Data Protection and Information Governance

Research active sites and practices are required to provide information to their patients about their research activities in order to meet transparency requirements under the Data Protection Act 2018. This can be done in a number of ways:

Website

It is suggested that you ensure transparency information with respect to research is included on your website. The Health Research Authority has provided transparency wording for NHS sites and we recommended you link to this information from your website.

New Patient Material

We suggest you include a statement to be clear that:

• • Your practice is research active;

  • You may be invited to take part in research; and

  • Your patient records may be reviewed to check whether you are suitable to take part in a research study before asking you whether you are interested or sending you a letter on behalf of the researcher, together with a link to the transparency information on the HRA website.

Poster in waiting areas

It is suggested you include a poster in a prominent place in your patient waiting area(s) to highlight that your practice/site is research active. We have developed a poster in conjunction with CRN East of England and the Cambridgeshire and Peterborough CCG Research Office which you can use for this purpose. If you would like a hard copy version please email NWICB.RandDoffice@nhs.net.

Screening of Notes to identify patients for research

A number of research studies require patients’ medical records to be reviewed to identify whether patients are suitable to take part in research. Where appropriate transparency information is in place, it is acceptable for individuals within a patient’s care team to undertake this activity.

Honorary Research Contracts (HRC) do not provide a mechanism for access to confidential patient information without consent. Access to confidential patient information, either with patient consent or statutory support, does not require a HRC (see the guidance on Letters of Access/Honorary Research Contracts).

A guidance note on Access to patient notes for Research Purposes which includes further guidance on screening of patient notes is available here.

Please direct any queries to NWICB.RandDoffice@nhs.net.

We have also produced a leaflet for patients Your Role in NHS Research which gives potential participants general information about taking part in research.

UK Policy Framework for Research

The UK Policy Framework for Health and Social Care, published in October 2017, sets out the principles of good practice in the management and conduct of health and social care research in the UK and the responsibilities of the parties involved. These principles protect and promote the interest of patients, service users and the public.

Practices and sites need to be aware of their responsibilities as a Research Site; Research Team Members and Employers of Research Teams.

An information sheet on the UK Policy Framework has been produced for General Practices, and for Providers.

Am I covered? A new indemnity scheme for GPs in England

The Clinical Negligence Scheme for General Practice (CNSGP) is a new state backed indemnity scheme which comes into effect from 1st April 2019. The CNSGP covers clinical negligence liabilities for general practice in England, including any negligence in relation to delivering research. However, it does not cover the risks from the design of research, which is expected to be covered by the study sponsor. GPs would need alternative cover arrangements if sponsoring research studies.