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Development of Ethical Codes and Regulations

In Module 3, we reviewed research design from a broad perspective, including qualitative and quantitative research methods.  Module 4 will explore ethical standards in research and professional ethical expectations.

Learning Objectives

Upon successful completion of Module 4, the student will be able to:

  1. Discuss the ethical background that led to the creation of various codes of ethics
  2. Identify the three primary ethical principles in the Belmont Report
  3. Discuss ethical principles for adhering to ethical principles and protecting study participants
  4. Identify vulnerable groups who may require extra protections in participating in research

Historical Background that Led to the Development of Ethical Codes and Regulations

German physicians conducted medical experiments in 1946 on thousands of concentration camp prisoners without their consent. The experiments included subjecting participants to high altitudes, freezing temperatures, malaria and typhoid fever bacteria, operation without anesthesia, and others. Most of the subjects of these experiments died or were permanently crippled as a result

In the Tuskegee Syphilis Study conducted 1932 in the USA, researchers did not treat 400 African-American men for syphilis simply to observe the natural outcomes of the disease. When subjects were diagnosed as having syphilis by other physicians, researchers intervened to prevent treatment. Many subjects died of syphilis during the study. The study was stopped in 1972.

In response to human rights violations, various codes of ethics have been developed. Some of these codes are the Nuremberg code (1949) and the International Declaration of Helsinki (1964). Most disciplines have developed their own code of ethics e.g. American Medical Association; the Code of Medical Ethics, the Code of Ethics for Nurses (ANA), and the International Council of Nurses (ICN) developed the ICN Code of Ethics for Nurses.  In the USA an important code of ethics was adopted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This code is referred to as the Belmont Report. This report articulated 3 primary ethical principles for protecting study participants.

In reading a research study, you should consider who the study participants were and what procedures were implemented to protect them. Were the participants subjected to harm or discomfort?  You might also need to consider who the study participants were.  For example, were minority groups included in the study?

Read Melnyk Ch. 23 and access the Belmont Report to complete the discussion question.

Read about  Informed consent in research Check the link:


Polit, D.F. & Beck, C.T. (2022). Essentials of nursing research: Appraising evidence for nursing practice (10th ed.).  Wolters Kluwer.

Question for paper writing using information above

Consider the information presented about ethics in this module, and address the following:

  • Discuss the role of informed consent in the protection of the study participants. What primary principles from the Belmont report are part of informed consent?
  • Identify and describe vulnerable groups that require additional protection in research.
  • What is the role of the Institutional Review Board (IRB) in research?

Last Updated on April 19, 2023

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