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History of Research Ethics

The History of Research Ethics

Overview of Ethics in Research

Research ethics is the discipline that deals with the ethical implications and standards of research practices, particularly concerning human subjects and integrity in the scientific process. This guide captures a comprehensive overview of the evolution of research ethics, significant historical milestones, and ethical guidelines that govern contemporary scientific research.

Historical Context

Scientific Revolution

  • The Scientific Revolution marked a pivotal turning point in the way knowledge was acquired and understood.

  • Key figures and their contributions include:

    • Copernicus (1543): Introduced the heliocentric model of the universe, which positioned the sun at the center rather than the Earth, challenging long-standing beliefs.

    • Galileo (1610): Continued the work of Copernicus, using observations to support heliocentric theory with empirical evidence.

    • Francis Bacon: Known as the "Father of Empiricism," Bacon emphasized the importance of using inductive reasoning, formulated through direct observation and experimentation.

    • Novum Organum (1620): This work by Bacon articulated a new method for scientific investigation.

Development of Scientific Method in Medicine

  • Edward Jenner (1749-1823): Developed the smallpox vaccine based on his observations that dairymaids who contracted cowpox (a less severe disease) did not get smallpox. He conducted an experiment where he vaccinated an 8-year-old boy using cowpox secretions.

  • Roberts Bartholow (1831-1904): Conducted controversial experiments on a woman with a skull injury, contributing to early understanding of brain functions.

  • Louis Pasteur (1885): Created the rabies vaccine, notably saving the life of a 9-year-old boy, Joseph Meister, who was bitten by a rabid dog.

  • Giuseppe Sanarelli (1897): His research on yellow fever resulted in three patient deaths, highlighting the risks involved in experimental medicine.

  • Tuskegee Syphilis Experiment (1932-1972): This notorious study observed the progression of untreated syphilis in 400 African-American men, resulting in 100 deaths, raising significant ethical concerns about informed consent and exploitation.

Psychological Studies

  • The history of psychological research exhibits numerous ethical breaches and misleading experiments:

    • Akbar the Great (1500s): Conducted an experiment raising children without speech to determine the true language of nature, reflecting early psychological inquiry.

    • Little Albert Experiment (1920): Conducted by John B. Watson, this experiment involved fear conditioning a child to associate a white rat with loud noises, culminating in significant ethical debates on child welfare.

    • Monster Study (1939): An experiment by Wendell Johnson involving orphaned children to instill stuttering, further complicating the ethical responsibilities researchers must uphold.

Francis Galton and Statistical Theories

  • Francis Galton: Adopted statistical methods to assess the strength of correlations between two variables.

  • Conducted experiments using sweet peas to examine how parent plants influence the height of offspring.

  • Introduced the Quincunx or Galton board to demonstrate the distribution of outcomes and contributed to the development of standard deviation and percentiles in statistics, paving the way for biometric and heredity studies, including twin studies.

Eugenics Movements

  • Eugenics: A movement aimed at improving the hereditary qualities of the human population through various practices:

    • Involved notions of “good” and “bad” genes and advocated for selective mating to propagate desired traits.

    • Controversially included sterilization policies to suppress perceived genetic inferiority, such as mental disabilities.

    • Nazi Eugenics: Infamously outlined in Mein Kampf, advocating for a racially homogenous society using eugenic strategies, resulting in horrific humanitarian consequences.

Human Experimentation in War

  • During World War II, unethical experimental practices emerged prominently:

    • Nazi Germany: Conducted inhumane experiments involving hypothermia, mustard gas, and other forms of bodily harm.

    • Japan’s Unit 731: Known for vivisection and weapon tests on live subjects without anesthesia.

    • Subsequent trials, such as the Nuremberg trials (1945-49) and Tokyo trials (1946-1948), sought to hold perpetrators accountable, establishing a foundation for modern research ethics.

Establishment of Ethical Guidelines

Nuremberg Code

  • Developed post-World War II, this code laid crucial foundations for the ethical treatment of research subjects:

    • Voluntary consent of subjects must be obtained without coercion.

    • Research outcomes should offer fruitful results for society.

    • Studies must be based on animal experimentation when applicable to minimize human suffering.

    • Risks should not exceed the importance of the research findings.

    • Proper preparations and experienced personnel must oversee research.

    • Participants must retain the freedom to withdraw at any stage of the study.

    • Research must be designed to ensure participant safety and readiness to terminate if necessary.

Declaration of Helsinki

  • Issued by the World Medical Association (WMA), this declaration outlines ethical principles for medical research involving human subjects, emphasizing:

    • Assessment of risks and benefits associated with the research.

    • Special considerations for vulnerable groups.

    • Requirements of scientific validity and review from ethics committees or Institutional Research Boards (IRB).

    • Standards of privacy and informed consent, including the use of placebos and post-research care.

Belmont Report (1978)

  • Produced in direct response to the ethical violations evidenced in the Tuskegee Experiment. The report establishes core ethical principles:

    • Respect for persons: Recognition of autonomy and protecting those with diminished autonomy.

    • Beneficence: Obligation to maximize benefits and minimize harm.

    • Justice: Fair distribution of research benefits and burdens among subjects.

Psychological Research After WWII

  • Post-war psychological studies increasingly highlighted ethical issues raised by the Nazi regime pertaining to:

    • Obedience: Investigating individuals’ responses to authority.

    • Authority Dynamics: The effects of authoritative figures on decision-making processes.

    • Peer Pressure: Understanding group behavior and individual compliance.

    • Aggression: Analyses of aggressive behavior patterns in distinct contexts.

Notable Experiments

  • Milgram Experiment (1961): Conducted by Stanley Milgram, this study evaluated the extent to which individuals would obey authority figures, even when instructed to perform actions contrary to their personal ethics.

  • Stanford Prison Experiment (1971): Led by Phillip Zimbardo, this controversial study utilized 24 male subjects to explore the psychological effects of perceived power, illuminating the dangers inherent in situational dynamics of power among guards and prisoners.

Role of Research Ethics Committees

  • Most countries mandate the existence of ethics committees (IRBs) within research institutions to ensure that:

    • Scientific quality of research is maintained.

    • Realistic project proposals are submitted, including evaluations of exclusion criteria.

    • Potential risks and benefits for participants are thoroughly assessed to adhere to ethical standards.

    • Research findings should be publicable and ethically sound, maintaining the balance between risks and benefits involved with human participation.