Beyond the Letter: Adhering to the Spirit of Ethical Principles in Human Research
Robert C. Baker
In partial fulfillment of MHE 602 Section 01 Research Ethics
Spring I, 2010
The recent 7.0-in-magnitude earthquake affecting Haiti is tragic on many levels. Combined with relentless local poverty, a decrepit infrastructure, poorly-constructed housing, and a weak central government unable to manage the crisis, the worst natural disaster to hit this small island nation in over 200 years has created a maelstrom of human suffering. While international relief efforts are underway, progress is slow and tedious. Even being rescued from underneath tons of rubble is no guarantee that one will survive. (1)
Medical teams responding to the crisis–from London to L.A., from Brasilia to Beijing–will strive to operate according to principles that seek to reduce suffering and to improve the lives of as many human beings as possible. So, too, do principles and protocols regulating the treatment of human participants in research. While many of these principles could be explored, (2) in this brief paper I would like to discuss two enunciated by Emanuel, Wendler, and Grady (2008): fair participant selection and informed consent. Following a look at how those principles have been violated in the past, I will offer a critique of the Nuremberg Code and the Belmont Report to point out ongoing need to comply with both the letter and the spirit of ethical principles in human research.
Ethical Infractions: Fair Participant Selection and Informed Consent
Doubtlessly, the Haitian crisis will expose both ethical and unethical treatment of human beings. As to the latter, researchers will recall the horrific medical experiments involving Jews, the Roma, the disabled, political prisoners, the mentally challenged, women and children, and others during the Nazi period. Exposed during the Nuremberg Doctor’s Trial, these violations included forced sterilization, euthanasia, and experiments on live human beings. (3) As such, the experiments violated the four benchmarks of fair participant selection as envisioned by Emanuel, et al: 1) the method of participant selection exposed the scientific invalidity of the experiments; 2) participant risks were not minimized; 3) equipoise between participant and societal benefit was neither attempted nor achieved; and 4) the vulnerability of the participant population was ignored. (4)
Researchers will likewise recall the infamous forty-year Tuskegee Syphilis Experiment involving 400 black men from or around Macon County, Alabama, who were observed but not treated for this progressively painful and, if left untreated, terminal bacterial disease. (5) These experiments violated at least five of the seven benchmarks of informed consent as envisioned by Emanuel, et al: 1) incentives offered to participants in no way provided equity given participant risk; 2) risk disclosure was insensitive to participants’ socio-economic and educational background; 3) dangers of non-treatment were not sufficiently disclosed and viable treatment options were actually withheld; 4) local, state, and federal officials colluded for a supposed societal benefit at the great harm to participants; 5) participants intentionally were not made aware of treatment options that would have allowed them refuse further participation in the research. (6)
Critique of Ethics Codes: Nuremberg and Belmont
Assuming that fair participant selection and informed consent are valid ethical principles, we can proceed to a critique of ethical codes that have been developed since World War II to see if they support, contravene, or overlook these principles. The Nuremberg Code is one of the most famous ethical codes, having been developed after Nazi medical atrocities were finally exposed. Nuremberg has even been recognized in the U.S. and various State courts. (7) However, while its chief emphasis is on ensuring the voluntary consent of human research participants, it overlooks a principle of justice: fair participant selection. Principles of autonomy, nonmaleficence, and beneficence are present within the Code but, curiously, where the Code brings voluntary consent to the forefront, which itself “did not fit the Nazi crimes” (Annas and Grodin, 2008:139), it ignores the vulnerabilities of the different populations abused by Nazi researchers. Simply put, Nazi medical experiments were inhumane torture and murder that specifically targeted vulnerable populations, not research in its proper sense, even though efforts were made to disguise it as being scientific.
