Parliamentary Question: Lightning Process trial ethical approval

Hansard citation

The Countess of Mar tabled a written question about the ethical approval given to the feasibility study at the Royal National Hospital for Rheumatic Diseases in Bath into the effects of the Lightning Process on children with ME.

The Countess  asked the Government what assessment had made on whether the decision by the South-West Research Ethics Committee to approve a pilot research study into the effects of the Lightning Process of children is consistent with the ethical guidance issued by the Medical Research Council to the effect that the clinical trials should only include children where the relevant knowledge cannot by obtained by research on adults, and that research involving adults cannot provide the same benefits.

A written answer was provided by Earl Howe, parliamentary under secretary of state for health, on 28 October 2010.

Earl Howe replied:

Research ethics committees’ decisions are expected to be impartial and independent of ministerial and other influences. The Government do not interfere with their deliberations, either while they are in progress or by reviewing the outcome. The practice of research ethics committees is subject to training, accreditation and other quality assurance by the arm’s-length National Research Ethics Service to ensure the competence and consistency of their decision-making.

It would be unethical if scientists did not seek to determine the safety and efficacy of treatments and care for all intended beneficiaries, male and female, young and old. When considering whether the particular sample of people proposed as research participants is appropriate, research ethics committees have regard to the established ethical principles reflected in the medicines for Human Use (Clinical Trials) Regulations 2004, international and professional codes of practice and guidelines from funding bodies such as the Medical Research Council (MRC), although the research project in question is neither a drug trial nor funded by the MRC.

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