ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS



                      Minutes: Meeting of July 5-6
                                    
                                    
                              July 5, 1994

Attending: Ruth Faden, Eli Glatstein, Jay Katz, Patricia King,
Susan Lederer, Lois Norris, Nancy Oleinick, Henry Royal, Philip
Russell, Mary Ann Stevenson, Duncan Thomas.



     The meeting was called to order by Philip Caplan, Special
Assistant to the President for Cabinet Affairs, at 11 a.m. at the
Vista Hotel, 1400 M Street NW, Washington, D.C. Dr. Faden noted
that Ruth Macklin was out of the country and Ken Feinberg would
join members later in the day. She briefed members on the agenda
and called upon Jonathan Moreno for the first report.



Staff Report: Update on Ethics Data Collection Efforts. Dr.
Moreno.


     Dr. Moreno briefed the Committee on ethics data collection,
including Department of Defense follow-up research on the 1953
Wilson memorandum regarding the Nuremberg Code. Policy documents
from the time show stress on ethics practices because of a
perceived lack of U.S. capability in biochemical and radiological
warfare. The documentary evidence suggests that proposed ethics
policies provoked debate and disagreement in both Defense and the
Atomic Energy Commission, with the AEC denying to the press
(1950) that it sponsored any human experimentation at all.



Subcommittee Report: Ethics Data Collection. Dr. Faden.


     Dr. Faden briefed the Committee on the subcommittee
proposals:

     An oral history project to elucidate actual research ethics
practices, with an emphasis on the earlier years of research,
through interviews with practictioners.

     A sampling of the current portfolio of human-subject
experiments, reviewing agency and researcher documentation to
answer key questions about the present status of human
experimentation and whether recommendations for change are
needed. Questions to be answered by the sample study would
include the extent to which experimental subjects are being put
at risk, and whether consent procedures appear to be adequate.

     Interviews with patients involved in research at hospitals
and federal laboratories with substantial research commitments.

     Members agreed to the first and second proposals, with the
amendment that the oral history project encompass current
investigators to give a wider view of practices from the
viewpoint of practictioners. Members of the Committee questioned
whether a representative sample of subjects or patients could be
obtained, and decided to defer the proposal to the July 25-26
meeting.

     

Subcommittee Report: Scope and Priorities. Dr. Thomas.


     The Scope subcommittee report noted the wide range of
exposures that may or may not be construed as experiments on the
basis of available evidence, but also observed that evidence has
come to light suggesting that a human experimentation component
might have existed in planning of weapons tests. Dr. Thomas said
human-subject experiments clearly were necessary to achieve the
type of data envisioned by the as-yet incomplete records of the
Joint Panel on the Medical Aspects of Atomic Warfare.

     To tell the entire story of human-subject experimentation
during the Cold War era, a variety of exposures must be dealt
with in the report, Dr. Thomas said, but the Committee retains
latitude in assessing which areas need extensive investigation
beyond what is already in the public record. He noted that the
Green Run, included in the Committee's charge, is only one of a
wide variety of intentional releases, but is the subject of a
major dose reconstruction study already. 

     Key questions raised by the variety of exposures include
whether an experimental purpose motivated the exposures, and
whether serious ethical improprieties need to be assessed and
referred to in the Committee's report.

     Dr. Thomas said a National Academy of Sciences research
group is reviewing studies of the dose measurement of atomic
veterans' exposures.

     For two of the relevant areas, uranium miners and
downwinders, Dr. Thomas noted that he was involved in analysis of
the miner data, and was deeply involved as a senior researcher in
downwinder exposures.

     Mr. Feinberg said the Scope report basically concludes that
the Committee should not draw early conclusions about which
categories of exposures are within or without the Committee's
ambit. He said the Committee will need to seek further
information from interested parties over the coming months, and
should not preclude discussion of activities not clearly included
under the charter if they are relevant to the comprehensive
story.

     Mr. Feinberg also observed that discussion of remedies is
premature until more specific information is developed by the
Committee's inquiries.

     Members questioned Scope subcommittee members on the impact
of their report on priorities of the staff; the definition of
what exposures and subsequent medical follow-up constitute
"experiments of opportunity" on the part of government officials;
and the range of definitions of experimentation that may be
necessary to classify the many experiments before the Committee.
Executive Director Dan Guttman noted that the Joint Panel
documents specifically use the word experiment in reference to
planning a biomedical component at weapons tests.

     The Committee accepted the Scope report and directed staff
to take care not to duplicate efforts in the case of
experiments/exposures which have been extensively studied by
Congress or other panels.



