Regulatory Support Centre
Providing support and guidance for those conducting research with human participants, their tissues or data.
Change is coming:
• The Data Protection Regulation (including amendments proposed by the rapporteur of the LIBE committee) has been approved by European Parliament's LIBE committee (the first step towards full approval by the European Parliament). All those working with Section 251 approval should visit the Wellcome Trust website to understand potential impact.
• The Public Health Committee endorsed a draft of the Clinical Trials Regulation at the end of May. For more please see the European Parliament’s website
• Both the HTA and HFEA will be retained as independent regulators. However, legislative changes may still be coming - see DH website
Watch this space for further updates.
New Research Data and Confidentiality e-learning