The Belmont Report outlines three ethical principles that human research should conform to: respect for persons, beneficence, and justice. These principles lead to certain practical consequences in informed consent, the assessment of risks and benefits, and subject selection.
The principle of respect for persons necessitates that humans are treated as autonomous, meaning that individuals are generally able to decide for themselves. In such cases where an individual is not completely autonomous, they should be protected from harm. In order to respect one’s autonomy, researchers must allow subjects to make decisions for themselves and allow them to make their own judgements. This means they cannot be intimidated into participation or be substantially deceived. Where individuals are incapable of making a well-considered decision regarding their participation, perhaps because of illness or age, they may need to be protected to prevent harm. Certain populations, like prisoners, may be coerced into participation by virtue of their environment. The principle of respect in such circumstances is often difficult to evaluate.
The requirement of beneficence mandates that subjects always be treated to help improve their health. This means that researchers should not harm patients. In the process of attaining a patient’s well-being, treatments may have risks. It is the duty of the physician to balance these risks and benefits. To the greatest extent possible, doctors should seek the greatest benefit with the least risk of harm. This principle applies on different levels, from specific studies to entire areas of research. Sometimes it may be difficult to determine what actions would be deemed ethical, especially with regard to research that may not have direct benefits to patients, but may vastly improve the condition of future patients.
Patients should be treated fairly and with justice. Justice implies that humans must not be deprived of benefits to which they are entitled. Additionally it means equal subjects should be treated the same. The factors which determine which individuals are equal can vary significantly between perspectives. Attention to justice is particularly important because of numerous past incidents of unethical research involving humans. Such research often involved manipulating vulnerable classes of people to their detriment while providing data which would be used to treat other populations.
The principle of respect for persons manifests itself in the informed consent process. Informed consent allows capable subjects to decide whether they will participate in research or not. This opportunity allows subjects to express their autonomy. For consent to be given, certain standards must be met. In general, subjects must be reasonably informed about the research they are consenting to, comprehend this information to an adequate degree, and give consent voluntarily. There are finer details to each requirement. Generally, informed consent involves revealing relevant research information such as the purpose of the procedure and the risks involved. Sometimes, however, complete disclosure may invalidate the results of the study. Even with full disclosure, the comprehension of the information may be limited by the mental abilities of the subjects. A decision made with full information and complete comprehension may still be invalided if consent is made in an environment of coercion or undue influence. Considerations must be made to each of these issues if informed consent is to be given and if autonomy is to be respected.
To maximize benefit and minimize harm as the principle of beneficence prescribes, one must systematically assess the risks and benefits of a procedure. This involves a clear and careful evaluation of data and other research to determine if the expected benefit to the subject and society at large outweighs the risks. There are a significant number of types of harms which must all be analyzed. Such an evaluation should take into consideration quantitative information, but the decision is usually a subjective one. Care must be taken to prevent it from being made under the influence of bias. Additionally, researchers must ensure humans are never treated brutally, that risk is reduced as much as possible, that significant risks have proportional justification, and that the use of vulnerable populations is justified. This analysis of risk and benefit must be available to the patient in the informed consent process. All this analysis allows researchers to evaluate the ethicality of a particular study and ensures that patients can make a well-informed decision regarding their participation.
The principle of justice implies that subjects are selected in a fair manner. Equal individuals should have equal opportunity to participate. This means researchers cannot select a group they favor without justification nor can they select vulnerable populations out of convenience. Ethical subject selection means that groups should be considered based on the abilities of individuals in the group and their specific burdens. As such, populations which do not bear significant burdens should be considered before those that do in cases where research involves significant risk. This prevents additional burdens from being unnecessarily imposed as the principle of justice requires. Certain vulnerable populations must also be protected to prevent selection due to convenience and to prevent individuals from being manipulated into participation.