The Belmont Report

The Belmont Report is one of the leading works dealing with ethics and healthcare research. It identifies basic principles and guidelines that protect human subjects and participants in clinical trials or research studies.

The Belmont Report contains three core ethical principles for research that involve human subjects.
 

1. Respect for Persons

Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.

  • An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation

  • Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them; other persons require little protection beyond making sure they undertake activities freely and with awareness of possible adverse consequence

  • The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit

  • The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations
     

2. Beneficence

Persons are treated in an ethical manner not only by respecting their decision and protecting them from harm, but also by making efforts to secure their well-being.

Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.

  • The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research

  • The principle of beneficence often occupies a well-defined justifying role in many areas of research involving human subjects

  • Ethical problems with research that presents more than minimal risk without immediate prospect of direct benefit. Some argue that such research is inadmissible, while others have pointed out that this limit would rule out much research promising great benefit


3. Justice

The principle of justice is related to the distribution of burdens and benefits.

Formulations of just ways to distribute burdens and benefit:

  • To each person an equal share

  • To each person according to individual need

  • To each person according to individual effort

  • To each person according to societal contribution

  • To each person according to merit