Keith Mack
Ethical guidelines are a set of principles that guide professionals in conducting business with honesty and integrity. They outline an organisation's guidelines and best practices for maintaining honesty, integrity, and professionalism. While ethical guidelines are not laws per se, they are often developed in response to contemporary conditions, such as major disruptions or scandals, and can be considered quasi-public due to their potential influence on legal judgments. In some cases, failure to comply with ethical guidelines can result in sanctions or expulsion from a profession. For example, the Nuremberg Code, established in 1948, set the stage for subsequent research codes and policies by stating the importance of voluntary participation and informed consent in research. In contrast, laws can be neutral on ethical issues or used to endorse certain ethical principles. While laws influence the conduct of some professions, many ethical issues are resolved independently of legality, and not all ethical dilemmas can be settled by the courts.
| Characteristics | Values |
|---|---|
| Ethical guidelines are written in response to contemporary conditions | To answer why ethical guidelines are necessary and consider the need for new or revised codes |
| The most influential ethical codes are responses to major disruptions, especially medical and behavioral research scandals | Medical and behavioral research scandals, e.g. the Nuremberg Code, Tuskegee Syphilis Study, Willowbrook, Milgram, and Stanford Prison |
| Ethics codes are widespread and seem obligatory | Widespread adoption of ethical codes |
| Ethics codes are detailed and provide answers to most ethical questions | Detailed and comprehensive ethical guidelines |
| Ethical guidelines are established by professional societies | American Medical Association, World Medical Association, American Bar Association, American Institute of Certified Public Accountants, American Psychological Association, etc. |
| Ethical guidelines are established by governments | Nuremberg Code, Tuskegee Syphilis Study, National Research Act of 1974, Belmont Report, etc. |
| Ethical guidelines can be enforced through various mechanisms | Enforcement mechanisms such as certification revocation, membership privileges revocation, social shunning, etc. |
| Ethical guidelines can have both inward-facing and outward-facing goals | Inward-facing: providing guidance, reducing internal conflicts, creating a sense of common purpose, etc. Outward-facing: protecting vulnerable populations, enhancing the reputation of the profession, establishing autonomy, etc. |
What You'll Learn
The Nuremberg Code and the Belmont Report
The Nuremberg Code
The Nuremberg Code was established in 1948 as a direct result of the Nuremberg Trials, which saw 23 leading German physicians and administrators convicted for their willing participation in war crimes and crimes against humanity. The Code was one of the first international documents to advocate for voluntary participation and informed consent in research with human subjects. It outlines ten points for conducting ethical research, including the requirement for voluntary consent, researcher qualifications, risks versus benefits, and the participant's right to terminate.
The Belmont Report
The Belmont Report was published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It identifies three basic ethical principles underlying biomedical and behavioral human subjects research: respect for persons, beneficence, and justice. The report also outlines methods for recognising these principles, including informed consent, risk/benefit analysis, and appropriate selection of patients.
The Belmont Report was developed in response to highly publicised cases of researchers' abuse of power, such as the Tuskegee Syphilis Study (1932-1972) and the actions of Nazi scientists during World War II. These cases highlighted the need for stronger ethical guidelines in research and led to the formation of the Institutional Review Board (IRB), a system of checks and balances for research with human subjects.
Observations to Laws: The Scientific Journey
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The Tuskegee Syphilis Study
A total of 600 men were enrolled in the study, with 399 having syphilis as the experimental group and 201 as the control group. The participants were mostly poor and illiterate sharecroppers from Macon County, Alabama, who had limited access to healthcare. They were offered medical examinations, free rides to and from clinics, meals on examination days, and free treatment for minor ailments. They were also promised burial stipends for their survivors. However, the study's true nature was not disclosed to them, and they were told they were being treated for "bad blood", a term used locally to describe various ailments including anemia, fatigue, and syphilis.
During the study, researchers did not obtain informed consent from the participants and withheld treatment even after penicillin became the standard cure for syphilis in 1947. As a result, dozens of men died, and their wives, children, and others were infected. The study continued until 1972 when its existence was publicized, causing international public outcry and leading to its termination.
In 1973, an Ad Hoc Advisory Panel was appointed by the Assistant Secretary for Health and Scientific Affairs to review the study. The panel concluded that the study was "ethically unjustified" as the participants were not informed of the study's true nature, purpose, and potential consequences. The panel also found that the participants were not given the choice to quit the study when penicillin became available as a cure.
The public revelation of the study's unethical nature led to a series of consequences. Attorney Fred Gray filed a class-action lawsuit in 1973 on behalf of the men in the study and their families, resulting in a settlement of over $9 million for the participants. In 1974, new guidelines were issued to protect human subjects in U.S. government-funded research projects. Additionally, the National Research Act of 1974 was passed, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission was tasked with identifying ethical principles and developing guidelines to ensure that future research involving human subjects was conducted ethically.
