I am particularly pleased to come before you to speak about recent reports of potentially unethical conduct involving experiments using radiation on human subjects during the Cold War. As you know, this subject has generated intense public and media attention over the past several weeks. During this time, I have spoken with many Americans around the country, some of whom were experimental subjects or the relatives of subjects. They have been deeply troubled, as I was, by these reports.
I have been asked frequently why these activities were allowed to take place. Some have expressed the view that they were motivated by concern about a need to counter Soviet threats of nuclear war and the atmosphere of secrecy that surrounded research in nuclear energy and ionizing radiation since the Manhattan Project. With the end of the Cold War and President Clinton's strong commitment to openness in government, these conditions have changed dramatically.
This change has brought about a unique opportunity for the Nation to debate important questions raised by some of the human radiation experiments questions about the role of secrecy in a democratic society, and the need for proper safeguards to ensure the rights of individuals to determine their own fates. We must take the necessary steps to ensure all Americans whether they are uneducated or poor or mentally retarded or incarcerated that they are not being used unwittingly in Federally sponsored research. The Clinton Administration is determined to disclose all records on experiments involving ionizing radiation on humans.
As unsettling as some of these experiments were, and as feared as radiation may be to many people, it is important to remember that many lives have been saved using radiation in the diagnosis and treatment of disease. During the same Cold War period that some scientists were conducting these controversial experiments, other scientists were inventing vaccines against polio, new and effective treatments for cancer, and new ways of visualizing the human body with CAT and cardiac scans. Science itself is not at issue here. What is at issue is the secrecy with which some scientists may have practiced their craft.
I also want to caution the American public against inordinate fear of current research practices. Institutional Review Boards enforce strict requirements for informed consent of any human subjects involved in scientific experiments. It is difficult to conceive of the ethical abuses about which we've been hearing occurring today in the United States. We are committed to a serious review of all experiments sponsored or carried out by Government agencies that involved intentional human exposure to ionizing radiation. We will use the results of this review to try and repair any wrongs that might have been done, and will, if necessary, take action to make today's standards even more stringent.
This Administration recognizes that public trust can only be achieved if American citizens believe that their government is open, truthful, and accountable. Since the earliest days of his campaign, President Clinton has been publicly committed to an open and responsive government. The openness initiative that I began at the Department of Energy last spring was a direct outgrowth of this commitment.
I am taking action to assure that the records search being conducted by the Department of Energy and its contractors will be thorough and comprehensive as we endeavor to tell the full story. At the Department of Energy, we have developed an action plan to expedite the identification, retrieval, management, declassification, and dissemination of information regarding human radiation experiments. Department of Energy personnel have been directed to cease routine and nonroutine destruction of documents and to identify all pertinent records and information in the Department's possession and in the possession of our laboratories and contractors.
I have established a multidisciplinary committee under the authority of the Assistant Secretary for Environment, Safety and Health. The committee is issuing detailed guidance to the field. The committee includes specialists in health, environment, and legal issues among other disciplines. The Department, both at Headquarters and in the field, has already undertaken activities to begin to collect and review the pertinent documents. For example, over 130 cubic feet of files have been collected and are being reviewed at Headquarters. The committee is developing guidance and will facilitate the process by which all records are identified, retrieved, inventoried, declassified, stored, and disseminated. Teams of similar makeup and functions are being established in the field to assure that the process is expedited.
Allow me to stress that our goal is to get all the facts out. We will also do our best to provide information as we learn it. All pertinent information that is found regarding human experimentation will be declassified as necessary on an expedited basis and permanently preserved for public review in an appropriate public archive. At the same time, we are taking appropriate steps to protect the privacy of people who were the subjects of experiments as well as their families.
We are funding approximately 120 experiments, and providing facilities for another 100 experiments involving human subjects. Not all of those experiments involve radiation, and the majority of those that do relate to nuclear medicine involve the use of low tracer doses. To illustrate, there are 24 studies at Los Alamos National Laboratory under the purview of their Institutional Review Board. In no case is there any exposure of living human subjects to radioactive or chemical agents. In addition, none of these projects is classified.
