Researchers should not waste time completing inappropriate training, according to updated HRA guidance. Instead, researchers should be appropriately trained by qualifications and experience for their role.
Our joint statement with the
& Healthcare products Regulatory Agency (MHRA) advocates
a proportionate approach to the application of Good Clinical Practice (GCP) to
researcher training. It has been created in partnership with the Devolved Administrations and is supported by a number of organisations including the Academy of Medical Sciences and the Ethical Medicines Industry Group.
GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
Amanda Hunn, Joint Head of Policy, HRA
“Those conducting clinical trials of investigational medicinal products (CTIMPs) must comply with the high level conditions and principles of GCP, but there is no legal requirement for other types of research to do so.
Such research should be conducted in a manner that provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data is reliable – but this can be achieved through means that are appropriate and proportionate to the activities being undertaken.
Different types of research may require different training, and some researchers are already well trained and competent in their area of expertise. Some researchers doing other types of clinical trials may also benefit from undertaking GCP training but other training may be more relevant.
We aim to make the UK a great place to do health research, with the view to ultimately improving the nation’s health. In order to achieve this, we are constantly streamlining the process of applying for research approval and making our procedures as simple and straightforward as possible – with this measure being just one example.
We have also listened to our key stakeholders, many of whom have told us how frustrating it can be to spend valuable time completing training they do not need.
However, we are also aware that we need to make clear what our statement means in practical terms for researchers, which is why we met with the Medical Research Council, NIHR and the NHS R&D Forum recently to consider whether current GCP training offered to researchers is supporting the production of valid and credible data, and the provision of adequate protections to the rights, dignity and well-being of research participants.”
You can download the HRA / MHRA statement on Good Clinical Practice training here.
The statement has been supported by the Academy of Medical Sciences, the Ethical Medicines Industry Group, the Faculty of Pharmaceutical Medicine, the HFEA, HTA, Royal College of GPs, Royal College of Radiologists and UKCRC.