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Response to: ‘We could be heroes: ethical issues with the pre-recruitment of research participants’ by Hunter
  1. Joan Kirkbride1,
  2. Catherine Blewett1,
  3. Jennifer Martin2
  1. 1Department of Operations, Health Research Authority, London, UK
  2. 2The Medicines and Healthcare products Regulatory Agency (MHRA), GCP Inspectorate, London, UK
  1. Correspondence to Dr Joan Kirkbride, Department of Operations, Health Research Authority, London SE1 6LH, UK; hra.comms{at}nhs.net

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There are a number of inaccuracies in the article by D. Hunter, which the Health Research Authority (HRA) and Medicines and Healthcare Products Regulatory Agency (MHRA) in collaboration would like to take the opportunity to clarify.

The article refers to clinical trials being ‘highly regulated’ by research ethics committees (RECs), which is not strictly accurate. Clinical trials are regulated by the competent authority (in the UK, this is the MHRA). Clinical trials may only run once they have been authorised by the MHRA and receive a favourable ethical opinion from an REC. However, the issue of recruitment is an issue for the REC to consider when deciding whether to issue the favourable opinion.

D. Hunter states in the article that non-study-specific advertisements for phase 1 clinical trials fall into a regulatory loophole as they fall outside the requirement for review by an REC, as set out in the Association of the British Pharmaceutical Industry (ABPI) code of practice. This is not entirely accurate as the HRA, …

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