[Congressional Record Volume 140, Number 16 (Wednesday, February 23, 1994)]
[Extensions of Remarks]
[Page E]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: February 23, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
       INTRODUCTION OF THE FEDERAL RESEARCH INFORMED CONSENT ACT

                                 ______


                            HON. JIM COOPER

                              of tennessee

                    in the house of representatives

                      Wednesday, February 23, 1994

  Mr. COOPER. Mr. Speaker, when the Secretary of Energy, Hazel O'Leary, 
announced the Department's openness initiatives in December, few of us 
imagined exactly what the declassification of documents would reveal. 
How could we possibly imagine that the Department of Energy would find 
that the Federal Government sponsored radiation experiments on American 
citizens during the cold war--that Americans have been used as guinea 
pigs without their consent?
  It shocked me. It shocked my colleagues. It shocked many of my 
constituents in the State of Tennessee, where many of the radiation 
experiments were conducted. We were all alarmed at the thought that 
American citizens were exposed to radiation without their consent, and 
that some may have suffered serious health problems as a result.
  Since Secretary O'Leary's announcement, I have received calls and 
letters from across Tennessee. People are panicked--afraid that they or 
members of their family may have been used as subjects in the cold war 
radiation experiments. These people have asked that I assure them of 
two things: one, that the Federal Government will provide full 
information to unwitting participants in the past experiments; and two, 
that American citizens will not be used as guinea pigs again.
  The Secretary of Energy has testified to several congressional 
committees that the Clinton administration is determined to disclose 
all records relating to the experiments in question. I intend to hold 
the administration to that promise. The Secretary also committed to a 
review of current experimentation involving human exposure to 
radiation. I applaud that effort as well. There has been no attempt, 
however, to ensure that the Federal Government may never use its 
citizens as unknowing subjects again.
  In seeking to provide that assurance to the people I met in 
Tennessee, I tried to find a Federal statute that prohibited the use of 
humans as subjects in experiments without their informed consent. I was 
surprised to find that none exists--there are regulations, but they 
leave a great deal of discretion in the hands of Federal agency heads.
  The regulations have done a good job of protecting human subjects in 
the last decade. The United States is among the world leaders in the 
regulation of human experimentation. The chance that Americans could be 
subjected to radiation experiments without their knowledge today is 
small. When we are dealing with the health and welfare of American 
citizens, however, small is not small enough. I think that we should go 
that extra mile to protect people--a statutory ban on the use of humans 
in federally sponsored experiments without their consent would provide 
that extra protection.
  Mr. Speaker, today I am introducing the Federal Research Informed 
Consent Act. This legislation establishes a statutory requirement of 
informed consent in Federal research using human subjects. It 
centralizes authority over such experiments at the Department of Health 
and Human Services, and requires the Secretary of that Department to 
notify the Congress of any exemptions made. In short, it creates an 
oversight mechanism that will protect the American public.
  I hope that never again are American citizens violated by their own 
Government. I think that this legislation will ensure that. We can 
never project into the future, however. That is why I have included a 
provision in this bill to provide legal remedy for individuals whose 
right to informed consent is violated. Americans have confidence in 
their Government, and most assume that their government will not 
subject them to harm. If the Government abuses that relationship, 
citizens are entitled to recover.
  Mr. Speaker, I introduce the Federal Informed Consent Act today to 
provide American citizens with renewed confidence in the relationship 
they have with their Government. The experiments revealed by the 
Department of Energy have troubled us all. We must ensure that such a 
terrible chapter in our Nation's history cannot be repeated. I 
encourage my colleagues to give serious consideration to this 
legislation, and hope that they will offer their support.

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