Nonconsensual experiments are unconstitutional but recent changes in the law allow just that by Cheryl Welsh,

Nonconsensual experiments are
but recent changes in the law allow just that
by Cheryl Welsh,
August 2008
Table of contents
I. Page 2 — A new Bush executive order (EO) includes an old waiver that allows
human subject protections to be modified or waived by intelligence agency
directors in complete secrecy.
II. Page 4 — The Department of Justice (DOJ) issued an Office of Legal Counsel
(OLC) opinion that allows human subject protections to be modified or waived by
the President in complete secrecy.
III. Page 5 — Experimentation law is firmly rooted in the U.S. Constitution and
international law.
IV. Page 8 — Utilitarian national security interests at the highest levels of government
continue to trump human subject protections.
I. A new Bush EO includes an old waiver that allows
human subject protections to be modified or waived by
intelligence agency directors in complete secrecy.
Illegal CIA mind control experiments and past unethical human radiation experiments
could happen again as a result of two new laws. On July 30th, 2008, President Bush
signed into law the EO entitled Further Amendments to Executive Order 12333,United
States Intelligence Activities. See
The original EO 12333, entitled United States Intelligence Activities was issued in 1981
by President Reagan as a result of the 1977 congressional hearing that uncovered the CIA
Mkultra mind control experiments. Before the Bush EO was issued, Reagan’s EO was the
current law. Both EOs include the following;
Section 2.10 Human Experimentation. No agency within the Intelligence
Community shall sponsor, contract for or conduct research on human
subjects except in accordance with guidelines issued by the Department of
Health and Human Services ( HHS). The subject’s informed consent shall be
documented as required by those guidelines.
As in the Reagan EO, the Bush EO allows for a waiver of any or all of the HHS federal
regulations, and for a statute or EO to override the notification and publication
requirements. It is notable that the Bush EO did not eliminate the waivers. After the
human radiation experiments scandal made headline news, the 1995 Advisory
Committee on Human Radiation Experiments (ACHRE), Final Report concluded that
the federal government was “blameworthy for not having had policies and practices in
place to protect the rights and interests of human subjects” in several thousand
experiments. See The ACHRE
made several recommendations including;
the adoption of a federal policy requiring the informed consent of all human
subjects of classified research and that this requirement not be subject to
exemption or waiver. In all cases, potential subjects should be informed of the
identity of the sponsoring federal agency and that the project involves
classified information.
President Clinton issued a presidential memorandum that implemented the ACHRE
recommendations. But the memorandum was not adopted by the federal departments or
intelligence agencies, in part because presidential EOs and memorandums are inherently
weak. They are “subject to evasion, rescission, or modifications as the commander in
chief sees fit.” 1 A 2003 US News and World Report article explained what happened
when Clinton lost his re-election bid and Bush was elected;
Bush’s chief of staff, Andrew Card, directed federal agencies to freeze more
than 300 pending regulations issued by the administration of President Bill
Clinton. The regulations affected areas ranging from health and safety to the
environment and industry. The delay, Card said, would “ensure that the
president’s appointee’s have the opportunity to review any new or pending
regulations.” 2
As a result, the ACHRE recommendations were only adopted by the Department of
Defense, which had done so before Bush was elected. 3
At a July 31, 2008 White House briefing, a senior administration official stated;
When you take a look at the order and compare it to the 1981 original 12333, I
think you’ll find that there were very, very few changes to Part 2 of the order.
The revised order, as with the original order, affirms that all U.S. intelligence
activities must be conducted in a manner that protects American civil liberties
and privacy rights. The longstanding protections and safeguards, in other
words, that are in place or that were in place and have been in place in the
original executive order remained unchanged in this revised order. …
I may add one point here simply because I realize we neglected to mention it
earlier in our — when we were making opening remarks. Many people
associate this executive order with the assassination ban and also the ban on
human experimentation, and if we didn’t mention it you should know that
those provisions are unchanged, carried over from the existing executive
order, and they appear prominently in Part 2 of this order. So there’s no
change in that area. …
See It becomes
clear that human subject protections are given lip service at the same time that the
protections have been completely neutralized by the waivers. The ACHRE Final Report is
completely at odds with the official Whitehouse statements.
