Record Display for the EPA National Library Catalog

RECORD NUMBER: 102 OF 226

OLS Field Name OLS Field Data
Main Title Guidance for Human Subjects Research in the National Exposure Research Laboratory.
CORP Author Environmental Protection Agency, Research Triangle Park, NC. National Exposure Research Lab.
Year Published 2009
Report Number NERL-RTP-HEASD-10-053; EPA/600/R-10/175
Stock Number PB2011-104592
Additional Subjects Human subjects ; Research ; Guidance ; Guidelines ; Management ; Investigation ; Ethical conduct ; Regulatory review ; Approval ; Safety ; Rights ; Methodology ; Policy ; Responsibility ; Oversight ; National Exposure Research Laboratory(NERL) ; Principal investigator(PI) ; Human Research Protocol Office(HRPO)
Internet Access
Description Access URL
https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=P100UZ7J.PDF
Holdings
Library Call Number Additional Info Location Last
Modified
Checkout
Status
NTIS  PB2011-104592 Most EPA libraries have a fiche copy filed under the call number shown. Check with individual libraries about paper copy. 07/20/2011
Collation 40p
Abstract
This document provides guidance to investigators and managers associated with the U.S. Environmental Protection Agency (EPA) Office of Research and Development's (ORDs) National Exposure Research Laboratory (NERL) on the ethical conduct, regulatory review, and approval of all human research activities. The focus of this document is twofold: first, on the methods for ensuring the safety and rights of human research subjects; and, second, on how to conduct such research in a manner consistent with EPA and NERL policy. Principal investigators (PIs) are responsible for obtaining approval for human subjects research. If a PI does not have significant experience in the approval process for human subjects research, he or she should rely on an experienced colleague or co-investigator (Co-I) or contact the Office of the Director of the Human Research Protocol Office (HRPO) located at the National Health and Environmental Effects Research Laboratory Human Studies Facility in Chapel Hill, NC. The mission of the HRPO is to assist investigators in all aspects of the ethical and regulatory review of human subjects research.