About this guidance
This guidance sets out ethical principles that support the use of a proportionate approach to seeking and evidencing informed consent in health and social care research.
It does not apply to emergency situations which poses its own set of challenges in terms of providing information about the research and seeking consent. For more information on emergency situations please see the HRA’s Principles of consent: Emergency.
We encourage users of this guidance to read The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
To help users better understand the legal requirements and ethical principles, this guidance outlines what sponsors and research team members must, should and could do to make sure they operate within legal and ethical requirements.
- must indicates a legal requirement. Where guidance states you must do something this describes a legal obligation that must be followed
- should does not refer to a legal requirement but indicates what we would expect you to do unless there is good reason not to do so
- could refers to an option you may wish to consider when aiming to follow best practice approaches
The principles set out in this guidance were developed collaboratively with an expert advisory group. The group included members of Research Ethics Committees, legal experts, researchers and sponsors, HRA staff and members of the public. Collectively, the advisory group had expertise in informed consent, ethics, and UK legislation, as well as experience of managing and taking part in clinical trials.
To make sure the principles reflected as wide a range of voices and experience as possible, the advisory group was supported by a review network. The network was made up of REC members, academics, researchers, sponsors, and members of the public, to provide important feedback and insights on the principles as they were drafted.
In total the advisory group met on 4 occasions, undertaking peer review exercises to develop the principles. All 8 principles outlined below draw on best-practice methods and are grounded in the understanding that informed consent is a continuous process.
A proportionate approach to seeking and evidencing informed consent
Members of the research team must seek, and evidence informed consent in accordance with all applicable regulatory requirements for the type of research being conducted. For clinical trials of investigational medicinal products (CTIMPs) sponsors and members of the research team must operate within the legal framework of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.
Seeking and evidencing informed consent for health and social care research is often perceived as challenging. Lengthy participant information sheets, containing complex, specialised language and legal jargon can deter people from participating in studies.
We advocate a proportionate approach, which means the methods and procedures used to seek and evidence informed consent and the level of information provided should be proportionate to:
- the nature and the complexity of the research
- the risks, burdens and potential benefits (to the participants and/or society)
- the ethical issues at stake
The closer the research is to standard clinical practice, the less need there is to provide potential participants with detailed and lengthy information about the research. By the same token, the more research deviates from established clinical practice or otherwise detrimentally affects the balance between the anticipated risks and benefits, the greater the need to cover a wide range of information in detail and to convey that complexity in a way that potential participants can understand.
Members of the research team should view the process of seeking and evidencing informed consent as an opportunity to establish clear communication with potential participants, generating trust. Regardless of whether the individual chooses to participate, they should have confidence in the integrity of the study and of health and social care research in general.
Proportionate principles
- respect for autonomy
- rights, safety and dignity
- expectations, requirements and risks
- clarity in the conversation
- accessibility
- public involvement
- evidencing consent
- when an individual cannot consent for themself
When planning to use a proportionate approach to seeking and evidencing informed consent, sponsors and research teams should consider the principles in this guidance early in the design process, working with public contributors to inform them.
The scenarios outlined in this guidance show how the proportionate principles can be applied.
1. Respect for autonomy
Respecting autonomy should go beyond a procedural formality and reflect the significance for those deciding if they wish to take part in health and social care research. The World Medical Association’s Declaration of Helsinki states: “Free and informed consent is an essential component of respect for individual autonomy”.
Facilitating choice
Respect for autonomy means putting in place the right conditions for people to make voluntary and informed decisions about taking part in research. Individuals who decide not to participate should be informed, at the point of making that decision, that their choice will not have a negative impact to their clinical care.
Tailoring information
The content and delivery of information should ensure that it remains meaningful to participants. This means that information should be provided in a clear, understandable, and accessible way, promoting understanding without diminishing its substance. The tailoring of information does not mean producing bespoke written information for each participant. Rather, it refers to how information is communicated and discussed, including responding to an individual participant’s specific questions, concerns, and priorities. While standard information materials provide a consistent foundation, what is meaningful for a participant is often shaped through dialogue.
Respect for autonomy scenario
You are a member of a research team working in a large teaching hospital, recruiting for the PULSE study run by the Lewis Population Health Centre. This data only study will investigate long-term patient outcomes in individuals who have been attending cardiac clinics across UK, including those who have had an episode of endocarditis in the past 24 months. Participants who agree to take part in this study, need to consent to relevant data from their medical records being collected over the next 15 years.