Another well-known code is the Belmont Report, which since the late 1970’s has provided a moral framework for conducting research. Belmont was issued primarily in response to the public and congressional outrage expressed after the Tuskegee Syphilis Experiment. (9) Its three general principles–respect for persons, beneficence, and justice (10, 11)–influence the processes found in the Common Rule, with which researchers will be familiar from their work on or for institutional review boards (IRBs). However, although Belmont emphasizes the application of informed consent (subsumed under the principle of respect for persons), its guidelines on information and comprehension do not account for variances for the processing or valuing of information across ethnic, cultural, socio-economic lines. (12)
From Letter to Spirit
A recent general critique of ethical codes notes that many codes: 1) were derived in response to a specific research controversy, 2) tend to gravitate towards practical application rather than general ethical treatment; and 3) are “neither comprehensive nor systematic.” (13) While this critique does not dismiss or seek to diminish the importance of well-recognized and universally-accepted ethical codes, it does suggest that mere adherence, that is, “living by the letter” of ethical codes, is an insufficient ethical approach when working with human participants in research. Rather, researchers can meet their high ethical standards by acquiring, considering, and bringing into their research participants’ backgrounds, life histories, and research expectations through empathetic listening, understanding, and other skills and behaviors. This can be said to be “living by the spirit,” and not merely the letter, of ethical research.
Two Practical Takeaways
A first practical takeaway is that researchers can be assured of ethical research by being cognizant of participants’ vulnerabilities or membership in a vulnerable population and by ensuring that those vulnerabilities are respected. A second practical takeaway is that researchers can expect different preferences of receiving and processing information by research participants beyond simple cognitive level or reading abilities. Armed with these principles and imbued with these additional values, researchers can be confident that their efforts at maintaining high ethical standards in their research with human participants, even in situations as harsh as Haiti, will be achieved.
Notes:
1. Cave D. For the Trapped, Rescue Is but the First Hurdle. The New York Times Web site. Available at: http://www.nytimes.com/2010/01/16/world/americas/16rescue.html?hp. Accessed January 15, 2010.
2. Beauchamp and Childress’s well-known “clusters of principles” include 1) respect for autonomy; 2) nonmaleficence; 3) beneficence; and 4) justice. See Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th ed. New York, NY: Oxford University Press; 1994:38.
3. See Annas JG and Grodin MA, The Nuremberg Code. In: Emanuel EJ, Grady C, et al, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008:136-137.
4. Emanuel EJ, Wendler D, and Grady, C. An Ethical Framework for Biomedical Research. In: Emanuel EJ, Grady C, et al, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008:128.
5. See Jones, JH. The Tuskegee Syphilis Experiment. In: Emanuel EJ, Grady C, et al, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008:86-96.
6. Eamanuel EJ, Wendler D, and Grady C. An Ethical Framework, 130-131.
7. Annas JG and Grodin MA. The Nuremberg Code, 138-139.
8. Ibid., 139.
9. Beauchamp, TL. The Belmont Report. In: Emanuel EJ, Grady C, et al, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008:149.
10. Ibid., 150.
11. Porter JP and Koski G. Regulations for the Protection of Humans in Research in the United States: The Common Rule. In: Emanuel EJ, Grady C, et al, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008:156.
12. National Institutes of Health. The Belmont Report: Ethical Principles and Guidelines for the Protectoin of Human Subjects of Research. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html#goc1. Accessed January 15, 2010.
13. Emanuel EJ, Wendler D, and Grady C. An Ethical Framework, 123.
References:
Cave D. For the Trapped, Rescue Is but the First Hurdle. The New York Times Web site. Available at: http://www.nytimes.com/2010/01/16/world/americas/16rescue.html?hp. Accessed January 15, 2010.
Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 4th ed. New York, NY: Oxford University Press; 1994.
Danis M, Clancy, C, Churchill LR eds. Ethical Dimensions of Health Policy. New York, NY: Oxford University Press; 2002.
Emanuel EJ, Grady C, et al, eds. The Oxford Textbook of Clinical Research Ethics. New York, NY: Oxford University Press; 2008.
National Institutes of Health. The Belmont Report: Ethical Principles and Guidelines for the Protectoin of Human Subjects of Research. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html#goc1. Accessed January 15, 2010.
Powers M, Faden R. Social Justice: The Moral Foundations of Public Health and Health Policy. New York, NY: Oxford University Press; 2006.
