Regulatory Support Centre
Providing support and guidance for those conducting research with human participants, their tissues or data.
Change is coming:
• Last December informal agreement was reached on the text of the European Clinical Trials Regulation. Once fully approved, it’s anticipated that the regulation will apply from mid-2016. For more please see the European Parliament’s website
• There are concerns around the Data Protection Regulation and amendments that have been adopted by the European Parliament. The MRC website provides further detail.
• Both the HTA and HFEA will be retained as independent regulators. However, legislative changes may still be coming – see the McCracken review
Watch this space for further updates.
New Research Data and Confidentiality e-learning