Flawed ethics recommendations of the U.S. EPA's Human Studies Review Board.

The U.S. Environmental Protection Agency's (EPA) new rule to protect human research subjects has generated scientific, ethical, and legal controversy (Burton 2006). Addressing pesticide studies submitted by third parties to the U.S. EPA for possible use in regulatory decisions, the rule also authorized an independent Human Subjects Review Board (HSRB) to evaluate these studies. How successful has the HSRB been?

The board's first report (HSRB 2006), a scientific and ethical review of third-party, intentional human-exposure studies on eight active ingredients used in pesticides, was issued 26 June 2006. The HSRB (2006) concluded that studies of seven pesticides [aldicarb, amitraz, azinphos-methyl, dichlorvos (DDVP), ethephon, methomyl, and oxamyl] "failed to fully meet the specific ethical standards prevalent at the time the research was conducted ..." (see also Lockwood 2004; Needleman et al. 2005; Oleskey et al. 2004; Sass and Needleman 2004). Nevertheless, the HSRB (2006) concluded that

  There was no clear and convincing evidence that the research [on these
  seven pesticides] was fundamentally unethical--intended to seriously
  harm participants or that informed consent was not obtained.

This second HSRB conclusion is ethically questionable on several grounds. First, it relies on an arbitrary definition of "fundamentally unethical" research as either intended to seriously harm participants or that fails to obtain informed consent. Yet neither the U.S. EPA (2006) nor the National Research Council (NRC 2004) defines "fundamentally unethical" so narrowly. Instead, both say only that studies which intend harm or violate consent are examples of "fundamentally unethical" research.

In reducing "fundamentally unethical" research to only two types of problems, the HSRB excludes much behavior that ethicists traditionally have condemned. Negligence and culpable ignorance (Aristotle 1985)--as well as lying, using people as means to an end, or pursuing self-interest at the expense of others (Kant 1964)--are unethical, even without intent to harm others.

To assume that bad intentions are required to make serious harms fundamentally unethical also ignores "errors of omission" and focuses merely on commission--having harmful intent. Yet researchers err through omission if they behave irresponsibly toward their subjects: Perhaps they intend no harm, but through laziness, greed, or carelessness (Aristotle 1985), they fail to recognize subjects' manifesting harmful symptoms.

The second HSRB conclusion also imposes an unfair burden on research victims or opponents, requiring them to establish researchers' intentions. Yet intentions are almost impossible to know; they are private--not empirical--and thus typically known only by the individual. Proof of intent to harm is not required to judge bank robbers or white-collar criminals. Why should evaluators of research have such an unfair burden?

One reason for the HSRB's questionable ethical conclusions may be inadequate bioethics expertise. No board members have terminal degrees in bioethics or even ethics. Fields represented are anesthesiology, environmental health sciences (2), epidemiology, medicine, microbiology, neurology, pharmacology (3), psychology, statistics (2), and toxicology (3) (HSRB 2006). The U.S. EPA also has not followed recommendtions of its Science Advisory Board (2000), the NRC (2004), and the Environmental Medicine Workgroup (Oleskey et al. 2004) to establish specific ethics guidelines for all U.S. EPA-related research. Without such guidelines (e.g., avoid low-power studies), questionable ethical conclusions likely will continue.

The author is a member of the U.S. EPA Science Advisory Board; all opinions expressed in this correspondence are those of the author, not the U.S. EPA.

The author declares she has no competing financial interests.

Kristin Shrader-Frechette

Department of Biological Sciences, Department of Philosophy University of Notre Dame Notre Dame, Indiana 

E-mail: [e-mail]

REFERENCES

Aristotle. 1985. Nicomachean Ethics (trans, Irwin T). Indianapolis, IN: Hackett.

Burton A. 2006. Human experimentation: a rule gone awry? Environ Health Perspect 114:A360-A362.

HSRB (Human Studies Review Board). 2006. April 4-6, 2000 Meeting EPA Human Studies Review Board Report. Washington, DC:U.S. EPA. Available: http://www.epa.gov/OSA/hsrb/files/april2006mtgfinalreport62606.pdf [accessed 15 September 2006].

Kant I. 1964. Groundwork of the Metaphysics of Morals. New York: Harper and Row.

Lockwood A. 2004. Human testing of pesticides. Am J Public Health 94:1908-1916.

Needleman H, Reigart JR, Landrigan P, Sass J, Bearer C. 2005. Benefits and risks of pesticide testing on humans [Letter]. Environ Health Perspect. 113:A804-A805.

NRC (National Research Council). 2004. Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: National Academy Press. Available: http://www.nap.edu/catalog/10927.html#toc [accessed 30 September 2006].

Oleskey C, Fleischman A, Goldman L, Hirschhorn K, Landrigan PJ, Lappe M, et al. 2004. Pesticide testing in humans: ethics and public policy. Environ Health Perspect 112:914-919.

Sass J, Needleman H. 2004. Industry testing of toxic pesticides on human subjects concluded "no effect," despite the evidence [Letter]. Environ Health Perspect 112:A150-A151.

U.S. EPA. 2006. Protections for subjects in human research. Fed Reg 71:6137-6176. Available: http://www.epa.gov/fedrgstr/EPA-GENERAL/2006/February/Day-06/g1045.htm [accessed 30 September 2006].

U.S. EPA 2000. Comments on the Use of Data from the Testing of Human Subjects. A Report by the Science Advisory Board and the FIFRA Scientific Advisory Panel. EPA-SABEC-00-017 Washington, DC: U.S. Environmental Protection Agency. Available: http://www.epa.gov/science1/pdf/ec0017.pdf [accessed 30 September 2006].