1. The Belmont Report:
An Ethical Framework for
Protecting Research Subjects
Janet F. Zimmerman, MS, RN, Clinical Research Training Consultant, Newtown, PA
I NTRODUCTION
Twenty years ago, a select group of 11 American men and women were in the
midst of a congressional assignment. The assignment was to “identify the basic
ethical principles that should underlie the conduct of biomedical and behavioral
research involving human subjects and to develop guidelines which should be followed to
assure that such research is conducted in accordance with those principles.” 1 In 1979,
these principles were published in what is commonly known as The Belmont Report.
While never formally adopted, The Belmont Report has become the primary ethical framework for
protecting human research subjects in the United States.
Most of us have some knowledge of BACKGROUND two international codes were adopted
the U.S. Food and Drug Administration At its basic level, the U.S. Congress for physicians and scientists conduct-
(FDA) statutes, which are published is an agent of change, enacting laws as ing research with human subjects.
in Title 21 of the Code of Federal Reg- a response to events or problems They were The Nuremberg Code in
ulations (CFR), or those of U.S. Public requiring national uniformity. On July 1947 and the Declaration of Helsinki
Health Service (PHS) which are pub- 12, 1974, Congress passed the in 1964, which has since been revised
lished in Title 45 CFR. However, we National Research Act, primarily in and updated. At the time, each of
may be less familiar with non-regula- response to the USPHS-sponsored these international standards delin-
tory guidelines, such as The Belmont syphilis studies that were conducted eated ethical principles for informed
Report, that have importance in on indigent African-American males consent and medical care of research
research involving human subjects. in Tuskegee, Alabama from 1932 to subjects, both of which were disre-
Our goal is to briefly explain some of 1972. When the story broke, the garded in the syphilis studies. For
the historical events that led to The tragic events of these studies were whatever reasons, the United States
Belmont Report and to provide an widely reported in the press. In fact, government continued to sponsor
overview of the Belmont principles the syphilis studies are still newswor- research in humans that should have
and the underlying message of the thy as exemplified by the made-for- been guided by the Nuremberg and
report. television movie, Miss Evers’ Boys, Helsinki principles. While the United
broadcast on HBO earlier this year.
It is interesting to note that during
the 40 years of the syphilis studies,
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2. States was the primary sponsor of The became the basis for future DHHS THE BELMONT REPORT
Nuremberg Code, the United States laws. In 1981, Congress enacted three The objective of The Belmont
was not a signatory to the Declaration DHHS statutes that demonstrated a Report “is to provide an analytical
of Helsinki. remarkable collaborative effort within framework that will guide the resolu-
However, codes and principles are DHHS. They are FDA regulation 21 tion of ethical problems arising from
not regulations, and therefore are not CFR Part 50 and PHS regulation 45 research involving human subjects.” 2
enforceable by law. With the 1974 CFR Part 46, both titled Protection of The framework of The Belmont Report
National Research Act, Congress Human Subjects. The third 1981 is presented in three discussion
mandated the establishment of insti- statute is FDA regulation 21 CFR Part topics: boundaries between practice
tutional review boards (IRBs) to 56, titled Institutional Review Boards. and research, basic ethical principles,
review all federally funded human and applications.
research. Until this time, hospital or
institutional review of research activi- 1. Boundaries Between Practice
ties for purposes of protecting human
subjects was voluntary, informal, and
“ Technically, and Research
Practice refers to interventions
without established criteria. that are intended to solely improve the
the United States
The National Research Act also well being of the patient. They are
created the National Commission for accepted standards that have a reason-
the Protection of Human Subjects of does not have a able expectation of success. The goal
Biomedical and Behavioral Research. of practice is to provide a diagnosis,
The 11 members of the Commission, preventive treatment, or therapy that
national policy for
who represented science, law, ethics, will enhance the patient’s wellness. In
and society, published several state- most cases, practice standards are
ments or reports on various aspects of protecting research supported by research findings.
research with human subjects. These Research refers to activities that
reports outlined recommendations to are designed to develop or contribute
subjects.”
the Secretary of the Department of to the general body of knowledge.
