EXECUTIVE SUMMARY


    The Advisory Committee on Human Radiation Experiments was
created by President Clinton to advise the Human Radiation
Interagency Working Group (the "Interagency Working Group")  on
the ethical and scientific criteria applicable to human radiation
experiments carried out or sponsored by the U.S. Government. The
Committee is composed of 14 members, including a citizen
representative and 13 experts in bioethics, radiation oncology
and biology, history of science and medicine, epidemiology,
nuclear medicine, and law.

    Human radiation experiments are defined by the Committee's
charter to include

         "(1) experiments on individuals involving
         intentional exposure to ionizing radiation.
         This category does not include common and
         routine clinical practices. . . . (2)
         experiments involving intentional
         environmental releases of radiation that (A)
         were designed to test human health effects of
         ionizing radiation; or (B) were designed to
         test the extent of human exposure to ionizing
         radiation.  ["Intentional Releases"]

The Committee's Approach

    The Committee seeks to answer several fundamental questions:
(1) What ethics criteria should be used to evaluate human
radiation experiments?  (2)  What was the Federal Government's
role in human radiation experiments? (3) What are the criteria
for determining appropriate Federal responses where wrongs or
harms have occurred?  (4) What lessons learned from studying past
and present research standards and practices should be applied to
the future?

    As a Federal advisory committee, the Committee asks these
questions and seeks to answer them in open public meetings.  In
addition to meetings in Washington, which contain a period for
public comment, and a full Committee meeting in San Francisco,
the Committee has scheduled at least three other sessions to hear
public comment in regions throughout the country.

    The Committee's ability to tell the story of past radiation
experiments requires more than the will to search through
hundreds of boxes for documents and the intuition to recognize
which ones are important. It depends on the Committee's ability
to find a common language to address the technically complex,
often highly emotional issues related to human radiation
experimentation. The voices to which the Committee must listen
speak in the languages of medicine, a multiplicity of sciences,
the military, sick patients, healthy subjects, policymakers, and
philosophers. The Committee cannot understand, much less tell,
the story unless it seeks out all who can aid its understanding,
and works to bridge the cultural and linguistic gaps among them.

    The Committee is also convinced that an important
determinant of its success will be its  ability to understand the
present just as well as, if not better than, it understands the
past.  Therefore, it has undertaken the task of sampling the
ethical practices and standards governing human radiation
research today, evaluating them, and deciding whether change is
needed.

    Finally, in order to focus its own inquiry, and the ability
of the public to assist it, the Committee has identified a number
of common themes that will guide its work, and give structure to
its final report. These themes include:

    o    Consent standards and procedures:  A cornerstone of
         modern research ethics is the requirement that research
         proceed only with the informed consent of a competent
         subject or with adequate safeguards to protect the
         interests of a subject who cannot give consent. The
         Committee must understand when policies and practices
         of informed consent were adopted, when, if ever, the
         requirement was disregarded and why.

    o    Risks and benefits of research:  It is inherent in most
         research that subjects are put at risk of harm in order
         to obtain desired benefits.  It is the Committee's
         charge to determine whether the risks to which subjects
         were exposed, however low, were justified.

    o    The selection of research subjects:  The ethics of
         research turn as much on considerations of justice in
         the selection of subjects as they do on questions of
         consent or acceptable risk.  The Committee deems it
         essential that it examine whether particular
         populations were targeted for participation as research
         subjects because of their relative lack of economic,
         social, or political power.

    o    Responsibility for experiments:  Who decided which
         experiments were carried out, and who was responsible
         for assuring that ethics policies, where they existed,
         were put into practice?

The Committee Begins Its Work

    The Committee was created in tandem with a Presidential
directive that the executive branch be open to searching inquiry.
When it began its work in April 1994, there were few records in
hand; the Committee was embarking on a daunting journey into the
past and present with neither stars nor compass to chart its
course. For example:

    o    How many human radiation experiments were conducted
         before 1975? Where could the answer be found? In April
         it was not clear whether the answer was in the hundreds
         or the thousands.

    o    What codes of conduct, if any, existed before 1975 to
         govern federally sponsored experiments?  The prevailing
         assumption was that until the mid-1960s Federal
         agencies, by and large, did not have ethics policies.

    o    What institutions planned, funded, and conducted
         experiments, and who had responsibility for ensuring
         the integrity of experimentation?  Where agency
         organization charts or other road maps existed to guide
         the way, the fragments at hand were often physically
         blurred beyond recognition.

     Time was short. The Committee therefore had to develop a
strategy to quickly gather, organize, and analyze vast amounts of
information.

Phase I.  The Phase I strategy has three components: (l) the
development of a framework for all the information the Committee
hoped to collect--the "big picture" into which pieces of the
puzzle could be fit; (2) the development of a strategy to mine
all available information sources; and
(3) the development of an information infrastructure to house and
organize all the data.  The components of the "big picture"
framework include:

    o    An experiment database, to provide a single locale for
         cataloguing experiments as they are identified;

    o    An ethics timeline, to chart the evolution of Federal
         and private sector policies and practices pertaining to
         research ethics;

    o    A scientific/medical standards timeline, to chart the
         evolution of these standards; and

    o    Institutional maps, to plot the network of public and
         private institutions that planned, funded, managed, and
         performed experiments.

Phase II.  While Phase I continues, the Committee's brief tenure
requires that it turn to the task of evaluating experiments. But
on which experiments should it focus? On the one hand, the number
of pre-1975 experiments may well be in the thousands, and the
number of post-1975 experiments far greater. On the other hand,
the Committee may be able to locate only fragments of data about
many of these experiments (for example, there is often no
information on who subjects were, much less what they were told
about the experiment).

