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How do regulatory and ethical issues differ?

Regulations are governmental, legally binding rules that govern a set of practices. Regulations usually are enforced by the application of penalties. Regulations on the protection of human subjects in research, for instance, stipulate key practices, such as informed consent and IRB review, that are designed to protect ethical values such as the autonomy of research subjects. Regulations may provide minimal protection for human subjects in research. Researchers subject to regulations are bound to comply with them. Ethical researchers are morally obligated to comply with relevant ethical principles in research even if specific ethical practices are not mandated by law.

Ethical practices constitute a domain of behavior that is broader than regulatory compliance. The regulatory goal of IRBs, for example, is to seek compliance with human subject regulations. The ethical goal of IRBs, to protect human subjects in research, may demand additional practices or higher standards than found in existing regulations. Ethical values are the cornerstone of our humanity and vital to a civil society. While regulations are applications of ethical principles to sets of practices, regulations are written with broad strokes to address ethical practices often on a large scale.

Key Point: Regulations designed to protect human subjects are based on ethical principles.

Key Point: Regulations provide minimal protection for human subjects.

Key Point: Ethical practice requires more than compliance with the regulations for the protection of human subjects.

Key Point: IRBs may set higher ethical standards than regulations demand.