The Bioethics Declaration: Applying the Principles

In one line

Four articles on how the principles are to be worked: how decisions are made, who reviews them, how risk is handled, and what happens when the activity crosses a border.

Their heading in the Declaration is APPLICATION OF THE PRINCIPLES, and that heading matters. Articles 3 to 17 say what is owed. Articles 18 to 21 say through what process the saying is made real, which is why an examiner asking "how is the Declaration applied?" is asking about exactly these four.

Article 18: decision-making and addressing bioethical issues

18(1). Professionalism, honesty, integrity and transparency in decision-making should be promoted, in particular declarations of all conflicts of interest and appropriate sharing of knowledge. Every endeavour should be made to use the best available scientific knowledge and methodology in addressing and periodically reviewing bioethical issues.

18(2). Persons and professionals concerned and society as a whole should be engaged in dialogue on a regular basis.

18(3). Opportunities for informed pluralistic public debate, seeking the expression of all relevant opinions, should be promoted.

Four things are worth pulling out.

Conflicts of interest are named. The article does not merely commend integrity; it specifies declarations of all conflicts of interest as the particular way integrity is shown, which is the point made in [Registration, Publication and Research Integrity].

The best available scientific knowledge is a requirement of ethics, not only of science. An ethical decision taken on out-of-date evidence is not merely a scientific failure; the article makes it an ethical one, and paragraph 4 of the Declaration of Helsinki takes the same view when it makes medical research subject to standards that promote and ensure respect.

Bioethical issues are to be reviewed periodically. The obligation does not close when a decision is taken, because the state of knowledge moves.

And paragraphs (2) and (3) make the public a participant. Not merely informed, and not merely consulted at the end: engaged in dialogue on a regular basis, with informed pluralistic public debate seeking the expression of all relevant opinions. That is a demanding standard, and it is the ground of the point in [What Ethics Adds to Law] that an ethical framework which is decided entirely by experts has no answer to the objection that it is a professional convenience.

Article 19: ethics committees

Independent, multidisciplinary and pluralist ethics committees should be established, promoted and supported at the appropriate level in order to:

• (a) assess the relevant ethical, legal, scientific and social issues related to research projects involving human beings;
• (b) provide advice on ethical problems in clinical settings;
• (c) assess scientific and technological developments, formulate recommendations and contribute to the preparation of guidelines on issues within the scope of the Declaration;
• (d) foster debate, education and public awareness of, and engagement in, bioethics.