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Ethical Guidelines for Human Research

The Belmont Report summarizes the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. The Commission was tasked with identifying principles for research involving human subjects and developing guidelines to ensure research follows those principles. The three basic ethical principles discussed in the report are: respect for persons, beneficence, and justice. Respect for persons includes informed consent and protection of subjects. Beneficence requires research to not harm subjects and maximize benefits while minimizing risks. Justice demands fair procedures and outcomes in the selection of research subjects.

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51 views4 pages

Ethical Guidelines for Human Research

The Belmont Report summarizes the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. The Commission was tasked with identifying principles for research involving human subjects and developing guidelines to ensure research follows those principles. The three basic ethical principles discussed in the report are: respect for persons, beneficence, and justice. Respect for persons includes informed consent and protection of subjects. Beneficence requires research to not harm subjects and maximize benefits while minimizing risks. Justice demands fair procedures and outcomes in the selection of research subjects.

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pradhansnehasis382
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THE BELMONT REPORT

When the National Research Act was signed into law on July 12, 1974, the National Commission for the
Protection of Human Subjects of Biomedical and Behavioural Research was created. The Commission was
charged with identifying the basic ethical principles that should underlie the condct of biomedical and behavioural
research involving human subjects and to develop guidelines which should be followed to assure that research is
conducted in accordance with those principles. During their discussions the Commission considered the
boundaries between medical practice and research, the role of assessment of risk-benefit in the determination of
the appropriateness of research involving human subjects, guidelines for the selection of human subjects and the
nature and definition of informed consent. The Belmont Report thus attempts to summarize the basic ethical
principles identified by the Commission in the course of its deliberations in February 1976. The report itself does
not make specific recommendations for administrative action, but rather its objective is to provide an analytical
framework that will guide the resolution of ethical problems arising during research involving human subjects.
BASIC ETHICAL PRINCIPLES

1. Respect for Persons ~ all volunteers are treated as individuals and are
entitled to protection.

•Informed Consent: ì...each subject to the degree they are capable, be given
the opportunity to choose what shall or shall not happen to them.

Information: The extent and nature of the information should be such that
persons can decide
whether they wish to participate in the furthering of knowledge. That
is to say,
consenting individuals are aware that the procedure is neither
necessary for their care
nor perhaps fully understood, and they understand clearly the
range of the risks.
Comprehension: The ability of a subject to understand is a function of
intelligence, rationality, maturity and language and therefore it is
necessary to adapt the presentation of the information to the subject's
capacities. Investigators are responsible for ascertaining that the
subject has comprehended the information.

Voluntariness: The agreement to participate in research is considered a


valid consent, if and only if voluntarily given under conditions free of
coercion and undue influence.
2. Beneficence
• Do not harm
• Maximize possible benefits and minimize possible harms
• Assessment of Risks and Benefits

3. Justice ~ fairness in distributionî


• 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

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