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The Belmont Report

Purpose and Applicability

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.

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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 [8] 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.

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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).
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Related Materials

GUIDANCE Consent [9]

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Regulatory References

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Version Information

Open the accordion below for version changes to this guidance.

Version History

Version Number Posted Date Implementation Date Change Notes
1.00 10.08.2021 10.08.2021 Newly posted guidance.

Key words: Ethical principles