A shocking secret came to light in November of 1993 when reporter Eileen Welsome published a series of Pulitzer prize winning articles, known as “The Plutonium Files.” In the files Welsome revealed that for three decades, leading research universities had been conducting U.S. government radiation experiments on humans, without their consent. Nearly half a million Americans were subjected to a variety of tests, including having plutonium injected directly into their bloodstream. The Plutonium Files revealed a
legal loophole in federal regulation Title 21 Chapter 1 Section 50: “Protection of Human Subjects,” namely researchers do not have to have our informed consent under certain circumstances, which include life threatening situations, unproven or unsatisfactory available treatments are, the collection of valid scientific evidence, or by department or agency heads choice. In response, President Clinton created the strengthened protections for human subjects of classified research memorandum. Unfortunately, Clinton’s
impeachment hearings began within a year, and the memorandum, lost in the controversy, was never implemented. As a result, we are still living under an outdated federal law and are still being exposed to harmful experiments without our knowledge. As Cheryl Welsh JD warns in the July 1, 2009 Activist magazine, that this vulnerability has given the government, as well as other institutions, “the power to carry out research projects without consent and without informing the participants of the dangers or future
complications.” If we are to help provide a solid protection for us as a people from nonconsensual human experimentation and restore our informed consent as a requirement for experimentation then we must, first examine to what extent this unethical problem has grown, then understand what has caused this injustice to bypass the American people, and finally take action to help remedy this situation.
When The Plutonium files were revealed the American public was shocked that their own government had been performing experiments on them, however; they were even more taken that U.S. federal regulation allowed it. Similarly, our problem has continued to grow overtime into two devastating forms; first the loophole is too broad, and second experiments are life threatening.
First, the current federal laws that create the loophole are extremely broad and will allow justification for nearly any experiment regardless of ethics. Changing what was intended to be a loophole, into a loop tunnel. According to the November 2009 Journal of Clinical Research Best Practices, “Government regulations are written broadly because it is impossible to anticipate every circumstance, especially those that may arise in the future. As a result, their application to specific situations is often unclear.”
However; the reason that the U.S. government has kept the laws that make up the loophole, actually serve a purpose. According to the Department of Health and Human Services’ unified agenda, released December 7, 2009, “The agency is issuing this rule because it is concerned that, during a potential terrorism event or other public health emergency, delaying testing of specimens to obtain informed consent may threaten the life of the subject or others who have been exposed to or who may be at risk of exposure to
a chemical, biological, radiological, or nuclear agent.” Though the intentions behind the law may be good, they are being stretched to justify nearly any experiment, skewing the line of ethics. For example, in May 2007 and March 2008 the U.S. Department of Defense “release[d] a dust simulating a biological attack.” The first in the Pentagon South parking lot was a bacterium linked to pulmonary disease and irreversible lung damage, and the second in the middle of Crystal City, Virginia was a suspected neuro and
respiratory toxicant. Though the reason was to observe the real world impacts of a biological attack, did it justify releasing potentially harmful substances on American citizens without our consent? According to current laws, yes. However; it is crucial that we remember as the previously cited Journal of Clinical Research states, “Human subject protection is broader than laws and regulations. It includes ethical principles as well.”
Second, because the loophole is so broad, the experiments that have utilized it to bypass our consent are becoming life threatening. While acknowledgeably not on a rampant or massive scope nonconsensual human experiments still continue on a life threatening scale. For example, according to the August 2009 medical journal “Clinics” a mere four years later, in 1998 “Baxter International launched their study under the exception for informed consent” loophole for HemAssist, a blood substitute. Upon arrival to the
ER a trauma victim would be administered some amount of the blood substitute without consent, instead of normal saline. The study was prematurely ended because 46% of its uninformed human subjects died. Despite past experiences, history then repeated itself in December 2006 when Northfield Laboratories utilized the loophole on entire communities, by enlisting “32 trauma centers in 18 states”. Where the only way you could opt out of the experiment was by “wearing color bracelets” indicating your lack of
and that was if you were lucky enough to hear about them.
The root of these problems stem from the fact that ironically, the memorandum designed to protect us was never implemented for two reasons: the loss of political momentum, and second, skewed citizen awareness.
