Medical Ethics: The Belmont Report


Medical Ethics: The Belmont Report

This is the third in a series of articles about medical ethics.  Our previous posts in this series included covering the basics of medical ethics and the difference between utilitarianism and deontology.  Today we’ll talk about the Belmont Report and its importance in establishing modern medical ethics guidelines.

In our next post in this series, we’ll continue to explore the foundations of medical ethics by reviewing The Belmont Report, which provides us with the modern distinction between medical research and practice, and affirms the three basic ethical principles generally accepted in our culture: respect for persons, beneficence, and justice.

The 20th century saw a growing awareness of what ethical treatment of humans in research meant.  In what we would now call egregious liberties taken by U.S. state and federal governments in human experiments, as well as by physician researchers in Nazi Germany, studies were conducted on people without their consent, and which caused them harm and sometimes death.  The infamous Tuskegee syphilis study began in 1932, without the consent of the 600 black men in the study, and which allowed the men to go untreated for syphilis even after a cure had been discovered.  The study continued for forty years, until, in 1972, it was investigated and ordered to stop by an Ad Hoc Advisory Panel commissioned by the Assistant Secretary for Health and Scientific Affairs.  Reparations began after the scandal and termination of the study and on May 16th, 1977, President Clinton formally apologized to the few remaining survivors on behalf of the nation.

Partly in response to the Tuskegee study scandal and partly due to another famous scandal where medical research was conducted on prisoners of the Holmesburg prison in Philadelphia, the US government enacted the National Research Act in 1974. This law created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The commission was charged with codifying the basic ethical principles that underlie the conduct of research involving human subjects and to consider the following things:

  1. the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine,
  2. the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects,
  3. appropriate guidelines for the selection of human subjects for participation in such research, and
  4. the nature and definition of informed consent in various research settings.

The Belmont Report summarizes the commission’s findings and defines the basic ethical principles that are generally accepted in our cultural tradition and are specifically relevant to human experimentation.  These principles are:

Respect for persons.  This principle is about autonomy, where an autonomous individual is capable of making decisions about their personal goals and beliefs. The tenet of respect for persons states, “Individuals should be treated as autonomous agents, and any person with diminished autonomy is entitled to protection.”  In research, this means that participants of research voluntarily agree to participate and have enough information provided to them for them to make that decision reasonably. Individuals, who lack this capacity, either fully or partially, are considered vulnerable because they may not have the maturity or capacity to make an informed decision. In the case of prisoners or soldiers, they may be under the influence of subtle coercion or undue influence.

Beneficence. Beneficence is much more than “do no harm”. It is also requires an effort to secure an individual’s well-being by maximizing the possible benefits and minimizing the possible harm to them.

Justice is about fairness or about what people deserve. This principle asks the question of who should benefit from the research and who should bear its burden.  It also requires consideration for in what respects people should be treated equally—what makes people equal or unequal?  Four frameworks for evaluating justice are used commonly:

  1. to each person an equal share,
  2. to each person according to individual need,
  3. to each person according to individual effort,
  4. to each person according to societal contribution, and
  5. to each person according to merit.

The Tuskegee experiment was a good example in our country where these three principles of ethics were not followed.

The study subjects were not informed of the experiment and did not provide voluntary and informed consent, and thus did not have autonomy under the tenet of respect for persons.

The study continued long after there was treatment for syphilis, thereby exposing the participants to undue harm and early death from the disease. There was certainly not an effort to maximize their well-being by treating their syphilis, thereby not meeting the principle of beneficence.

And last, the participants of the Tuskegee study bore the burden of the study without any expected benefit for that population.  They, nor their families, benefited from the burden of the research and the disease was not only limited to a disadvantaged, black population, resulting in an injustice for these men.

Our current use of informed consent and many other clinical trial practices flow out of the ethical principles laid out in the Belmont Report.

These principles protect all people from the injustices perpetrated in the past.  We must never forget our country’s infamous past every time we write, review, or obtain informed consent, and every time we conduct any aspect of a clinical trial.

Thank you for tuning into HCC’s ethics series.

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