pd09oc95 Proclamation 6833--National Children's Day, 1995...

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half, the only thing that stood between them and the truth were all the 
late nights and hard work they had to put in.
    This report I received today is a monumental document--[laughter]--
in more ways than one. But it is a very, very important piece of 
America's history, and it will shape America's future in ways that will 
make us a more honorable, more successful, and more ethical country.
    What this Committee learned I would like to review today with a 
little more detail than

[[Page 1758]]

Dr. Faden said, because I think it must be engraved on our national 
memory. Thousands of Government-sponsored experiments did take place at 
hospitals, universities, and military bases around our Nation. The goal 
was to understand the effects of radiation exposure on the human body. 
While most of the tests were ethical by any standards, some were 
unethical, not only by today's standards but by the standards of the 
time in which they were conducted. They failed both the test of our 
national values and the test of humanity.
    In one experience, scientists--experiment--scientists injected 
plutonium into 18 patients without their knowledge. In another, doctors 
exposed indigent cancer patients to excessive doses of radiation, a 
treatment from which it is virtually impossible that they could ever 
benefit.
    The report also demonstrates that these and other experiments were 
carried out on precisely those citizens who count most on the Government 
for its help, the destitute and the gravely ill. But the dispossessed 
were not alone. Members of the military--precisely those on whom we and 
our Government count most--they were also test subjects.
    Informed consent means your doctor tells you the risk of the 
treatment you are about to undergo. In too many cases, informed consent 
was withheld. Americans were kept in the dark about the effects of what 
was being done to them. The deception extended beyond the test subjects 
themselves to encompass their families and the American people as a 
whole, for these experiments were kept secret. And they were shrouded 
not for a compelling reason of national security but for the simple fear 
of embarrassment, and that was wrong.
    Those who led the Government when these decisions were made are no 
longer here to take responsibility for what they did. They are not here 
to apologize to the survivors, the family members, or the communities 
whose lives were darkened by the shadow of the atom and these choices.
    So today, on behalf of another generation of American leaders and 
another generation of American citizens, the United States of America 
offers a sincere apology to those of our citizens who were subjected to 
these experiments, to their families, and to their communities.
    When the Government does wrong, we have a moral responsibility to 
admit it. The duty we owe to one another to tell the truth and to 
protect our fellow citizens from excesses like these is one we can never 
walk away from. Our Government failed in that duty, and it offers an 
apology to the survivors and their families and to all the American 
people who must--who must be able to rely upon the United States to keep 
its word, to tell the truth, and to do the right thing.
    We know there are moments when words alone are not enough. That's 
why I am instructing my Cabinet to use and build on these 
recommendations, to devise promptly a system of relief, including 
compensation, that meets the standards of justice and conscience.
    When called for, we will work with Congress to serve the best needs 
of those who were harmed. Make no mistake, as the committee report says, 
there are circumstances where compensation is appropriate as a matter of 
ethics and principle. I am committed to seeing to it that the United 
States of America lives up to its responsibility.
    Our greatness is measured not only in how we so frequently do right 
but also how we act when we know we've done the wrong thing, how we 
confront our mistakes, make our apologies, and take action.
    That's why this morning, I signed an Executive order instructing 
every arm and agency of our Government that conducts, supports, or 
regulates research involving human beings to review immediately their 
procedures in light of the recommendations of this report and the best 
knowledge and standards available today and to report back to me by 
Christmas. I have also created a Bioethics Advisory Commission to 
supervise the process, to watch over all such research, and to see to it 
that never again do we stray from the basic values of protecting our 
people and being straight with them.
    The report I received today will not be left on a shelf to gather 
dust. Every one of its pages offers a lesson, and every lesson will be 
learned from these good people who put

