Randomised controlled trials ethics

Therefore we provide a brief discussion of some relevant ethical aspects (and particularly of the randomised controlled trial). 

Marshall M, Lockwood A, Bradley C et al. Unpublished rating scales a major source of bias in randomised controlled trials of treatments for schizophrenia. Br J Psychiatry 2000 176 249-52 Pocock SJ. Clinical Trials A Practical Approach. Chichester John WUey, 1983 Savulescu J, Chalmers I, Blunt J. Are research ethics committees behaving unethically Some suggestions for improving performance and accountabihty. BMJ 1996 313 1390-3... 

The prerequisite for an ethical randomised control trial is that it provides no certain benefit to the individual patients and in fact could harm the child as the result of potential side effects. Research is justified when there is no convincing ground that any patient would be advantaged or disadvantaged if allocated to one treatment arm over the others (Freedman, 1987a). It has been shown that research participants often fail to understand that their treatment has been selected at random... 

Edwards S B, Lifford R J, Braunholtz D A, et al. (1998). Ethical issues in the design and conduct of randomised controlled trial. Health Technol Assess 2 1-132. 

Palmer CR, Rosenberger WF. Ethics and practice alternative designs for phase III randomised clinical trials. Control Clin Trials 1999 20 172-86. 

---