PART I.   AREAS OF INQUIRY:  THE FRAMEWORK AND PIECES OF THE
         PUZZLE

    When the Committee began operations in late April 1994, it
had limited information about the experiments it was to study and
about the ethical and scientific standards of the past in which
they were set.  The Committee had not only to collect information
scattered in files and warehouses throughout the country but, at
the same time, to create and test the framework needed to ensure
that there is a "big picture" into which pieces of the puzzle
could be fit. In this section we discuss the components of the
framework, and some of the pieces of the puzzle that have already
been assembled. In Part II, we discuss the methods for locating
the pieces,  including the Committee's work with the Interagency
Working Group search teams. While the framework and search method
are discussed separately, in practice they are inseparable, and
continually inform one another.


    A.   THE PROBLEM: WIDELY DISPERSED AND FRAGMENTARY
         INFORMATION

    How many human radiation experiments were conducted prior to
1975? By whom? What were they about? In April, even the most
approximate answers to such questions were guesswork.  There was
no known place or combination of locations to investigate that
ensured the quick compilation of even a reasonably complete list
of experiments.

     The Committee could begin with documents that were
assembled during the 1980s and that underlay the "Markey report."
[6]  But review of the materials available for the Markey report
confirmed that, even for that relatively well-known group of
experiments, basic information was lacking. The Department of
Health and Human Services (HHS) reported that its data on mid-
century research grants was limited to capsule descriptions that
often did not permit distinction of work performed on humans from
that performed on other forms of life.  Components of Department
of Defense (DOD) and other agencies did provide lists of human
experiments;  in many cases, however,  even when reports on the
research were available they often lacked data on basic questions
of concern (for example, who the subjects were and what they were
told about the risks of the experiment).

    What codes of conduct, if any, existed to govern federally
sponsored experiments? Who developed them?  How were they put
into effect?  There was no readily identifiable body of ethics
policies that governed human experimentation in the pre-1974
period.  Indeed, the prevailing assumption was that until the
mid-1960s Federal agencies, by and large, did not even  possess
such policies for their extramural research programs. [7]  In
order to evaluate experiments it also is necessary to understand
the scientific or medical standards in effect during the period
of their performance.  What were they?  How were they made known
and put into effect?

    Where would information be found that would show whether
experiments were conducted for military, scientific, or medical
purposes, or some combination, and thus would reveal the
considerations of public benefit that went into their conduct?

    Finally, when the facts and standards are assembled, by what
factors is the past to be judged? By what criteria are wrongs to
be assessed?  

    In each of these areas of inquiry,  the well-lit streets and
well-known landmarks had long since been altered beyond
recognition or demolished.  Where agency organization charts or
other road maps existed to guide the way, the fragments at hand
were often blurred beyond recognition.


    B.   BIOMEDICAL EXPERIMENTS:  1944-1974

         1.   Phase I:  Mapping of Experiments and the World in
              Which They Were Set

    The Committee has tried simultaneously to recreate both the
world of experiments and the basic framework in which they were
set and must be understood.  These efforts have involved trying
to get the Committee's arms around a potentially huge number of
experiments, retrieving the ethical and scientific norms that
were prevalent during the time experiments were conducted, and
identifying and reconstructing the institutions that planned,
funded, set policy for, carried out, and used data from the
experiments.

              a.   Experiment Database

    The aim of this activity is to provide a living electronic
document that will serve as a central record on the identity of
many (but by no means all) Government-sponsored human radiation
experiments,  with basic information on each experiment and keys
to permit further research.  To this end, the Committee created a
form to collect standard information regarding  each biomedical
experiment of which it became aware. [8]  As of mid-October, the
database comprised about 400 experiments that were conducted
prior to 1975.  In addition to the experiments in the database,
the Committee has at least fragmentary data that may involve
1,000 or more further experiments. [9]

    The core of the database is the experiments identified by
the agencies. [10]  However, it is now clear that these comprise
only a portion of the research conducted, albeit a significant
portion.  The Committee seeks further sources to identify
additional experiments and to provide missing data on those
already identified.  These include the following:

    o    Information provided by members of the public;

    o    Biomedical textbooks, histories, and journal articles,
         and bibliographies of radiation research;

    o    The Atomic Energy Commission (AEC, predecessor to the
         Department of Energy) listing of recipients of isotopes
         and other AEC reports;

    o    Documents provided by the agencies or located by staff
         in public or private archives or records centers
         (including, for example, agency program and budget
         documents, agency  histories,  and the minutes of
         relevant committees); and

    o    Presentations to Congress.

