The NHS Health Research Authority has launched an advisory group on simplified arrangements for consent in low-intervention clinical trials.
The NHS Health Research Authority, which protects and promotes the interests of patients and the public in health and social care research, has established an advisory group to help develop a set of principles for simplified arrangements for consent in low-intervention clinical trials.
The group has been set up as part of the authority’s work on amended clinical trials regulations, which come into force at the end of April next year.
Updated regulations will offer sponsors of clinical trials on existing medicines that meet certain criteria the option to use simplified arrangements for seeking and evidencing informed consent.
It will provide guidance for those looking to use simplified arrangements and will assist research ethics committee members to evaluate the ethical considerations of using simplified arrangements.
The advisory group, which met for the first time in October, is made up of 12 members and includes HRA staff, research ethics committee members, legal experts, researchers and sponsors, and members of the public. Collectively, the group has expertise in informed consent, ethics, and UK legislation, as well as experience in managing and taking part in clinical trials.
The advisory group will meet four times up until early next year to discuss and develop the principles, with input from the review network throughout the process.
The final set of principles is expected to be developed by spring next year, ahead of the amended regulations coming into effect.
