The UK policy framework for health and social care research sets out 19 principles of good practice in the management and conduct of health and social care research in the UK.
These principles protect and promote the interests of patients, service users and the public in health and social care research by describing ethical conduct and proportionate, assurance-based management of health and social care research to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.
Quality research culture
Some of the principles and requirements set out in the UK policy framework are clear-cut. Many require judgement and interpretation. It is therefore essential to understand the standards, principles and requirements and apply them correctly.
Some of the key elements of a quality research culture are:
- Respect for participants' dignity, rights, safety and wellbeing
- Valuing the diversity within society
- Personal and scientific integrity
- Leadership
- Honesty
- Accountability
- Clear and supportive management
- Openness
RG standards
- Principle 1: Safety
- Principle 2: Competence
- Principle 3: Scientific and Ethical Conduct
- Principle 4: Patient, Service User and Public Involvement
- Principle 5: Integrity, Quality and Transparency
- Principle 6: Protocol
- Principle 7: Legality
- Principle 8: Benefits and Risks
- Principle 9: Approval
- Principle 10: Information about the Research
- Principle 11: Accessible Findings
- Principle 12: Choice
- Principle 13: Insurance and Indemnity
- Principle 14: Respect for Privacy
- Principle 15: Compliance
The safety and well-being of the individual prevail over the interests of science and society.
All the people involved in managing and conducting a research project are qualified by education, training and experience, or otherwise competent under the supervision of a suitably qualified person, to perform their tasks.
Research projects are scientifically sound and guided by ethical principles in all their aspects.
Patients, service users and the public are involved in the design, management, conduct and dissemination of research, unless otherwise justified.
Research is designed, reviewed, managed and undertaken in a way that ensures integrity, quality and transparency.
The design and procedure of the research are clearly described and justified in a research proposal or protocol, where applicable conforming to a standard template and/or specified contents.
The researchers and sponsor familiarise themselves with relevant legislation and guidance in respect of managing and conducting the research.
Before the research project is started, any anticipated benefit for the individual participant and other present and future recipients of the health or social care in question is weighed against the foreseeable risks and inconveniences once they have been mitigated.
A research project is started only if a research ethics committee and any other relevant approval body e.g. the HRA, the Administration of Radioactive Substances Advisory Committee (ARSAC), the Human Fertilisation and Embryology Authority (HFEA) or the Medicines and Healthcare products Regulatory Agency (MHRA) have favourably reviewed the research proposal or protocol and related information, where their review is expected or required.
In order to avoid waste, information about research projects (other than those for educational purposes) is made publicly available before they start (unless a deferral is agreed by or on behalf of the research ethics committee).
Other than research for educational purposes and early phase trials, the findings, whether positive or negative, are made accessible, with adequate consent and privacy safeguards, in a timely manner after they have finished, in compliance with any applicable regulatory standards, i.e. legal requirements or expectations of regulators. In addition, where appropriate, information about the findings of the research is available, in a suitable format and timely manner, to those who took part in it, unless otherwise justified.
Research participants are afforded respect and autonomy, taking account of their capacity to understand. Where there is a difference between the research and the standard practice that they might otherwise experience, research participants are given information to understand the distinction and make a choice, unless a research ethics committee agrees otherwise. Where participants’ explicit consent is sought, it is voluntary and informed. Where consent is refused or withdrawn, this is done without reprisal.
Adequate provision is made for insurance or indemnity to cover liabilities which may arise in relation to the design, management and conduct of the research project.
All information collected for or as part of the research project is recorded, handled and stored appropriately and in such a way and for such time that it can be accurately reported, interpreted and verified, while the confidentiality of individual research participants remains appropriately protected. Data and tissue collections are managed in a transparent way that demonstrates commitment to their appropriate use for research and appropriate protection of privacy.
Sanctions for non-compliance with these principles may include appropriate and proportionate administrative, contractual or legal measures by funders, employers, relevant professional and statutory regulators, and other bodies
Principles that apply to interventional health and social care research
The following principles apply to interventional research only, i.e. where a change in treatment, care or other services is made for the purpose of research:
Principles 16 and 17
The intended deviation from normal treatment, care or other services is adequately supported by the available information (including evidence from previous research).
The research proposal or protocol and the participant information sheet explain the special arrangements, if any, after the research intervention period has ended (e.g. continuing or changing the treatment, care or other services that were introduced for the purposes of the research).
Principle 18: Integrity of Care Record
All information about treatment, care or other services provided as part of the research project and their outcomes is recorded, handled and stored appropriately and in such a way and for such time that it can be understood, where relevant, by others involved in the participant’s care and accurately reported, interpreted and verified, while the confidentiality of records of the participants remains protected.
Principle 19: Duty of Care
The duty of care owed by health and social care providers continues to apply when their patients and service users take part in research. A relevant health or social care professional (Who may or (particularly where the research team is not local to the research site) may not be a member of the research team) retains responsibility for the treatment, care or other services given to patients and service users as research participants and for decisions about their treatment, care or other services. If an unmanageable conflict arises between research and patient interests, the duty to the participant as a patient prevails.