In 1997, under mounting pressure, President Bill Clinton issued a formal apology for the study and announced an investment to establish the National Center for Bioethics in Research and Health Care at Tuskegee University. This center was created to address the ethical behavior of government-led research and promote public education about the study. The final study participant passed away in 2004.
Public Policy to Law: Understanding the Process
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The Nuremberg Trials and informed consent
The Nuremberg Code is a set of ethical research principles for human experimentation that emerged from the Nuremberg Trials, a series of military tribunals held after World War II to hold members of the Nazi party accountable for war crimes. The Code was formulated in August 1947 by American judges who sat in judgment of Nazi doctors accused of conducting inhumane and torturous human experiments in concentration camps.
The Code's ten principles outline the ethical guidelines for permissible medical experiments, with a strong focus on informed consent. The first principle states that the voluntary consent of the human subject is "absolutely essential". This means that the person giving consent should have the legal capacity to do so, be free from coercion, and have sufficient knowledge and comprehension of the experiment to make an enlightened decision. The responsibility for ensuring the quality of consent rests with those conducting the experiment.
The Nuremberg Code also addresses the purpose and design of experiments, emphasising that they should yield fruitful results for the benefit of society and be based on prior animal experimentation and knowledge of the disease or problem under study. The Code further stipulates that experiments should be conducted by qualified individuals, minimise physical and mental suffering, and avoid situations where death or disabling injury is likely. Additionally, the Code grants the human subject the right to terminate the experiment if they reach a physical or mental state where continuation seems impossible.
While the Nuremberg Code has not been officially adopted as law by any nation, it has had a significant influence on global human rights and clinical research ethics. It has informed international guidelines, such as the International Covenant on Civil and Political Rights, and inspired the creation of institutional review boards to ensure the ethical treatment of human research subjects. The Code's principles, particularly those regarding informed consent, continue to shape the ethical framework for medical research and protect the rights of research participants.
The Evolution of English as the Language of Law
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The World Medical Association and the Declaration of Helsinki
The World Medical Association (WMA) developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human participants. The WMA adopted the first version in 1964, and it has since been amended eight times, most recently in 2024. The Declaration of Helsinki is the WMA's best-known policy statement, and it is intended to guide medical doctors in biomedical research involving human subjects.
The development of the Declaration of Helsinki was a direct response to the atrocities committed by physicians conducting unethical medical research during World War II. The statement outlines ethical principles for medical research involving human participants, including research using identifiable human material or data. It emphasizes the importance of informed consent, respect for individual autonomy, and the protection of the health, well-being, and rights of patients involved in medical research.
The Declaration of Helsinki has had a significant impact on the medical community, with researchers, ethics review committees, and governments worldwide relying on its high-level enduring principles to guide ethical considerations and decision-making. The document addresses various aspects of medical research, including the assessment of risks and benefits, the involvement of vulnerable populations, scientific requirements, and the role of research ethics committees.
To ensure the Declaration remains relevant and effective, the WMA invites periodic reviews and revisions to address evolving ethical challenges in the global research community. The collaborative, transparent, and inclusive revision process involves regional and topical meetings with local and international experts, public comment periods, and input from diverse audiences. The Declaration of Helsinki has thus evolved over time to adapt to changing ethical standards and continues to be a cornerstone of ethical guidelines in medical research.
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The National Research Act of 1974
The Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was tasked with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects. The commission was also responsible for developing guidelines to ensure that such research is conducted in accordance with these ethical principles. The commission drafted the Belmont Report, a foundational document for the ethics of human subjects research in the United States.
The National Research Act also formalized a regulated Institutional Review Board (IRB) process through local institutional review boards, overseen by the Office of Human Research Protections. The Act included the creation of federal rules to protect human participants in research, ensuring that individuals are treated as autonomous agents and are given the opportunity to choose what happens to them during the research process.
The Journey of a Bill to Law Explained
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Frequently asked questions
A code of ethics outlines an organisation's guidelines and best practices for maintaining honesty, integrity, and professionalism. It provides standards of behaviour and principles to be observed regarding an individual's moral and professional obligations toward one another, their clients, and society in general.
Yes, there are two main types: compliance-based and value-based. Compliance-based codes of ethics set guidelines for conduct and determine penalties for violations. Value-based codes address a company's core value system and set standards of responsible conduct that benefit the public and the environment.
Ethical guidelines are not always legally enforceable, but they can influence legislation and be used as evidence in legal judgments. In some cases, violating a code of ethics can result in sanctions or termination.
The Nuremberg Code, established in 1948, stated that "the voluntary consent of the human subject is absolutely essential". This was the first international document advocating for voluntary participation and informed consent in research. While it did not have the force of law, it set a precedent for subsequent research codes and policies. Another example is the National Research Act of 1974 in the US, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research following the Tuskegee Syphilis Study scandal.
Contemporary ethics codes across various domains typically include principles such as respect for persons (autonomy, privacy, informed consent), balancing risks and benefits, careful selection of participants, independent review of research proposals, and self-regulating communities of professionals.