[[Page 1759]]

a year and a half of their lives into the effort to set America 
straight.
    Medical and scientific progress depends upon learning about people's 
responses to new medicines, to new cutting-edge treatments. Without this 
kind of research, our children would still be dying from polio and other 
killers. Without responsible radiation research, we wouldn't be making 
the progress we are in the war on cancer. We have to continue to 
research, but there is a right way and a wrong way to do it.
    There are local citizens' review boards; there are regulations that 
establish proper informed consent and ensure that experiments are 
conducted ethically. But in overseeing this necessary research, we must 
never relax our vigilance.
    The breathtaking advances in science and technology demand that we 
always keep our ethical watchlight burning. No matter how rapid the pace 
of change, it can never outrun our core convictions that have stood us 
so well as a nation for more than 200 years now, through many different 
scientific revolutions.
    I believe we will meet the test of our times, that as science and 
technology evolve, our ethical conscience will grow, not shrink. 
Informed consent, community right-to-know, our entire battery of 
essential human protections, all these grew up in response to the health 
and humanitarian crises of this 20th century. They are proof that we are 
equal to our challenges.
    Science is not ever simply objective. It emerges from the crucible 
of historical circumstances and personal experience. Times of crisis and 
fear can call forth bad science, even science we know in retrospect to 
be unethical. Let us remember the difficult years chronicled in this 
report, and think about how good people could have done things that we 
know were wrong.
    Let these pages serve as an eternal reminder to hold humility and 
moral accountability in higher esteem than we do the latest development 
in technology. Let us remember, too, that cynicism about Government has 
roots in historical circumstances. Because of stonewallings and evasions 
in the past, times when a family member or a neighbor suffered an 
injustice and had nowhere to turn and couldn't even get the facts, some 
Americans lost faith in the promise of our democracy. Government was 
very powerful but very far away and not trusted to be ethical.
    So today, by making ourselves accountable for the sins of the past, 
I hope more than anything else, we are laying the foundation stone for a 
new era. Good people--like these Members of Congress who have labored on 
this issue for a long time and have devoted their careers to trying to 
do the right thing and having people justifiably feel confidence in the 
work of their Representatives--they will continue to work to see that we 
implement these recommendations.
    And under our watch, we will no longer hide the truth from our 
citizens. We will act as if all that we do will see the light of day. 
Nothing that happens in Washington will ever be more important in 
anyone's life affected by these experiments, perhaps, than these reports 
we issue today. But all of us as Americans will be better off because of 
the larger lesson we learned in this exercise and because of our 
continuing effort to demonstrate to our people that we can be faithful 
to their values.
    Thank you very much.

Note: The President spoke at 11:07 a.m. in Room 450 at the Old Executive 
Office Building. In his remarks, he referred to Ruth R. Faden, Chair, 
Advisory Committee on Human Radiation Experiments.


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[Page 1759-1761]
 
Monday, October 9, 1995
 
Volume 31--Number 40
Pages 1749-1788
 
Week Ending Friday, October 6, 1995
 
Executive Order 12975--Protection of Human Research Subjects and 
Creation of National Bioethics Advisory Commission

October 3, 1995

    By the authority vested in me as President by the Constitution and 
the laws of the United States of America, it is hereby ordered as 
follows:
    Section 1. Review of Policies and Procedures. (a) Each executive 
branch department and agency that conducts, supports, or regulates 
research involving human subjects shall promptly review the protections 
of the rights and welfare of human research subjects that are afforded 
by the department's or agency's existing policies and procedures. In 
conducting this review, departments and agencies

[[Page 1760]]

