Professional Self-Regulation as a Normative Response

In one line

Doctors and researchers wrote the rules of research ethics before any State did, and the rules worked everywhere the profession worked and nowhere else.

In the wording a student can write in an exam: professional self-regulation is the adoption by a profession of binding standards for its own members, enforced by professional consequence rather than by law; the Nuremberg Code 1947 and the Declaration of Helsinki, first adopted by the World Medical Association in 1964 and revised many times since, are its two great instances in this field; their advantages are speed, specificity and reach across borders; and their limits are that they bind only the profession, provide the injured person no remedy, and are made by the people they regulate.

Why the professions got there first

Three reasons, and each is a general feature of the technique rather than an accident of history.

The profession knows before the legislature does. A capability appears in a laboratory or a clinic years before it appears in a Bill, and the people who can see what it will do are the people using it. [The Ethics of Emerging Technology] shows the same pattern with the 2011 influenza episode: the restraint was agreed among researchers because there was nothing else available in the time.

The profession's rules cross borders and a State's do not. A researcher who moves to another country carries the profession with them. That is why the Declaration of Helsinki matters in jurisdictions that have never legislated on research ethics, and why [Research Carried Out in Developing Countries] can treat it as the governing standard even where the host State has none.

And the profession has a sanction that operates without a court. The refusal of a journal to publish, the refusal of an ethics committee to approve, and the loss of a licence are all consequences that do not require proof beyond reasonable doubt, a complainant, or a limitation period. [Registration, Publication and Research Integrity] shows the publication sanction doing most of the practical work.

The Nuremberg Code

What it is. Ten points on permissible medical experiments, set out in the judgment of the tribunal in the trial of physicians at Nuremberg in 1947. [The Nuremberg Code] works all ten.

Its peculiar origin. It was not adopted by a profession or by States. It was written by judges, in a criminal judgment, as the standard by which the defendants' conduct was to be measured, and it was afterwards taken up by the professions as their own. So its authority is the authority of a judgment that nobody enforces, transmitted by adoption.

Its first point is the one everything else rests on. The voluntary consent of the human subject is absolutely essential. [Free and Informed Consent in Research] traces the line from there to article 6 of the 2005 Declaration.