This section of the framework is wide ranging and includes: independent ethical review; informed consent; valuing patient diversity; patient confidentiality; data protection; use of tissue or organs; the use of animals; and involvement of patients in research. The guiding principle is that the dignity, rights, safety and wellbeing of participants must be the primary consideration in any research study.

The requirements for the ethical review of research and participant consent are covered in Chapters 10 and 11.

This part of the framework aims to ensure that all new research builds on the learning of previous work and will add something new and useful to the body of knowledge once complete. Thus, adequate review of the relevant literature is vital. Reviewing the literature is covered in Chapter 4.

The framework also makes clear that peer review by experts in the relevant fields is essential for all research to maintain scientific quality. The level of peer review should reflect the size of the study and its inherent risks. For example, a large and expensive clinical trial is likely to need review by an external panel of experts, whereas small unfunded projects could be reviewed by one or two people within the organisation. The arrangements will vary locally but there should be a system for peer review available.

This section of the framework covers the use and dissemination of information arising from the research. The general principle is that all results should be made freely available subject to appropriate scientific review, and also be in a format understandable by the general public. The framework recognises that there may be issues around intellectual property or possible commercial development of the results of research and allows flexibility in the timing of the publication of results.

The framework emphasises the importance of health and safety regulations. You must make sure you are following all health and safety guidelines in force in your organisation. We are all responsible for our own and others’ safety, and should act with this in mind. If you need to undertake any specific activity or procedure make sure you have been trained to do so in a safe manner, and understand the relevant health and safety regulations, such as regulations for working in a laboratory, taking blood, or operating equipment.

The framework underlines the need for compliance with the law and with the rules set out by HM Treasury for the use of public funds. It covers guidance on intellectual property rights, and it also covers the issue of indemnity against negligent and non-negligent harm to research participants, which is required to protect participants in trials. Research run within the NHS is covered by the standard complaints procedure, and the patient information sheet must include the indemnity procedure for the research. Sample wording is given in the National Ethics Research Service guidance (for website address see resources section).

If your research is being run in collaboration with an academic or commercial organisation there will be different indemnity arrangements. The National Research Ethics Service form asks for details of these, which you should be able to obtain from your local research services office or other management department.

The framework recognises that although some parts of its guidance are clear and unequivocal, other parts require interpretation and judgement. In order to carry out high quality research that will meet all other requirements of the governance framework, strong research leadership and expert management is required. To engender an environment that will nurture excellence in research the following are listed as key principles:

Respect for participants’ dignity, rights, safety and wellbeing

Valuing diversity within society

Personal and scientific integrity, honesty and accountability

Clear and supportive management and leadership

A culture of openness