Guidance for general practices/sites hosting research
Guidance for General Practices about restarting research activities paused due to COVID-19
Most research, apart from national priority COVID-19 studies was either paused or delayed in light of the COVID-19 pandemic in line with the suspension of many routine NHS services. As the pressure on the system has begun to ease, researchers, Sponsors and the NIHR have started looking at how studies can be reinitiated, and a framework for restarting research was published on 21 May 2020. The RESTART Framework sets out the basis for prioritisation and decision making.
An information sheet for GPs can be found here.
Practice Payments for Research in CRN:Eastern
Many research studies come with funding attached.
For studies supported by CRN Eastern, monies associated with the study will be paid in accordance with the detail given on the Study Summary Document provided by CRN Eastern. This will include details of amounts and payment mechanisms.
For studies not supported by CRN Eastern, any monies payable will usually be detailed in an agreement directly with the research sponsor which will give details of invoicing/payment processes.
Quarterly payments for CRN Eastern supported studies, CRN Eastern operates a quarterly payment system for practices – further guidance can be found here.
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:
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 Eastern 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 NWCCG.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 NWCCG.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.
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.