belmont report

belmont report

The Ethical Principles of the Belmont Report

1. Introduction

The Belmont Report’s (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 18) introduction is the articulation of the primary ethical principles and guidelines in the “protection of human subjects of research.” The report is specifically centered based on clinical and biomedical research. The principles identified in this document may be applicable to other types of research involving human subjects. It is the articulation of ‘ideal’ guidelines for the protection of human subjects. The Belmont Report is a statement of basic ethical principles and guidelines which provide assistance to resolving the ethical problems that surround the conduct of research with human subjects. It is also the first of many reports to be a product of the National Commission for the Protection of Human Subjects. Established in 1974 and lasting for a few years, the National Commission was charged to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.

2. The Principle of Respect for Persons

Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. It is applied by acknowledging autonomy and protecting those with reduced autonomy. An autonomous person is an individual capable of deliberation about personal goals and acting under a direction formulated with the deliberative will. A person’s autonomy is to be respected. An autonomous individual should be considered the author of their own life and thus a self-respecting and self-governing individual. To deprive an individual of freedom of action is to deprive them of the ability to be self-directing. It is to treat weaker as seen in the case of children or adults with diminished autonomy; intervention in their lives can only be justified. The requirement for informed consent is to ensure that individuals are given an opportunity to choose what will or will not happen to them. This is not restricted to a particular form of consent and is dependent on the situation. Consent can be given verbally, or by simple deed of showing up. High-risk research places emphasis on ensuring that permission is received but the process of consent, another means of showing respect for autonomy, must occur willingly and without any form of intimidation. Finally, it is because respecting the decision-making capacities of autonomous agents in contributor to their well-being and sense of being and children or others with diminished autonomy have no ability for self-determination, it is necessary to prevent risk, which is a greater health law standard for these individuals from impeding on their ability to obtain their goals. The principle of respect for persons also requires that subjects be given protection for those with diminished autonomy. This usually accounts for any situation in which an individual’s action and ability to choose is impaired. Any decision on this subject’s behalf should be a reflection of what they would choose for themselves if able and the subject is still an information regarding such decision provided by others. It is not always possible to prevent more harm than good for such individuals and thus, the principle of respect for persons allows the decision whether to involve them in research to balance their well-being as a subject help lead and a need for the advancement of knowledge which may provide direct benefits to the person group in which the individual is a member. Any decision to involve such subject in research at signed seek expressed or authorized consent is revocable. So at any point where the research has adverse effect on the subject with potential to reverse the cause the subject’s participation in the research can be stopped without any loss of the respect the person requirement. Overall, the principle of respect for persons is to be upheld in all dealings with other people; as it is morally wrong to treat someone in a way, which does not acknowledge their status as a human being capable of self-determining and autonomy is insistence on the respect for the autonomy of others its essential application being when the would-be beneficence and of the has potential research are weighed against the risk to the well-being of the subject.

3. The Principle of Beneficence

The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, it is used in a strong sense to refer to ethical obligation. Two general types of actions are usually classified under this heading. The first type includes those actions which seek to prevent or to remove harms or to improve the situation of others. The principle of beneficence often occupies a well-defined justifying role in many areas of moral theory. The principle also has inviolable limiting implications. This suggests that it is a complex and multifaceted principle. A further issue is raised by its use in the familiar context of professional ethics. How is the principle of beneficence applied to the conduct and goals of research, and how is it used to address research that poses a threat to the wellbeing of subjects. At least three distinct argumentative elements can be identified. (1) It is argued that research ought to be socially useful, that it ought to yield a worthwhile product. This suggests that research must have the capacity to benefit or to improve the welfare of some population, and that it is therefore a necessary condition of informed research involvement that individuals or communities understood as vulnerable not be excluded from research benefits. This applies to both medical and non-medical research. (2) It can be argued that the interests of various research populations require that the testing of certain hypotheses or interventions is a high priority. An application of this version may be a claim that an effective means of preventing a problem which primarily affects a certain vulnerable population has not yet been adequately tested. The decision by the US Public Health Service to treat the prevention of sexually transmitted infections in southern states adolescents may serve as an example. (3) There is a frequently encountered utilitarian argument that the way to minimize overall harm is by conducting some harmful research. This has been the argument by defenders research involving prisoners, a provocatively example by cases of research involving positive interventions in conflict situations.

4. The Principle of Justice

Involves a fair balance between the kinds of people who participate in research and the kinds of people who benefit from research. Subject selection procedures should not be based on the vulnerability of the population, rather the needs of the research. It requires those who are selected to share the burdens of the risks and of the benefits of the research should be selected equitably across the population. The most vulnerable are those with limited ability to protect their own interests. “An injustice occurs when the benefits of research are available to some participants or to others, but the risk of injury is not shared generally (equity of risk and benefit). This can occur when some populations are easy to involve in research and the other end of the spectrum where an excluded population is denied the chance to participate. This is most evident with the poor and minority populations. This does not mean that all research must be available to all populations, however some form of the research should be made available. Failure to enhance the equitable availability of treatments discovered in research may also be viewed as an unfair trade-off.

5. Conclusion

In retrospect, it is fair to say that the goal set for this commission has been accomplished. The approach we have taken is in sharp contrast to the way in which these issues are often discussed. When people pull examples out of the air to support a particular ethical view, often all they can agree about is that the issue is a “dilemma.” And that is the last word. No progress is made. In contrast, deliberations at the level of moral theory if they are to be relevant to decisions about specific issues, must be capable of influencing the more particularized, concrete rules and principles of action by which men (and institutions) guide their conduct, personal and official. This means that such decisions about public policy must be capable of being stated in terms of shared rules and standards, open to rational scrutiny, and revisable in light of changing circumstances. By identifying a basic common morality, and then applying that approach to the issue of protecting human subjects, we believe we have provided practical ethical guides for the resolution of issues in such policy. This conclusion is supported by the fact that in preparing its regulations, the HEW has used the staff of the commission as an informal, off-the-record, sounding board. In so doing, they have been asking not for examples, but for rules and principles to serve as guidelines for policy. Our proposed principles have been used to fill that need. And as we assess the work of the commission, we are confident that our approach has enabled us to better fulfill our charge than would have been the case had we simply compiled diverse opinion and made recommendations.