The unbearable lightness of Helsinki

It is a mandatory quiz question for introductory research ethics courses: what is the Declaration of Helsinki?

• Standard answer: the Declaration of Helsinki is a well-known international ethical guidance document for biomedical research involving human beings, first formulated in 1964 and revised 5 times since. Although propagated by the World Health Association, the document is meant to be the property of humanity, promoting responsible research wherever it takes place in the world.
• Less than standard answer: the Declaration of Helsinki is a oft-cited document containing lofty moral aspirations but zero legal bite, a brief laundry list of problem areas in human subjects research rather than a resource for real-world solutions, produced by an obscure agency (the World Medical Association) whose main claim to fame is that ... it produces the Declaration of Helsinki, in a deliberative process that makes the Vatican look like a model of transparency. The Declaration joins the bewildering number of international guidance documents that bioethics workers/policy geeks pay far more attention to than researchers ever will or should.

Which answer would get -- or should get -- the higher grade?

There is certainly something to the less than standard answer. Ordinary mortals are apparently not even allowed to see, much less weigh in on, the newest draft version of the Declaration. We can glimpse some aspects of the draft revision in a recent article on the Bioethics Forum, written by those who have apparently visited the inner sanctum. How is the concealed debate of a 'universal' document to be explained? About ten years ago, after controversial prevention of mother-to-child HIV trials, people were sweating over the revisions of the Declaration as if life and death of vast populations were at stake with each word. Is the relative secrecy is meant to circumvent another round of endless debate and heated controversy?

They might not need to worry. There have been lessons learned over the last ten years, and according to some bioethics workers, the key lesson is that the Declaration is dead as a moral and regulatory force in international health research. Dead, because the Declaration's wording is always under pressure to align with the interests of powerful groups, especially regulatory bodies in the United States and their associates in the pharmaceutical industry. Dead, because however the Declaration is formulated, its general prescriptions can be reasonable to ignore and unwise to follow in particular cases. Dead, because it encourages an utterly wrongheaded idea of what is involved in trying to tackle ethical challenges as they messily emerge in the field of health research, i.e. the application of universal statements to particular circumstances. That's not how it goes. And if it doesn't help with that, what good is it?

Perhaps the best place of the Declaration of Helsinki really is the classroom, as a pedagogical device, as a possible teaching moment. It can usefully introduce students with an interest in international research ethics to some general areas of enduring debate, and some tasty value language, before moving on to explore issues in greater detail and nuance. Outside the classroom, however, Declaration's authority, scope, status and usefulness are getting increasingly obscure.