    The working solution, therefore, is a strategy that seeks to
address the basic questions of concern to the Committee and the
public by an overlapping set of case studies and samples. First,
the Committee is focusing on five groups of biomedical
experiments, with each group anchored in one or more specific
experiments that have received public attention. Second, the
Committee is simultaneously focusing on institutions that
conducted the experiments, in order to examine the decisionmaking
process and determine responsibility.  Third, the Committee's
inquiry into intentional releases will focus on determining (l)
whether (at this late date) the public can learn who planned the
releases, why, and what precautions if any were taken; and (2)
whether  intentional releases, which were often shrouded in
secrecy, could take place today in the absence of meaningful
public notice.

    For evaluating the contemporary world of research, the
working solution is to conduct three projects:  (1) a review of a
sample of recently funded research proposals; (2) interviews with
subjects of current research; and (3) review of current Federal
agency policies for oversight.

Phase III.  While Phase I continues, and Phase II has just begun,
the Committee is simultaneously turning to Phase III--the tasks
of evaluating past and present experiments, recommending policy
changes, and developing criteria for a range of remedies that may
be appropriate where wrongs or harms have occurred.

Taking Stock: Some Accomplishments and Challenges

    Openness:  The President's request that the Federal
Government open a substantial portion of its Cold War files to
the Committee, and the public, was ambitious. There were many
reasons for skepticism, including the enormous number of records,
the vast number that remained classified, and the potential for
bureaucratic delay.  These factors remain real.  As detailed in
this report and agency-specific appendices, the Committee and
agency search terms have retrieved important records collections,
some of them previously secret, that will provide a new basis for
understanding our past and present.  In doing so, these
collections are producing a road map that should, as present work
continues, permit the completion of a substantial search within
the Committee's life, and that will remain as a guide for the
public in the years to come.  It is now clear to the Committee
that, with continued public support and interest, the agency
commitment to the opening up of a substantial portion of our Cold
War archives can continue to be substantial, even unprecedented.
It is the Committee's task to help ensure that this search
produces results that merit its continuation when the Committee
is no longer in existence.

    Piecing Together the Secret and Public Worlds of
Experiments:  The Committee's experiment database presently
contains about 400 biomedical experiments conducted before 1975.
The Committee possesses at least fragmentary indications of over
1,000 additional experiments.  In addition to the 13 intentional
releases of ionizing radiation identified in the Charter, the
Committee is now aware of hundreds of additional intentional
releases.

    The Committee is learning that secrecy is not always the
primary bar to comprehending the past. A vast amount of data
already is public, but it is often widely scattered.  For
example, piecing together the story of human experimentation in
connection with atomic bomb tests requires the Committee to
combine discrete collections of public data with newly
declassified data while continuing to search for further secret
and public pieces of the puzzle.

    Piecing Together the Hidden History of Federal Ethics Policy
and Practice:  Documents delivered by the agencies, and others
located by the Committee, have revealed that there was discussion
at the highest reaches of government--often in secret--about the
need for  human experimentation and for policies to govern it.
Committee and agency staff  have placed the highest priority on
tracking down the twists and turns in these discussions and in
the policies and practices that flowed from them.

    Discovery of the Past in the Present:  When the Committee
began its work six months ago, it might reasonably have been
assumed that research conducted in the mid-century world was so
different from current research that its relevance would be
limited. However, the story that is unfolding raises questions of
continuing relevance to today. For example:

    o    At mid-century, ethics policies were discussed and
         recorded on paper. A key question then, as today, is
         the relationship between policy and practice.

    o    Even as policies were put on paper, it was not always
         clear what they covered. Did they cover sick patients
         as well as healthy volunteers?  In cases involving
         soldiers and workers, for example, what was understood
         by responsible decisionmakers to be the difference
         between experimentation with healthy volunteers and
         occupational safety monitoring? Then, as today, the
         boundaries of experimentation may not have been fixed.

    o    Even with the benefits of openness, basic information
         on some experiments (notably the intentional releases)
         remains secret. Could these releases be conducted today
         without basic public disclosure?

    Outreach:  The Committee has heard from many members of the
public who have written, called, visited its offices, or
testified at its open meetings. In many cases these
communications have brought important insight and information to
the Committee's attention.  The Committee's public reading room
provides access not only to basic Committee material (e.g.,
transcripts of meetings) but a collection of important documents
that were previously classified or not readily available in an
organized form. The Committee's experiment and document
collection databases should soon be available to the public on
Internet.

    Challenges:  The primary challenge to the Committee now, as
at the onset, is the overwhelming nature of its tasks. Agency and
Committee document and information searches are progressing and
should result in substantial new information about known
experiments, policies, and practices, and perhaps discovery of
heretofore unknown experiments, policies, and practices.
However, (l) search efforts are necessarily time consuming and
uncertain; (2) data on many experiments will likely continue to
remain fragmentary; (3) it appears that many important
collections have been long since lost or destroyed; (4) a great
number of relevant collections contain classified data; the
declassification process may be a substantial bottleneck.

Work To Be Done

    In the next six months, the Committee will continue with the
tasks of data gathering and organizing. The focus of the work,
however, will be developing criteria for judging historical and
contemporary experiments, policies, and procedures, as well as
criteria for remedies that may be appropriate where harms or
wrongs have occurred.  Based on what the Committee has learned,
it will make specific recommendations regarding policies for the
future.


Interim Report of the Advisory Committee on Human Radiation
Experiments, October 21, 1994