First, if Welsome’s Pulitzer Prize winning articles galvanized the American public and its president to action, then the announcement of Clinton’s memorandum had the complete opposite effect. The issue lost its political momentum before the solution was enacted. Not only because the OJ trial verdict was announced on the same day, but the 2009 bulletin report explains that memorandums “can be created quickly to address temporary situations and then forgotten when the media move their attention to the next crisis
on the horizon.” Similarly, after the memorandum was prepared Clinton’s scandal lead to a change in administration, resulting in the media as well as our own attention being completely shifted off of taking action. In a July 31, 2008 White House briefing, which is only done every four years with the new terms president, a senior administration official stated on human experimentation policies “if we didn’t mention it you should know that those provisions are unchanged, carried over from the existing executive
order. So there is no change in that area.” Without the American people to fuel the political momentum of the memorandum, it was tossed around and quickly forgotten.
Second, despite past mistakes citizens either remain unaware of the problems, or their perspective skews what they do know. One of the biggest critiques by the 2009 bulletin report was that the subject of legal human subject protection is “unnoticed by experts, the media and the public.” Welsh contends that “Few are aware of the obscure facts and law. As a result, most experts, the media, and public have believed that there were human subjects protections, when in fact there were none and there are none to this
day.” However; even if individuals do become aware of human subject protections, our need for the comfort of safety overrides our logic and skews our perspective. Which CNN on February 23, 2010 calls, the “outbreak narrative” it explains that when faced with some “unknown. It feels like the world is being overtaken.” Therefore, “You err on the side of caution. It could’ve been really bad—it wasn’t. [But] It’s much better than not reacting and having a public health disaster.” And when citizens are either not
aware or not properly aware, citizens have no way to monitor the problem if they have no idea it exists.
The legal experimentation of American citizens has gone without amendment long enough, and if we are to ensure our safety then we must demand solvency for this problem by taking two forms of action, first restoring political momentum, and second creating citizen awareness.
First, we must move to restore political momentum to the issue of nonconsensual human experimentation by expressing our concerns to political and ethics leaders. When the plutonium files were revealed, several universities were exposed for collaboration with the government. So that is where we begin. Cheryl Welsh advises in an August 27, 2009 personal interview to take action into our own hands by contacting our own universities’ institutional review board to include regulations that prohibit nonconsensual experiments
in any research. Then petition them to stop any form of nonconsensual experimentation that maybe in progress. Also, to reawaken the concern of the Clinton memorandum do not underestimate writing your congress representative asking them to reexamine the guidelines for classified human experimentation, because this problem has a written solution for a model, it just has to be passed. By making noise surrounding this issue and establishing our firm stance against the lack of laws on human protection, we will remind
leaders to pick up where they left off, and ensure the passing of new human subject protections.
Second, we must become properly informed and active on a personal level to create citizen awareness. To help stay aware of this and similar issues join, subscribe, or donate to a human experimentation rights watch group, such as the Alliance for Human Research Protection. Where you can be kept up-to-date by following them on twitter, or signing up for e-news letters. Please take one of the business cards I have with their website. It also includes the website for the U.S. Department of Health and Human Services’
Office for Human Research Protections. By following the instructions on the card you can search for institutions with the FWA distinction, which assures that they are in compliance with the Department of Health and Human Services’ strict guidelines. So search your university or local hospital and become properly aware. Because by staying aware, we can take preventative measures to ensure our safety. For example, when receiving medical care ask doctors about treatments you or your loved ones are undergoing. Be
careful not to fall victim to the outbreak narrative, don’t worry about the ‘what if’s that could happen, worry about the treatments you are getting for what is. Ask questions and exercise your right to be informed as to what is being done to your body. With our awareness, we will no longer be at risk of being victims of the lack of informed consent.
By publishing the Plutonium Files in 1993 Eileen Welsome brought to light a loophole that had left nation the entire nation vulnerable. And while the problem has yet to be resolved, now, after examining the problems associated with nonconsensual human experimentation, understanding the causes behind this issue, and finally becoming aware of some solutions to remedy this problem, we are poised to close a legal loophole that has remained open for decades. We have been close to a solution before this time all it
takes is a little effort, follow through, and your consent.