Subcommittee Report: Cold War Data Collection. Dr. Stevenson.


     Efforts to group experiments in categories have begun and
the staff will report Wednesday afternoon on the pilot project of
sorting through the 61 experiments in the Markey document
collection, Dr. Stevenson reported.

     Committee members discussed the problems of mapping
experiments with limited evidence from fragmented records
collections, and the use of groupings in the preparation of a
Committee report. 



Subcommittee Report: Outreach. Stephen Klaidman.


     In the absence of  Dr. Tuckson, who was abroad,
Communications Director Stephen Klaidman reported that the
subcommittee recommended that three full-scale committee meetings
be held outside Washington, and four other panels be dispatched
to hear testimony in or near cities that are loci of experiments,
e.g. Spokane, Albuquerque, Nashville, etc.

     Cities proposed for full Committee meetings were San
Francisco, Atlanta and Chicago, based on geographic criteria
suggested by Committee in June. The meetings would provide
extended opportunities to hear from citizens. Panels to hear
testimony would be focused on loci of experiments, e.g. Spokane,
Albuquerque, Nashville.

     Members of the Committee questioned whether staff work would
be disrupted by out-of-town meetings, and directed the Outreach
subcommittee to cut back its proposal for full Committee meetings
outside of Washington.



Staff Report: Structure and Current Project Assignments. Jeffrey
Kahn.


Staff Director Jeffrey Kahn introduced Barbara Birney, Noel
Theodosiou, Sandra Thomas, John Harbert. Dr. Kahn briefed members
on staff assignments.



Committee Discussion: Goals and Objectives. Dr. Faden.


     Committee members were given a preliminary draft of ideas
for an outline of the Committee's reports. Members were asked to
review the ideas for discussion next day, with the goal of
providing guidelines the staff can use to help organize its work
in coming months.



Public Comment Period.


     The Ambassador of the Republic of the Marshall Islands,
Wilfred Kendall, and Tony deBrume, a senator in the Marshalls
parliament, presented the Committee with documents it has
discovered concerning exposures in the Marshalls. They asked the
Committee for its help in identifying documents hitherto
unavailable about exposures in the Marshalls. 

     Jonathan Weisgall, author of a book on the Bikini tests and
an attorney representing the Bikini islanders, briefed the
Committee on evidence which he said indicated foreknowledge of
radiation effects and clear evidence of official
misrepresentation, both suggesting an official plan to derive
data on human experimentation from the weapons tests.

     Members questioned Mr. Weisgall about the extent of exposure
and standards set by the government; the effectiveness of
dosimetry at the sites; and potential remedies, which he
suggested included a formal apology and potential memorial for
atomic veterans. 

     Cooper Brown, president of the National Committee for
Radiation Victims, urged the Advisory Committee to address issues
of remedies in its final report.

                                    
                                    
                              July 6, 1994
                                    


Briefing: History of Human Experimentation. Dr. Katz.


     Dr. Katz briefed members on key dates in human
experimentation, including instances of promulgation of codes of
ethics which were often disregarded in practice. He noted that at
the same time that NIH/PHS were debating increased protection for
subjects, the PHS did not re-evaluate its notorious syphilis
study at Tuskegee until it became a cause celebre.

     Issues: latitude extended to physicians on issues of
disclosure and consent, a license which is extended to research
situations; blurring of lines between therapy and research as the
new specialty of physician/researchers developed in the wake of
the scientific method; the military concerns that drove research
in both the United States and Nazi Germany, and Nazi experiments
driven by a policy of genocide; the impact of secrecy in
government, and the relative secrecy of local decisionmaking by
IRBs.

     Members questioned Dr. Katz about distinctions among
particular cases of controversial experiments; about how
questions of exploitation and fairness in the selection of
research subjects also need to be considered; about the impact of
litigation and insurance liability; about the regulatory
structure which might enforce appropriate policies; and about the
preparation of IRB members to deal with ethical issues.



Staff Report: Methodological Review of Agency Data Collection,
Central Intelligence Agency.       Gary Stern.


     Mr. Stern said CIA reported no radiation experiments,
although some agency documents suggested official concern about
radiological warfare issues. CIA may have more information of
interest to the Committee about Green Run and other intentional
releases, as well as intelligence background which can lend
context to the Committee's inquiries, and information about
research conducted by other agencies. CIA has indicated its
willingness to focus its search on the basis of direction by the
Committee.

     Members questioned Mr. Stern about classification issues and
the ethical and policy framework for experiments. Members
authorized the staff to proceed along lines of the staff
memorandum to the Committee.



