The Guidance on Information Principles for Consent has been drafted by the Department of Health as a guide to assist researchers.
It is not a legally binding document, nor is it intended to be a complete and mandatory list of principles that must be addressed in patient information leaflet for the purposes of obtained consent.
Three key points are set out in the document;
- The onus is on the health researcher to (a) justify what information is or is not provided and (b) ensure that the data subject is not surprised by any use or disclosure of his or her personal health data by the researcher.
- The researcher must always ensure that the language used avoids jargon and is easy to comprehend by the data subject.
- The information provided should be written from the perspective of the data subject and not the researcher.
A researcher can further consult the WP29 guidance on transparency
A researcher can further consult the WP29 guidance on consent.
Researchers should review existing consent and information documents to determine if the information is aligned with the guideline of information principles that reflect data protection compliance under GDPR and the Health Research Regulations.
Researchers should consult with their Data Protection Officers (DPOs) or Research Ethic Committees (RECs), as appropriate.