Transparency
Under the new regulations, for the first time it will be a legal requirement to register clinical trials in a World Health Organization (WHO) recognised public register, and to publish a summary of results within 12 months of the end of the trial.
Offering to share trial findings with participants in a timely way, and in language which they can understand will also be required by law.
Simplified means of seeking and recording consent
The updated regulations also include the ability to use simplified means of seeking and recording consent in ‘lower risk’ trials. These are trials involving medicines that have already been approved and therefore pose minimal risk to participants.
Our informal consultation asking for feedback on how this new simplified means of seeking and recording consent will work in practice is still open.
Research Ethics Committees
The 2004 regulations contained specific requirements for the make-up of Research Ethics Committees (RECs) and how these groups function.
We received feedback that these requirements have been restrictive.
The new regulations have removed the specific requirements and replaced them with a new provision on how an ethics committee should be constituted, aligning with international good clinical practice standards ICH-GCP E6.
This will give RECs greater flexibility to meet demand and respond to particular situations while still meeting international standards.
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