President Obama directed his Presidential Commission for the Study of Bioethical Issues (Commission) to review human subject protections to
determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government. Obama ordered the report last year in response to revelations that in the 1940s, the U.S. Public Health Service conducted unethical research on human subjects without their consent. U.S. researchers intentionally infected over 1,500 human subjects in Guatemala with sexually transmitted diseases. The Commission issued a report last December 14th and concluded that current U.S. rules are adequate and would prevent such abuses from happening again.
However, the Commission disregarded the lack of legal reforms for nearly half a million victims of unethical Cold War government research. The Cold War research was often conducted in secret and without consent. The ethical consensus today is that a person must agree to participate in any research and must be informed about the possible risks, known as informed consent. But bureaucratic roadblocks prevented crucial legal reforms from being implemented, including the requirement of informed consent in classified research. Today, U.S. law still allows for a waiver of informed consent.
The Commission report should have recommended an informed consent requirement for classified research but did not. Instead, the report’s central finding was that
the U.S. system provides substantial protections for the health, rights, and welfare of research subjects. In failing its mandate, the Commission has put the public at risk for further unethical experiments in classified research. Significantly, the number of Cold War victims far surpassed the total number of victims of unclassified research, as in Guatemala, making the Commission’s failed mandate even more egregious shocking and inexcusable.
Between 1940 and 1974, Americans were used in military-related Cold War experiments involving radiation, blister and nerve agents, biological agents, LSD, and more. The story made headline news in the early 1990s and the public was outraged. Another presidential panel, the Advisory Committee for Human Radiation Experiments (ACHRE) issued a 1995 report on the Cold War research and stated that the federal government was
blameworthy for not having had policies and practices in place to protect the rights and interests of human subjects. The ACHRE recommended two special rules to protect human subjects in classified research; an absolute informed consent requirement, and an independent review panel that must approve any classified research.
A 1997 memorandum issued by then President Clinton included both the ACHRE recommendation to prohibit a waiver of informed consent in classified research, and also a modification of the ACHRE’s second special rule. But the Clinton memorandum was never implemented. Despite reform efforts, since 1991, the federal regulations for the protection of human subjects have remained unchanged. The regulations are popularly known as the Common Rule, and cover both classified and unclassified research.
The Common Rule is found at 45 U.S. Code of Federal Regulations (CFR) 46. CFR 46.101(i) allows a director of a federal department or intelligence agency to waive any of the Common Rule requirements, including the informed consent requirement and to do so in secret. The waiver effectively nullifies the regulations, and as happened in past Cold War experiments, allows for a complete lack of protections for human subjects in classified research, at the discretion of top officials.
The endnotes of Obama’s Commission report briefly mentioned the current rules that cover classified research; an Institutional Review Board (IRB) must include a nongovernmental member and must review classified research, and expedited review is not allowed. However, without the consent requirement, U.S. rules still fail to meet even the minimal standards for adequate human subject protections today.
Nonconsensual human experimentation is a violation of the Fourth, Fifth and Eighth Amendments of the U.S. Constitution. The U.S. government has acknowledged as much in a U.S. Department of State report and past presidential commission reports. Today, human subjects have the constitutional right to informed consent but they don’t have the necessary tools–a rule or statute–to exercise that right.
The ethical consensus for the informed consent requirement and the constitutional right to be free from nonconsensual experiments provide a solid foundation for long overdue reforms. Additionally, the ACHRE special rules and Clinton’s memorandum support that informed consent in classified research is sound public policy.
It is true, most experts believe that the ethical standards and U.S. rules in place today would prevent the large numbers of Cold War experiments from happening again. While that may have been the thinking of the Commission, this disregards the overwhelming evidence that the legal requirement of informed consent in classified research is essential for adequate human subject protections.
Obama will now act on the Commission report and public opinion can make a difference. Let’s ask Obama to finish what Clinton started and give human subjects the legal tools to ensure substantial protections, a U.S. rule or statute that requires informed consent in classified research.
For further information
Presidential Commission for the Study of Bioethical Issues, Moral Science, Protecting Participants in Human Subjects Research, p.113 at http://bioethics.gov/
ACHRE Report at http://www.hss.doe.gov/healthsafety/ohre/roadmap/achre/chap18.html
For ethical consensus for informed consent, see ACHRE,
Research Ethics and the Medical Profession, Report of the Advisory Committee on Human Radiation Experiments, (7 August 1996), 276, No 5, Journal of the American Medical Association, (JAMA), p.405.
Clinton Memorandum, Strengthened Protections for Human Subjects of Classified Research at http://www.fas.org/sgp/clinton/humexp.html
For failure to implement Clinton memorandum, see email from Pat Elhinnawy, HHS OHRP, Director, Public Affairs to author (1 April 2009) (on file with author).
Common Rule, Federal Policy For the Protection of Human Subjects, 45 U.S. Code of Federal Regulations (CFR) Protection of Human Subjects 46 at 46.101(i)
For illegality of CIA experiments, see Commission on CIA Activities Within the United States, Report to the President (Rockefeller Commission Report), (Washington, U.S. GPO, June 1975), p.37
For informed consent under U.S. Constitution, see 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), (1994), p.73
The Whitehouse at http://www.whitehouse.gov/contact
Author: Cheryl Welsh JD., Op-Ed,
Outlaw Nonconsensual Human Experiments Now, Bulletin of the Atomic Scientists, Web Edition, June 16, 2009. Available at http://thebulletin.org/web-edition/op-eds/outlaw-nonconsensual-human-experiments-now
In Name Only: The disturbing legacy of the Cold War nonconsensual experiments, Essex Human Rights Review, to be published April 2012