Staff Report: Methodological Review of Agency Data Collection,
NASA. Mark Goodman.


     Dr. Goodman said the staff continues to seek human research
records, particularly involving total-body irradiation. A primary
concern of the agency was radiation exposure of astronauts,
either because of environmental radiation or propulsion studies.
No formal ethical policies have been found before 1969, although
the agency continues to search for records of formal or informal
policies in effect at field laboratories. A1981 Congressional
study found that many records were destroyed. Some bedrest
studies may have involved vulnerable populations, e.g. inmates in
California prisons.

     Members questioned Dr. Goodman about the nature of NASA
exposures; and about recent ethical procedures and conferences.
The Committee authorized staff to proceed along the lines of the
staff memorandum.



Update:  Other Agency Data Collection Efforts. Dr. Faden.


     Dr. Faden and Mr. Guttman briefed members on status of
efforts to follow up on initial data collection by agencies. A
new data collection effort will be required of all agencies to
denominate the current portfolio of human subject experiments for
sampling on ethics issues.

     Members questioned Mr. Guttman about declassification issues
and about Department of Energy criteria for its recent release of
experiment information.



Staff Report: Overview of Information System Management and
Experimental Groupings. Mr. Guttman.


     Mr. Guttman briefed members on potential groupings of
experiments for purposes of the Committee's report. David
Saumweber outlined how information will be processed for the
Committee's work and Gil Whittemore and Jonathan Engel reported
on the pilot project characterizing the Markey Report experiments
using the Committee's classification scheme.

     Members discussed what publication citations might be
included on the experiment form, the speed with which primary
documents can be assessed, targeting of staff efforts and the
ability of the Committee to gain access to information not
readily available in the public record, e.g. selection of
vulnerable populations.

     Staff members briefed members on possible groupings of
experiments, as follows: Government purpose, Jim David. Total
body irradiation, Ron Neumann. Radiological warfare, Gregg
Herken. Intentional releases, Mr. Guttman.



Committee Discussion: Goals and Objectives. Dr. Faden.


     Members discussed draft outlines of the groups of
experiments to be covered in the Committee's interim and final
reports. Issues included the structure of the report and whether
the groupings represented meaningful differences among
experiments. Dr. Royal suggested that staff pay particular
attention to use of sealed sources of radiation in some
environmental releases.

     Drs. Oleinick and Stevenson suggested that the history of
radiation experimentation clearly outline both the positive and
negative outcomes, including the benefits for therapeutic
medicine.

     Dr. Katz suggested that the history of the doctor-patient
relationship be outlined to illuminate how research was
conducted, and the report also delve into the influence of the
medical profession on policymaking.

     Dr. Lederer suggested that statements from patients be
included, and also a thorough section on the tensions between
scientific and national security motivations of experimentation.
Ms. King said the report needs an additional theme about openness
in government.

     Dr. Royal suggested that narratives should encompass those
who have seen benefits from participation in experimentation.

     Dr. Russell said an important factor is the management of
experiments by the various agencies and the official structures
that oversaw, and oversee, experimentation. Dr. Oleinick said
that theme includes issues of the funding of science.

     Dr. Glatstein suggested a theme exploring the attitude of
investigators, e.g., that the ends justified the means.

     Dr. Royal said a relevant question is how research with
radiation differed from other human subject experimentation.

     Dr. Russell noted that all Defense Department grants were by
definition for military purposes, and that significant basic
research was funded by broad-brush grantmaking.

     Drs. Glatstein and Faden noted that experiments of
opportunity may bation.



Staff Report: Overview of Information System Management and
Experimental Groupings. Mr. Guttman.


     Mr. Guttman briefed members on potential groupings of
experiments for purposes of the Committee's report. David
Saumweber outlined how information will be processed for the
Committee's work and Gil Whittemore and Jonathan Engel reported
on the pilot project characterizing the Markey Report experiments
using the Committee's classification scheme.

     Members discussed what publication citations might be
included on the experiment form, the speed with which primary
documents can be assessed, targeting of staff efforts and the
ability of the Committee to gain access to information not
readily available in the public record, e.g. selection of
vulnerable populations.

     Staff members briefed members on possible groupings of
experiments, as follows: Government purpose, Jim David. Total
body irradiation, Ron Neumann. Radiological warfare, Gregg
Herken. Intentional releases, Mr. Guttman.



Committee Discussion: Goals and Objectives. Dr. Faden.


     Members discussed draft outlines of the groups of
experiments to be