Andrew Gwynne – 2014 Parliamentary Question to the Department of Health
The below Parliamentary question was asked by Andrew Gwynne on 2014-06-18.
To ask the Secretary of State for Health, if he will bring forward legislative proposals to ensure that clinical research is carried out by suitably qualified professionals.
Norman Lamb
The Health and Safety Executive is responsible for the enforcement of the Health and Safety at Work Act 1974 and ensuring that “risks to people’s health and safety from work activities are properly controlled”.
The Health Research Authority (HRA) ensures that ethically-approved clinical research is carried out by suitably qualified professionals through its arrangements for research ethics committee review. Research ethics committee review includes scrutiny of researchers’ suitability to conduct the research they are proposing. This review is required by Departmental guidance, which applies to all health and adult social care research, and by legislation, for instance, in the case of clinical trials, by Schedule 1 part 2(2) of the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031).
The HRA publishes a register of research summaries, including a contact name (usually that of the chief investigator) and the research ethics committee’s opinion. The register is publicly available on line at:
www.nres.nhs.uk/researchsummaries
From September 2013, registration of clinical trials in a publicly accessible database is a condition of the favourable ethical opinion given by a research ethics committee.
