Medicina

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

Release Date: June 5, 2000 (Revised August 25, 2000)NOTICE: OD-00-039 (Also see Notice NOT-OD-08-054)

National Institutes of Health

Policy: Beginning on October 1, 2000, theNIH will require education
on the protection of human research participants for all investigators
submitting NIH applications for grants or proposals for contracts orreceiving new or non-competing awards for research involving human
subjects.

Background

To bolsterthe Federal commitment to the protection of human research
participants, several new initiatives to strengthen government
oversight of medical research wereannounced by HHS Secretary Shalala
on May 30, 2000. This announcement also reminds institutions of their
responsibility to oversee their clinical investigators andinstitutional review boards (IRBs). One of the new initiatives
addresses education and training. This NIH announcement is developed
in response to theSecretary’s directive.

Implementation

Before funds are awarded for competing applications or contract
proposalsinvolving human subjects, investigators must provide a
description of education completed in the protection of human subjects
for each individual identified as “keypersonnel” in the proposed
research. Key personnel include all individuals responsible for the
design and conduct of the study. The description of education will be...