The Office of Energy Research is preparing a list of all Department of Energy experiments identified by institution, title, principal investigator, and funding source. We estimate that the total funding of these projects is approximately $50 million.
The complete details of all human subject experiments conducted by the Department, or at Departmental facilities (including funding, location, number of volunteers, procedures, and other agency contributors) will be available on a computer retrievable data base by March 15, 1994. The data base will serve as the Department of Energy clearinghouse for all current and future experiments involving human subjects.
As far as we have been able to ascertain, the Department is not conducting any experiments that violate medical or ethical standards, or the Nuremburg code. In another case, Brookhaven National Laboratory has 42 projects under the purview of its Institutional Review Board. These are nuclear medicine studies that use low dose tracers. Additionally, Department of Energy procedures call for all volunteers in Departmental projects to be fully informed on all the procedures used.
The Department of Energy has established a toll-free telephone Helpline. The purpose of the Helpline is to aid us in identifying those persons who may have been affected by the activities in question. The number of calls to the Helpline has been overwhelming. We have received more than 15,000 telephone calls since December 24, 1993. The majority of callers appear not to have been subjects of human radiation experiments. The calls do reflect the concerns of people in every state and of all different backgrounds. The Department is requesting that callers provide additional written information that can be used to identify and locate documents related to these experiments.
In addition, we have received over 1,000 letters in the last 2 weeks. Approximately one third of the letters are from individuals or their relatives who believe that they may have been subjects of human experimentation, and another third of the letters are from individuals who believe that they have been exposed to radiation while serving in the military or while living next to a Government facility. The remaining third of the letters express support, offer assistance, or request information.
If our review determines that American citizens were treated wrongfully by their government, we believe this Administration owes the American people a full accounting and, where justified, an attempt to right any wrong done to individuals. The Administration is planning to take the following actions in response to individuals affected by the human radiation experiments:
1. Information will be provided to subjects and their families as soon as it becomes available.
2. When required to protect the health of individuals who were subjects of human radiation experiments, or their descendants, the Government will notify these subjects, or their descendants, of any potential health risk or the need for medical follow-up.
3. The Legal Issues Subcommittee (of the Human Radiation Interagency Working Group, see article appended) is currently examining various models for appropriate Federal responses, including those incorporated into other Federal programs such as those used to respond to "downwinders," veterans exposed to radiation, and the Japanese Americans interned in the United States during World War II. The range of Federal responses under consideration include potential monetary compensation, medical followup, disclosure of detailed information, and formal apologies or other recognition.
4. We are also developing specific recommendations for legislative and other action that may be appropriate.
Only by "coming clean" on the details of these experiments and separating Cold War habits of secrecy from proper ethics in scientific and medical research will we eventually reduce the bitterness and suspicion which has surrounded the debate on the health effects of radiation. Finally, let me reiterate to you and the American people our commitment to opening up the Department of Energy. We have a tremendous amount of work to do in this area, but I believe we have made a good start.
An Advisory Committee on Human Radiation Experiments, created by Presidential Executive Order, will advise the Human Radiation Interagency Working Group on human radiation experiments conducted by the Government since the 1940's. The focus will be on ethical and scientific standards applicable to the experiments.
The membership will be made up of outside-Government experts in medicine, science, and ethics. Up to 15 members will be appointed by the President. The Committee will terminate 30 days after submitting its final report to the Human Radiation Interagency Working Group.
The Interagency Working Group, announced by the White House earlier, will coordinate the Governmentwide effort to uncover the nature and extent of any Government-sponsored experiments on individuals involving intentional exposure to ionizing radiation. Working Group members include the Secretaries of Energy, Defense, Health and Human Services, and Veterans Affairs; the Attorney General; the Administrator of NASA; and the Directors of Central Intelligence and the Office of Management and Budget.