DOCUMENT N

December 12, 1963

A. R. Keene, Manager
RADIATION PROTECTIONS	

RADIOLOGICAL EXPERIMENTS ON HUMAN TEST SUBJECTS

Purpose

The purpose of this study was to review the radiological
experiments on human test subjects, to make recommendations
as to the propriety of continuing these studies and the
record requirements on the personnel involved.

Findings

The records on the past experiments are inadequate.  The
experiments do not appear to have been in compliance with
the criminal codes of the State of Washington and there is
some question as to whether or not the experiments were
conducted in compliance with federal laws.

Discussion

Experiments on human test subjects may be conducted either
with or without having established formal compliance with
federal and state laws.  If it is desired to continue these
experiments in compliance with all applicable laws and
regulations, this study indicates that an official
endorsement of such programs testing should be specifically
stated or received from the Atomic Energy commission.  such
an approach will involve some rad tape and delay in
obtaining the necessary approval.  It could very well
jeopardize continuance of such programs.  Nevertheless it
seems that if there isn't sufficient justification to
warrant conducting these programs, then we shouldn't be
doing them.  If it is decided to continue these unofficially
it would be difficult and unwise to specify the official
records requirements for undercover unofficial activities.

Recommendations

1.	Recommend that the gray area as to whether or not
radiological experiments on human test subjects here at
Hanford are in compliance with federal laws be
clarified as soon as possible and in any event before
further testing is done.  Legal counsel can upon
request secure from the Atomic Energy Commission an
answer to the question as to the extent to which the
AFC regards such programs as begin within the scope of
our prime contract.  This will resolve compliance with
federal laws.

2.	Recommend that if such programs are not within the
scope of our prime contract and such experiments are
interpreted as in violation of either federal or state
laws that such experiments cease.

A. R. Keene	-2-	December 12, 1963

3.	Recommend that experiments conducted that comply with
federal laws be undertaken only if they also comply
with state laws.  Implementation of the circumstances
suggested by Professor David W. Louisell, quoted by
Jules Pearlman in the attached letter dated November
21, 1963 and repeated here should give the required
assurance.

	a.	"The experiment enjoys the consensus of 
informed medical opinion as to its legitimacy and is not in
violation of statues:

	b.	The subject, a competent adult person, knowingly
and voluntarily consents, after full explanation,
and

	c.	There has been adequate preparation by animal
experimentation."

4.	Recommend that the strict control of all phases of the
program emphasized as necessary by Mr. Pearlman be
initiated by the implementation of the formal procedure
attached as Appendix A, which also assures adoption of
recommendation No. 3 above.


				C.E. Newton, Jr., Manager
				COMPOSITE DOSE STUDIES & RECORDS

DEN:bwe

Attachments

  (1)	Procedure for Radiological Experiments on Test
	Subject with enclosed form
  (2)	Letter Legal Counsel: Subject - Voluntary and
	Planned Human Exposure

cc:  File
     LB

APPENDIX A

PROCEDURES FOR RADIOLOGICAL [ILLEGIBLE]

Recommend that a formal procedure be established that would
govern the conduct at Hanford of any experiments involving
human test subjects.  The procedure would require a project
director, a review committee, and appropriate integration
with RPO personnel, operating as follows:

A.	Project Director

	The Project Director is the individual who is primarily
responsible for the exposure of the humans.  It will be
his responsibility to:

	1.	Prepare a written, detailed proposal for
submission to the review committee.  The document
will contain all applicable references, if such
exist, which establish a precedent for this type
of study.

	2.	Provide data on the estimated dose levels and the
anticipated effects.

	3.	Provide the details of the techniques to be used
to give reasonable assurance that the experiment
will result in the dose as planned.

	4.	Provide the names of the volunteer individuals
involved.

B.	Review Committee

	The Review Committee shall be constituted of at least 3
members who represent the following disciplines: 
Medical, Radiation Protection and Biology.  The
membership should be appointed for no less than 1 year. 
It is recommended that the medical representative be a
physician from the Occupational Health Operational;
that the representative from Radiation Protection be
the Manager of RPC and that the representative from the
Biology Laboratory staff be a biophysicist.

