Medicines: Clinical Trials
These regulations affect anyone conducting a Clinical Trial in the UK. The purpose of these regulations is to protect the rights, safety and well being of participants in research and ensure that the results from research are both robust and credible.
The UK legislation is based on the European Clinical Trials Directive which aims to harmonise the regulation of clinical trials across the EU. The European Commission has consulted twice over the last two years on the impact of this directive and proposals to improve it. The plan is to publish the final proposals mid 2012.
However we still want to hear your views on what you would like to see to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, and maintain necessary safeguards and legal protections. You can find the regulations that relate to Clinical Trials to the left below.
Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031
Implements the Clinical Trials Directive, which sets out approximation of the laws, regulations and administrative provisions of the Member States relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, SI 2006/1928
Implements the Clinicial Trials Directive by: setting out fee requirements and arrangements for payment for Clinical Trial Authorisations; principles and guidance for good clinical practice; and provisions on sponsors of Clinical Trials.
Medicines for Human Use (Clinical Trials) Amendment (No 2) Regulations 2006, SI 2006/2984
Amends the Clinical Trial Directive in that incapacitated adults cannot be included in a clinical trial of a medicine without the consent of a legal representative unless certain conditions are met.
Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008, SI 2008/941
Amends the authority and involvement of the Gene Therapy Advisory Committee (GTAC) and the provisions relating to ethics committees for a clinical trial application; changes the requirements for minors participating in trials; and states that record keeping by hospital blood banks must be similar to that of blood establishments.
Tell us what you think should happen to these regulations and why, being specific where possible:
- Should we scrap them altogether?
- Could their purpose be achieved in a non-regulatory way (eg through a voluntary code?) How?
- Could they be reformed, simplified or merged? How?
- Can we reduce their bureaucracy through better implementation? How?
- Can we make their enforcement less burdensome? How?
- Should they be left as they are?