RESEARCH ROADMAP

What approvals do I need?

The approvals you will need depend on what type of project you are carrying out.

Is your project research or a project aimed at improving the quality of clinical practice such as a Service Evaluation, Audit or Quality Improvement project?

Checking you have the consent you need

Approvals for Service Evaluations, Clinical Audits or Quality Improvement projects are granted locally by Solent NHS Trust and further information is available by emailing clinicalaudit.evaluation@solent.nhs.uk

If you are a member of Solent NHS Trust staff, further information about non-research projects (eg. Service Evaluation) can be found on SolNet.

Approvals for research projects

The following section provides information on the approvals required for carrying out research in an NHS setting such as Solent NHS Trust. However before thinking about what approvals you may need you will first need to identify a sponsor for your project.

The sponsor

The sponsor is responsible for initiation, management and financing (or arranging the financing) of the research. However in reality the sponsor usually delegates specific responsibilities to any other individual or organisation that is willing and able to accept them, such as the individual researcher or research team. The sponsor also provides the indemnity insurance for the research. If you are undertaking your research as part of an educational course such as a masters or PhD the university you are studying with will act as your sponsor. Each university will have a different way of applying for sponsorship, usually through their institutional ethical approval process. Your university supervisor should be able to provide you with more information about this process. If you are employed by Solent NHS Trust and are undertaking your project independently the Trust may be able to act as your sponsor. In this case you will need to contact the Research and Improvement team to discuss your project. More information can be a found about research roles and responsibilities on the Health Research Authority (HRA) website. What approvals do I need for a research project?

What approvals do I need for a research project?

If you are going to be doing a research project within Solent NHS Trust you will need a number of different approvals before you can start. The main approvals you might need are: Health research Authority (HRA) approval, Research Ethics Committee (REC) approval, Solent NHS Trust sign off. Some specific studies may need additional approvals depending on what the research involves. You can find out more about these types of approval on the HRA website.

Health Research Authority (HRA) Approval

The HRA are the Health Research Authority and their main purpose is to protect and promote the interest of patients and the public in health and social care research. The HRA was created to streamline the regulation of NHS research. The HRA review and assess all research being undertaken in an NHS setting. HRA approval comprises a review by an NHS Research Ethics Committee (REC) (where required) as well as an assessment of regulatory compliance on behalf of the NHS organisations involved. The HRA will work with Solent as the hosting NHS organisation to ensure it is safe and possible to undertake your proposed research within the trust. However you should also contact the Solent Academy of Research and Improvement to introduce us to the study so we can assist you with this process. All research being carried out in an NHS setting requires approval from the Health Research Authority (HRA). Some projects will also require additional approval from a Research Ethics Committee (REC).

Research Ethics Committee (REC) Approval

You may be undertaking a project which needs to be reviewed by an NHS REC. The REC review gives an opinion about the proposed participant involvement and whether the research is ethical. However, not all projects need to be reviewed. To find out about whether your project requires a review by an ethics committee you can use the online decision tool to help you decide. If you are still unsure you can find more resources to help you decide on the HRA website, or you can contact the Academy of Research and Improvement for advice.

The HRA Website

Visit the HRA Website - https://www.hra.nhs.uk/approvals-amendments/what-approvals-do-i-need/ If you are undertaking social care research there is specific guidance about the ethical review of social care research available on the HRA website.

Proportionate Review

Some studies can gain ethical approval using the proportionate review system. This service provides a fast and proportionate review of certain low risk research projects. The service aims to review studies and provide a final decision within 14 days of submitting an application. The review is undertaken by a REC subcommittee via email/teleconference instead of at the full committee meeting, however it is as rigorous as a full review and will not affect the decision given. To use the proportionate review service your study should have no material ethical issues i.e. there is minimal risk, burden or intrusion for the participants. When you submit your IRAS application you will be notified whether proportionate review is an option for your study. For more information see the HRA guidance.

Solent NHS Trust sign off

The final approval you will need is confirmation of capacity and capability from Solent NHS Trust. Once all your national approvals are in place Solent will need to review everything. We will sign off a document called the Statement of Activities and issue you a final confirmation email. However, you should feel free to contact us as at any point in the approvals journey for support, early involvement by our team can speed up the approvals process.

Starting your application

Whatever the combination of approvals you need they can all be applied for using an online portal called the Integrated Research Application System (IRAS). You can register for an account at www.myresearchproject.org.uk. Follow on down the road map for further help on how to complete your application using this portal.

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