Historical Development of Research Ethics Guidelines
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This document provides a historical overview of the development of research ethics guidelines and codes. It discusses key events that shaped the field, such as the Nuremberg Code established after World War II experiments and the Declaration of Helsinki. It also outlines several international guidelines and regulations established over time to protect human subjects, including the Common Rule in the US and ICH guidelines requiring ethics review and informed consent. The document stresses that while guidelines are important, ethical conduct in research also requires vigilance and no place is immune from violations.
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Historical Development of Research Ethics Guidelines
- 10. Born in Scandal… The Evolution of Research Ethics 9/1/2010 Research Ethics. Ghaiath
- 26. US National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research wrote The Belmont Report in response to the Tuskegee and Willowbrook Controversies. This Led the US Department of Health and Human Services (and others) to adopt Federal Regulations regarding Research Ethics: The Common Rule or US 45 CFR 46, last revised in 2001
Editor's Notes
- - also known as "moral philosophy" and "philosophical ethics" - refers to philosophical reflection on the nature and function of morality (that is, philosophical reflection on social conventions about right and wrong human conduct--on social principles about doing good, avoiding harm, respecting others, observing rules of justice, etc.) descriptive ethics: more social science, empirical; attempts to describe and explain moral views that are held A systematic understanding of right and wrong as it relates to: - rules or standards of right conduct - good character, virtuous behaviour
- When there is conflict of moral values , beliefs, and objectives e.g. between the health care providers and the patients. For instance, the classical example of blood transfusion to a severely bleeding Jehovah Witness who refuses to take blood, even this refusal can lead to severe life threat and eventually death. When there is conflict of commitments and responsibilities : for example at one hand there is the commitment of the health care provider to preserve his/her patients' lives, however there is the responsibility to "rationally" use the resources available to him/her on the other hand. The classical example of which is "one ICU bed, and two patients: whom to choose?" When there is the concern that our patients rights/values are not respected . When the issue in focus is related to justice in allocating the available resources . A classical example is which of the cancer drugs should be funded publicly. Should we choose a drug which efficiently improves the quality of life of few patients? Or a drug that makes little improvement for a larger number of patients. Finally, when we, as care providers feel that we are not sure what we should do .
- this is usually the hardest exercise, and commonly known in the bioethics literature as "moral reasoning". There are 10s of ethical approaches, theories, principles etc. to make a sound ethical/moral reasoning.
- At the end of World War II, the International Military Tribunal prosecuted Nazi war criminals, including Nazi doctors who performed experiments on concentration-camp prisoners. The tribunal’s decision includes what is now called the Nuremberg Code , a 10-point statement outlining permissible medical experimentation on human participants. Other provisions require the minimization of risk and harm, a favorable risk/benefit ratio, qualified researchers using appropriate research designs, and freedom for the participant to withdraw at any time.
- In 1972, the public became aware of the Tuskegee study, which took place in the southern United States from 1932 to 1972. More than 400 men with latent syphilis were followed for the natural course of the disease rather than receiving treatment. As a result, in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established. In 1978, the commission submitted its report titled, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research . Those principles—respect for persons, beneficence and justice—are accepted as the 3 fundamental principles for the ethical conduct of research involving human participants.
- In 1993, CIOMS issued the International Ethical Guidelines for Biomedical Research Involving Human Subjects , with the purpose to indicate how the ethical principles of the Declaration of Helsinki can be applied effectively, particularly in developing countries. • informed consent • research in developing countries • protection of vulnerable populations • distribution of the burdens and benefits • role of ethics committees
- Underdeveloped communities: 1. Can’t use if could be conducted in developed communities 2. Research is responsive to the health needs and priorities of community where carried out 3. Reviewed by persons who know community and its customs/traditions