Attachment 3

 
United States Government
Memorandum

To:       Charles L. Duncan, M.D. Director
          Division of Biology and Medicine Headquarters
From:     A.M. Waggoner, Assistant Manager for Administration
          Richland Operations Office
Subject:  Use of Human Volunteers in Biomedical Research

RS:RDW

Attached is a copy of a letter we received from Dr. W.D. Norwood of
the Hanford Occupational Health Foundation (HOHF), our occupational
health prime contractor, regarding certain legal aspects of
proposed 06 research program entitled "Whole Body Counting".  This
program, which will be primarily the responsibility of the Pacific
Northwest Laboratory (PNL), involves the use of human volunteers. 
We understand that PNL and HOHF now contemplate using local college
students as paid volunteers and possibly PNL employees in this
program.

In addition to this program, PNL is planning to initiate a study
entitled "Excretion Rates vs. Ling Burdens in Man" in FY 1967. 
This project also involves the use of human volunteers; in this
case PNL plans to use inmates at the Walla Walla State
Penitentiary.  Initiation of this program is consistent with
division of Biology and Medicine (DBM) FY-1967 Program Assumptions
transmitted to us March 4, 1965.  As you know, DBM is supporting
research programs at the University of Washington under Dr. Paulsen
(Contract AT(45-1)-1781) and at the Pacific Northwest Research
Foundation under Dr. Heller (Contract AT(45-1)-1781), both of which
involve the use of human volunteers at penal institutions.  Also,
the DBM supported research project conducted jointly by Battelle's
Radiological Physics and Dr. W.B. Nelp of the University of
Washington on (illegible) utilized human subjects at the
University's Medical School.  Although these projects involve
different types of volunteers, we believe that many of the legal
questions are common to all of them.

Several questions are raised in the letter from Dr. Norwood which
require clarification.  On the question of licensing requirements
it should be noted that HOHF would perform its work in privately
owned off-site facilities.  We have taken the position that the
Contractor would be exempt from licensing, under authority of 10
CFR 30.12, for work performed in its own facilities (in the Kadlec
Medical -Dental Building) on the basis that the site is Government
"Controlled", i.e., we approve the annual lease and allow the lease
payment as a proper item of cost under the HOHF prime contract. 
However, we request that you assist us by determining if HOHF's
activities in Kadlec Hospital (no lease) would remove the
Contractor from its exempt status.

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Our Office of Chief Counsel advises that the use of humans presents
several legal problems, especially since we have a direct
responsibility under the HOHF cost-type contract.

We request your guidance on the questions contained in Dr.
Norwood's letter and a statement of DBM policy with regard to these
research programs involving human volunteers.  Our Counsel's office
is contacting John Reich, Assistant General Counsel for Research
and Development, on this matter.  A copy of their memorandum to
Reich is attached.

Enclosures:
1.  Letter, 3/11/66
Norwood/Waggoner
2.  Memo, 3/30/66
Brinck/Reich

cc:  John Reich, Assistant General Counsel for Research and
development, HQ

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