If your research project involves direct contact with patients, the Research Ethics Committee will want to know how you intend to identify potential participants. There are a number of things to consider including confidentiality and information governance.
If you are identifying patients as potential study participants that you already treat or care for, there is no issue, as these people will know who you are and will not be surprised to be approached by you. However, if you want to identify and contact other patients with a particular condition, you will need a legal basis for accessing their medical notes. Alternatively somebody that does have an appropriate legal basis (such as a member of their care team) can do this on your behalf.
Many researchers and organisations are setting up so called ‘consent to be approached’ or ‘consent for consent’ registries/databases of people who are willing to be contacted about opportunities to take part in research including clinical trials. This allows research active organisations to be ready to contact patients with particular conditions as soon as they know that a relevant trial wishes to recruit at their site. Patients who agree to be contacted directly by researchers will still be asked to consent to taking part in the clinical trial in the usual way.
We will be issuing
guidance on this subject shortly.