Medicine: Research

Health written question – answered on 25th June 2014.

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Photo of Andrew Gwynne Andrew Gwynne Shadow Minister (Health)

To ask the Secretary of State for Health

(1) if the Health and Safety Executive will create a register of qualified professionals to ensure that clinical research is carried out safely;

(2) if he will bring forward legislative proposals to ensure that clinical research is carried out by suitably qualified professionals.

Photo of Norman Lamb Norman Lamb The Minister of State, Department of Health

The Health and Safety Executive is responsible for the enforcement of the Health and Safety at Work etc. 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 online 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.

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