Executive Summary

"Our greatness is measured not only in how we . . . do right but also [in] how we act when we know we've done the wrong thing; how we confront our mistakes, make our apologies, and take action."

--President Clinton October 3, 1995

In January 1994, President Clinton established the Advisory Committee on Human Radiation Experiments (ACHRE) to examine reports that the government had funded and conducted unethical human radiation experiments and releases of radiation during the Cold War. The President directed ACHRE to uncover the truth, recommend steps to right past wrongs, and propose ways to prevent unethical human subjects research from occurring in the future. The Committee published its findings and recommendations in October 1995.

This report presents the Administration's actions to respond to ACHRE's findings and recommendations. The Committee found that the government had conducted several thousand human radiation experiments from 1944 to 1975. Although the majority of the experiments advanced biomedical science and were unlikely to have caused harm, some were conducted unethically. ACHRE made 18 recommendations to improve openness in government, protect human subjects in the future, and redress past wrongs. The Admin-istration has adopted most of ACHRE's recommendations and has acted throughout the government to implement them.

The Administration has adopted most of ACHRE's recommendations and hasacted throughout the government to implement them.

Opening the Record

ACHRE recommended that the government take a number of steps to organize the historical records of human radiation experiments and to give the public access to these records. ACHRE identified the National Archives as the appropriate repository for documents. The Committee also recommended an independent review of the CIA's recordkeeping system and all of its documents related to human radiation experiments.

Key Actions

  • The Administration has invested heavily in making documents accessible. ACHRE transferred more than 1 million pages of documents to the National Archives. The Administration has made 300,000 fully searchable pages of documents available on the Internet, and will add an additional 200,000 pages shortly. The Departments of Energy and Defense have published document search guides.
  • The President signed Executive Order 12958 directing Federal agencies to review and declassify thousands of documents, including documents on radiation experiments.
  • The National Archives and Records Administration is conducting an independent review of the Central Intelligence Agency's (CIA's) recordkeeping system and the CIA's Inspector General reviewed and reported on the CIA's human experiments.

The Administration has invested heavily in making documents accessible.

Protecting Human Subjects in the Future

The Advisory Committee recommended steps to strengthen protec-tions for human subjects and ensure the government does not repeat past mistakes.

Key Actions

  • President Clinton is issuing a directive to strengthen protections for subjects of classified (secret) research. Agencies will propose new rules to eliminate waiver of informed consent; disclose the identity of the sponsoring agency; ensure a more independent review process; and require permanent records. Agencies will also report annually on the number of classified human research projects and the number of human subjects involved in each project.
  • President Clinton established the National Bioethics Advisory Committee (NBAC) to examine bioethical issues, including human research issues. A subcommittee of NBAC will address certain broad questions raised by ACHRE, including how to strengthen Institutional Review Boards (IRBs) -the local ethics panels for federally sponsored research.
  • President Clinton directed agencies to develop plans to improve oversight of ethics rules. NBAC will review these plans in the coming months.
  • Agencies have undertaken nationwide education efforts to raise the profile of ethical considerations, and are funding research to improve our understanding of ethical issues.

A subcommittee of National Bioethics Advisory Committee will address certain broad questions raised by ACHRE, including how to strengthen Institutional Review Boards--the local ethics panels for federally sponsored research.

Righting Past Wrongs

The Advisory Committee recommended, among other things, that the government apologize to all subjects, compensate certain subjects, and consider modifying the Radiation Exposure Compensation Act, and its regulations, to compensate additional uranium miners.

Key Actions

  • The President apologized to all subjects on behalf of the government; former Energy Secretary Hazel O'Leary made apologies in certain individual cases.
  • ACHRE recommended that the government compensate the families of the 18 subjects of the plutonium injection experiments. The government has settled compensation claims with the 16 families who have come forward. ACHRE and the government have not been able to identify participants in additional experiments that ACHRE included in its recommendation for compensation.
  • The Administration will propose legislative and regulatory changes to the Radiation Exposure Compensation Act to incorporate the latest science and better compensate affected uranium miners.
  • The Administration will propose legislation to make veterans treated with nasopharyngeal radiation eligible for health screening under the Department of Veterans Affairs' Ionizing Radiation Program.

The actions and policies described in this report will help bring justice to those harmed by the mistakes of the Cold War, and prevent the recurrence of past wrongs. The report presents those actions that are completed or underway. The Administration will continue to take steps to open the government's records, raise ethical standards, and right the wrongs of the past.

The Federal government has settled the compensation claims of the 16 families of plutonium injection subjects who have come forward.