Practice research projects

08 October 2019

Q. Do I need a patient's consent to enrol them in research projects?

The capture and sharing of a patient's clinical information for research purposes should be anonymised. Exceptions to this arise where legislation is in place to allow analysis and research on patient-identifiable information. Examples of this include the National Cancer Registry and infectious disease regulations. Where research involves identifiable patient clinical information, explicit consent must be sought by the GP and documented in the patient's record. Where extracted data is anonymised, it is no longer personal data and data protection regulations do not apply. It will be a matter for each GP to carry out an assessment in this regard and review that assessment periodically to ensure that the data remains anonymous or unlikely to be re-identified.

In general, the concept of data minimisation and anonymisation should be maintained. Where informed patient consent is used as the legal basis for research, the data controller must be able to demonstrate that consent has been forthcoming and must allow for the right of the patient to withdraw consent at any time. Researchers must comply with the Health Research Regulations 2018. 

With modern technology evolving, we are more likely to take photographs or even videos of patients to improve our referrals and sometimes for research and presentations. If you take pictures of patients, it is essential to have clear informed consent for taking the images. You need to give an assurance that the photo will only be copied into their medical notes and not left on the camera or downloaded to any other medium. If you plan to include this media in research for publication or presentation, then you need to get signed consent from the patient outlining what you propose to do with the images or video.