Health, Education, and Welfare General knowledge includes theories,
(DHEW), now known as the Depart- principles, and relationships.
ment of Health and Human Services Since neither Congress or DHEW Research activities test a hypothesis,
(DHHS). (now DHHS) moved to formally adopt are validated by statistical measures,
One of the Commission’s statements The Belmont Report in its entirety, and allow conclusions to be drawn.
was The Belmont Report: Ethical Prin- arguably, the United States does not Research is written in a formal
ciples and Guidelines for the Protection have a national policy for protecting protocol that can be reviewed and
of Human Subjects of Research com- research subjects. Yes, there are the replicated by others. In research, ben-
monly referred to as The Belmont aforementioned DHHS statutes, but efits are not always known nor are
Report. The Commission recommended these are mandates too restrictive and they assured. Because harm may
to the DHEW Secretary that The Bel- inflexible to be used as a dynamic result during research, the protection
mont Report be adopted in its entirety, foundation for evolving biomedical of subjects is paramount.
representing DHEW policy. While The ethics. It is not uncommon to have practice
Belmont Report was never officially Despite the lack of endorsement and research occur simultaneously in
endorsed, many of the Commission’s by either DHEW or Congress, The clinical trials, particularly if the safety
recommendations in this statement Belmont Report is indeed alive. It is and efficacy of the investigational
recognized by many, albeit quietly, as treatment are being evaluated. During
the United States’ contribution to the the informed consent process,
short list of international guidelines
for protecting human subjects
involved in research.
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3. subjects must clearly know which efforts to improve an individual’s well activities: informed consent, assess-
study activities are standard practice being. The principle of beneficence is ment of risks and benefits, and selec-
and which are research. firmly embedded in the ethical tradi- tion of research subjects.
tion of medicine as defined by Hip-
2. Basic Ethical Principles pocrates: “As to diseases, make a a. Informed Consent
The Belmont Report identifies three habit of two things — to help, or at The first Belmont principle,
fundamental principles that underlie least to do no harm.” However, in respect for persons, requires that
all research involving human subjects: order to help and avoid harm, we must research subjects be given the oppor-
respect for persons, beneficence, and first learn what is harmful. tunity to decide what will or will not
justice. For research that will benefit soci- happen to them. This opportunity
ety, subjects may be exposed to a risk occurs during the informed consent
a. Respect for Persons of harm with no personal benefit. In process, which contains three compo-
Respect for persons includes two research, an ethical dilemma occurs in nents: information, comprehension,
ethical presumptions. The first is that deciding when it is proper to pursue and voluntariness.
persons should be treated as certain benefits despite the risks Information. When presenting
autonomous individuals, capable of involved, and when the benefits information, it is essential for subjects
making their own decisions. should be foregone because of known to understand the research is neither
Autonomous individuals possess the or potential risks to the subject. necessary for their well being nor are
capacity for self-determination. We the effects of the research fully known
demonstrate our respect for persons c. Justice or understood. Understanding this,
when we encourage and accept an Justice is the third basic principle subjects can decide if they wish to
individual’s opinions and choices. We identified in The Belmont Report. Jus- participate in the research for the pur-
show a lack of respect for persons tice requires that each person is treat- pose of contributing to general knowl-
when we withhold information and ed fairly, equitably, and given what he edge. If a direct benefit to subjects is
deny individuals the freedom to make or she is due. There is an equal distri- expected, they should clearly under-
an informed decision. bution of benefits as well as burdens. stand the range of risks.
The second presumption is that not An injustice occurs when a benefit to The minimum information required
every person is capable of self-deter- which a person is entitled is denied to be provided to subjects is found in
mination. The capacity for self-deter- without good reason or when an exces- 21 CFR 50.25 for FDA reviewed
mination develops during a person’s sive burden is imposed. research and 45 CFR 46.116 for all
life. Therefore, the very young have In clinical research, we should federally funded research. These sec-
diminished autonomy. Additionally, always be mindful that certain classes tions contain the 14 elements of
some individuals may lose the capacity of persons, e.g., the indigent, ethnic informed consent. While these regula-
for self-determination because of groups, or the institutionalized may be tions pertain to DHHS activities, they
physical illness, mental disabilities, or selected because of their availability, have become a framework for prepar-
situations that restrict personal free- dependence, or because they are easy ing and reviewing informed consents
dom, such as prisons and the military. to manipulate rather than for reasons in all types of research involving
Respect for persons who are immature, related to the problem being studied. human subjects.
incapacitated, or restricted requires These classes are frequently referred Comprehension. Another compo-
that we provide them protection as to as “vulnerable populations” and nent of informed consent is compre-
human subjects. require protection as human subjects. hension. Comprehension is the
capacity to understand. The informa-
b. Beneficence 3. Applications tion provided to a subject must be in a
The second basic ethical principle We can gain an understanding of language and at a level that he or she
is beneficence. Beneficence is the the Belmont principles by applying can comprehend. Informed consent is
practice of doing good, making all them to some of the steps in the invalid if the consentor does not
clinical research process. The Belmont
Report singles out the following
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