Good practice in research: Scope of the guidance

1. Research in this guidance refers to an attempt to derive generalisable new knowledge. Research aims to find out what is best practice by addressing clearly defined questions with systematic and rigorous methods. It includes studies that aim to generate hypotheses as well as those that aim to test them.

2. This guidance covers research with people, as well as research involving human tissue and records-based research that does not involve people directly.

3. It also applies to clinical trials, which cover a broad range of different types of research involving people.For example, they can test medicines or vaccines, treatments, surgical procedures, devices, or health prevention or care. A clinical trial of investigational medicinal products is a particular type of trial that is governed by legislation. The key elements of the law for conducting a clinical trial of investigational medicinal products in the UK are set out in annex B.

4. This guidance does not apply to clinical audit or service evaluation projects, which aim to measure standards of care.5 Nor does it cover innovative treatments designed to benefit individual patients. These activities are covered by the standards and principles set out in Consent: patients and doctors making decisions together and Confidentiality: good practice in handling patient information

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