Tutorial Chapter 2: What are the basic elements of the research code of ethics?

In reaction to experiments conducted by the Nazis during World War II, the Nuremberg Code was issued by the Nazi War Crimes Tribunal in 1947. This was the first internationally recognized code of research ethics. It stressed the importance of "voluntariness" of the subject and prevention of unnecessary physical or mental suffering.

In 1964, the 18th World Medical Assembly developed the Declaration of Helsinki which laid out the basic principles for biomedical research. A clear distinction was drawn between medical research combined with clinical care and nontherapeutic research involving human subjects.

In 1979, the United States Department of Health, Education, and Welfare issued the Belmont Report, which remains the standard set of ethical principles for US researchers today.

The Belmont Report sets forth three basic ethical principles:

  • Respect for persons: This principle incorporates the dual notion that individuals should be treated as autonomous agents and that persons with diminished autonomy are entitled to protection.
  • Beneficence: This term is used to convey the obligation that researchers should "do good." Subjects must be protected from harm, but researchers are also obliged to maximize possible benefits.
  • Justice: Who ought to receive the benefits of research and bear its burdens? The selection process of research subjects needs to ensure that criteria are not based on gender, race, easy availability, manipulability, or compromised position. The notion of justice also requires that studies providing advantages should be offered not only to the wealthy or better educated, but also to the poor and less advantaged.

Chapter Review

Question 1

The Nuremberg Code stressed (select all that apply):

  • voluntary participation
  • scientific outcome
  • prevention of suffering
  • increased knowledge
  • all of the above

Question 2

The standard for human subjects research in the US is:

  • the Phoenix Plan
  • the Warren Commission
  • the Belmont Report
  • none of the above

Question 3

U.S. regulations state that subjects should be selected according to age, equitable standards, easy availability and race.

Question 4

Beneficence is the term used in the Belmont Report to ensure that researchers “do good” and protect subjects from harm.

Next Chapter: What are the current regulations concerning human subjects research?

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Glossary
  • References