Reading

Schmidt & Brown (2021). Evidence-Based Practice for Nurses:

• Chapter 2.4: Keeping It Ethical

Objectives

• Identify five unethical studies involving the violation of the rights of human participants or falsification of data

• Discuss international and national initiatives designed to promote ethical conduct

• Describe the rights of participants who volunteer for research studies

• Describe the three ethical principles from the Belmont Report that must be upheld when conducting research

Five Studies Recognized as Unethical

4 major studies involved the violation of the rights of human participants:

• 1. Nazi Experiments

• 2. Tuskegee Study

• 3. Jewish Chronic Disease Hospital Study

• 4. Willowbrook Studies

An example of misconduct involving falsification and fabrication of data:

• 5. Red Wine Studies

3. Jewish Chronic Disease Hospital Study

• = Unethical study involving injection of cancer cells into participants without their consent

• Began in 1963 to examine whether the body's inability to reject cancer cells was due to cancer or the presence of a debilitating chronic illness

  • Hypothesis: debilitated patients would reject the cancer cells at a substantially slower rate than healthy participants did because earlier studies indicated that injected cancer cells were rejected

• Researched failed to inform participants about the injection of cancer cells to avoid fear

  • Oral consent obtained but not documented consent

  • Also failed to inform physicians caring for the patients about the study

• Reviewed by the Board of Regents of the State University of New Work

  • Researchers found guilty of scientific misconduct, including fraud and deceit

• Learn more about the Jewish Chronic Disease Hospital Study

5. Red Wine Studies

• = Unethical studies involving the fabrication of data about the effects of red wine on heart health

• Conducted by Dr. Dipak Das at the University of Connecticut in 2008 to study the beneficial health effects of red wine and other foods on cardiac health and longevity

• Falsified data in more than two dozen papers and grant applications

  • Created public distrust of research findings

  • Can inhibit researchers' ability to recruit participants

Discussion:

Do you think the findings from those unethical studies should be still accessible to the public through publications and other forms? Or, do you think all findings from those unethical studies should be deleted and not be accessible to the public? Why?

International:

• 1. Nuremberg Code

• 2. Declaration of Helsinki

National:

• 3. Belmont Report

  • Three major principles of ethical research:

    • (1) Respect for Persons

    • (2) Beneficence

    • (3) Justice

• 4. The Nurse in Research: ANA (American Nurses Association) Guidelines on Ethical Values

• 5. Institutional Review Board (IRB)

1. Nuremberg Code

• = Ethical code of conduct for research that uses human participants

• Contained in the written verdict at the trial of the German Nazi physicians accused of torturing prisoners during medical experiments

• Voluntary consent is absolutely necessary for participation in research

2. Declaration of Helsinki

• = An international standard providing physician guidelines for conducting biomedical research

• Adopted by the World Medical Association (WMA) in 1964

• Informed consent

  • = An ethical practice requiring researchers to obtain voluntary participation by participants after they have been informed of possible risks and benefits

  • The Hallmark requirement for the conduct of ethical research

• The Declaration of Helsinki offers more specific detail about what constitutes ethical scientific research than does the Nuremberg Code

3. Belmont Report (Three Major Principles of Ethical Research)

• A report outlining three major principles: (1) Respect for Persons, (2) Beneficence, and (3) Justice

• Issued in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

• (1) Respect for Persons

  • Principle that individuals should be treated as autonomous and that those with diminished autonomy are entitled to protection

  • Autonomous

    • = Having the ability to make decisions

• (2) Beneficence

  • The principle of doing good

• (3) Justice

• The principle of equity or fairness in the distribution of burdens and benefits

4. The Nurse in Research: American Nurses Association (ANA) Guidelines on Ethical Values

• Approved by the ANA board of directors in 1968

• Emphasized the rights of human participants in three ways:

  • (1) right to freedom from harm

  • (2) right to privacy and dignity

  • (3) right to anonymity

One-sentence description of the article

• Ethical issues concerning AIDS research in developing countries

• Children's Environmental Exposure Research Study accused of ethical violations

• Ethical and safety concerns of a gene-editing study in China

• A tobacco industry's strategy to influence public opinion on secondhand smoke

• The U.S.'s role in Japan's medical studies during World War II

• Premature infants develop health problems while participating in an oxygen therapy study (note: article begins at the end of the first page)

• MMR vaccine controversy

• Two studies testing the effect of radiation on spermatogenesis in male prisoners