shall take account of the recommendations contained in the report of the 
Advisory Committee on Human Radiation Experiments.
    (b) Within 120 days of the date of this order, each department and 
agency that conducts, supports, or regulates research involving human 
subjects shall report the results of the review required by paragraph 
(a) of this section to the National Bioethics Advisory Commission, 
created pursuant to this order. The report shall include an 
identification of measures that the department or agency plans or 
proposes to implement to enhance human subject protections. As set forth 
in section 5 of this order, the National Bioethics Advisory Commission 
shall pursue, as its first priority, protection of the rights and 
welfare of human research subjects.
    (c) For purposes of this order, the terms ``research'' and ``human 
subject'' shall have the meaning set forth in the 1991 Federal Policy 
for the Protection of Human Subjects.
    Sec. 2. Research Ethics. Each executive branch department and agency 
that conducts, supports, or regulates research involving human subjects 
shall, to the extent practicable and appropriate, develop professional 
and public educational programs to enhance activities related to human 
subjects protection, provide forums for addressing ongoing and emerging 
issues in human subjects research, and familiarize professionals engaged 
in nonfederally-funded research with the ethical considerations 
associated with conducting research involving human subjects. Where 
appropriate, such professional and educational programs should be 
organized and conducted with the participation of medical schools, 
universities, scientific societies, voluntary health organizations, or 
other interested parties.
    Sec. 3. Establishment of National Bioethics Advisory Commission. (a) 
There is hereby established a National Bioethics Advisory Commission 
(``NBAC''). NBAC shall be composed of not more than 15 members to be 
appointed by the President. NBAC shall be subject to the Federal 
Advisory Committee Act, as amended (5 U.S.C. App.).
    (b) The President shall designate a Chairperson from among the 
members of NBAC.
    Sec. 4. Functions. (a) NBAC shall provide advice and make 
recommendations to the National Science and Technology Council and to 
other appropriate government entities regarding the following matters:
    (1) the appropriateness of departmental, agency, or other 
governmental programs, policies, assignments, missions, guidelines, and 
regulations as they relate to bioethical issues arising from research on 
human biology and behavior; and
    (2) applications, including the clinical applications, of that 
research.
    (b) NBAC shall identify broad principles to govern the ethical 
conduct of research, citing specific projects only as illustrations for 
such principles.
    (c) NBAC shall not be responsible for the review and approval of 
specific projects.
    (d) In addition to responding to requests for advice and 
recommendations from the National Science and Technology Council, NBAC 
also may accept suggestions of issues for consideration from both the 
Congress and the public. NBAC also may identify other bioethical issues 
for the purpose of providing advice and recommendations, subject to the 
approval of the National Science and Technology Council.
    Sec. 5. Priorities. (a) As a first priority, NBAC shall direct its 
attention to consideration of: protection of the rights and welfare of 
human research subjects; and issues in the management and use of genetic 
information, including but not limited to, human gene patenting.
    (b) NBAC shall consider four criteria in establishing the other 
priorities for its activities:
(1)         the public health or public policy urgency of the bioethical 
            issue;
(2)         the relation of the bioethical issue to the goals for 
            Federal investment in science and technology;
(3)         the absence of another entity able to deliberate 
            appropriately on the bioethical issue; and
(4)         the extent of interest in the issue within the Federal 
            Government.
    Sec. 6. Administration. (a) The heads of executive departments and 
agencies shall, to the extent permitted by law, provide NBAC with such 
information as it may require for purposes of carrying out its 
functions.

[[Page 1761]]

    (b) NBAC may conduct inquiries, hold hearings, and establish 
subcommittees, as necessary. The Assistant to the President for Science 
and Technology and the Secretary of Health and Human Services shall be 
notified upon establishment of each subcommittee, and shall be provided 
information on the name, membership (including chair), function, 
estimated duration, and estimated frequency of meetings of the 
subcommittee.
    (c) NBAC is authorized to conduct analyses and develop reports or 
other materials. In order to augment the expertise present on NBAC, the 
Secretary of Health and Human Services may contract for the services of 
nongovernmental consultants who may conduct analyses, prepare reports 
and background papers, or prepare other materials for consideration by 
NBAC, as appropriate.
    (d) Members of NBAC shall be compensated in accordance with Federal 
law. Members of NBAC may be allowed travel expenses, including per diem 
in lieu of subsistence, to the extent permitted by law for persons 
serving intermittently in the government service (5 U.S.C. 5701-5707).
    (e) To the extent permitted by law, and subject to the availability 
of appropriations, the Department of Health and Human Services shall 
provide NBAC with such funds as may be necessary for the performance of 
its functions. The Secretary of Health and Human Services shall provide 
management and support services to NBAC.
    Sec. 7. General Provisions. (a) Notwithstanding the provisions of 
any other Executive order, the functions of the President under the 
Federal Advisory Committee Act that are applicable to NBAC, except that 
of reporting annually to the Congress, shall be performed by the 
Secretary of Health and Human Services, in accordance with the 
guidelines and procedures established by the Administrator of General 
Services.
    (b) NBAC shall terminate two years from the date of this order 
unless extended prior to that date.
    (c) This order is intended only to improve the internal management 
of the executive branch and it is not intended to create any right, 
benefit, trust, or responsibility, substantive or procedural, 
enforceable at law or equity by a party against the United States, it 
agencies, its officers, or any person.
                                            William J. Clinton
The White House,
October 3, 1995.

[Filed with the Office of the Federal Register, 2:11 p.m., October 3, 
1995]

Note: This Executive order was published in the Federal Register on 
October 5.


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Monday, October 9, 1995
 

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