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U.S. Department of Energy				POLICY
 Washington, D.C.					DOE P 443.1A

							Approved:12-20-07

SUBJECT: PROTECTION OF HUMAN SUBJECTS

PURPOSE AND SCOPE

Research using human subjects provides important medical and
scientific benefits to individuals and to society. The need for
this research does not, however, outweigh the need to protect
individual rights and interests. Department of Energy (DOE)
policy regarding this issue is established in the Federal Policy
for the Protection of Human Subjects, adopted by DOE
June 18, 1991, as Title 10 Code of Federal Regulations (CFR) 745,
Protection of Human Subjects. The purpose of this Policy is to
establish DOE-specific principles for the protection of human
subjects involved in DOE research.

This Policy cancels and supersedes DOE P 443.1, Protection of
Human Subjects, dated 5-15-00.

POLICY

DOE research is conducted by or for DOE institutions, supported
with DOE funds, or performed by DOE employees (including the
National Nuclear Security Administration) whether done
domestically or in an international environment and includes
classified and proprietary research. Regulations and directives
that specifically address the protection of human subjects
include10 CFR Part 745; 45 CFR Part 46, Subparts B, C, and D;
Department of Health and Human Services Regulation on Protection
of Human Subjects; and DOE O 443.1A, Protection of Human
Subjects, dated 12-20-07. The requirements of all applicable
regulations and directives must be met before any research
involving human subjects is initiated.

In addition to traditional biomedical and clinical studies, such
research includes but is not limited to studies that—

•	use humans to examine devices, products, or materials with
	the express purpose of investigating human-machine interfaces or
 	evaluating environmental alterations when humans are the subjects
	being tested;
 
•	use personally identifiable bodily materials such as cells,
	blood, tissues, urine, or hair, even if the materials were
 	collected previously for a purpose other than the current
 	research;
 
•	collect and use personally identifiable information such as
 	genetic information or medical and exposure records, even if the
 	information was collected previously for a purpose other than the
 	current research;
 
•	collect personally identifiable data, surveys, or
 	questionnaires through direct intervention or interaction with
 	individuals; and
 
•	search for generalizable1 knowledge about categories or
 	classes of subjects (e.g., linking job conditions of worker
 	populations to hazardous or adverse health outcomes).
 
Human subject research does not include the following:

•	studies to improve the safety or execution of procedures
 	that apply to routine occupational activities;
 
•	occupational health surveillance of DOE Federal and
	contractor employees to determine apparent departures from
	typical health status and not for the purpose of obtaining
	generalizable knowledge; and
 
•	employee surveys used as management tools to improve worker
 	or contractor performance as long as the identity of the
 	participant is protected.
 
RESPONSIBILITY

All DOE employees, contractors, and financial assistance
recipients share the responsibility to protect the rights and
welfare of human research subjects. The Secretary of Energy is
responsible for the conduct of DOE-related human subjects
research. The requirements for implementing this policy are
described in DOE O 443.1A to ensure that the research program
keeps pace with the changing and complex nature of human subjects
research, develops and implements comprehensive educational
programs, and performs program compliance reviews. Any new
proposal for research with human subjects requires that the
Institution administering the Institutional Review Board (IRB)
for review and approval of the proposal hold a valid Federalwide
Assurance (FWA) from the Department of Health and Human Services
Office of Human Research Protections.

BY ORDER OF THE SECRETARY OF ENERGY:

CLAY SELL
Deputy Secretary


_______________________________
1New information that has relevance beyond the population or
 program from which it was collected, or information that is
 added to the scientific literature