International Journal of Technology Assessment in Health Care

Special Section: The Quality of the Medical Evidence: Is It Good Enough?

Competing or Complementary?: Ethical Considerations and the Quality of Randomized Trials

Judith Lumleya1 and Hilda Bastiana2

a1 University of Oxford

a2 Consumer Advocate, Blackwood


The ethical principles of beneficence (doing the best for one's patients and clients), nonmaleficence (doing no harm), autonomy, justice, and equity, are positively associated with the quality of a trial rather than being opposed to it. Ethical considerations involve such important questions as appropriate design and documentation, participation rates, 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 considerations and the trial's scientific quality do occur, the ethical considerations must be paramount.