§ Dr. Roger Thomas
asked the Secretary of State for Education and Science (1) if he will consider a departmental inquiry into the need of a new code of conduct of clinical trials following the decision not to proceed on the lines announced with the research into the value of vitamin and other nutritional supplements in the reduction of the incidence of neural tube and allied foetal abnormal developments;
(2) if he will consider a requirement that patients who are included in clinical trials are very well briefed as to the methodology and implications of the trial procedures.
§ Mr. William Shelton
The trial to which the hon. Member refers is the proposed Medical Research Council multi-centre clinical trial of folate and vitamin supplementation in the prevention of neural tube defects. Contrary to reports which have appeared in the press, a decision has not been taken to cancel the trial. I am aware that the trial has been the subject of public debate. The council is alive to the sensitivity of the issues raised and is considering them with great care.
Guidance on the ethical aspects of clinical research investigations has been given by the medical profession. I understand that both the Medical Research Council and the British Medical Association have issued guidance which deals with the need to obtain the informed consent of patients; that is, consent freely given with proper understanding of the nature and consequences of what is proposed. Full informed consent by the patients will be a prerequisite for entry into the council's neural tube defects trial.