    The database includes many categories of data with provision
for electronic sorting by category.  It was quickly apparent that
data on some key categories of information (e.g., whether or not
consent was obtained, who the subjects were, how they were
selected) are lacking for most experiments. Given the fragmentary
data presently available on most experiments, the database will
not itself be the basis for evaluating individual experiments,
but it will provide a guide or index for further research.

              b.   Ethics Policies and Practices

    The aim of this effort is to determine what Federal and
private sector research ethics policies and practices were in use
prior to 1975.  Following its first meeting, the Committee asked
the agencies to provide basic information on the development of
their research ethics policies and regulations.  The retrieval of
agency information is ongoing.  The Committee is simultaneously
searching private archives and conducting an interview program to
trace private sector, as well as public sector, policies and
practices.

    It is now apparent that from the onset, the government
engaged in high-level debates on human experimentation during the
Cold War period.  Committee staff, working with agency search
staff, have attached high priority to tracing down the twists and
turns in these debates and the development and implementation of
policies that flowed from them.

                   i.   Department of Defense (DOD).   In the
case of the military, documentation of consent policies predates
the 1947 creation of DOD. [11]  In February 1953, the Secretary
of Defense issued, as a top secret document, a policy adopting
the Nuremberg Code "to govern the use of human volunteers by the
Department of Defense in experimental research in the fields of
atomic, biological and/or chemical warfare." [12]  Research
questions for the Committee include the following:

    o    The extent to which the Secretary's policy, which was
         stamped "Top Secret", was known throughout DOD and by
         civilian researchers funded by DOD;

    o    Whether and how the Armed Services implemented the
         Secretary's policy;

    o    The extent to which implementing directives were
         actually applied to particular experiments;

    o    How the 1953 policy was interpreted:  what research
         activities were considered to be covered by the
         directive and which were not?  For example, how was
         research distinguished from training maneuvers?  Were
         activities conducted by DOD contractors, as well as DOD
         employees, covered?; and

    o    The meaning of "human volunteers" in the context of
         military activities.

                   ii.  Central Intelligence Agency (CIA).  The
Committee is seeking information on the relation between early
ethics policies in DOD, HHS, and AEC, and experiments conducted
by the CIA. In the 1970s, public and congressional attention
focused on MKULTRA, and other programs of CIA experiments on mind
control (most famously involving LSD), at least some of which
involved unknowing subjects, including members of the public.
Documents show that CIA officials who were involved in the
predecessors to MKULTRA also were members of the DOD Committee on
Medical Science and probable participants in the DOD Joint Panel
on the Medical Aspects of Atomic Warfare, groups at which human
experimentation planning and policy, among other items, were
discussed.

                   iii. AEC/Department of Energy (DOE).  At AEC,
evidence for a consent policy dates to 1947, the year of AEC's
creation. The Committee has been seeking to determine whether
policies indicated in high-level documents were enacted as formal
guidelines or rules, and whether these policies were put into
practice by AEC-sponsored investigators.

                   iv.  Department of Health and Human Services
(HHS).  The initial HHS policy appears to have been that applied
to the National Institutes of Health (NIH) Clinical Center, which
opened in 1953. The Committee has been researching the
development and application of that policy.  Policies governing
extramural research were initiated during the 1960s.

                   v.   National Aeronautics and Space
Administration (NASA).  NASA was created in 1958. The policies
initially retrieved by NASA dated to 1972.  At its birth, NASA
drew upon the research work of other agencies, such as DOD.  The
Committee is researching how NASA developed these policies and
the extent to which early NASA research relied upon ethics
policies developed by others.

                   vi.  Department of Veterans Affairs (VA).
The recovery of policies related to experiments sponsored by the
then-Veterans Administration has been limited. However, it
appears that work done under VA auspices was often performed in
coordination with other agencies or by investigators who also
worked under DOD, AEC, or HHS (its predecessor) funding.  The
relation between the policies and practices of VA and those found
elsewhere should be of interest.

