COMPETING OR COMPLEMENTARY - ETHICAL CONSIDERATIONS AND THE QUALITY OF RANDOMIZED TRIALS

The ethical principles of beneficence (doing the best for one's patien ts and clients), nonmaleficence (doing no harm), autonomy, justice, an d equity, are positively associated with the quality of a trial rather than being opposed to it. Ethical considerations involve such importa nt questions as appropriate design and documentation, participation ra tes, withdrawals or losses to follow-up, careful monitoring of safety and efficacy, timely completion, generalizability, and publication and dissemination of findings. When conflicts between ethical considerati ons and the trial's scientific quality do occur, the ethical considera tions must be paramount.