EPA vs. The Rules for Protection Human Study Subjects

So let’s compare conduct of EPA and the University of North Carolina with the rules for protecting human subjects that have been set since World War II.

EPA/UNC vs. the Nuremberg Code

  • Voluntary and Informed Consent. At no time did EPA inform any study subject about how toxic (i.e., death within hours after any exposure, cancer risk) EPA had determined PM2.5 to be. Consent obtained by misrepresentation and/or fraud is not consent.
  • Beneficial and necessary. EPA was already regulating PM2.5 for its lethality when these experiments were conducted. Given the EPA-determined risk and the fact of already existing regulation, it’s hard to see how these small experiments with extremely high exposures in highly selective subpopulations would further any regulatory efforts.
  • Anticipated Results Justify Experimentation. Did EPA hope to kill or otherwise harm study subjects to validate its extant regulation?
  • Avoid Unnecessary Harm. At least one study subject (i.e., the Case Report) was harmed by the EPA experimentation, according to EPA researchers. However, the lives of all study subjects were endangered by the EPA. The harm and risk were unnecessary as EPA had already determined and regulated on the basis that PM2.5 is ultrahazardous.
  • No Dangerous Experimentation. PM2.5can kill within hours of exposure, according to the EPA. Enough said.
  • Proportional Risk. The experiments solved no problem. EPA risked lives for no purpose.
  • Scientist Obligation to Terminate Experimentation. Though the EPA had already determined that PM2.5 exposure was deadly and even after the woman in the Case Report was injured by PM2.5, the EPA continued with the experiments.

EPA/UNC vs. The Common Rule

  • Risk must be minimized. The risk of death was present for all study subjects, more so considering many of the study subjects were unhealthy (e.g., metabolic syndrome, asthmatic, elderly and combinations thereof). Even though any exposure to PM2.5 could result in death within hours of exposure, the EPA tested levels of PM2.5 reaching 20 times greater than its own regulatory standards.
  • Risks must not be unnecessary. See discussion in Nuremberg Code analysis, above.
  • Risks must be reasonable in relation to anticipated benefits. The human study subjects received no benefits (Note: the subjects’ wage of $12 per hour doesn’t count as a benefit).
  • Informed Consent Requirement.See discussion in Nuremberg Code analysis, above.
  • IRB duty to terminate. The UNC IRB failed to terminate the experiments despite the occurrence of the event described in the Case Report. Seventeen more experiments were conducted even though the EPA and IRB knew that cardiac arrhythmias (requiring emergency medical attention) could result from the experiments.
  • Minimal risk exceeded. The PM2.5 exposures exceeded minimal risk because: (1) they could cause quick death and (2) they exceeded those that the study subjects would normally have been exposed to in their everyday lives.

EPA/UNC vs. EPA Order 1000.17

  • Risk of Substantial Injury. Given the EPA-determined ultrahazardous nature of PM2.5, there was a presumption under EPA Order 1000.17 that the experiment would not be approved without “strongly persuasive additional justification.” EPA has so far produced no evidence to show this was done — or that any other part of EPA Order 1000.17 was satisfied.
  • Minimal risk. As described above for the Common Rule, these experiments exceeded minimal risk as the experimental PM2.5 exposures greatly exceeded what Chapel Hill, NC-area residents would normally inhale. EPA’s failure to protect human subjects from anything more than minimal risk equates to “material non-compliance” of the Common Rule and EPA Order 1000.17.

EPA/UNC vs. North Carolina state laws.

  • Battery. The EPA researchers failed to lawfully obtain informed consent from the study subjects before exposing them to a highly lethal/toxic substance.
  • Negligence. The EPA researchers failed to disclose the risks of PM2.5 to the study subjects. All study subjects there by unknowingly put their lives in jeopardy. One study subject was, in fact, injured by the experiments according to EPA.
  • Fraud. Subject participation was obtained through fraud — i.e., the EPA researchers knowingly omitted the dangers of PM2.5 from the consent forms.
  • N.C. Gen. Stat. §90-21.13. The EPA researchers failed to obtain informed consent from the study subjects before undertaking the experiment.

The bottom line is that the EPA and UNC violated every significant provision of every rule set since World War II designed to protect human study subjects. The question now is, can EPA and UNC get away with it?

What have courts said about EPA and human testing?

  • In Environmental Defense Fund v. EPA [510 F.2d 1292 (D.C. Circuit, 1975)], a case involving whether certain pesticides were carcinogenic to humans, the U.S. Court of Appeals for the D.C. Circuit noted that it was appropriate to extrapolate the results of animal testing because:

    [T]he ethical problems of conducting cancer experiments on human beings are too obvious to require discussion.

  • In Ethyl Corporation v. Environmental Protection Agency [541 F.2d 1. Certiorari Denied June 14, 1976.See 96 S.Ct. 2662, 2663], a case involving the toxicity of leaded gasoline, the U.S. Court of Appeals for the District of Columbia Circuit noted:

    [S]ignificant exposure to lead is toxic, so that considerations of decency and morality limit the flexibility of experiments on humans that would otherwise accelerate lead exposure from years to months, and measure those results.

    As “toxic” as the Court and EPA may have considered lead to be, that level of toxicity pales in comparison to the EPA-claimed toxicity of PM2.5 — as no one has ever contended that ambient levels of lead in the air could cause death in the hours following exposure. Yet the EPA does just that.

  • In Glastetter v. Novartis [252 F.3d 986 (2001), at 992], a medical products liability case involving the medication Parlodel, the Eight Circuit Court of Appeals noted,

    [Scientists] cannot perform controlled experiments because it would be unconscionable to induce strokes in postpartum women simply to advance the medical community’s understanding of Parlodel.

    In the 41 human experiments conducted by EPA researchers — experiments in which study subjects risked their lives and health — the EPA conducted them merely to increase, by a small increment, the EPA’s understanding of PM2.5. The EPA’s experiments provided no chance of health benefits to the human study subjects and, in fact, only involved risk of serious harm — thereby violating, at the very least, a basic ethical principle of acceptable human experimentation.

NEXT: Is this a partisan issue?

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