    In parallel with the reconstruction of Federal ethics
policies and practices, the Committee is seeking to reconstruct
the policies and practices that governed privately funded or
performed biomedical research. This effort includes a search of
relevant literature and records collections and an oral history
project, described in more detail in Part II.B. below.

              c.   Institutional Mapping

     The goal of this effort is to identify and understand the
policies and programs in which experiments were set and to
identify responsibility for these programs, policies, and
ultimately experiments. A subsidiary goal is to provide the
roadmap needed to ensure that as many experiments as possible can
be identified, and to locate potential additional sources of
information on those already known. The effort has already shown
that headquarters-level records can aid in the reconstruction of
the "big picture" in which experiments fit, as can be seen from
the following examples.

    From its creation in 1947, AEC had components that funded
human experimentation and provided needed experimental tools
(radioisotopes as well as equipment grants). AEC's Division of
Biology and Medicine, created in 1948, awarded grants for
research and set the overall biomedical research program agenda.
Its Isotope Development Division distributed radioisotopes to
researchers throughout the country, and its Human Use
Subcommittee of the Committee on Isotope Distribution reviewed
applications for the use of isotopes in human subject research.
Documents reveal early policy debates and declarations on human
experimentation. But as discussed at Committee meetings (and in
related staff memoranda), the scope of ethics policies and the
way in which they were translated from headquarters to field
application remains to be reconstructed.

    The Committee is also constructing a picture of DOD
organizations, programs, and policies that provided high-level
direction and oversight of human radiation experimentation.  For
example, in 1949, the Office of the Secretary of Defense created
the Joint Panel on the Medical Aspects of Atomic Warfare. The
Joint Panel included participation by private medical researchers
and representatives of the AEC, Public Health Service (PHS), and
probably the CIA.  The Joint Panel served as a focal point for
planning and information gathering on experimentation (including
human experimentation) related to atomic warfare. At the same
time, the Office of the Secretary of Defense also included the
Armed Forces Medical Policy Council, whose work led the Secretary
of Defense to issue DOD's Nuremberg Code policy and led the Joint
Panel to consider human experimentation in connection with U.S.
atomic bomb tests. The Committee has been following the trail of
plans and policies formulated by these groups.

    Mid-century debates and sponsorship of human experimentation
often involved participation by multiple agencies. It is
therefore necessary to understand relationships among agencies,
as well as within them.  For example, AEC and DOD (and their
consultants), engaged in vigorous discussion over the need for
human experimentation in connection with the nuclear-powered
airplane (which was never built).  Civilian agencies or their
representatives also were involved in defense-related discussion
and planning.  Following World War II, the National Institutes of
Health (NIH) inherited many of the research grants and contracts
of the World War II Committee on Medical Research, the medical
research and development component of the military effort.
During the Korean War period, representatives of VA, NIH, and
PHS, as well as AEC and DOD, were involved in the discussions of
the Joint Panel on the Medical Aspects of  Atomic Warfare.  PHS
played an important role in monitoring bomb tests and conducting
fallout measurement.  When NASA was created in 1958, it was able
to rely on a research heritage from agencies such as the Air
Force and AEC.  NASA established a joint research program in
radiobiology with the AEC in the early 1960s.

              d.   Scientific Standards Timeline

    The goal of this effort is to identify the scientific and
medical standards that governed judgments about risks and
potential benefits during the period in which experiments were
undertaken.  Areas of inquiry include the following:

    o    Determining the radiation standards that existed at the
         dawn of the Cold War, the manner in which they were
         set, and their basis;

    o    Examining the levels of risk developed and assumed by
         AEC's Isotope Development Division;

    o    Determining the extent to which the early research now
         under study played a role in the development of
         standards; and

    o    Identifying documents that contain key discussions of
         risks and potential benefits of human experimentation
         and reviewing risk/benefit discussions in contemporary
         literature.

         2.   Phase II:  Focus on Specific Experiments and Their
         Context

    While the reconstruction of the world of experiments
continues, the Committee at its September meeting adopted a
particular analytic strategy for focusing its efforts.  This
strategy involves two overlapping approaches that together
capture as complete a picture as is reasonably possible.  These
approaches are (1) examining groups of biomedical experiments;
and
(2) examining the institutions that conducted and sponsored them.
The program is ambitious, and its success will depend critically
on the ability to retrieve needed information, as well as staff
and Committee resources.

