Research ethics provides guidelines for the responsible conduct of biomedical research. In addition, research ethics educates and monitors scientists conducting research to ensure a high ethical standard.
The birth of modern research ethics began with a desire to protect human subjects involved in research projects. The first attempt to craft regulations began during the Doctors Trial of 1946-1947.
The Doctors Trial was a segment of the Nuremberg Trials for Nazi war criminals. In the Doctors Trial, 23 German Nazi physicians were accused of conducting abhorrent and torturous “experiments” with concentration camp inmates. The accused physicians tortured, brutalized, crippled, and murdered thousands of victims in the name of research. Some of their experiments involved gathering scientific information about the limits of the human body by exposing victims to extreme temperatures and altitudes. The most gruesome and destructive experiments tested how quickly a human could be euthanatized in order to carry out the Nazi racial purification policies most efficiently.To prosecute the accused Nazi doctors for the atrocities they committed, a list of ethical guidelines for the conduct of research – the Nuremberg Code – were developed.
The Nuremberg Code consisted of ten basic ethical principles that the accused violated. The 10 guidelines were as follows:
1. Research participants must voluntarily consent to research
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior animal testing
4. Research must avoid unnecessary physical and mental suffering
5. No research projects can go forward where serious injury and/or
death are potential outcomes
6. The degree of risk taken with research participants cannot exceed
anticipated benefits of results
7. Proper environment and protection for participants is necessary
8. Experiments can be conducted only by scientifically qualified persons
9. Human subjects must be allowed to discontinue their participation at any time
10. Scientists must be prepared to terminate the experiment if there is cause to believe that continuation will be harmful or result in injury or death
The Nuremberg Guidelines paved the way for the next major initiative designed to promote responsible research with human subjects,
The Helsinki Declaration.
The Helsinki Declaration was developed by the World Medical Association and has been revised and updated periodically since 1964, with the last update occurring in 2000. The document lays out basic ethical principles for conducting biomedical research and specifies guidelines for research conducted either by a physician, in conjunction with medical care, or within a clinical setting.
The Helsinki Declaration contains all the basic ethical elements specified in the Nuremberg Code but then advances further guidelines specifically designed to address the unique vulnerabilities of human subjects solicited to participate in clinical research projects. The unique principles developed within the Helsinki Declaration include:
• The necessity of using an independent investigator to review potential research projects
• Employing a medically qualified person to supervise the research and assume responsibility for the health and welfare of human subjects
• The importance of preserving the accuracy of research results
• Suggestions on how to obtain informed consent from research participants
• Rules concerning research with children and mentally incompetent persons
• Evaluating and using experimental treatments on patients
• The importance of determining which medical situations and conditions are appropriate and safe for research
Following the Helsinki Declaration, the next set of research ethics guidelines came out in the Belmont Report of 1979 for the Protection of Human Subjects of Biomedical and Behavioral Research.
The report outlines:
1. The ethical principles for research with human subjects
2. Boundaries between medical practice and research
3. The concepts of respect for persons, beneficence, and justice
4. Applications of these principles in informed consent (respect for persons), assessing risks and benefits (beneficence), and subject selection
The Nuremberg, Helsinki, and Belmont guidelines provided the foundation of more ethically uniform research to which stringent rules and consequences for violation were attached. Governmental laws and regulations concerning the responsible conduct of research have since been developed for research that involves both human and animal subjects.