Good practice in research

There are many ways in which patients and the public can take part in healthcare research, whether as study participants, collaborators in study design and delivery, or advisers on research priorities—drawing on their lived experience of health conditions. However, some people are not aware of these opportunities, or may have a poor understanding of what would be involved. Some groups, such as women, children and young people, older people, ethnic minorities, and people with disabilities, are less well-represented in clinical studies and other research activity. This can affect the quality and relevance of research outputs.

To support more people to access and contribute to research, you should:

1. tell patients if you’re aware of opportunities for them to participate in research activities that may be relevant to their condition or of particular interest to them
2. signpost patients to research teams who can provide further information about a specific study
3. signpost patients who express a general interest in research to information on how they can get involved (see Annex B for examples)
4. avoid making assumptions about who may be interested in taking part, or eligible to be involved
5. encourage people from under-represented groups to consider getting involved.

When explaining opportunities that may exist for taking part in research, you must:

1. make clear that participation is voluntary and that deciding to take part (or not) will not affect someone’s relationship with their usual doctor and healthcare team
2. make clear that research is governed by legal and ethical requirements
3. be open and honest about any interests you have in research that may affect (or could be seen to affect) your advice or recommendations.

When healthcare professionals engage with research opportunities as part of their clinical work, there are clear benefits to individual patients, overall patient care, the work of healthcare teams, care organisations, and professionals themselves.⁴ 

You should be willing to offer support to the wider team, to help create a research supportive workplace environment. Depending on your role this might include:

1. sharing information with colleagues about research opportunities
2. identifying possible areas for study and local research priorities
3. supporting and encouraging those you manage or supervise to take part in research
4. supporting the design, funding, or delivery of research
5. ensuring that colleagues from under-represented groups have fair access to research opportunities.

If you’re aware of research findings that could improve clinical practice or service delivery, you should use appropriate opportunities to share this evidence with colleagues.

You must make sure the information you communicate to colleagues about research reports and findings is accurate and gives a balanced view of the evidence.

You must work in line with the Policy Framework established jointly by the Health Research Authority; the health departments in Scotland, Wales, and Northern Ireland; and other national oversight bodies. The Framework includes a description of all the roles that must be in place to support research projects and programmes, and their specific responsibilities.⁵  Many of these responsibilities will be undertaken or supported by healthcare organisations (such as NHS trusts), or by Higher Education Institutions.

The Policy Framework sets out principles of good practice to make sure that research participants are safe; their rights are respected; and the public can have confidence in research integrity and outcomes. ⁶  The principles are consistent with our professional standards.

Research projects are typically scrutinised by funding agencies (typically using external peer review), the Health Research Authority (HRA), the Medicines and Healthcare products Regulatory Agency (MHRA) where appropriate, and by research sponsors (usually the NHS trust or similar organisation). The design of research projects should therefore follow the principles of these organisations.

Proposed research must be scientifically sound, ethical, legal, and seek to maximise the safety of those involved. Good research design ensures a project meets standards for integrity, quality, and transparency, and, where possible and relevant, includes patient and public involvement.

You must make sure the research design ensures the safety, dignity, and wellbeing of participants.

You must make sure that foreseeable risks of research to participants are kept as low as possible. You must be satisfied as far as you can that the anticipated benefits of the research outweigh the foreseeable risks to participants.

When you’re planning research, you must make sure that the proposals or protocols are properly developed, in line with guidance on good practice from the HRA and other approval bodies.⁷ 

Before you submit a proposal or protocol for approval, you should consider whether it pays sufficient attention to:

1. including people from groups that are less well-represented in research
2. ensuring that people who share protected characteristics have equal access to participate and equal opportunity to benefit from the proposed research
3. the perspective of people with lived experience of any condition to be studied.

Before you start your research the proposal or protocol must have received approval by a research ethics committee, or other relevant approval body⁸  – where their review is expected or required.

If you have a designated role in overseeing, sponsoring, or leading research projects, (as set out in the UK Policy Framework), you must take steps to make sure you have the necessary training and support to meet the requirements of the role.

If you lead a research team, you must make sure that all members of the team have the necessary skills, experience, training, and support, to carry out their research responsibilities as effectively as possible.

Whatever your role, you should be satisfied that appropriate monitoring systems are in place to make sure research is being carried out in line with the law, the UK Policy Framework, and clinical practice.

You must be open and honest in any financial and commercial dealings relating to your research and its funding. You must declare any commercial and non-commercial interests that you have in the project, in accordance with local and national governance arrangements.

You must not allow your judgement about the research to be adversely affected by conflicts of interest. You must:

1. take care to identify actual or potential conflicts of interest, including between your responsibilities to participants and the wider public and:
   1. your own interests in the research project
   2. your interests in any of the organisations involved in funding or supporting the project
2. comply with your employing or contracting organisation’s policies, and any external requirements (such as those of research funding or approval bodies, and research ethics committees), for identifying, declaring, and addressing conflicts of interest
3. declare conflicts of interest as soon as possible
4. if you’re unsure whether a particular matter would be seen as a conflict of interest, act as though it is and seek advice from the relevant person or organisation on making a declaration.

