Over recent years, considerable attention has been paid to the National Health Service (NHS) research governance and ethics approvals process in the UK. New regulations mean that approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) is now also needed for conducting all clinical trials. Practical experience of gaining MHRA and sponsorship approval has yet to be described and critically explored in the literature. Our experience, from start to finish, of applying for these four approvals for a multicentre randomised controlled trial of two licensed drugs for opiate detoxification in the prison setting is described here. In addition, the implications of the approvals process for research projects, particularly clinical trials, in terms of time and funding, and also indirect implications for NHS patients are discussed. Inconsistencies are discussed and suggestions that could improve and streamline the overall process are made. The current approvals process could now be hindering non-commercial clinical trials, leading to a loss of important evidence-based medical information.
- LEEDS, Leeds Evaluation of Efficacy of Detoxification Study
- MHRA, Medicines and Healthcare Products Regulatory Agency
- MREC, multicentre research ethics committee
- NHS, National Health Service
- RCT, randomised controlled trial
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Funding: No external funding was available for the preparation of this paper.
Competing interests: None.
Read the full text or download the PDF:
Other content recommended for you
- Ethical approval for research involving geographically dispersed subjects: unsuitability of the UK MREC/LREC system and relevance to uncommon genetic disorders
- The ESRC research ethics framework and research ethics review at UK universities: rebuilding the Tower of Babel REC by REC
- Using the Clinical Research Network for psychosocial cancer research: lessons learned from two observational studies
- Streamlined research governance: are we there yet?
- Regulation—the real threat to clinical research
- Prisoners as research participants: current practice and attitudes in the UK
- The effect of the neonatal Continuous Negative Extrathoracic Pressure (CNEP) trial enquiries on research in the UK
- The experiences of ethics committee members: contradictions between individuals and committees
- Falling research in the NHS
- Determining the need for ethical review: a three-stage Delphi study