DISCLAIMER

The following is a staff memorandum or other working document 
prepared for the members of the Advisory Committee on Human
Radiation Experiments.  It should not be construed as representing
the final conclusions of fact or interpretation of the issues. 
All staff memoranda are subject to revision based on further 
information and analysis.  For conclusions and recommendations of
the Advisory Committee, readers are advised to consult the Final
Report to be published in 1995.


			 Scope and Priorities


                             MEMORANDUM


TO:       Advisory Committee on Human Radiation Experiments

FROM:     Subcommittee on Scope and Priorities

DATE:     July 19, 1994

RE:       Recommendations of the Subcommittee




CHARGE TO THE SUBCOMMITTEE

The Subcommittee on Scope and Priorities was formed to advise the
main Committee on (1) criteria for deciding what medical
experiments and environmental releases should be considered in
our report, and (2) the relative priority that should devoted to
each.

The Subcommittee feels that, while these questions have not yet
been entirely resolved  we have made enough progress that general
recommendations can now be made and that further investigation
would be better undertaken by the full committee, staff, or new
groupings of committee members.  We therefore recommend that the
Subcommittee's work in its  resent form be suspended and offer
the following interim recommendations.

GENERAL RECOMMENDATIONS

The Subcommittee recommends that no absolute "in or out"
decisions be made regarding scope.   Rather, we recommend that
all human medical and environmental radiation exposures other
than standard diagnostic and therapeutic medical procedures,
routine occupational exposures, and routine releases from nuclear
plants be discussed to some extent in the final report- The depth
to which we pursue each will be guided by the criteria described
below and the specific recommendations made below may be modified
in the light of future evidence. (Note: In response to points
raised during the subcommittee's discussion of these
recommendations, Jay Katz developed a preliminary classification
scheme for radiation studies which also has implications for the
Committee's development of its Trial report.  His thoughts are
attached to this report for your review and consideration).

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GENERAL RECOMMENDATIONS REGARDING PRIORITIES

The Subcommittee recognizes the impossibility of pursuing all the
stories we have identified in exhaustive depth and the fact that
some stories are inherently more important than others.   General
criteria which should guide our priority decisions include the
following:

     1.   Secrecy and the extent to which we suspect further
untold stories remain to be told,

     2.   Dose, risk of medical consequences, or evidence of harm
done;

     3.   Ethical concerns, including consent, information
provided to subjects, use of vulnerable populations, real options
to refuse, etc.;

     4.   Whether the primary purpose was to study adverse
effects of radiation;

     5.   Whether the study was experimental or observational;

     6.   Where there has been previous extensive reviews of
these studies When prior reviews have occurred, the staff should
make efficient use of existing materials.

GENERAL RECOMMENDATIONS REGARDING REMEDIES

The Subcommittee feels that our report will have to include
statements about remedies that are broad enough to encompass all
of the experiments we choose to address.  This could be done by a
mixture of generic and specific recommendations.  For example, we
might endorse some general principles for mass exposure
situations (perhaps along the lines of those discussed by the 
Commission on Catastrophic ;Nuclear Accidents) and reserve more
specific recommendation's for particular medical experiments. 
Further discussion of remedies might be more appropriately
postponed until we are further along with our fact finding
activity and assigned to a new subcommittee.

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SPECIFIC RECOMMENDATIONS REGARDING MEDICAL EXPERIMENTS

1. The subcommittee endorses the following scheme (based on a
preliminary proposal by the Cold War Subcommittee) for
classifying medical experiments, namely:

     I.   Radiation Research Primarily for Military Purposes

               A.   Studies on Acute (Deterministic) Radiation
Effects Following Intentional or Accidental Exposures (EDE > 25
Rems or Organ dose > 25 rems except for Thyroid (dose > 500 rems)
or gonadal dose > 10 rems). Dose delivered in less than I week.

