In most cases you will need the patient’s prior consent – commonly known as ‘opt-in’. If obtaining this is impossible, or requires disproportionate effort, you may reuse the patient data provided the research project serves a public interest and patients have not objected (opted-out) to the use of their data for scientific research purposes.  

There are strict criteria to meet for circumstances to qualify as disproportionate effort: e.g. there are no patient contact details available, or you’re dealing with a huge dataset. In such cases, you must include sufficient safeguards to guarantee that the privacy of the data subjects isn’t disproportionately harmed. 

It depends on how you ask, or asked, patients for consent. To avoid seeking specific consent prior to every research project, you can request consent in more general terms for future scientific research. This is often referred to as ‘broad consent’, which is defined below. The bottom line is that if the consent you obtain, or have obtained, does not adequately cover the use of patient data for your research project, you will have to go back to your (former) patients to ask for consent, unless this is impossible or requires disproportionate effort. 

Broad consent is an alternative to study-specific consent that can be used if identifying every conceivable type of research that you might conduct is neither possible nor desirable. For example, you may consider seeking consent for the reuse of patient data for research in one or more clearly and well-defined areas, instead of a single specific project. However, this request must be specific enough to be valid. To satisfy the consent requirement, broad consent must include a general description of the types of research that might be conducted, and the information provided must be sufficient for a reasonable person to conclude that they would consent to the potential research: e.g. ‘I consent to using my health data for future scientific research projects into the genetic factors of breast and lung cancer’.