    The first approach identifies for intensive study five
groups of experiments (outlined below) covering the spectrum of
human radiation research.  Each group is anchored in one or more
relatively well-publicized experiments.  The second approach
focuses on two institutions that were among several sites that
were hubs of planning and research in human radiation research.
Both approaches provide rich opportunities for exploring the nine
overarching themes noted in the Introduction above.

              a.  Biomedical Experiments

                   i.  Biodistribution.  This group centers on
the plutonium injection experiments. From those well-known
experiments it reaches out to include (1) other experiments
designed to test the biodistribution of isotopes with no clear
immediate therapeutic or diagnostic potential; and (2) other
experiments whose primary purpose was to advance the health and
safety of those directly involved in weapons production, such as
experiments related to toxicology or chelation therapy.

                   ii. Total Body, Partial Body, and Local
Irradiation. This group includes the Cincinnati whole body
irradiation experiments and other external irradiation
experiments where the subjects were predominately persons who
were ill.

                   iii. 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 that
included institutionalized mentally compromised children.
Vanderbilt University conducted studies on pregnant women using
radioactive iron to determine maternal-fetal iron exchange.

                   iv. Radiation Research where Subjects were
Predominately Healthy Adults.  This group includes the testicular
irradiation of prisoners and other experiments on healthy adults
(such as flash-blindness studies and other experiments 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.

                   v.  Radioisotope Research.  This group, which
includes experiments at the Wrentham School, encompasses studies
using radioisotopes that were products of the nuclear age and
also had major medical applications in both diagnosis and
therapy.  Examples of  these radioisotopes include iodine and
iron.  Unlike the biodistribution group, this group allows a
purposive sampling of cases that include research on medical
applications.

    It is hoped that these five groupings, although by no means
mutually exclusive, will serve as useful devices for organizing
research and analytic efforts.

              b.   Institutional Case Studies

    It  now appears that these experiments took place in a world
in which there was official debate at the highest level about
human experimentation and the policies that should govern it. The
primary purpose of the institutional inquiry is to advance the
theme of management responsibility (see Introduction) by adding
to our understanding of how decisions to experiment (or not) were
made, and to answer questions such as:

    o    Where  higher-level  policies existed,  how were they
         supposed to flow down from headquarters to research
         institutions and, ultimately, to investigators and
         subjects?

    o    Where did responsibility lie for determining the formal
         and practical reach of policies and the requirements
         for implementation?

    o    If policies were limited in coverage, or in their
         implementation, why was that the case?

    o    Where did responsibility lie for failure to implement
         and/or enforce policies and was a policy oversight
         process either in place or considered?

    By focusing on institutions that sponsored or conducted many
relevant experiments, the institutional case studies also should
provide further basis for focusing on, and evaluating, particular
groups of experiments, as well as other themes of interest to the
Committee.  

    Staff researched a number of institutions as candidates for
case studies, including AEC sites that conducted or sponsored
research, such as Oak Ridge and Los Alamos; key DOD
organizations, including the School of Aviation Medicine; and
research centers funded by multiple agencies (such as the UCLA
complex, which included work funded by the AEC, DOD, and VA, and
similar complexes in the Boston and San Francisco areas).  The
Committee has decided to pursue two institutional case studies:
the Oak Ridge complex and the Bay Area components of the
University of California.  Research on sites not chosen for case
studies nevertheless continues to be of value in providing data
on individual experiments, and on prevailing ethics policies and
scientific standards.


    C.   INTENTIONAL RELEASES

    The Committee's Charter includes 13 intentional releases of
radioactive material into the environment. [13]  These releases
were generally related to radiation warfare tests, the gathering
of intelligence, and the development of instrumentation.  The
category of intentional releases is now known to be larger, in
variety and quantity, than the 13 releases identified in the
Charter.  For example:

    o    The Charter included 8 radiation warfare experiments;
         the number is at least 53.

    o    The Charter includes 4 Los Alamos, New Mexico,
         implosion tests involving radiolanthanum. DOE reports
         that the number of such tests approximates 250.

    o    The Charter includes one intentional release from a
         plutonium production facility (Green Run).  Examples of
         further releases from nuclear production facilities
         have been found.

    In addition to the types of releases identified in the
Charter, other intentional releases  include:

    o    Releases related to the development of nuclear rocket
         and nuclear aircraft technology;

    o    One-point safety tests of fission warheads at the
         Nevada test site that were performed to determine
         whether the accidental detonation of the high explosive
         at one point in a warhead would produce a nuclear
         yield;

    o    Radioecology tests, in which radioactive material was
         introduced into the environment to test for retention
         or transmission through the environment; and

    o    Tests of reactor safety and simulated accidents, such
         as reported by DOE's Idaho National Engineering
         Laboratory.

