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The Belmont Report states that “persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.”
Securing a research subject’s well-being falls under the principle of beneficence. Beneficence, as described in the Belmont Report, obligates the investigator to follow two general rules. The first is to “do no harm,” and the second is to “maximize possible benefits and minimize possible harms.” With respect to the first general rule of beneficence, the authors of the Belmont Report did not intend for investigators to reach the standard of “above all do no harm” (primum non nocere), which is
commonly said to be the first principle of medical ethics. Rather, the Commission intended to forbid the deliberate injury of a human subject for the purpose of developing generalizable new knowledge, no matter how important that knowledge might be. They endorsed the acceptability of exposing an individual subject to a possibility (or statistical probability) of injury as long as an IRB determined that this was justified in light of the probability and magnitude of the sought-for benefits.
Benefits may accrue to individual subjects or, through the development of generalized knowledge, to society, perhaps in the form of better health care. Risks, however, are borne by individual subjects. The risks and benefits of research are not always known, and investigators, along with the IRBs that approve their protocols, must decide with imperfect knowledge when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the
risks. The second general rule of beneficence obligates investigators to design their protocols so as to maximize the probability and magnitude of benefits to individual research subjects as well as to society. It further requires investigators to minimize the probability and magnitude of injury to individual research subjects. It is during the process of informed consent that the risks of participation in research are disclosed and that a promise to pursue the individual or collective
benefits is made with each potential subject. Some authors have argued that the two general rules described above are actually two fundamental ethical principles, beneficence (do good) and nonmaleficence (do no harm). However, others feel beneficence should be viewed as a single principle, because in a research context, it is necessary to consider harms and benefits in relation to each other. The authors of the Belmont Report drew upon
medical tradition when considering the ethical principle of beneficence. It is commonly said that the first principle of medical ethics is “do no harm.” This principle can trace its origin back over 2,500 years to Hippocrates. However, the National Commission recognized that “even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to the risk of harm. Further, the Hippocratic Oath requires physicians to benefit their
patients ‘according to their best judgment.’ Learning what will in fact benefit may require exposing persons to risk.” Determining when the pursuit of certain benefits is justified despite the risks is the difficult question faced daily by investigators and IRBs. Although beneficence is generally viewed as acts of kindness and charity which individuals are not obligated to pursue or bestow upon others, the National Commission viewed beneficence (to do or promote good) as a strict
obligation or duty in the research context, because investigators consent or pledge to be bound by it. Investigators pledge to promote good, by creating new knowledge or providing some benefit to subjects, when they accept public support for their work. In addition, during the process of informed consent, investigators pledge to pursue the benefits with potential subjects. It would be unethical to put human beings at risk without the prospect of creating beneficial new knowledge or promoting the
social good. In each case, the foundation of the obligation is like the obligation to keep promises. An investigator’s ethical obligation to treat subjects with beneficence is primarily carried out during the process of assessing and balancing the risks and benefits faced by subjects (See Module 3). However, ethical norms derived from this principle are discussed in each of the modules. Beneficence – Philosophical Foundation
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:
- Respect for persons
- Beneficence
- Justice
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:
- Do not harm
- Maximize possible benefits and minimize possible harms
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.