	The responsibilities of the review committee will be
to:

	1.	Determine that the applicant is qualified by
training and experience to undertake the proposal.

	2.	Assure that the applicant's proposed equipment and
facilities are adequate for the experiment.

	3.	Review the details of the experiment to assure
that there are no undue health hazards.  Reference
where possible all procedures for this type of
study.

	4.	Verify that the technical procedures are adequate
to assure that the experiment will be conducted as
planned.

	5.	Assure that the records are detailed sufficiently
to provide an adequate personal history for the
individuals concerned in the test.  This
information should be retained on a strictly
private company basis.
	6.	Assure that the volunteers are fully orientated
and medically qualified to participate in the
experiment.

	7.	Maintain complete minutes of the committee meetings.

C.	RPO

	The responsibilities of the RPO personnel will be to:

	1.	Maintain complete individual records on the
personnel involved (Official Use Only).

	2.	Verify, when it is possible to do so in advance,
the estimated damages to be received by the
volunteers.

	3.	As applicable, measure all doses after they have
been received by the individual.  These may be
only verifications of experimental results, but
will provide independent measurements.  The
results of these measurements are to be filed in
the individual's exposure history file.

	The method of implementing these proposed requirements
is as follows:

	1.	Project Director

		The Project Director will forward three copies of
the form "Application for Approval - Radiological
Experiments on Human Test Subjects" to the
Chairman of the Review Committee with such
attachments as may be required by the experiment.

	2.	Review Committee

		The Committee will met at the call of the
Chairman, review the proposal and return a signed
approved or disapproved application to the Project
Director, retain one copy for official minutes and
forward the third copy to Composite Dose Studies &
Records, Radiation Protection Operation.

	3.	RPO

		Composite Dose Studies & Records will notify RPO
components of the extent of their participation
and support of the experiment.  This component
will maintain the official use only records
regarding the exposure of the individuals
concerned.

12/11/63
CE Newton:bwe
Attachment	("Application for Approval - Radiological
		Experiments on Human Test Subjects")


APPLICATION FOR APPROVAL - RADIOLOGICAL EXPERIMENTS ON HUMAN
TEST SUBJECTS

If it is planned to non-occupationally administer internally
radioactive materials, the radiations therefrom or from any
radiation producing devices such as X-ray and Van deGranff
machines, this form is to be completed and submitted for
approval to the committee reviewing experiments on human
test subjects.

1.  Project Director   2. Position Title      Dept. 	 Telephone
					      Location   Extension


3.  Have you conducted this type of experiment previously  
						Yes | |  No | |

                                 At Hanford?	Yes | |  No | |

4.  Attach investigative proposal for human use.  (Attachment should 
    include data from animal studies and/or abstract of literature 
    reference, if any.)


5.  If item 4 is not applicable, describe in detail the nature, 
    methods to be used and objective of the test.



6.  Brief statement on project director's experience with this type 
    of radiation and its application to humans.  (Do not repeat if 
    previously submitted on prior application.)


7.	If exposure dose is not obtained in precalibrated form,
for oral administration, or in precalibrated and sterilized form for 
parental administration, describe identification, processing, and 
standardization procedure or for external sources, etc., calibration
procedures.



8.  Names and PR number of volunteer subjects.



9.  Specify what arrangements have been made with Composite
    Dose Studies & Records, RPO, regarding the recording of
    exposure dose results.

			OFFICIAL USE ONLY

		     REVIEW COMMITTEE ACTIONS

1.  Approved (Circle answer)		      Conditional
					Yes	 sec	  No
					      Item 2 or 4


2.  Restrictions, if any, to be imposed including limits on
    frequency or number of experiments.


3.  List of the names of the volunteers whose medical records 
    have been reviewed and who are approved to participate in 
    this proposal.


4.	Remarks



				Chairman - Review  Committee


				OFFICIAL USE ONLY