What historical events have influenced the development of ethical codes and regulations for nursing and healthcare research?

From the Guidelines

The development of ethical codes and regulations in nursing and healthcare research has been profoundly shaped by several historical events that exposed serious ethical violations, including the Nuremberg trials, the Tuskegee Syphilis Study, and the thalidomide tragedy, which collectively led to the establishment of principles of informed consent, beneficence, justice, and respect for autonomy. These events have had a lasting impact on the field of healthcare research, leading to the development of various codes and guidance documents that set forth ethical standards and principles for the conduct of research involving human subjects, such as the Nuremberg Code of 1947 1 and the Declaration of Helsinki 1. The Nuremberg Code, developed in the aftermath of the Nuremberg War Crimes Trial, set forth the standards for conducting ethical and humane research with human participants, including the requirement for voluntary consent 1. The Declaration of Helsinki, adopted in 1964, emphasizes the patient's right to withdraw at any time from participation in the research project and that refusal to participate in the trial should not affect the patient's future treatment or have any negative effect on the patient's relationship with the physician 1. Some key historical events that have influenced the development of ethical codes and regulations include:

• The Nuremberg trials, which revealed horrific Nazi medical experiments conducted without consent
• The Tuskegee Syphilis Study, where researchers withheld treatment from African American men with syphilis to observe the disease's progression
• The thalidomide tragedy, where a medication prescribed for morning sickness caused severe birth defects
• Henry Beecher's 1966 article exposing 22 unethical studies conducted without adequate consent
• The case of Henrietta Lacks, whose cancer cells were harvested without permission in 1951. More recent guidelines, such as those published by the Council for International Organizations of Medical Sciences 1, have expanded and clarified the ethical principles presented in the Belmont Report and the Declaration of Helsinki, particularly with regard to the provision of guidelines for the application of ethical standards in local circumstances. In emergency research, where informed consent may not be possible, regulations such as those issued by the FDA in 1996 1 provide a framework for the conduct of such research, including the requirement for community consultation and public disclosure. Overall, these historical events and subsequent guidelines have transformed healthcare research ethics by establishing principles of informed consent, beneficence, justice, and respect for autonomy that now form the foundation of modern research protections.

From the Research

Historical Events Influencing Ethical Codes and Regulations

• The Nuremberg Code, developed in 1947, is considered a foundational document in the history of ethical codes and regulations for nursing and healthcare research, emphasizing voluntary informed consent, favorable risk/benefit analysis, and the right to withdraw without repercussions 2.
• The Declaration of Helsinki, released by the World Medical Association in 1964, built upon the principles of the Nuremberg Code and further established guidelines for human-subjects research 2.
• The National Research Act of 1974 in the United States created the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, which issued the Belmont Report, stating three fundamental principles for conducting human-subjects research: respect for persons, beneficence, and justice 2.

Development of Nursing Ethics

• The evolution of nursing ethics has been shaped by the development of professional codes, with the American Nurses Association (ANA) playing a significant role in creating and refining a code of ethics for nurses 3, 4.
• The ANA's Code of Ethics for Nurses with Interpretive Statements has undergone periodic revisions to reflect changes in nursing practice and societal concerns, with the most recent revision being in 2015 4.
• The history of nursing ethics is important, as it provides a foundation for understanding the development of the profession and its ethical principles, and can inform contemporary nursing practice and education 5.

Regulation of Nursing Practice

• The regulation of nursing practice has been shaped by a range of historical, social, and economic factors, including changes in demographics, economics, education, and nursing practice itself 6.
• Understanding the factors that have influenced the development of nursing regulatory bodies over time can help inform the creation of effective policies and regulations that prioritize public safety and promote high-quality nursing care 6.