Challenges to Human Subject Protections in US Medical Research
JAMA. 1999 Nov 24; 282(20): 1947-1952.
United States regulations governing federally supported research with human subjects derive in part from 2 international codes, the Nuremberg Code and the Declaration of Helsinki. The Declaration of Helsinki states that "concern for the interests of the subject must always prevail over the interests of science and society." The concept of minimal risk and the principle of informed consent are the key means by which US federal regulations seek to protect the rights and welfare of the individual in the research setting. Current trends in medical research-including increased funding, ever-greater capabilities of computers, development of new clinical tools that can also be used in research, and new research tools developed through research itself are creating greater demand for human subjects, for easier recruitment and conscription of these subjects, and for unimpeded access to patient medical records and human biological materials. Nationally and internationally, there are new pressures to subordinate the interests of the subject to those of science and society. The National Bioethics Advisory Commission, which is about to undertake a comprehensive review of the US system of human subject protections, faces a daunting task.
Advisory Committees; Behavioral Research; Bioethics; Body Parts and Fluids; Competence; Computers; Consent; Ethical Review; Ethics; Ethics Committees; Evaluation; Federal Government; Genetic Research; Government; Government Financing; Government Regulation; Guideline Adherence; Guidelines; Human Experimentation; Informed Consent; Medical Records; Medical Research; Patients; Records; Regulation; Research; Research Ethics; Research Ethics Committees; Research Subjects; Review; Rights; Risk; Risks and Benefits; Science; Standards; Third Party Consent; Tissue Banks; Trends; Vulnerable Populations;
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