What are the 3 principles of Belmont Report and discuss each of the principle?

All UW human subjects research is guided by the statement of ethical principles called the Belmont Report. This guidance is intended to present human subjects regulatory concepts within the context of the Belmont Ethical Principles.

Context

In an attempt to strengthen human research protections, the National Research Act was passed in 1974. As part of this Act, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created and tasked with developing a code of human subjects research ethics. The Commission published the Belmont Report in 1976 which identified the following basic ethical principles:

1. Respect for Persons expresses the ethical convictions that the autonomy of individuals should be respected and that persons with diminished autonomy are entitled to equal protection.
2. Beneficence describes an obligation to protect subjects from harm by maximizing possible benefits and minimizing possible harms.
3. Justice promotes equitable representation in research in terms of fairly distributing the risks and benefits of research.

The Belmont Ethical Principles provided the foundation for the Common Rule (45 CFR 46) human subjects research regulations. This guidance page describes regulatory concepts, such as consent, within the context of these ethical principles. Additional content will be added over time.

Consent and Belmont

The requirements for Respect for Persons are satisfied when subjects are provided with a meaningful consent process in which they are provided with all relevant information about a study that a reasonable person would need and that they fully comprehend the information they are provided. This helps to ensure that they are able to make a voluntary decision about whether or not to participate.

The requirements for Beneficence are met when the anticipated risks and benefits of research are disclosed to prospective subjects as part of the consent process and in the consent form (if there is a form).

The principle of Justice is most relevant to consent in the context of equitable selection of subjects. It is important to consider whether the subject populations(s) who bear the risks of research might also stand to benefit from it and, conversely, whether those populations most likely to benefit from the research are also being asked to share in the risks.

The Belmont Principles can conflict with each other with respect to research consent. Considerations of Beneficence must be balanced against an obligation to allow for subject autonomy when subjects have consent capacity (Respect for Persons) and promoting equitable representation in research (Justice). The IRB and researchers will need to consider the particulars of each study and subject population to identify the appropriate balance between the principles.

Example: Children participating in research do not provide consent on their own behalf. Rather, a parent or guardian provides their permission and the child, when they have the capacity, provides assent. The Belmont Principles may conflict with each other when the child does not want to enroll in the study but their parent/guardian wants them to be enrolled.

In general, a child’s dissent should be respected (Respect for Persons) and every effort should be made to come to a consensus between the child and their parent/guardian. However, there are some circumstances involving children where the regulations favor Beneficence and Justice over Respect for Persons:

• When the research is greater than minimal risk and there is a potential for direct benefit to the child, the IRB may allow the wishes of a single parent/guardian to override the wishes of the child in order to obtain the benefit (Beneficence).
• The IRB may approve greater than minimal risk research where the only likely benefit is the knowledge to be gained for other children with the disorder or condition being treated (Justice). However, the IRB will generally require two-parent permission in these cases as an additional safeguard that the risks are reasonable given the anticipated benefits (Beneficence).

Related Materials

GUIDANCE Consent

Regulatory References

• 45 CFR 46
• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979

Version Information

Open the accordion below for version changes to this guidance.

Version NumberPosted DateImplementation DateChange Notes1.0010.08.202110.08.2021Newly posted guidance.

The Belmont Report states that “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. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.” The Belmont Report goes on to describe an autonomous person as “an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.” To respect an individual’s autonomy is to allow an individual to develop opinions, make choices, and act as they please, unless their actions are clearly detrimental to others. Investigators may not touch or examine subjects or interfere in their lives in any way unless they agree or consent to the examination or interference. Investigators’ actions must recognize and affirm subjects’ autonomy. Lack of respect is shown when individuals’ considered judgments are rejected, their ability to act on their judgments is denied, or information is withheld that is necessary to make a thoughtful, considered judgment when there is no compelling reason to do so.

Not all human beings are capable of acting autonomously. The ability to set personal goals, develop opinions, and make choices may be compromised at times in a person’s life and, in the case of children, only develops over time. In other instances, individuals (such as the severely or terminally ill, mentally handicapped, and imprisoned) may lose the capacity for acting autonomously partially or completely, or for a period of time. Respect for these persons, as defined by the Belmont Report, requires that these vulnerable individuals be offered special protections during that period when they cannot act autonomously. Offering special protections for vulnerable individuals is also a major emphasis of the principle of justice which is discussed later in this module. The principle of justice requires that the vulnerable be extended special protections with regard to the distribution of the benefits and burdens of research. The vulnerable should be assured of receiving their fair share of the benefits and protected from having imposed upon them more than their fair share of the burdens of research.

Respect for Persons – Philosophical Foundation

A philosophical basis for treating individuals as autonomous agents can be found in the writings of Immanuel Kant. Kant argued that respect for persons is required due to our inherent dignity, which in turn is due to our being rational creatures. Rational beings have the capacity to use reason in forming decisions, and act not only in accordance with reason, but also for the sake of reasons we believe are right (thus becoming a moral agent). According to Kant, it is the capacity to choose right from wrong, and the responsibility that follows from possession of such a capacity, that accords persons the Kantian sense of dignity that deserves respect. As free and autonomous beings, we become responsible for our actions in ways that nonrational creatures cannot be.

To treat persons with respect is to treat them as beings who are morally self-determining. People must never be used simply as a means to the ends of others, but always as ends in themselves. Respect for persons, in Kantian terms, implies that what is crucial is that a person be free to act for the sake of reasons they believe are right. Thus, a person’s moral agency or autonomy is violated if that decisional process is denied or subverted, even if the person would have acted in the same way had they been given the opportunity to decide. In such a case, a person who is denied decisional involvement is thus denied the status of moral agent. And this, in turn, denies something essential to having moral dignity. This philosophical basis for treating individuals as autonomous agents and always as ends in themselves is consistent with the Judeo-Christian doctrine, which asserts that each human has infinite value.

An investigator’s ethical obligation to treat persons with respect is primarily carried out in the informed consent process, which is discussed in Module 2. However, ethical norms derived from this principle are discussed in each of the modules. 

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