               1.   Whole body radiation from an external source 
               2.   Gonadal radiation
               3.   Radiation from an internal source or sources'

          B.   Intentional Environmental Releases (EDE > 500 mR,
Thryoid > 25 rems)

          C.    Follow-up of Accidental Exposures



     II.   Radiation Dosimetry Research for Scientific Purposes

         A.   Biodistribution experiments

         B.   Metabolic studies involvina routine use of
radioactive tracers

     III.   Therapeutic/diagnostic Research

        A.   Experiments involving use of radiation for medical
diagnosis and therapy

        B.   Experiments involving use of radiation as a research
tool

       C.   Routine radiation use in non-radiation related
experiments

       D.   Observational Studies of effects of non-standard
radiation treatments (e.g., nasopharyncreal radium treatments)

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2.   The Subcommittee suggests that each of these categories be
pursued as a group, but only selected examples  of  each  be 
described  in  detail.  In  addition,  there  needs  to  be  some
overall characterization of the  extent  of  each  group,  by 
some  form  of  sampling.

3.   Highest priority  should  be  devoted  to  the  category  of 
radiation  effects   research.

4.   The  Subcommittee  recommends  that  staff  be  assigned  to 
 review various lists of experiments that have been identified
and attempt to classify each into the above system.  A  plan 
should  be  developed  for  sampling  each  of  these  categories 
(including the unclassifiable)  and  for  prioritizing  the 
search  for  further  documentation, both from government and
university sources.


SPECIFIC RECOMMENDATIONS REGARDING ENVIRONMENTAL RELEASES

1. Highest priority should be devoted to the specific releases
listed in the Executive Order.

The following comments relate to other groups that do not clearly
fall within the scope of our charter but are felt to merit some
comment by the Committee:

2.   The experience of the Marshall Islanders is clearly a part
of the larger Cold War story that deserves to be told in our
report,  There is no dispute that some of the Islanders  were    
exposed to trial doses of fallout; that some thyroid disease and
possibly other health effects occurred as a result; that some of 
the Islanders were relocated back into contaminated islands; and
that they were not adequately informed about the risks. These
parts of the story have been told before, and we should rely on
the previous reports for the details. The most controversial part
of the story appears to be whether there was an "experimental" 
purpose; this part of the story  merits further  investigation  
by  our committee, and staff efforts should  be  directed  
particularly  towards  ferreting  out information about this 
aspect.

3 .  The uranium miners are also clearly  part  of  the  Cold 
War story and represent a public health failure that should not 
go without comment.  The story has been extensively    
documented, and we should rely on this documentation.  Although
there was no if experimental' purpose, there are still ethical
issues to be discussed such as the responsibility of physicians
to inform their patients of risks they are exposed to and    
responsibility whether the PHS should have acted more directly 
rather than study the problem.

4.   The atomic veterans appear to have been subjected to two
types of exposures, occupational hazards (such as those involved
in clean-up activities) and possibly experiments relating to
nuclear warfare concerns. Documentation of the latter is elusive  
but There are leads that are worth following. If nothing else,
the  extensive  discussions about the need for and ethics of
human experimentation needs to be pursued. Differences between
medical ethics and military ethics and their interplay are
another important and closely related topic.

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5.   The "downwinders" from the Nevada Test Site also need to be
mentioned. Leukemias and thyroid neoplasms have been associated
with fallout exposures  in  this  population.  Although the
releases were not done for the purpose of studying human health
effects or the extent of human exposures, ethical issues such as
information provided to the exposed population need to be
addressed.

6.   The Subcommittee recommends that the following exposures be
considered as outside the scope of our charter- routine
occupational exposure of radiation workers at DOE facilities
And elsewhere (except for volunteers in specific medical
experiments); routine emissions from DOE facilities (except to
put the intentional releases for experimental purposes in
context); and the Japanese atomic bomb survivors.

7.   Staff has been charged with the task of assembling a 
comprehensive  list  of  known environmental releases. [Staff
note: Please see Tab J of this briefing book for the Additional
environmental releases will be considered as they arise.

GENERAL RECOMMENDATIONS REGARDING FURTHER WORK

The Committee suggests that some restructuring of subcommittees
might be appropriate at this stage to allow committee members to
pursue particular stories in greater depth in collaboration with
staff.  This might be done by forming a large set of
"mini-subcommittees" directed atparticular groups of experiments,
perhaps combined with a medical and an environmental
subcommittee to ensure that all the relevant stories receive
adequate attention.  This is but one of a number of
possibilities, which should be discussed at the July 25th
meeting.

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