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UK Proposes Simplified Consent Method For Low-Risk Trials

 
• By Vibha Sharma

The UK’s proposed approach to recording informed consent for lower-risk trials is designed to ensure that patients still receive the critical information they need to consider participation, but are supported to give their consent in an easier way.

Medical Informed Consent , Information of treatments and risks agreement
The UK Supports Flexibility On Consent Provisions For Lower Risk Trials (Shutterstock)
Key Takeaways
  • The Health Research Authority is gathering feedback on the UK’s proposal to simplify the process of seeking and recording consent in low-risk clinical trials.
  • Currently, in low-risk trials, prescribers and participants read, review and sign the consent form.
  • Under the revised approach, the participant will still receive all the necessary information to take part in the study, but will no longer have to sign a consent form.
  • Instead, the prescribers will be allowed to document consent in the participant's medical records.
  • Study sponsors will have to justify in their regulatory and ethics applications why they chose to use the simplified approach.

The UK’s Health Research Authority is inviting stakeholder feedback on plans to simplify the current process of seeking and recording informed consent in low-risk clinical trials by allowing the drug

The proposed process is designed to reduce the burden on potential participants, as they would no longer have to fill out and sign a consent form

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