If a parent agrees, but the adolescent objects to participation, the objection should be binding unless the research intervention directly benefits the adolescent and is not available outside the context of the research. A 1983 amendment to the Regulations requires the IRB to ensure that provisions are in place for the consent of children and youth, unless the child or youth is unable to provide them or there is no direct benefit. A more recent Institute of Medicine recommendation on consent in children and adolescents is presented in Box 9-6. Virtually all human research in the United States is governed by the federal policy for the protection of human research subjects [1]. This policy was developed by the Department of Health and Human Services in the late 1970s and early 1980s and adopted by 14 federal agencies. The ideological basis of the policy was laid by the National Commission for the Protection of Human Subjects from Biomedical and Behavioral Research [2]. The Commission`s 1978 report, commonly referred to as the Belmont Report, identified three ethical principles as fundamental to the ethical orientation of human research: respect for persons, charity and justice. This influential analysis still forms the context of ethical policy in human research today. The report was published on September 30, 1978[1] and published in the Federal Register on April 18, 1979. [2] The report takes its name from the Belmont Conference Center, where the document was partially written. The Belmont Conference Center, formerly part of the Smithsonian Institution, is located in Elkridge, Maryland, 10 miles south of Baltimore, and was operated by Howard Community College until late 2010.
[3] Scientific research has brought significant social benefits. It has also raised troubling ethical questions. Public attention has been drawn to these issues by reports of mistreatment of humans in biomedical experiments, particularly during World War II. During the Nuremberg war crimes trials, the Nuremberg Code was conceived as a set of standards for evaluating doctors and scientists who had conducted biomedical experiments on concentration camp prisoners. This code became the prototype for many subsequent codes[1] designed to ensure that research involving human subjects was conducted ethically. It is beyond the scope of this article to examine how the principles of charity and justice guarantee informed consent requirements. However, in the absence of such a review, the emphasis on respect for the individual as the primary basis for informed consent in the context of research involving human subjects seems quite unreasonable. Informed consent should not be the primary tool for preventing harm to research participants and ensuring fairness. Instead, ethics governance should ensure that subjects are not exposed to undue risk or treated unfairly.
Indeed, it would be unfair to place the primary burden of assessing the risks and benefits of informed consent on the individual subject. To protect people`s rights and well-being, the University conducts research with human participants in accordance with the ethical principles of the U.S. Department of Health and Human Services` Belmont Report: Respect for Persons, Charity, and Justice. The commitment to the Belmont Principles is defined in a legally binding national insurance between the university and the Federal Office for the Protection of Research Involving Human Beings. The treatment of an individual patient may constitute “research” if, “prior to treating the patient, there is a clear intention to use systematically collected data that would not normally be collected in clinical practice when reporting and publishing a case study. Research-based treatment must be distinguished from the application of innovative therapeutic practices” (46). The need for ethical principles first emerged in the wake of the atrocities inflicted on human subjects during World War II. During the Nuremberg war crimes trials, the Nuremberg Code was drafted, which established standards for the evaluation of doctors and scientists who conducted biomedical experiments on concentration camp prisoners.
The Nuremberg Code was exemplary for later codes that established rules for the protection of persons involved in research. However, these rules have proved insufficient to cover complex situations, sometimes conflictual and often 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 earlier codes, the Belmont Report was deliberately broader and established three fundamental ethical principles: 1) respect for individuals, 2) charity, and 3) justice. The Belmont Report explains the unifying ethical principles that form the basis of the National Commission`s thematic reports and the regulations that contain its recommendations. Unlike most other Commission reports, the Belmont Report does not contain specific recommendations regarding administrative actions taken by the Minister of Health, Education and Welfare. Instead, the Commission recommended that the Belmont Report be adopted in its entirety as a statement of departmental policy. The Department invites the public to comment on this recommendation.
The Belmont Report seeks to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the result of an intense four-day discussion period held in February 1976 at the Smithsonian Institution`s Belmont Conference Center, supplemented by the Commission`s monthly deliberations over a period of nearly four years. It is a statement of basic ethical principles and guidelines designed to help resolve ethical issues surrounding research involving human subjects. By publishing the report in the Federal Register and providing reprints upon request, the Secretary intends to make it readily available to researchers, institutional review committee members, and federal employees. The two-volume annex containing detailed reports by experts and specialists who assisted the Commission in fulfilling this part of its mandate is available as DHEW Publication No.