    In addition to the intentional releases stipulated in its
Charter, the Committee may also investigate examples of further
intentional releases.

    In general, the focus of efforts will be (1)  to locate and
retrieve for public release (where possible) information that may
shed light on the planning of, and responsibility for, the
releases; and (2)  to determine whether releases that took place
in the past, typically shrouded in secrecy, could be conducted
today.  As a complement to the Committee's overarching themes,
the following questions are being pursued:

    o    What was the purpose of the release (e.g., bomb
         testing, reactor testing, long-range detection,
         environmental study)?

    o    How much radioactivity was released and in what form?

    o    Was radiation monitored on and off site? Who was
         responsible for the monitoring?

    o    Were there human biomedical studies in connection with
         the releases?

    o    Were participants and bystanders notified in advance of
         potential hazards?

    o    What measures were recommended or taken to minimize
         risks to participants and bystanders?
    o    What rules govern intentional releases today (for
         example, environmental impact regulations)?

    o    How would the historical releases be conducted today?
         For example, would environmental impact statements be
         required?  Would there be public notice?  Could all or
         portions of the review process be kept secret?

    o    What kind of releases are being conducted today, and
         what rules are being followed?


    D.   A NOTE ON SCOPE

    At the outset, the Committee had to consider the scope of
its activities.  During its early meetings, the Committee heard
public comments from veterans of the atomic bomb era and their
families (military personnel exposed during atomic bomb tests),
downwinders  (for example, private citizens exposed to fallout
from nuclear tests in Nevada), the Marshallese (inhabitants of
the Marshall Islands, many of whom were exposed to radiation from
bomb tests conducted in the Pacific), and representatives of
uranium miners (who were exposed to radon as workers in AEC
uranium mines).  The Committee also received comments regarding
once-common radium treatments and written communications or
office visits from other individuals and groups.

    The question of the scope of the Committee's activities was
assigned to a subcommittee that recommended, and the full
Committee agreed, that for purposes of inquiry hard and fast
lines should not be drawn. In the absence of some degree of
inquiry, the facts may be insufficient to determine whether human
experimentation took place. The Committee's inquiry has revealed
that, both in the past and at present, the factual and conceptual
boundaries separating an experiment from other kinds of data
gathering are not always clear.  Finally, analysis of activities
that may not be deemed experimental may shed important light on
the conduct of human experimentation by showing why experimental
data were needed.

    In general, in cases of group exposure, the Committee
directed the staff to review previously organized accounts, with
an eye toward information that shows or suggests biomedical
experimentation.  Staff was also directed to focus on materials
that have not previously been made public.

    In piecing together the records of DOD's 1949-1953 Joint
Panel on the Medical Aspects of Atomic Warfare, the Committee
found a trail of discussion and planning that appears to have led
to the conduct of at least some biomedical human experiments in
connection with atomic bomb tests.  These experiments are being
pursued as part of the group of biomedical experiments involving
subjects who are predominately healthy adults.  The Committee
asked staff to pursue this trail of inquiry, and at the
Committee's request, DOD and DOE have agreed to locate and
retrieve documentation related to actual or potential human
experimentation in connection with atomic bomb tests.   The areas
of inquiry include:

    o    Documents related to the biomedical panels (or offices,
         committees, etc.) that planned the biomedical
         components of atomic bomb tests;

    o    Documents related to human subject data-gathering
         activities that, according to available documentation,
         may have been experiments (including, for example,
         flash-blindness testing, psychological observation or
         testing, the measurement of radioisotopes in body
         fluids, and the measurement of radiation doses to
         certain ground or aircrews, all in connection with
         weapon tests); and

    o    Documents related to DOD's ethics policies
         (particularly the 1953 Secretary of Defense Directive)
         to atomic bomb test activities.

    In agreeing to search for the information, the agencies and
the Committee reserve for future discussion whether particular
activities constitute experiments.  In conducting the search, the
Committee will work with the agencies to ensure that previously
retrieved data (such as that assembled for DOD's Nuclear Test
Personnel Review) are used efficiently.

