INTRODUCTION


CHARGE AND MANDATE

    The Advisory Committee on Human Radiation Experiments was
created by President Clinton to advise the Human Radiation
Interagency Working Group [1] (the "Interagency Working Group")
on the ethical and scientific criteria applicable to human
radiation experiments carried out or sponsored by the U.S.
Government.  (See Appendices A and B for Executive Order and
Charter.)  The Committee is composed of 14 members, including a
citizen representative and 13 nationally recognized experts in
bioethics, radiation oncology and biology, history of science and
medicine, epidemiology,  nuclear medicine, and law.  (A list of
Committee members is attached as Appendix C.)  

    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." [2]

    The Committee is mandated to review experiments conducted
between 1944 and May 1974, the date the Department of Health,
Education, and Welfare issued regulations for the protection of
human subjects.  Experiments done after May 30, 1974, may be
sampled to determine if further inquiry into experiments is
warranted.

    The Committee is also mandated to determine the ethical and
scientific standards and criteria by which to evaluate the pre-
May 1974 experiments, and the extent to which the experiments
were consistent with such standards.  The Committee "shall
consider whether (A) there was a clear medical or scientific
purpose for the experiments; (B) appropriate medical followup was
conducted; and (C) the experiments' design and administration
adequately met the ethical and scientific criteria, including
standards of informed consent, that prevailed at the time  of the
experiments and that exist today." [3]  Upon completing its
review, the Committee may recommend that subjects (or families)
be notified of potential health risks and the need for medical
followup, and it "may recommend further policies, as needed, to
ensure compliance with recommended ethical and scientific
standards for human radiation experiments." [4]


HOW THE COMMITTEE FUNCTIONS

    The Committee, as a Federal advisory committee, is an
exercise in open government.  Basic decisionmaking is conducted
in open public meetings.  The Committee has scheduled 13
(generally two-day) full Committee meetings over the course of
its one-year term.  In addition to a full Committee meeting in
San Francisco, the Committee has scheduled at least three other
public comment sessions in different regions of the country, as
discussed below.  Each meeting is announced in the Federal
Register. (Dates and locations of meetings can be found in
Appendix D.)

    At each meeting, staff and Committee members provide
progress reports on the range of ongoing and anticipated tasks
and projects.  These have included the investigation and
retrieval of documents related to agency searches, experiments
and the world in which they were set, institutions of interest,
past and present ethics policies, and contemporary research
practices.  Each meeting includes a public comment period.
Committee meetings also include self-education presentations on
the relevant aspects of radiation, ethics, law, history of
experimentation, and Federal regulation.  All meetings are
transcribed, and the transcripts and meeting minutes are
available to the public.

    The Committee has been extremely fortunate to assemble a
multidisciplinary staff of substantial talent.  The staff
currently includes 34 full- and part-time members, supplemented
by several expert consultants.  The staff includes individuals
with backgrounds in internal medicine, nuclear medicine,
bioethics, physics, epidemiology, molecular biology, history
(e.g., radiation science, human experimentation, the Cold War),
law, health policy, communications, archival creation and
management, and information systems development.  The staff works
at the direction of the Committee, and subcommittees have been
formed to oversee staff work between meetings.  The staff also
consults with experts in dose reconstruction and other relevant
technical areas.

    As discussed in Part III of this report, outreach is an
essential component of the Committee's activities.  Staff
routinely meets with individuals and groups who are interested in
learning about the Committee and from whom the Committee can
learn.  A public reading room at the Committee's offices contains
basic Committee materials (such as Committee meeting  briefing
books and transcripts) and key collections of historical
documents assembled by the Committee.  The Committee expects that
indices to document collections and its experiment database will
shortly be available on Internet.


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?

    The Committee has been gathering vast amounts of information
and working to render it orderly and accessible.  Its members are
currently engaged in the complex task of analyzing the scientific
and ethical standards and procedures by which experiments on
human subjects should be judged, both retrospectively and in the
present.  Once this task is completed, the Committee will draft a
final report answering the above questions in the form of
recommendations to the Interagency Working Group.

    Created in tandem with a Presidential directive that the
executive branch be open to searching inquiry, the Committee
began its work with few records, a huge task, and a short time
frame.  The work began with an examination of a largely untold
part of the history of the Cold War.  The examination entails
digging into warehouses full of public and private records and
probing the memories of numerous individuals.

    The Committee's work involves integrating ideas and
information relating to big science and microdoses of radioactive
isotopes, global policy and knotty ethical dilemmas, and the pain
and fear of ordinary individuals.  But this represents only half
the job.  The Committee is convinced that an important
determinant of its success will be its ability to understand the
present as well as, if not better than, it understands the past.
Therefore, it has taken on the task of sampling and evaluating
the ethical practices and standards governing human radiation
research today, in order to determine whether change is needed.  