You should also take into account any national guidance on the steps that researchers can take to avoid and manage conflicts of interest (see Annex B for examples).

You should act to make sure that commercial and other interests held by members of the research team, or the organisation funding or supporting the research, do not adversely affect the conduct of the research or its completion. If you’re concerned about the effect of interests held by others, you should follow the approach in our guidance on Raising and acting on concerns about patient safety. 

If you approach a patient to discuss the possibility of participating in a research project, you must share with them (or those representing the patient if they are not able to make the decision themselves), the information they need to understand the nature of the research and the benefits and risks of taking part. To do this effectively, you should have sufficient knowledge of the proposed research and its associated benefits and risks.

If you’re responsible for obtaining consent, you must get this from potential research participants who have capacity to decide whether to take part. You must have other valid legal authority before you can involve an adult, or a child or young person, who does not have capacity to give consent to participating.⁹ 

In discussing potential participation, you must follow the guidance in Decision making and consent which promotes a person-centred, proportionate approach to providing information. The guidance makes clear that you must answer questions honestly and accurately, being clear about the limits of your knowledge. You must explain any uncertainties that a patient may want to consider in making their decision. Where relevant, you should also consider paragraphs 36–40 of 0–18 years, which deal with involving children or young people in research.

Where an approved research project involves an intervention that’s different from the standard treatment or care that a patient might otherwise receive, you should provide potential participants with information explaining this aspect of the research design – so they can make a considered choice about whether to take part.

You must make sure that people are informed of their right to decline to take part in research, and their right to withdraw from a research project at any time. They must be advised that making these decisions will not affect their relationship with their usual doctor and healthcare team.

To support the overall safety and continuity of care for research participants, you should seek their consent to inform their general practitioner (or other clinician responsible for their care) about their involvement in the research project.

You should discuss with participants, or those representing them, who else you should consult if it becomes necessary to reconsider their participation in the project (also see paragraphs 44–45).

You must respect participants’ rights to confidentiality. You must make sure that the collection, storage, and use of research participant information meets the requirements of data protection and privacy laws, and our guidance on Confidentiality.

All members of a research team have individual and shared responsibilities for monitoring and reporting on participants’ safety and well-being and any adverse events. This is in line with guidance from the HRA, the MHRA or other relevant bodies. The sponsor of the research project and the employer of the members of a research team have responsibilities to make sure that safety and other reporting systems are in place – and to make sure appropriate action is taken in response to adverse events. 

You should be clear about your role and the extent of your responsibilities for protecting research participants from harm. You should encourage open and honest incident reporting, so that issues can be acted on quickly, lessons learned, and improvements made; to increase the safety and quality of research, and maintain public confidence. 

While there are both potential benefits and risks to research, it’s possible that a research participant may experience unexpected, unwelcome side effects from a research intervention. Or the balance of risks and benefits of taking part in the research may change during the course of the project. If you become aware of this, whatever role you play in the project, you should make sure the participant has an early opportunity to discuss whether to continue with the research intervention, switch to another treatment, or withdraw from the project. You should also consult any persons it’s been agreed you may communicate with (see paragraph 40). The participant’s wishes or decisions must be respected. 

You must keep under review the situation of research participants who may not be able to clearly communicate about unwelcome side effects, or other developments that may make it appropriate to consider whether to continue with a research intervention. You should discuss their experiences and options with any relevant persons it’s been agreed you may consult, for instance, their carer or other representative (see paragraph 40).

Where it’s within your power, you must stop research where the results (whether final or not) show that participants are at risk of significant harm or that no patient benefit can be expected from the intervention under investigation. Where stopping research is not within your power, you must promptly inform a relevant person¹⁰  or authority that can act. You should also consider policies or rules for stopping research earlier than planned, which may apply. The safety of individuals must take priority over the interests of the research.

You must conduct research honestly and with integrity. If you’re concerned about the quality or integrity of a research project, including allegations of fraud or misconduct, you must follow our guidance on Raising concerns. You must report evidence of financial or scientific fraud, or other failures to follow the requirements of the UK Policy Framework, to an appropriate person in your employing or contracting organisation and relevant regulatory bodies.

You must be open and honest with research participants and members of the research team, answering any questions accurately and as fully as possible.

You must make clear, accurate, and legible records of research results, as soon as possible after the data are collected. You must keep records for an appropriate period, to allow adequate time for review, further research, and audit, and to help resolve any concerns about the data or the research project. You should take account of any guidance on retention of research data that may apply to your research.¹¹ 

You must report research results accurately, objectively, and in a way that can be clearly understood. You must make sure that research reports are properly attributed and do not contain false or misleading information.

You must report the outcome(s) of your research project to the register that holds the record of your approved proposal or protocol. You should seek to publish research results, including adverse findings, through peer-reviewed journals. 

You must declare conflicts of interest when reporting research findings in publications.   

You should make the findings of a research project publicly available, whatever the results. You should do this in a timely manner after the research has completed, taking account of participants’ consent and privacy rights. You should make information about the findings available in a format that is accessible and easy to understand for any interested groups or communities, and the public.

If you're planning to communicate study findings directly to participants, you should respect any choices they’ve made about whether and how to receive this information.¹²