Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential effect of the MHRA offering training to researchers on how to introduce flexibility into the protocol of trials on (a) patient safety and (b) compliance with ethical research practices.

The Medicines and Healthcare products Regulatory Agency (MHRA) supports the inclusion of flexibility in clinical trial protocols to enable research to be conducted efficiently but without compromising participant safety. The MHRA has published guidance on building flexibility and resilience into clinical trial protocols and provides regulatory and scientific advice to researchers on flexible and innovative trial design.

In October 2020, the MHRA hosted a two-day workshop for researchers, industry and academia on novel trial designs. While an official assessment of the impact of further training in this area has not been made, the MHRA will continue to support researchers via its innovation services. Compliance with ethical research practice falls within the remit of the United Kingdom’s research ethics services.