 GUIDANCE ContentsAll 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. Back to Table of Contents ContextIn 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:
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. Back to Table of Contents Consent and BelmontThe 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:
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Key words: Ethical principles The quest to discover effective treatments and cures for diseases and conditions is a worthwhile and compelling goal. Scientific research is responsible for innovative breakthroughs that improve quality of life, extend survival, and even prove life-saving. But alongside the potential benefits of scientific research are the potential risks to the people who participate in the journey that makes breakthroughs possible. The Belmont Report identifies basic ethical principles for conducting research that involve human subjects. It also sets forth guidelines to assure these principles are followed throughout the research process. The Belmont Report is the result of over 4 years of meetings that began in 1976 and were conducted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Commission). With the Food and Drug Reauthorization Act of 2017’s recent amendment of the term patient experience data to now include both “physical and psychosocial impacts of a disease or condition, or related therapy or clinical investigation,” it is a particularly relevant and important time to revisit the ethical principles established in the Belmont Report. History of the Belmont Report The need for ethical principles first arose as a result of the reported atrocities inflicted on human subjects during World War II. During the Nuremberg War Crime Trials, the Nuremberg Code was drafted that set forth standards used to judge physicians and scientists who conducted biomedical experiments on concentration camp prisoners. The Nuremberg Code set the example for subsequent codes that established rules to help protect human subjects involved in research. But these rules were found to be inadequate to cover complex situations, at times in conflict, and frequently difficult to interpret or apply. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Research (Bethesda, Md.) The Commission, 1978. To avoid the limitations of these past codes, the Belmont Report was deliberately broader and established 3 basic ethical principles:
The 3 Basic Ethical Principles and Their Applicability to Clinical Trials Respect for Persons The first ethical principle in the Belmont Report, respect for persons, is made up of 2 important but distinct requirements. The first is the recognition that people are autonomous and entitled to their own opinions and choices, unless detrimental to others. The second is the recognition that due to various reasons, not all people are capable of self-determination and instead require protection. The amount of protection provided to an individual should depend on the risk of harm and the likelihood of benefit offered by the research. The Report promotes the idea that in most cases, respect for persons demands that people enter into research voluntarily and with adequate information. Beneficence The Report’s second ethical principle, beneficence, is the recognition that people are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts — or, more specifically, making it an obligation to secure their well-being. The Belmont Report identifies 2 general and complementary rules regarding beneficence:
While the obligation to “do no harm” is often the focus of discussions, the obligation to maximize possible benefits, while minimizing possible harms, is an obligation that warrants equal consideration. The Report notes that it is the obligation of scientific investigators and members of their institutions to think about both maximizing benefits and reducing risks in their research. Also discussed is the obligation of society at large to recognize longer term benefits and risks that may result from the improvement of knowledge and development of novel medical, psychotherapeutic, and social procedures. These obligations closely align with the Cancer Support Community’s belief that in order to maximize the benefits and minimize the risks of clinical trials, both physical data and patient experience data should be required to be collected as part of the research. Justice The last of the Belmont Report’s 3 basic ethical principles, justice, raises questions about who ought to receive the benefits of research and who ought to bear its burdens. Following a provocative discussion of equality and differential treatment, the Belmont Report considers the need to scrutinize whether some classes of people — economically disadvantaged, racial and ethnic minorities, or persons confined to institutions — are systematically selected as research subjects due to their position or vulnerability rather than their connection to the problem being researched. Today, the principle of justice may demand scrutiny of whether classes of people considered compromised or vulnerable are excluded from participation in clinical trials due to financial and other barriers even though they have a connection to the problem being considered. The Report states that justice demands therapeutic devices and procedures developed from public funds must not provide advantages only to those who can afford them. Learn about cancer clinical trials Though approximately 40 years have passed since the 1979 publication of the Belmont Report, the 3 basic ethical principles identified and set forth as guidelines for the conduct of biomedical and behavioral research involving human subjects — respect for persons, beneficence, and justice — remain particularly relevant and necessary for today’s clinical trials. |
According to the Belmont Report, implementing the principle of respect for persons involves
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