‘Caldicott 2’ is the health and social care information governance review being conducted by Dame Fiona Caldicott with a due date for completion this autumn.  The title of the review is ‘Information: to share or not to share?’

I passed by the official website today and noticed that it now has a huge amount of information on there about the review panel membership, process and forthcoming evidence sessions.

Of particular note is the fact that the panel is holding an evidence-gathering session on research on  10th July and have invited submissions on the theme.  The above link will take you to the specific page about the research theme including a comprehensive document outlining the questions on which they are seeking views. This includes a ‘section 6’ which focuses on Patients and the Public and I thought it might be helpful to cut-and-paste these particular questions below:

Patients and the Public

a. What information should patients and the public be given about how their information is used and to whom it may be disclosed? How can we ensure patients and the public are better informed about research and how their information may be used for research?

b. How can patients’ and the public’s views and wishes in relation to the use of personal and confidential data be accommodated? To what extent should patients be able to exercise control over anonymised and pseudonymised data?

c. To what extent should minority views be accommodated within systems?

d. What and how should consent and the withholding or withdrawal of consent be recorded?

e. How granular do you think the consent recording requirements need to be?

f. The UK Life Sciences Strategy has proposed that the NHS Constitution commitments are amended to reflect the presumption that:

• data collected as part of NHS care can be used for approved research, with appropriate protection for patient confidentiality; and
• •that patients are content to be approached about research studies for which they may be eligible, to enable them to decide whether they want a discussion about consenting to be involved.

Patients will retain the right to opt out but it will remove the current requirement for consent for the disclosure of confidential patient information to researchers.

What are your views of these proposed changes to the NHS Constitution? Do you have suggestions for how this might be implemented? Do you have concerns about the ways it might be implemented?

However, I encourage you to look at the full range of questions because many of the others are of relevance.

Details of where to send evidence too can be found here.