Written question asked by Countess of Mar (Crossbench), in the House of Lords. It was answered by Earl Howe (Conservative) on Thursday, 28 October 2010.

Children: Lightning Process

Question: 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.

Answer: 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.

Secondary information

Type: Written question
Reference: 3014; 721 c311WA
Session: 2010-12
Subjects: Children Ethics Research ethics committees Clinical trials South West
Link: View this Written question on www.publications.parliament.uk