Parliamentary Question: Lightning Process trial ethical approval

October 30, 2010

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.

1 thought on “Parliamentary Question: Lightning Process trial ethical approval”

  1. It sounds like a good argument, but the fact remains that a preliminary efficacy test could be done on adults alone. Surely the decision whether to conduct an efficacy test on children should be left until it can be scrutinised by the results of an adult trial, to find out if it is truly necessary.

    As a crude example, after realising that you have touched an acidic chemical and your skin is burning, you wouldn’t then throw it on a child to see if the same happened. I realise that’s something of a sensational juxtaposition, but it’s not without merit.

    It seems like something isn’t being said. I wouldn’t blame anyone for drawing the speculative conclusion that, they want to test children because they cannot direct adults with questioning as easily.

    I’ll be curious to find out at what point they intend to publish their results. If it is anything less than a year or two after the ‘treatment’ (no beneficial connotations there, I assure you), then once again we will be left with a zero credibility piece of evidence that’ll get wafted in the faces of an oft marginalised group of patients.

    I genuinely hope my suspicions are wrong and the true aim of this trial is to do everything by the book for good reason. Only time will tell.

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