    Among the obstacles the Committee must overcome in meeting
its mandate is the lack of 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, philosophers, and individuals in a
variety of other roles.   The Committee is seeking out and paying
careful attention to everyone it can find who can contribute to
its understanding, and it is working hard to bridge the
linguistic and cultural gaps that can hinder its  progress. [5]
Together with the documentary evidence that the staff has
unearthed and is continuing to gather, the Committee is drawing
on these disparate voices to articulate the vital themes that
will give structure and substance to its final report.  To date
the Committee has identified nine such themes, italicized in the
paragraphs that follow, but other themes may come to light as the
work shifts to analysis and normative judgment.

    It was obvious to the Committee from the language in its
charter that a primary theme would be 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.  It now appears
that, as it relates to government-conducted or government-
sponsored research, this requirement and its application have
evolved over time.  It is important to understand when these
policies and practices were adopted; when, if ever, the
requirement was disregarded; and why.

    Similarly, it was clear that the Committee would have to
make assessments of the potential harms and benefits of the
experiments it is charged with studying.   It is in the nature of
most research that subjects may be exposed to risks in order to
obtain desired information.  It is therefore important to
understand (to the extent possible) the level of risk to which
subjects were exposed, as well as researchers' perceptions of the
risk.  It is also important to assess whether the potential
benefits to the subject or to society were sufficient to justify
the risk to which subjects were exposed.  The Committee is aware
that, within and outside the scientific community, there is study
and debate regarding the effects of low doses of radiation.  The
Committee must be sensitive to all viewpoints.  At the same time,
the Committee and the public must understand the relation between
this discussion and the Committee's charge.  For example, the
doses in historical experiments evaluated by the Committee may
not differ from those in use today in routine and accepted
diagnostic procedures.  It is not the Committee's charge to go
beyond presently accepted radiation standards.  By the same
token, it is not the Committee's view that contemporaneously
accepted practices are risk free, and can have no health effects;
accepted practices often may well involve risks.  It is the
Committee's charge to assess whether the risk, however low, was
justified.  For example, were subjects informed of the risk and
the purpose(s) for its being undertaken?  Was their consent
obtained?  Where consent was obtained, were some populations
(e.g., indigent persons) chosen as subjects to the exclusion of
others?

    Another theme the Committee noted early in its work concerns
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.  For instance, fetuses, infants, children, prisoners,
soldiers, minorities, the poor, the terminally ill, persons with
cognitive disabilities, and the institutionalized may have been
chosen as subjects because of their relative powerlessness.

    The Committee also recognizes the importance of
understanding the organizational and structural context in which
experiments were carried out.  This theme includes the way in
which (and by which) agency experiments were funded, the
evolution of the institutions involved in the experimentation,
and the way in which decisions were made.  This area also
addresses questions such as who decided which experiments and
research programs were carried out and which were not, and by
what authority these decisions were made.

    Along with the institutional factors, the Committee
recognizes the human elements that must be taken into account if
it is to fulfill its mandate.  For example, what were the
attitudes of  researchers about the experiments they were
conducting?  How did researchers reason about whether to use
animal or human subjects for their experiments?  What were
researchers' personal views about what constituted an acceptable
consent from a subject?  What did the word "informed" mean to the
researchers in the context of consent?

    Although the Committee was appointed in response to
potential abuses, it was evident to members from the outset that
the medical and other scientific benefits of radiation was a
theme that deserved attention.  A great many diagnostic,
therapeutic, and basic science applications have been developed
as a result of government-sponsored research involving radiation.
The story of human radiation experiments would be incomplete if
it did not include an account of the benefits derived from this
research.

    Because radiation experimentation evolved in tandem with the
development of nuclear weapons, it seemed inevitable to the
Committee that national security considerations would become part
of the radiation experimentation story.  Therefore, the
relationship of experimentation, secrecy, and national security
forms an important theme for the Committee to consider.  One key
question is the extent to which national security may have been
invoked to justify the bypassing of ethics policies or the
intentional exposure of populations to releases of radioactive
materials.

    Underlying all of these themes is a central question for the
Committee:  what was the role of the U.S. Government where harms
or wrongs were done to citizens who took part in radiation
research?  Information about the knowledge or ignorance of
Federal agencies and officials relating to harms or wrongs to
research subjects, and the extent to which relevant policies were
followed or violated, will inform the Committee's conclusions and
recommendations.

    Finally, the over-arching context for the Committee's
retrospective judgments is that during the historical period
specified by its charter (1944-1974), the United States was not
only in the throes of the Cold War, but it was also living
through the early stages of a profound scientific and social
revolution.  It was the dawn of the Atomic Age.  The power of the
atom was seen as a source of great promise--it would cure cancer
and provide limitless cheap energy.  But  it was also the source
of the most destructive force ever created by humanity and
unleashed on the earth.  A complete understanding of human
radiation experiments must situate the research in this complex
cultural context.      


TASKS AND STRATEGIES:  AN OVERVIEW OF THE FIRST SIX MONTHS AND
THE INTERIM REPORT

    In order to begin its task of evaluation, the Committee had
to obtain basic information about the experiments it had
identified and the worlds in which they were set.  Relevant
information might be located in any of hundreds of libraries or
warehouses throughout the country, and in the memories of
thousands of citizens. Time was short.

