Are the rationale and regulatory system for protecting human subjects of biomedical and behavioral research obsolete and unworkable, or ethically important but inconvenient and inadequately enforced?

Many critics of U.S. regulation to protect human subjects of biomedical and behavioral research deem the system inherently unworkable and variously inadequate or unnecessary. Many deem its rationale, the Belmont Report, outdated and philosophically deficient. Some would scrap or revamp the system. These criticisms and prescriptions are challenging factually, legally, and ethically. Similar minimalist, audited self-regulation operates smoothly elsewhere in life science. Events suggest Belmont's continuing validity in its administrative-law role as interpretive touchstone for human subjects protection regulations. U.S. human subjects protection and related regulations are constitutionally grounded and consistent with U.S. obligations under human rights law. Criticisms that the system is inconvenient do not respond to ethical and legal duties--to acknowledge the innate dignity of human subjects of research, to recognize and squarely face ethical issues in human subjects research, to heed applicable domestic and international law, to say no to projects when no is warranted, to foster researcher involvement in the system, to focus on substance rather than form, and to resist automaticity. If the system is to function protectively and reasonably efficiently, then the legitimacy of the pertinent law and Belmont's legal role should be recognized as the primary resource for interpreting the human subjects regulations; the system and proposed changes should be viewed critically for efficacy rather than convenience; and policy and practice should emphasize (a) predictability, stability, and clarity of the regulatory system, and (b) resources and will to comply and enforce.