![]() ![]() ![]() ![]() The Belmont Report, in its entirety, can be found here. Applying beneficence requires that research will be justified on the basis of a favorable risk/benefit assessment, in which risk is considered as the. economically disadvantaged or those with limited cognitive ability) or those who are easily manipulated as a result of their situation. It forbids the exploitation of vulnerable people (e.g. This third principle raises questions about who ought to receive the benefits of the research and who ought to bear its burdens or the fairness of distribution. The third basic ethical principle is that of justice. 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 Belmont Report identifies two general and complementary rules regarding beneficence: 1) do no harm, and 2) maximize possible benefits and minimize possible harms. 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 an obligation to secure their well-being. The amount of protection provided to an individual should depend on the risk of harm and the likelihood of benefit offered by the research.īeneficence is the second ethical principle. The second is the recognition that due to various reasons, not all people are capable of self-determination and instead require protection. The first is the recognition that people are autonomous and entitled to their own choices and opinions, unless detrimental to others. ![]() This first principle is made up of two important, but distinct, requirements. The first principle is respect for persons. There are three basic principles set forth in the Belmont Report. The Commission was created as a result of the National Research Act of 1974 and charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines to assure that such research is conducted in accordance with those principles. Application of this principle requires the close scrutiny of the enrollment process to ensure that particular classes (welfare patients, racial and ethnic minorities, or persons confined to institutions) are not selected for their compromised position or convenience to the research investigator.The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The possibility for benefits and the potential burdens of the research should be equitably distributed among the potential research subjects. Risk evaluation must include the consideration of both the probability and magnitude of harm, including psychological, physical, legal, social, and economic harm. Application of this principle involves a risk/benefit analysis in which the risks to subjects must be reasonable compared to the potential for benefit either to subjects directly or to society. The research study must be designed and implemented so as to maximize possible benefits and minimize possible harms. Exceptions to this informed consent requirement must be outlined in the federal regulations and subsequently approved by the University of Pittsburgh IRB. This involves a process in which participation in the research is acknowledged by the research subject (or by a legally authorized representative) as a voluntary act free from coercion or undue influence from the investigator or members of the research team. Application of this principle requires that human subjects are enrolled into research studies only under the conditions of effective informed consent. minors, prisoners, persons who are mentally disabled) are entitled to additional protections. Individuals should be treated as autonomous agents afforded the right to make decisions for themselves. All University personnel involved in the conduct and oversight of human subject research must abide by the fundamental principles set forth in the Belmont Report which include: Respect for Persons The Belmont Report, published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, provides the ethical foundation for the federal regulations for the protection of human research subjects. The University of Pittsburgh is committed to ensuring that all human subject research 1 in which it is engaged 2 is conducted in accordance with the ethical principles stated in the Belmont Report. Ethical Foundation for Human Subject Protections ![]()
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