Medical Research and Patients' Rights

The issue of patient rights in medical research has developed over the years because of unethical practices that have occurred in the past.

• The Nuremberg Code was formulated in 1947 because of the trial of Nazi physicians who had experimented on unwilling subjects. The Code states that "the voluntary consent of the human subject is absolutely essential."
  
  
• In 1964, the Declaration of Helsinki softened the stipulations of the Nuremberg Code by allowing the legal guardians of incompetent persons to provide consent on their behalf, at least for "therapeutic" research.
  
  
• After the exploitation of subjects in the Tuskegee study of syphilis, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created in 1974. The Commission discussed the problem of using vulnerable groups as research subjects. A recent article in the Journal of the American Medical Association proposed 7 requirements that provide a framework for evaluating the ethics of clinical research studies:
  
  
  • Value: Enhancements of health or knowledge must be derived from the research.
    
    
  • Scientific validity: The research must be methodologically rigorous.
    
    
  • Fair subject selection: Scientific objectives, not vulnerability or privilege, and the potential for and distribution of risks and benefits, should determine communities selected as study sites and the inclusion criteria for individual subjects.
    
    
  • Favorable risk-benefit ratio: Within the context of standard clinical practice and the research protocol, risks must be minimized, potential benefits enhanced, and the potential benefits to individuals and knowledge gained for society must outweigh the risks.
    
    
  • Independent review: Unaffiliated individuals must review the research and approve, amend, or terminate it.
    
    
  • Informed consent: Individuals should be informed about the research and provide their voluntary consent.
    
    
  • Respect for enrolled subjects: Subjects should have their privacy protected, the opportunity to withdraw, and their well-being monitored.
  
  
• Clinical trial: As in medical treatment, patients have the right to refuse to participate in clinical research, and this should not affect their care. Enrollment in a clinical trial also should not prevent a patient from obtaining timely and appropriate medical care.
  
  
  • The institutional review board (IRB) is the essential element of the current regulatory system for research. The system relies on a local, institution-based review of proposed research. When a study involves human experimentation, almost every major funding agency and academic institution in the United States and Europe requires that the study be approved by a formally organized IRB.
    
    
  • The purpose of the IRB is to review studies and protect patients from the potential harms of research, especially patients who may not be competent to consent to participate in research. In the past, minority groups have been subject to exploitation by medical research. Research using minority participation involves issues of cultural and linguistic differences and the potential for increased risk of coercion and exploitation.