INTERNAL AUDITOR HOME | HU HOME
Office of the Internal Auditor Howard University
Controls Related to Research Projects Covering Human Volunteers
  You are at: Home > List of Audits - FY 2002 > Controls Related to Research Projects Covering Human Volunteers

Function, Project, Program, Organization, Activity:

Controls Related to Research Projects Covering Human Volunteers

Reason(s) Why Audit Is Needed:

This area has never been audited. Federal regulators recently suspended clinical trials at Virginia Commonwealth University and the Duke Medical Center because institutional review boards (IRBs) did not provide sufficient oversight of human subject research studies. In the case of Duke, the trials were halted because it failed to review continuing research projects "at least once a year". Federal regulators also indicated that the board lacked formal training on regulations covering human volunteers. Suspension of the trials not only had a pecuniary impact on the institution, it also "embarrassed" the institution, according to articles published in the Chronicle for Higher Education.

Audit Objectives:

The objective of this audit is to determine the adequacy of controls over the monitoring of experiments involving humans. Specifically, we will determine whether the current system of oversight adheres to University and federal regulations.

Priority: High


2001 Howard University, all rights reserved.
HOWARD UNIVERSITY, 2225 George Avenue, NW, Suite 701, Washington, DC 20059
Phone: 202-238-2470 - Contacts - WWW Disclaimer