The Belmont Report and its Principles

The Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979; see the Useful links pod), a code of the ethical standards for research with human subjects, was published in 1979. The report identifies three basic ethical principles for the treatment of participants: respect for persons, beneficence, and justice.

Click on the cards to read about the three principles included in the Belmont Report.

The Three Basic Principles

Respect for persons

Respect for persons is based on two rules:

Individuals should be treated as autonomous agents.
Persons with diminished autonomy, such as children or incapacitated individuals, are entitled to protection.

Beneficence

Beneficence is explained with two rules:

Do no harm
Maximize possible benefits and minimize possible harm.

Justice

There are 5 ways to distribute burdens and benefits justly among participants. To each person:

An equal share
According to need
According to effort
According to contribution
According to merit.

Useful links

See the Belmont Report for further information on the three principles.

These three basic principles provide a broad framework on which more specific rules or interpretations can be made. In the U.S. all research projects involving human subjects that are funded with federal resources must be approved by an Institutional Review Board (IRB). The IRB is tasked with evaluating whether or not a project involving human subjects follows the ethical framework established by the Belmont Report.

The Belmont Report also includes three specific applications that must be taken into account when conducting research with human subjects:

Informed consent
Assessment of risks and benefits
Selection of subjects.

Match the description of the applications with the basic Belmont principle from which it is derived.

Select the correct Belmont Principle for each application description.

Application Description	Select Principle	Correct Answer
Informed consent: The researcher must inform the subject and ensure the subject understands the information and consents voluntarily.		Show Answer Respect for persons
Assessment of risks and benefits: Risks and benefits must be analyzed to decide whether the research is justified. Inhumane treatment is never warranted.		Show Answer Beneficence
Selection of subjects: Select subjects fairly, with consideration of whether specific classes of subjects should be included/excluded (e.g. children).		Show Answer Justice

Since all federally funded projects involving human subjects must be reviewed by an IRB and approved before the project is implemented, all academic institutions that conduct research with human subjects have an IRB. The IRB is composed of at least five members with various backgrounds, including at least one member not affiliated with the institution, to ensure a fair and objective review.

Importantly, although IRBs are only required to review federally-funded projects, most academic institutions review all research projects involving human subjects, regardless of the source of funding. This practice follows the recommendation of the Belmont Report and ensures the ethical treatment of human subjects in all research conducted at the institution.

Useful links

In the U.S. the Code of Federal Regulations Title 45 Part 46 (45 CFR 46) mandates that all research with human subjects conducted by federal agencies or with federal funds must be reviewed by an Institutional Review Board (IRB).