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Regulatory Support Centre

Providing support and guidance for those conducting research with human participants, their tissues or data.

RSC News:

Participant Information Sheet guidance (version 1) is now available from the HRA website it joins Do I need NHS REC approval as an output from our secondment with the HRA.

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
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