II. The DOJ issued an Office of Legal Counsel (OLC)
opinion that allows human subject protections to be
modified or waived by the President in complete secrecy.
A 2007 OLC opinion says that EOs may be “unilaterally abrogated by the President
without public notice,” according to April 2008 Senate testimony by Steve Aftergood,
director, Project on Government Secrecy at the Federation of American Scientists.
Aftergood specifically mentioned that the OLC could affect “protection of human subjects
in scientific research.” Instead of the director of an intelligence agency waiving human
subject protections according to EO 12333 and the HHS regulations, this legal
mechanism allows the president to waive or modify EO 12333 without informing the
public. See Aftergood
The Office of Legal Counsel at the Justice Department produces opinions on
legal questions that are generally binding on the executive branch. Many of
these opinions may be properly confidential. But others interpret the law
authoritatively and in ways that are reflected in government policy. Yet most
of these opinions are secret, so that the legal standards under which the
government is actually operating at any given moment may be unknown to
the public. …
One secret OLC opinion of particular significance, identified last year by
Senator Whitehouse, holds that executive orders, which are binding on
executive branch agencies and are published in the Federal Register, can be
unilaterally abrogated by the President without public notice. Because many
executive orders are partly rooted in statute or reflect statutory imperatives,
this approach has the potential to subvert Congressional intent and to do so
secretly. …
Executive orders are used to define some of the most basic policy positions of
the United States, on everything from assassination of foreign leaders to
domestic intelligence activities to protection of human subjects in scientific
research. But now it appears that none of these policies are securely
established. In fact, any of them may already have been violated (or, rather, “
waived”) without notice. We just don’t know. …
III. Experimentation law is firmly rooted in the U.S.
Constitution and international law.
The Nuremberg Code is the “most complete and authoritative statement of the law of
informed consent to human experimentation.” 4 The Nuremberg Code has its’
beginnings in the Nuremberg Doctors’ Trial in 1947. The trial of twenty German doctors,
charged with war crimes and crimes against humanity focused on the infamous human
experiments on nonconsenting prisoners in the Nazi concentration camps during World
War II. The judgment concluded with a ten point code of human experimentation ethics,
the Nuremberg Code. The first rule is that the voluntary consent of the human subject is
absolutely essential. 5
Article 7 of the International Covenant for Civil and Political Rights (ICCPR) treaty
includes the Nuremberg Code voluntary consent requirement. This treaty was adopted by
the UN in 1966 and ratified by the U.S. Congress in 1992. A 1994 governmental human
rights report cited the human radiation experiments as an example of noncompliance
with the ICCPR by the U.S. government. The report explained how Article 7 of the ICCPR
applied to the U.S. Constitution.
Article 7. Freedom from torture or cruel, inhuman, or degrading treatment or
punishment In particular no one shall be subjected without his free consent to
medical or scientific experimentation. …
The United States considers itself bound by Article 7 to the extent that ‘cruel,
inhuman or degrading treatment or punishment’ means the cruel and
unusual treatment or punishment prohibited by the Fifth, Eight and/or
Fourteenth Amendments to the Constitution of the United States.
Medical or scientific nonconsensual experimentation is illegal in the US.
Specifically it would violate the Fourth Amendment proscription against
unreasonable searches and seizures (including seizing a person’s body), the
Fifth Amendment’s proscription against depriving one of life, liberty or
property without due process, and the Eight Amendment’s prohibition
against the infliction of cruel and unusual punishment. 6
IV. Utilitarian national security interests at the highest
levels of government continue to trump human subject
From World War II to the 1970s, top officials knowingly conducted human experiments
for national security purposes, above the law and in secret. A 1963 CIA inspector general’
s report on MKULTRA acknowledged the illegalities. “Some activities raise questions of
legality implicit in the original charter. … A final phase places the rights and interests of
US citizens in jeopardy.” 7 And the ACHRE Final Report stated that it “could conclude
with certainty that the AEC (Atomic Energy Commission) was aware of the potentially
negative legal and public relations effects of publicity surrounding the plutonium
injection [late 1940s experiments].” As a result, the experiments were kept secret.
