![]() ![]() 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. ![]() ![]() 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. 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. 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. Maximize possible benefits and minimize possible harms.The Belmont Report identifies 2 general and complementary rules regarding 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 Report promotes the idea that in most cases, respect for persons demands that people enter into research voluntarily and with adequate information. 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 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 opinions and choices, unless detrimental to others. The first ethical principle in the Belmont Report, respect for persons, is made up of 2 important but distinct requirements. The 3 Basic Ethical Principles and Their Applicability to Clinical Trials To avoid the limitations of these past codes, the Belmont Report was deliberately broader and established 3 basic ethical principles: But these rules were found to be inadequate to cover complex situations, at times in conflict, and frequently difficult to interpret or apply. The Nuremberg Code set the example for subsequent codes that established rules to help protect human subjects involved in research. During the Nuremberg War Crime Trials, the Nuremberg Code was drafted and set forth standards used to judge physicians and scientists who conducted biomedical experiments on concentration camp prisoners. The need for ethical principles first arose as a result of the reported atrocities inflicted on human subjects during World War II. With the Food and Drug Reauthorization Act of 2017’s 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. 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. It also sets forth guidelines to assure these principles are followed throughout the research process. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research identifies basic ethical principles for conducting research that involve human subjects. But alongside the potential benefits of scientific research are the potential risks to the people who participate in the journey that makes breakthroughs possible. Scientific research is responsible for innovative breakthroughs that improve quality of life, extend survival, and even prove life-saving. The quest to discover effective treatments and cures for diseases and conditions is a worthwhile and compelling goal. ![]()
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