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

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