Getting an NHS Study Approved

Getting the Ball Rolling...

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In the United Kingdom, the National Health Service (NHS) plays a major role in the governance and approval of clinical trials. The NHS is involved in various stages of the clinical trial process, ensuring that research involving human participants is conducted ethically, safely, and in compliance with regulatory standards. It's important that such research is monitored or assessed sufficiently enough that participants health, safety and wellbeing can be ensured.

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Before your study can get greenlit, you'll need a few things to provide evidence that you can run the study effectively and safely. Here are a few essentials:

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• Research Ethics Committee (REC) approval
• Informed Consent Documents
• Advertising Material
• Protocol
• IMP Dossier
• Clinical Trial Agreement
• Data Management Plan
• Site-specific Information

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REC Approval

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A REC will comprise of people of many backgrounds. Lay persons, as well as people familiar with clinical trials operations and regulations. This team will assess your protocol, documents and plans, and determine whether your study is ethical and doesn't involve any harm or coercion of participants.

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Informed Consent Documents

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While the study might have been greenlit by the ethics committee, you will also need to show that you can provide your prospective participants with enough information so that they are informed of all the risks and potential benefits of being involved in the study. Full transparency is key to getting participants onboard safely.

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Advertising Material

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In order to get participants, you will need to advertise your study somehow. These days this can take many forms, and many organizations will advertise studies on social media (e.g. Facebook, LinkedIn, X [formerly Twitter] or Instagram). Demonstrating that you can potentially recruit - if you are to do this yourself - in an honest and transparent way without misleading potential participants will be useful. Provide enough information about the study for them to gain interest, without going into too much detail.

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Protocol

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The most comprehensive document in your study will be your protocol. It will outline the study, design, objectives, methodology, statistical analysis plan and criteria for the subject selection.

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IMP Dossier

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Be sure to include an Investigational Medicinal Product (IMP) dossier that provides comprehensive information about the investigational product, manufacturing details, and quality control measures.

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Clinical Trial Agreement (CTA)

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The CTA is a legally binding agreement which will manage the relationship between the sponsor and the organisation conducting the study. The sponsor will typically be the funder and will have a vested interest in the study (E.g. owning the product or intellectual property which is to be tested). The CTA will outline any responsibilities in addition to instructions for the data, results and publication of the study outcomes. The CTA will also outline any financial, insurance or reimbursement conditions. This document is essential in ensuring that, in addition to participants, all personnel working on the study are legally protected.

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Data Management Plan

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With the provision of more and more digital systems which are used to gather data in clinical investigations, what these data are, where it is stored and who is responsible for processing and controlling these data are key. You will likely need to collect some personally identifiable information (PII) and protecting this from potential leaks is a must. Principles of GDPR will come into play, so ensure that you are aware of your responsibilities. You should ideally have a Data Protection Officer that you can speak with.

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Site-specific Information

What are the sites that are involved in the study? Will participants be visiting? You will need to provide information on what the sites are and if they are suitable for your proposed work. Include any information which describes facilities that are available, in addition to any certifications that are required of that location, and qualifications of staff that might be required.

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These are just a small number of critical items that can help you get your study off the ground as quickly as possible when you are needing NHS approval for your work. You'll want to complete your study in a timely manner to avoid delay, avoid additional costs, and the risk of things changing which will need re-review and re-approval which will drag out your timelines.