Ethical Principles and Guidelines for the Protection of Human Subjects in Research 

The Belmont Report outlines ethical principles for conducting human subjects research; it also provides the framework for US regulations to protect human subjects.  The Belmont Report was written in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was developed as a result of the National Research Act of 1974, which responded to egregious human rights violations in research, such as the Tuskegee Study.  Congress wanted ethical principles with flexible review criteria to protect human subjects; the goal was to create a system like the Bill of Rights for research participants (National Library of Medicine, 1986).   

The Belmont Report articulates 3 basic ethical principles: Respect for Persons, Beneficence, & Justice.  These principles are tied to concrete research applications, such as – study design, recruitment, & informed consent. The Belmont “…Report cautioned that its principles are best viewed as ‘an analytical framework’ more akin a compass than to a checklist or formula” (Adashi, Walters, & Menikoff, 2018). 

Respect for Persons  

  • Research subjects should be regarded as autonomous agents 

  • If research subjects have diminished autonomy, extra precautions should be taken to ensure their rights & safety 

Beneficence 

  • Risks and benefits of research should be systematically analyzed 
  • The goal is to maximize benefits and minimize risks 

Justice 

  • Risks & benefits of research should be distributed equitably across society 
    • No age, race, class, gender, or ethnicity should disproportionately bear the risks 
    • No age, race, class, gender, or ethnicity should disproportionately reap the benefits