Countess of Mar Written Question on ethical approval of Lightning Process study: Response from Earl Howe

Countess of Mar Written Question on ethical approval of Lightning Process pilot study in children aged 12 to 18: Response from Earl Howe, Parliamentary Under Secretary of State (Quality)


House of Lords Business
Questions for Written Answer [House of Lords]

Tabled on 21 October and due for answer by 4 November.

House of Lords Written Question

The Countess of Mar (Crossbench)

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

House of Lords Written Answer

Hansard source (Citation: HL Deb, 28 October 2010, c311W)

Earl Howe (Parliamentary Under Secretary of State (Quality), Health; Conservative)

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.