![]() ![]() ![]() 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. 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. Rather, a parent or guardian provides their permission and the child, when they have the capacity, provides assent. The IRB and researchers will need to consider the particulars of each study and subject population to identify the appropriate balance between the principles.Įxample: Children participating in research do not provide consent on their own behalf. 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 Belmont Principles can conflict with each other with respect to research consent. 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 principle of Justice is most relevant to consent in the context of equitable selection of subjects. 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). This helps to ensure that they are able to make a voluntary decision about whether or not to participate. 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. Additional content will be added over time.īack to Table of Contents Consent and Belmont This guidance page describes regulatory concepts, such as consent, within the context of these ethical principles. ![]() The Belmont Ethical Principles provided the foundation for the Common Rule (45 CFR 46) human subjects research regulations. Justice promotes equitable representation in research in terms of fairly distributing the risks and benefits of research.Beneficence describes an obligation to protect subjects from harm by maximizing possible benefits and minimizing possible harms.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.The Commission published the Belmont Report in 1976 which identified the following basic ethical principles: 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. In an attempt to strengthen human research protections, the National Research Act was passed in 1974. ![]()
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