In certain scenarios, researchers may need to access CPI to ensure that the individual meets the criteria for clinical trials and interventional studies, for example has a particular condition, has received a specific treatment or is on a certain drug regime. In these scenarios’ researchers must establish the legal gateway before they can identify and approach eligible participants in order to contact them to ask for their consent to participate in their research studies.
Where researchers need to identify people to participate in research studies, the national data opt-out may apply if the research is relying on support under section 251 regulations as the legal gateway to identify the potential research participants.
The impact of the introduction of the national data opt-out on the process to recruit people into research studies should be relatively small as the mechanisms for recruiting potential participants for research studies remain the same.
There are a range of mechanisms available to researchers for recruiting potential participants which are set out in the IG Report 2013: To Share or Not to Share – Information Governance Review, and summarised in appendix 2.