The new clinical trials regulations will offer sponsors of clinical trials that meet certain conditions the option to use simplified arrangements for seeking and evidencing informed consent.
The conditions that clinical trials will need to meet are:
- the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, is authorised for use in the United Kingdom and is used in accordance with that authorisation
- the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, is given to the participant in the course of that participant’s routine health care
- the participant receives no additional medication and undergoes no additional intervention or diagnostic procedure, solely for the purposes of the clinical trial
If a sponsor is planning to use simplified arrangements, these will need to be detailed in the protocol. The sponsor will need to include:
- the reason for obtaining consent using simplified arrangements
- the information to be provided to the participant, and the means of providing that information
- the means by which consent shall be evidenced
What guidance is currently available for consent arrangements in clinical trials?
We recommend you continue to use our existing guidance on applying a proportionate approach to the process of seeking consent.
The new legislation is designed to reduce burden and increase flexibility while safeguarding participants. We want to see greater adoption of this proportionate approach, which is supported by the new legislation for the benefit of patients.
This guidance should be read in conjunction with the HRA’s informing participants and seeking consent guidance which provides more detailed information on consent, and how to prepare documents to support the informed consent process.
Ongoing work to support simplified arrangements for consent in clinical trials
We're in the process of developing a series of principles on simplified arrangements for consent to support important clinical trials on existing medicines, while maintaining public trust.
The principles will provide guidance for those looking to use simplified arrangements and assist Research Ethics Committee (REC) members in evaluating the ethical considerations of using simplified arrangements.
To help advise on the development of the principles, we're establishing an advisory group. The group will include HRA staff, members of RECs, members of the HRA Community Committee, and researchers and sponsors. Collectively, the group will have expertise in informed consent, ethics, and UK legislation, as well as experience of managing and taking part in clinical trials