    Public presentations also spurred Committee consideration of
the concept of "experiment of opportunity," that is, situations
in which the initial exposure to radiation may have been
accidental (or, if premeditated, not for the primary purpose of
human subject study), but the opportunity presented by the
exposure led to an organized research effort.  In discussing the
concept, the Committee is mindful that, if only because of staff
and resource limits, its mission cannot include the examination
of human data gathering solely for safety monitoring purposes.
However, the question of the boundary between such data gathering
and experiments of opportunity is a focus of inquiry.


    E.   THE CONTEMPORARY STORY

    As part of its mission, the Committee must establish the
current status of the policies and practices related to human
radiation research and make recommendations regarding future
policies.  In an effort to gain insight into this area, the
Committee has undertaken three separate research projects aimed
at describing contemporary practices related to the ethics of
human subject research.  The Subject Interview Study aims to
discover the beliefs and attitudes of research subjects regarding
their understanding and voluntary participation in research; the
Research Proposal Review Project aims to discover the adequacy of
current policies and practices in the protection of the rights of
the subjects of research; and the Agency Oversight Review aims at
assessing both the policies and practices of the agencies for
oversight of the review and monitoring of human subject research
supported or performed by them.  The bulk of the work for these
projects will be undertaken and completed during the remaining
months of the Committee's term.  Up to this point, work on the
contemporary projects has consisted of seeking administrative
approval (through the Office of Management and Budget), designing
the projects, requesting the necessary information and materials
from agencies, and preparing sufficient staff resources to
successfully carry out the projects.

         1.   Subject Interview Study

    The purpose of this project is to collect data concerning
(1) the extent to which patients of radiation oncology, medical
oncology, and cardiology services at both major research
institutions and community hospitals believe they are
participants in research;  (2) the perceived voluntariness of
this participation; and (3) subjects' reasons for agreeing to
participate.  This project will enrich the deliberations of the
Committee with direct information about the contemporary
experiences of some research subjects.  

    The project will proceed in three phases.  Focus groups will
be conducted (Phase I) to assist in development of a short
survey, which  will be administered to approximately 1,000
patients drawn from approximately 15 different institutions
(Phase II), followed by  a semi-structured interview to be
administered to a subsample of  approximately 150 subjects (Phase
III).

Phase I:  Focus Groups.  Focus groups comprised of patients from
two different institutions will be conducted by a professional
facilitator.  Issues to be covered in focus groups include:

    o    Voluntariness: did subjects feel as if they had a
         choice about whether to participate in an experimental
         protocol, and were others involved in the decision?

    o    Reasons for participating, including whether
         participation had been recommended and, if so, by whom?

    o    Understanding of what it means to participate, such as
         what it means for a drug or treatment to be
         experimental, and how being a patient in a research
         project differs from receiving regular medical care.  

Phase II:  Short Survey.   Based on the focus group responses, a
short survey, anticipated to take 5-10 minutes to complete, will
be designed by Committee staff in conjunction with survey
research consultants.  The survey instrument will be designed to
capture the following topics, provided as potential examples:  

    o    Beliefs about being a research participant, such as
         whether the subject is currently receiving any
         treatments or drugs considered to be experimental, or
         participating in any research studies or proposals.        

    o    Voluntariness (to be asked of those who believe they
         are currently participants in research), such as
         whether he/she believes there was a choice about
         whether to participate in research or experimental
         therapies, and why or why not.

    o    Reasons for participating, e.g., to receive state-of-
         the-art treatment; to help  advance science; to receive
         compensation; because someone recommended they should,
         etc.

    o    Understanding of what it means to participate in
         research, such as whether the subject understands what
         it means for radiation therapy to be experimental, the
         difference from regular medical care, whether everyone
         in their research proposal is getting the same therapy
         or treatment.  

Phase III:  In-Depth Interviews.  Semi-structured, in-depth
personal interviews then will be conducted with 10-15 patients
who are participants in research at each of the 15 institutions.
An interview guide will be developed with the help of the focus
groups, and the same issues covered in the survey will be
included in the interviews, with questions posed in an open-ended
fashion and followup questions asked based on the subject's
responses.  Through this process, considerably more attention can
be given to the relevant topics, such as the meaning of research
participation for subjects.  

         2.   Research Proposal Review Project

    The project will evaluate the extent to which the rights and
interests of persons currently involved as subjects of radiation
research conducted or supported by the U.S. Government appear to
be adequately protected in the proposal review process, and to
compare this level of protection with that afforded the subjects
of nonradiation research.  The objectives of this project are (1)
to determine, based on research proposal and IRB materials,
whether harms and benefits, informed consent procedures, and
selection of subjects appear to be appropriate; and (2) to
determine whether research proposals and IRB materials provide
sufficient information to make judgements about the protection of
human subjects.

