Healthcare Ethics
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This document discusses the history and principles of healthcare ethics. It outlines key events that led to the establishment of international ethical standards for research involving human subjects, such as the Nuremberg Code and Declaration of Helsinki. The four main principles of healthcare ethics are also presented: autonomy, beneficence, non-maleficence, and justice. A case study example shows how a doctor must consider all these principles when making decisions about a patient's treatment.
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Healthcare Ethics
- 1. HEALTHCARE ETHICS SCHOOL OF HEALTH SCIENCE MASTER OF PUBLIC HEALTH 2016/2017
- 2. CONTENTS 1. INTRODUCTION 2. HISTORY 3. PRINCIPLES 4. CASE-STUDY 5. SUMMARY 6. REFERENCES
- 3. INTRODUCTION Ethics is concerned with moral principles, values and standards of conduct. The field of health and health care raises numerous ethical concerns, related to, for example, health care delivery, professional integrity, data handling, use of human subjects in research, and the application of new techniques, such as gene manipulation.
- 4. HISTORY Prior to 1906, when the Pure Food and Drug Act was passed, there were no regulations regarding the ethical use of human subjects in research. There were no consumer regulations, no Food and Drug Administration (FDA), no Common Rule, and no Institutional Review Board (IRB). What follows is a brief discussion of why federal rules and regulations were established and why the IRB became a necessity.
- 5. Nuremberg Trials A well-known chapter in the history of research with human subjects opened on December 9, 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity. Among the charges were that German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent. Most of the subjects of these experiments died or were permanently crippled as a result. As a direct result of the trial, the Nuremberg Code was established in 1948, stating that "The voluntary consent of the human subject is absolutely essential," making it clear that subjects should give consent and that the benefits of research must outweigh the risks.
- 6. Declaration of Helsinki. In 1964, the World Medical Association established recommendations guiding medical doctors in biomedical research involving human subjects. The Declaration of Helsinki (DoH) is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics. The Declaration of Helsinki was revised in 1975, 1983, 1989 and 1996 and is the basis for Good Clinical Practices used today. Issues addressed in the Declaration of Helsinki include: Research with humans should be based on the results from laboratory and animal experimentation Research protocols should be reviewed by an independent committee prior to initiation Informed consent from research participants is necessary Research should be conducted by medically/scientifically qualified individuals Risks should not exceed benefits
- 7. The Belmont Report A report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report was first written by the National Commission for the Protection of Human Services of Biomedical and Behavioral Research. Prompted in part by problems arising from the Tuskegee Syphilis Study (1932–1972) and based on the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974–1978). The Belmont Report is one of the leading works concerning ethics and health care research. It allows for the protection of participants in clinical trials and research studies.
- 8. Indian Council of Medical Research Guidelines on Code of Conduct for Research Scientists engaged in field of Life Sciences Guidance on transfer of human biological material for research/commercial purposes 'ICMR-DBT' Guidelines for evaluation of probiotics in food Knowledge Management policy for Health - Service, Education and Research (Draft) Ethical Guidelines for Biomedical Research on Human Participants Intellectual Property Rights Policy
- 9. PRINCIPLES The four principles of health care ethics developed by Tom Beauchamp and James Childress in the 1985 Principles of Biomedical Ethics provide medical practitioners with guidelines to make decisions when they inevitably face complicated situations involving patients 1. AUTONOMY: In medicine, autonomy refers to the right of the patient to retain control over his or her body. A health care professional can suggest or advise, but any actions that attempt to persuade or coerce the patient into making a choice are violations of this principle. In the end, the patient must be allowed to make his or her own decisions – whether or not the medical provider believes these choices are in that patient’s best interests – independently and according to his or her personal values and beliefs.
- 10. 2. BENEFICENCE: This principle states that health care providers must do all they can to benefit the patient in each situation. All procedures and treatments recommended must be with the intention to do the most good for the patient. To ensure beneficence, medical practitioners must develop and maintain a high level of skill and knowledge, make sure that they are trained in the most current and best medical practices, and must take their patients’ individual circumstances into account: what is good for one patient will not necessary benefit another.
- 11. 3. NON-MALEFICENCE: Non-maleficence is probably the best known of the four principles. In short, it means, “to do no harm.” This principle is intended to be the end goal for all of a practitioner’s decisions, and means that medical providers must consider whether other people or society could be harmed by a decision made, even if it is made for the benefit of an individual patient.
- 12. 4. JUSTICE: The principle of justice states that there should be an element of fairness in all medical decisions: fairness in decisions that burden and benefit, as well as equal distribution of scarce resources and new treatments, and for medical practitioners to uphold applicable laws and legislation when making choices.
- 13. CASE STUDY A Closer Look: Case Study One hypothetical case study involves a patient who has an ovarian cyst that, left untreated, will result in kidney failure. An operation to remove the cyst is the best treatment, but the patient is frightened of needles and is against the surgery which would require a needle to give her anesthesia. The doctor must work with the patient to respect the fact that she dislikes needles and doesn’t want the operation (her autonomy), and needs to find a solution that would prevent her from going into kidney failure, which is in her best interest (beneficence). Although the surgery is the best choice, forcing the patient to accept the needle would be harmful to her (non-maleficence). Finally, the doctor needs to consider the impact that the patient’s choices might have on others if she starts to go into preventable kidney failure, she’ll need dialysis, which affects other people who need the same treatment (justice). So before making the final decision the doctor must consider all four principles of health care ethics which will help the physician make the choice that will have the best possible benefits for both the patient and society.
- 14. SUMMARY Nazi atrocities in World War II drew attention to the lack of international standards on research with human subjects and led to the formulation of the Nuremberg Code, the first international document which advocated voluntary participation and informed consent. The Declaration of Helsinki is the basis for Good Clinical Practices used today.. The National Research Act codified the requirement that human subjects in research must be protected and set the stage for the issuance of the Belmont Report. Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants. As such, all research involving human beings should be reviewed by an ethics committee to ensure that the appropriate ethical standards are being upheld. Discussion of the ethical principles of beneficence, justice and autonomy are central to ethical review.