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Ethical Approval

Before a study can go ahead, it has to be given ethical approval. This means that the study must conform to the relevant ethical guidelines. Generally speaking, this means that the study must be in the public interest, and that there is not a significant risk of the study causing harm or distress to the participants involved in the study. It also involves checking that any data will be stored securely, and (ideally) that participants remain anonymous and cannot be identified from their responses.

 

Since our study involves gathering participants’ health data from their GPs, we had to obtain ethical approval from the Scottish National Health Service (NHS). This involves three stages:

 

1. Sponsorship approval

 

A Sponsor is an institution or organisation that takes on the legal responsibility for the initiation and management of the research study. A study’s Sponsor is not necessarily the same as its funder. In our case, the project is funded by theEconomic and Social Research Council (ESRC), but is co-Sponsored by The University of Dundee (our University) and NHS Tayside (our local branch of the NHS).

Our Sponsorship approval was managed by The Tayside Science Centre (TASC), which is situated at Ninewells Hospital in Dundee. TASC is a joint enterprise between the University of Dundee and NHS Tayside, and is part of the Eastern node of the Scottish Academic Health Science Collaboration (SAHSC). 

 

2. Research Ethics Committee (REC) approval

 

The National Research Ethics Service (NRES) - which is the core function of the Health Research Authority (HRA) - is committed to enabling and supporting ethical research to maximise the benefits of research in the UK. This includes a number of Research Ethics Committees (RECs) whose aim to safeguard the rights, safety, dignity and well-being of people participating in research in the NHS.

NRES RECs review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical. NRES RECs are entirely independent of research Sponsors and investigators.

 

There are several RECs in Scotland. Each of four regional Research Ethics Service centres (North, South-East, East, and West, each of which has a Scientific Officer, coordinator, and REC assistants) includes a number of RECs. For instance, NHS Tayside’s REC is included in the East of Scotland, while NHS Lothian’s REC is included in the South-East of Scotland.

 

Our project was submitted to, and approved by our local REC, the East of Scotland Research Ethics Service (EoSRES) REC 1. This REC is based in the TASC building at Ninewells Hospital. 

 

3. NHS Research & Development (R&D) Management Approval

 

Our project was also submitted to, and approved by NHS Research & Development (R&D). Since our study is multi-centre (involving NHS Tayside and NHS Lothianpatients), we had to get approval from both of these NHS branches. To do this, we submitted all our documents to the North of Scotland Research Ethics Service (NRES), who liaised with both branches. We also had to submit an R&D form, which contains similar questions to the REC form, and a Site-Specific Information (SSI) form, which asks questions about the two GP practices from which we are collecting data. 

 

R&D Management Approval is required from all NHS organisations hosting research studies involving NHS patients, their tissues, their data, or NHS resources. Approval provides insurance/indemnity for research studies under the Clinical Negligence and Other Risks Indemnity Scheme (CNORIS). 

 

After completing these three stages, our project obtained NHS ethical approval. Finally, we had to liase with NHS lawers in order to draw up a GP contract. This explains the role that the GPs will play in the project, and outlines their study-related duties. The GPs involved in the study had to sign the contract before research could commence. 

 

Scottish School of Primary Care and the Health Informatics Centre

We also contacted the Scottish Primary Care Research Network (SPCRN) and the Health Informatics Centre (HIC) at the University of Dundee School of Medicine.SPCRN and HIC can assist researchers (and the GPs involved in the research) by going into the relevant GP practices and helping to obtain patient lists, contact patients, extract patient records, etc.

 

 

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