THE BELMONT REPORT ETHICAL PRINCIPLES AND GUIDELINES

FOR THE PROTECTION OF HUMAN SUBJECTS OF RESEARCH

The Belmont Report (Belmont Report: Ethical Principles and Guidelines for
the Protection of Human Subjects of Research, 1978) resulted in a dramatic change
in human subjects-based research in response to several scandals. It seems that the
notion of autonomy was suddenly injected into the conversation and became the
dominant driver of ethical behavior in human subjects-based research. Indeed, the
history of human subjects-based research clearly demonstrated that obligations to
beneficence and nonmaleficence, as well as appealing to the virtue of scientists,
were insufficient. Thus, the surest way to enforce justice was to enforce the
principle of autonomy. The principle of autonomy was proceduralized in the
formality of informed consent for research participation and rapidly found
adoption in medical and clinical ethics, formally or informally.

A historical analysis argues that until the late 1960s and early 1970s, at least
in North America, the ethics of everyday medicine was largely physician-centric.
The transition that occurred was not to a patient-centric ethic but rather to a
business- and government-centric ethics. This is not to say that the consequences
are unjust, necessarily. However, this transition does require examination of how
such business- and government-centric ethics comport the assumptions of a
pluralistic modern liberal democracy that ethics (principles, theories, laws, and
precedent) are derived from a consensus of those governed (for example, the
citizen as a patient or potential patient) sufficient to enforce universally. Recently,
particularly with the emergence of evidence-based medicine, the ethics of everyday
medicine has become scientist/academic-centric and enabled by business- and
government-centric ethics.

The Belmont Report prepared by the National Commission for the

Protection of Human Subjects of Biomedical and Behavioral Research is a
statement of basic ethical principles and guidelines that provide an analytical
framework to guide the resolution of ethical problems that arise from research with
human subjects. The basic ethical principles delineated in the report include:
Respect for Persons:
It entails treating individuals as autonomous persons capable of choosing for
themselves. In the case of persons with limited autonomy, additional protection
even to the extent of excluding them from activities that may harm them should be
advocated. The extent of protection would depend on the nature of potential risk of
harm and the likelihood of benefit. The application of this principle involves
an informed consent process during which subjects are provided all information
(in a comprehensible form) necessary for an individual to make a decision to
voluntarily participate in a study.

Beneficence:

This requires an assessment of the potential risks (probable harm) to the

anticipated benefits (promotion of health, well-being, or welfare). Investigators are
required to devise mechanisms that maximize the benefits and reduce the risk that
may be involved in the research. The public too need to take cognizance of the
risks and benefits that may result from novel medical, psychological, and social
processes and procedures.

Justice:

This principle advocates fair treatment for all and a fair distribution of the
risks and benefits of the research. It forbids exploitation of vulnerable people (for
instance, economically disadvantaged or those with limited cognitive capacity) or
those who are easily manipulated as a result of their situation. It also requires that
the researcher verifies that the potential subject pool is appropriate for the research
and that the recruitment of volunteers is fair and impartial.
Although never officially adopted by the US Congress or the Department of Health
Education and Welfare (now Department of Health and Human Services), the
Belmont Report has served as an ethical framework for protecting human subjects
and its recommendations incorporated into other guidelines. It is an essential
reference document for Institutional Review Boards (IRBs) that review and ensure
that research proposals involving human subjects conducted or supported by the
Human & Health Services (HHS) meet the ethical standards of the regulations.