    This project involves collecting the necessary documents
from agencies and grantee institutions.  To achieve these
objectives, listings of pertinent research projects will be
obtained from the Departments of Defense, Energy, Health and
Human Services, Veterans Affairs, and NASA, [14] including:

    o    All human subject research proposals involving ionizing
         radiation that were newly approved and funded or
         renewed by the agency in fiscal year 1993, and a sample
         of such proposals from previous years.

    o    Human subject research proposals not involving ionizing
         radiation that were newly approved and funded or
         renewed during the same period as the ionizing
         radiation proposals, for the purpose of creating a
         comparison group.

    Both intramural and extramural proposals in each category
will be considered for review.  Grantee institutions and the
agencies will be asked to provide relevant documents for a sample
of the radiation research proposals as well as a parallel sample
of non-radiation research.  A subset of Committee members and
staff will review and evaluate the proposal materials based on
evaluation criteria developed by Committee and staff.  This team
of evaluators will include persons with technical radiation risk
and medical expertise, knowledge of the appropriate standards for
informed consent and selection of human subjects, and any
additional expertise necessary to address the objectives listed
above.  

         3.   Agency Oversight Review

    In an effort to assess both the status and efficacy of
current policies regulating human subject research, Committee
staff has requested that each of the six agencies identified
above (CIA, DOD, DOE, HHS, NASA, and VA) provide information
related to oversight of research involving human subjects that it
either conducts or supports, including any special procedures for
oversight of research involving ionizing radiation.  This
includes information and materials related to the roles and
responsibility of the appropriate office, personnel, process, and
authority for oversight of human subject research review in each
agency, as well as any applicable rules, regulations, or policies
for the conduct, funding, or oversight of human subject research.
Agencies also will be asked what procedures would be followed
should it be determined that there is a need to bypass applicable
research policies or regulations in the conduct of specific
research projects.  This information will be compiled, analyzed,
and recommendations for future policy will be made during the
next months of the Committee's work.


**********

6.   "American Nuclear Guinea Pigs: Three Decades of Radiation
    Experiments on U.S. Citizens," Report Prepared by the
    Subcommittee on Energy Conservation and Power of the
    Committee on Energy Commerce, U.S. House of  Representative,
    November, 1986, chaired by Edward Markey (D-MA).

7    For example, in February 1991 the Congressional Research
    Service issued a    report that fairly reflected prevailing
    understanding on the history of federal regulations for the
    protection of human subjects.  The report begins the story  
    of Executive Branch regulation in the 1960s, focusing on the
    activities at HHS' predecessor.  "Protection of Human
    Subjects in Research, "Irene Stith-Coleman, CRS Report 94-
    179 SPR, February 28, 1994.  As discussed above, we now know
    the story starts far earlier, and involves DOD and the
    Department of Energy (DOE) predecessor, AEC, as well.

8.   The form contains entries for the range of basic data that
    should be of importance to the Committee, the Interagency
    Working Group, and the public. For example, categories
    include (1) classification of the experiment by scientific
    and governmental purpose(s) (if any); (2) isotope and
    dosage; (3) source(s) of funding; (4) researcher(s) and
    institution(s); (5) provisions for consent, if any; (6)
    subject population and selection method; and (7) relevant
    publications.

9    As discussed in this report, intentional releases are being
    catalogued separately.

10   Appendix E discusses the number of experiments located in
    the case of each agency.

11   Most notably, Walter Reed employed a form of release in the
    turn of the century battle against yellow fever.  The Navy
    has retrieved evidence of a relevant policy dating to the
    1930"s.  Documentation obtained by the Committee staff shows
    discussion of consent policy in the World War II Committee
    on Medical Research, which coordinated the wartime medical
    research effort.

12   The Nuremberg Code was the standard that was codified by the
    International Military Tribunal following the prosecution of
    Nazi doctors who engaged in human experimentation.

13   See Charter, section 3(2), Appendix B.

14   CIA maintains that it neither funded nor performed any human
    subject research involving ionizing radiation in fiscal year
    1993.  The Committee is currently determining whether CIA
    supported such research in 1990-1992.


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