After the 1970s CIA mind control experiments and the 1990s human radiation
experiments scandals, the executive branch implemented EOs to protect human subjects
in national security experiments. The 1981 Reagan EO contained waivers that neutralized
human subject protections. The Bush EO included the same Reagan waivers even while
the official White House statements assured that civil liberties and privacy rights were
being protected. Now the OLC opinion allows for the president to make changes in
human subject protections in total secrecy. The history of human subject protections
reflects a purposeful avoidance of passing laws that make classified nonconsensual
experiments illegal, enforceable and punishable under U.S. and international law. The
problem is extensive. A 1994 congressional hearing reported that “nearly half a million
Americans were subjected to some kind of cold war era tests,” often without being
informed and without their consent. See Cold War Era Human Subject Experimentation:
Hearing Before the Legislation and National Security SubComm. of the Comm. on
Government Operations House of Representatives, 103rd Cong. 54 (1994). The problem
is deeply rooted and is not easily remedied. Utilitarian national security interests at the
highest levels of government continue to trump human subject protections. George
Annas, law professor and expert on experimentation law for over twenty years, explained
Even when the Nuremberg Code applies directly we have never taken it
seriously. We say that the rights of the individual are outweighed by national
security concerns. This has been true even where those concerns are unclear
or unarticulated, as where the experiments are carried out in secret and
produce death and permanent disability. . . . when medical progress has been
invoked, ethics continues to take a backseat to expediency. 8
In the 1999 New York Timesreviewed book, Undue Risk, Secret State Experiments on
Humans, ethicist Jonathan Moreno explained that national security experiments are
Today and ever since the end of the World War II, the universal sensitivity
about human experiments is coupled with the fact that they are probably
unavoidable in the real world of national security. Textbook theories,
laboratory experiments, and computer and animal models can only go so far.
At some point, when information is needed about how human beings will
react to new forms of weaponry, human experiments will have to continue in
this business. In a dangerous world one might well argue that it would be
irresponsible for us not to do so. 9
The failures of past attempts to protect human subjects in national security experiments
call for a more impartial, balanced examination of the ethical, cultural and political
factors and their influence on experimentation law. By understanding why the failures
have occurred, more realistic approaches may have a much better chance for progress.
Now the government has argued that cold war national security and post 9-11 conditions
require increased secrecy and the sacrifice of individual rights guaranteed by the
Constitution. Before accepting this argument, many lessons can be learned from the
history of cold war human experimentation law within a framework of national security
law and presidential powers. For further background information and alternative
approaches for human subject protections in national security experiments, see; and
1. Kenneth R. Mayer, With the Stroke of a Pen: Executive orders and Presidential
Power, 181 (Princeton University Press) (2001).
2. Christopher H. Schmitt and Edward T. Pound, Keeping Secrets: The Bush
Administration is doing the public’s business out of the public eye. Here’s how-and
why, US News and World Report, December 22, 2003. 18.
3. Memorandum on Protections for Human Subjects of Classified Research, 62 F.R.
26369 (1997).
4. George J. Annas and Michael A. Grodin, The Nazi Doctors and the Nuremberg
Code: Human Rights in Human Experimentation, 2 (1992).
5. Ulf Schmidt, Justice at Nuremberg: Leo Alexander and the Nazi Doctors’ Trial, 3
6. John Shattuck, United States Department of State Civil and Political Rights in the
United States Initial Report of the United States of America to the U.N. Human
Rights Committee under the International Covenant on Civil and Political Rights
(ICCPR) 73 (1994).
7. Alan Scheflin, Freedom of the Mind as an International Human Rights Issue
Human Rights Law Journal Vol. 3 No. 1-4 59 (1982).
8. George J. Annas, Mengele’s Birthmark: The Nuremberg Code in United States
Courts, Journal of Contemporary Health Law and Policy Vol 7:17. 21(1991).
9. Jonathan D. Moreno, Undue Risk: Secret State Experiments on Humans 5 (1999).


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