
outlined.

SECTION ONE: THE UNIVERSITY HUMAN INVESTIGATIONS AND STUDIES
                 COMMITTEE

Institutional responsibility for protection of human subjects at the University
of Kentucky rests with the Human Investigations and Studies Committee, a
University-wide committee appointed by and responsible to the President.
This Committee also has the responsibility of insuring that the University
fulfills its contractual obligations relative to investigations involving human
subjects, and membership composition of the Committee is kept consistent
with federal regulations from granting agencies such as the Department of
Health, Education, and Welfare. The Committee will maintain policies and
procedures consistent with federal regulations. The specific charge to the
Committee is to: