What Ethics Adds to Law

In one line

Most of what has gone badly wrong in science was lawful when it happened, which is why the instruments in this module exist.

In the wording a student can write in an exam: ethics and law diverge in scientific research more sharply than in almost any other field, because the law regulates what is known to be dangerous and research is by definition the pursuit of what is not yet known; the instruments in this module, the Nuremberg Code, the Declaration of Helsinki and the three UNESCO declarations, are the international community's attempt to close that gap by stating standards that bind before any legislature has acted, and they matter to a lawyer because they supply the content of the acceptability element of the right to science, are relied on by treaty bodies, and are increasingly written into domestic statutes.

Why a law paper spends a module on this

Three reasons, and a candidate should be able to give all three.

Because what happened was lawful. This is the point that makes the module necessary rather than decorative. The experiments that produced the Nuremberg Code were conducted by qualified physicians, in accredited institutions, under a legal order that permitted them. Nothing unlawful was done in the sense that a domestic lawyer would recognise, which is precisely why a purely legal framework was inadequate to the problem and why a statement of principle that did not depend on any State's law had to be made.

Because law arrives late. The pattern in [How a Technology Becomes a Rights Question] is that a capability exists before the rule that governs it. In the interval, the only available standard is an ethical one, and the interval is where the harm occurs. Research ethics is therefore not a soft alternative to regulation but the only operative constraint at the moment when constraint matters most.

Because the law now incorporates it. This is the reason the module belongs on a law paper rather than a philosophy one. General Comment 25 makes the incorporation express: the acceptability element of the right to science requires that scientific research incorporate ethical standards in order to ensure its integrity and the respect of human dignity, and it names the standards proposed in the Universal Declaration on Bioethics and Human Rights as the reference. Ethics is thus a component of a Covenant right, and a State that permits research without those standards is in breach of the Covenant.

Where ethics and law diverge

Four situations, and naming them is what turns a general observation into an answer.

Conduct that is not unlawful and is wrong. A trial conducted where regulation is weakest, on participants who have no alternative source of treatment, with a design that would not be approved at home. Every step may comply with the host State's law.