    The Committee had to develop a strategy to address the
simultaneous undertaking of  three basic tasks--information
gathering, information organization, and information analysis--
each of which was fraught with uncertainty.  The strategy had to
be sufficiently disciplined to  meet the Committee's time frame,
yet sufficiently ambitious to understand and address the details
of experiments with ionizing radiation, ethics policies governing
them, and organizational charts of long-lost governmental
organizations and agencies.  At the same time, the strategy had
to be sufficiently flexible to accommodate the possibility of
dead ends, incomplete information, and most importantly, new
discoveries leading to new avenues of research.

Phase I:  Gathering Information - "Big Picture" Mapping, Targeted
         Document Searches, and the Creation of  Data Management
         Infrastructure

    The first phase of the strategy involved three components,
the first of which was the development of a framework for all the
information-the "big picture" into which the pieces of the puzzle
could be fit.  As discussed below, the components of this
framework included:

    o    An experimental database, to provide a single locale
         for cataloguing experiments as they are identified and
         storing basic information as it is retrieved;

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

    o    A scientific and 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 the experiments and used the resulting data.


    The second component of this phase was an effort to identify
the world of potential  sources of information, and the most
efficient methods to mine these sources.  As discussed in Parts
II - III below, for example, this strategy involved:

    o    Refocusing agency document searches on headquarter
         level collections, in order to gain an overview of the
         forest in which individual experiments were set and
         identify data trails that might be followed;

    o    Surveying private archives and library sources;

    o    Initiating oral history, interview, and outreach
         projects to tap individual memories; and

    o    Planning several research projects to assess and
         evaluate human experimentation that is ongoing today.

    The third component of this first phase of the strategy was
the development of the technical infrastructure needed to house
and make accessible the increasingly large body of  information
being received by the Committee.  As discussed in Part IV, this
component includes the creation of electronic databases available
to both the Committee and the public.

Phase II:      Information Organization - Gathering the Threads,
              Focusing on Experiments

    While Phase I is still in progress, the Committee's brief
tenure requires that it simultaneously focus on particular
experiments (or groups of them) in order to begin the evaluative
process.  But on which experiments should energies be focused?
The elements of the strategic problem include the following:  (l)
the number of  pre-1975 experiments and intentional releases may
well be in the thousands, and the number of post-1975 experiments
even larger;  (2) data gathering will remain incomplete even as
evaluation begins; and (3) the Committee may be able to collect
only fragments of data about many (and probably most)
experiments.

    The need, therefore, was for a strategy that (l) made use of
available data; (2) was likely to address particular experiments
and releases of clear public concern; (3) would not neglect
experiments and releases simply because applicable data were not
readily available;
(4) addressed experiments and releases that involved basic issues
of concern to the public and the Committee; and (5) was
sufficiently flexible so as not to be derailed by information
roadblocks.

    The working solution for the pre-1975 world of experiments,
as discussed in Part I, is a two-part strategy that combines  (1)
a focus on groups of experiments, with each group anchored by one
or more well-publicized, widely discussed experiments; and (2) a
focus on the institutions that conducted experiments, with each
institution offering the opportunity to examine responsibility
for decisionmaking about undertaking, funding, and performing
experiments. The hope and expectation is that this strategy will
permit an understanding of both important  individual experiments
(or groups of them) and the systems and contexts in which they
were set.

    The working solution for the intentional releases is to
determine (1) 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.  The working solution for the
contemporary world of research involves three activities:

         1.   a review of a sample of recently funded research
              proposals (including radiation and non-radiation
              treatments), with the ethical evaluation focusing
              upon the processes of subject selection,
              harm/benefit, and informed consent and disclosure
              of information;

         2.   interviews with subjects of current research,
              attempting to assess their attitudes and beliefs
              related to research participation; and

         3.   collection of current agency policies related to
              the oversight of research on human subjects.

The details of the components and activities of Phase II are
discussed in the body of this interim report.

Phase III:     Information Analysis - Evaluation and
              Recommendations

    While Phase I continues, and Phase II has just begun, the
Committee must simultaneously turn to the Phase III 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.  The
development of a strategy for this effort is the immediate
priority of the Committee as the first six months of its tenure
come to an end.  Specifically, the Committee currently is
focusing on the development of ethical standards for judging past
and present experiments and releases, as well as the above
mentioned criteria.  In Part V of this interim report, the
Committee takes stock of where it has been; in Part VI the
Committee summarizes the work to be done in the next six months.


**********

1    The members of the Interagency Working Group include the
    Secretaries of Defense,  Energy, Health and Human Services,
    and Veterans Affairs; the Attorney General; the
    Administrator of the National Aeronautics and Space    
    Administration; the Director of the  Central Intelligence
    Agency; and the Director of the Office of Management and
    Budget.

2    Charter, section 3, Appendix B.

3    Charter, section 4.a, Appendix B.

4    Charter, sections 4.c and 4.d, Appendix B.

5    At the end of this report is a sampling of the bureaucratic
    terms and acronyms  that punctuate the Committee's reading
    material, and to some extent this interim report.


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