CONTRACTOR REQUIREMENTS DOCUMENT

DOE O 443.1, PROTECTION OF HUMAN SUBJECTS

The following requirements must be incorporated by reference into
management and operating (M&O)

contracts with the potential to involve human subjects research.

1\. Ensure that the DOE Human Subjects Research Program Manager (SC-72)
is notified of any

new human subjects research project involving

a\. an institution without an established IRB;

b\. a foreign country;

c\. the potential for significant controversy (e.g., negative press or
reaction from stakeholder or

oversight groups);

d\. research subjects in a protected class; or

e\. the generation or use of classified or sensitive unclassified
information.

2\. [Ensure]{.mark} that research involving human subjects conducted at
the contractor-operated institution,

with the contractor\'s DOE-contract funding, or by contractor personnel
is conducted in

accordance with the applicable requirements of 10 CFR Part 745 and 45
CFR Part 46.

3\. [Ensure]{.mark} that contractor-issued solicitations or proposals
for research, studies, tests, surveys,

surveillance, or other data collection are reviewed to identify research
involving human subjects.

4\. [Ensure]{.mark} no research involving human subjects conducted at
the contractor-operated institution,

with the contractor\'s DOE-contract funding, or by contractor personnel
is initiated without prior

institutional review board (IRB) approval under the terms of an approved
assurance covering the

research. For research involving current or former DOE employees or DOE
contractor

employees at DOE sites or facilities, either the IRB or the assurance
must be approved by SC-

72\.

5\. [Apply for SC-72 approval]{.mark} of any single project assurance
(SPA) or multiple project assurance

(MPA), with notice to the cognizant DOE Program Secretarial Officer
(PSO), NNSA

Administrators or Head of Field Organization (HFO).

6\. [Ensure]{.mark} research is reviewed at intervals appropriate to the
degree of risk, but not less than once

per year, to determine whether test subjects are at risk and if they
are, whether the risk is

reasonable in relation to anticipated benefits.

7\. Periodically conduct self-assessments to [ensure]{.mark} compliance
with the Human Subjects Research

Program procedures and other requirements.

8\. [Prepare and submit an annual report for the DOE Human Subjects
Research Database in]{.mark}

[accordance with directions and schedules provided by SC-72 and the
contracting officer.]{.mark}

9\. [Report the following]{.mark} to SC-72 (and any designated PSO, NNSA
Administrators or HFO point

of contact):

a\. any adverse events, unanticipated risks, or complaints about the
research, and a description

of any corrective actions taken and/or to be taken;

b\. any changes in the IRB membership;

c\. any suspension or termination of IRB approval of research;

d\. any significant non-compliance with Human Subjects Research Program
procedures or

other requirements.

(The adverse effects of any study are to be reported to the IRB for
evaluation for further action

with SC-72, the PSO, the NNSA Administrators and the HFO, if necessary.)

10\. Submit requests for waivers from these requirements in writing,
through the designated cognizant

PSO, NNSA Administrators or HFO point of contact) to SC-72, with
appropriate justification.

11\. Actively participate in human subjects research educational
programs.