Medicine: Research

(asked on 18th June 2014) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, if the Health and Safety Executive will create a register of qualified professionals to ensure that clinical research is carried out safely.


Answered by
Norman Lamb Portrait
Norman Lamb
This question was answered on 25th June 2014

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.

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