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.
								TAB I
 
		DRAFT    FOR DISCUSSION PURPOSES

MEMORANDUM

TO:	Members of the Advisory Committee on Human Radiation Experiments

FROM:	Subcommittee on Sampling of Biomedical Experiments

DATE:	October 7, 1994

RE:	Biomedical Experiments Case Studies


     To implement the strategy developed by the Committee at its last 
meeting, the subcommittee recommends that the following steps be 
taken:

     1.  No random sampling, in the rigorous statistical sense, will 
be undertaken now. The question of whether to do so at some point also 
will be tabled for a time. 

     2.     As an alternative to random sampling, a "convenience" 
approach will be used.  This approach will have as its foci highly 
visible cases, each of which serves as a starting point for a larger, 
but manageable, group of experiments.  Although this "convenience 
approach" should allow us  to analyze information in a meaningful way, 
we will be unable to draw any statistically rigorous conclusions about 
how representative the experiments chosen for study are of the entire 
set of human radiation experiments.

     3. The foci are:

     a. Biodistribution.  This group centers on the plutonium 
injection experiments. From those well-known experiments it reaches 
out to include: (a) other experiments designed to test the 
biodistribution of isotopes with no clear immediate therapeutic or 
diagnostic potential; and (b) other experiments whose primary purpose 
was the health and safety of those directly involved in weapons 
production, such as experiments related to toxicology or chelation 
therapy. 

     As well the bedrock questions ( risk/benefit, consent, and 
subject selection), this group permits focus on questions particular 
to cases where a) there is no clear diagnostic or therapeutic intent; 
and/or b) occupationally-related toxicology is a primary research aim.

     b. Total Body Irradiation. This group includes the Cincinnati 
whole body irradiation experiments and other total body irradiation 
experiments. In some cases, as in Cincinnati, at least some aspects 
of the experiments were funded by  the government with an express 
purpose of providing information of use to the military.

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     In addition to bedrock questions, this group raises questions of:

     1.   The facts and ethics of "piggy-backing", i.e., the use 
          government makes of a putatively medical setting to fund 
          research for unrelated government purposes; and 

     2.   Conceptual boundaries, including, on the one hand, the 
          boundary between experimental and therapeutic activity, and, 
          on the other, the boundary between the  testing of a new 
          hypothesis and the retesting of a hypothesis that has been 
          previously tested and found wanting.

     "Piggy-backing" questions under (1) include:

*    To what extent was the design of experiments influenced by the 
     availability of funding for government purposes?

*    In deciding whether or not to perform research, who determined 
     the governmental purposes to be served, and who weighed the 
     potential social benefits against the risks to which individuals 
     were exposed (e.g., military officials, civil servants, doctors)?

*    What portions of the design and conduct of this research were 
     secret, and how did this impact the research?

*    What restraints did the Cold War setting impose on the critique 
     of the work of one's scientific/medical peers, or the research 
     related statements of officials?

     c. Research involving or affecting children.  This group is 
anchored in the Fernald School and Vanderbilt experiments.  The 
Fernald School experiments were tracer studies using radioactive 
calcium in a population of institutionalized mentally compromised 
children.  Vanderbilt University conducted studies on pregnant women 
using radioactive iron to determine maternal-fetal iron exchange.
  
     This class of experiments brings unique concerns with regards to 
risk/benefit because the  susceptibilities of fetuses and children to 
the effects of radiation is different than that of adults.  This group 
also provides an opportunity to look at the selection and use of 
vulnerable populations.  

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     d. Boron/neutron capture. This group includes experiments in the 
therapeutic use of irradiation from an external source, but targeting 
on internally administered stable isotopes, focusing on experiments 
conducted in the early 1950's, and again today.  In addition to the 
bedrock questions, these experiments raise questions about the ethics 
of revisiting experimental approaches that have been rejected 
previously.  The roles of central federal expert panels can be 
reviewed with this case material.

     e. Testicular irradiation/burn experiments. This group, based on 
the testicular irradiation of prisoners, includes experiments (such as 
flash-blindness studies related to atomic bomb tests) in which 
external sources of energy were applied  with no potential for 
therapeutic or diagnostic benefit for the experimental subject.

     f.  Fallout products. At the close of the September meeting of 
the Committee, concern was raised about the "aberrational question": 
whether focusing our studies around well-publicized cases would skew 
our overview. The primary purpose of the "fallout isotopes" group is 
to address this concern by developing a feasible purposive sampling 
which will draw on unpublicized cases, without presuming to achieve 
the rigor of a truly random sample.

     The group is defined as studies using isotopes which were  major 
fallout products, some of which also had major medical applications in 
both diagnosis and therapy. Initially, these would be isotopes of 
iodine, strontium, cesium, gallium, barium and beryllium. This list 
could be expanded depending on research results.  Unlike the plutonium 
group, this group allows a purposive sampling of cases which include 
research on  medical applications. (Cases already covered in the 
"Vanderbilt: fetuses and children under 18" group would not be studied 
a second time, but referenced.)

      In addition to the bedrock questions, this group also raises the 
"piggy-backing" questions presented by the total body irradiation 
group; i.e., the proper balance of interests where experiments are 
said to serve both government and therapeutic purposes. 

     By comparison with the total body irradiation group, both this 
group and the biodistribution group also present the opportunity to 
compare systems of regulation.  External irradiation (e.g., total body 
irradiation) was subject to little, if any, regulation.  Isotopes 
distributed by the AEC were regulated in detail. How did the 
differences in regulation effect human experimentation?  Isotopes were 
available directly from the AEC, indirectly via private firms, from 
private suppliers (e.g., university cyclotrons), and from foreign 
suppliers.  Did the administration of the differing suppliers affect 
the human use?

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4.   Next steps (subject to Committee revision and/or redirection):

*    Core staff have been assigned 

*    Staff is researching available data to identify all experiments 
     within the groups (the sources include experiment lists provided 
     by the agencies,  AEC isotope lists, bibliographies, etc.)

*    Based on the database search, journal literature is being 
     obtained for review.

*    Where groups include large numbers of experiments (which will 
     include groups b, c, d, f) cases will be selected for further 
     investigation.  If the numbers are large enough, the question of 
     statistical sampling will be revisited.

5.   Other investigative areas to be coordinated with this effort: 

*    Intentional releases (including experiments of opportunity and 
     human experimentation in connection with atomic bomb tests)

*    Institutional case studies


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