Today you will be meeting Jay for the first time. Jay is aged 27 and has recently been referred by his GP after showing new symptoms. He has had an episode of endocarditis in the past. You know from his pre-assessment questionnaire that Jay has high stress levels and has struggled to get childcare today, so will be short on time at this first appointment.
You will need to consider when and how best to introduce this research opportunity. During the consent conversation you want to give a proportionate amount of information to cover the nature, complexity, risks, benefits and impact of participation.
Although the PULSE study is a data only study, with no additional research interventions it is still important to consider how to facilitate choice and tailor information so Jay can voluntarily make an informed decision whether to participate.
2. Rights, safety and dignity
Respect for the rights, safety and dignity of potential participants remain core ethical requirements in all health and social care research and should be addressed as part of the consent conversation.
Rights
Ensure participants understand their legal rights regarding participation, including their right to withdraw at any time without penalty, their rights under data protection law, their rights to raise concerns and how to do so.
Safety
The safety and wellbeing of the potential research participant should prevail over the interests of science and society.
Dignity
Potential participants should be valued, respected as individuals; and an understanding of their needs, abilities and limits in a potential research setting should be sought. The emotional weight, stigma, or the cumulative effects of repeated research participation for potential participants should be taken into account.
UK GDPR (General Data Protection Regulation) requirements
Members of the research team must comply with UK GDPR and provide transparency information including the legal basis relied upon and other details of processing personal data. Further information is available in our GDPR guidance. Researchers should consider how the participant’s data will be managed, stored, used for future research and where appropriate, destroyed. All of which should be clearly explained to the potential participant.
Rights, safety and dignity scenario
You are the sponsor of KNEE-0A-2 a Phase 2 clinical trial of a new injectable treatment for Knee Osteoarthritis in patients under 65. This trial investigates the effectiveness of a new injection designed to reduce inflammation in patients with moderate to mild knee osteoarthritis.
When this study was being designed, an essential component, was to ensure participants could understand their legal rights, including their right to withdraw their participation at any time without it affecting their ongoing clinical care. This messaging will be reinforced during the consent conversation with a member of the research team and clearly outlined in the patient information sheet with contact details and appropriate steps to follow to withdraw from the study.
3. Expectations, requirements and risks
The UK Policy Framework for Health and Social Care Research describes proportionality as an approach to mitigating risks that gives at least the same consideration to the risks that arise if the research does not take place as to those that arise if it does, and the same consideration to their likelihood as to their impact.
Risks
Members of the research team should detail any study-specific risks associated with changes to clinical care or aftercare resulting from research participation. Potential participants might need time to consider and ask questions. Risks and requirements of participation should be continuously assessed throughout the research lifecycle. Members of the research delivery team should be mindful that the impact of participation can be subjective and vary significantly depending on personal circumstances.
Transparency
Being clear about the study risks and benefits, and the impact of participation promotes integrity, aligns with participants' values and promotes trust in research.
Explaining the research
Inform potential participants why this research is being conducted. Offer a balanced view of what, if any, direct benefits are associated with participation, or if there are any potential benefits for future health and social care recipients or to society more broadly.
Expectations, requirements and risks scenario
Monica is aged 43 and has recently been diagnosed with a rare form of lymphoma. You are Monica’s clinician and the Chief Investigator for a Phase 2 clinical trial looking at using an unlicensed drug as a course of treatment.
The study involves many different arms including different dosing schedules, combining the new study drug with existing licensed medications and looking at efficacy at different stages of the disease.
The trial will include several research interventions such as additional scans (MRI, PET/CT), blood samples, lumbar punctures and collection of tissue samples.
As the Chief Investigator of this Phase 2 study, you should carefully consider the nature, significance, risks and implications of participation for Monica and how best to introduce and communicate these so she can make a voluntary, informed decision.
Since Monica is newly diagnosed, you should be mindful of the potential need for sensitivity during the consent conversation. Monica’s wellbeing remains of primary importance. However, her newly diagnosed status should not preclude her being offered the opportunity to take part in research.
Monica’s participation would bring significant impact in the form of research interventions, some of which are invasive and could cause discomfort or additional emotional distress. It is important that you are transparent about the impact of participation. Whether Monica chooses to participate in this study or not, her welfare is paramount.
4. Clarity in the conversation
Research design often focuses on the written materials used for seeking and evidencing informed consent. However, understanding is typically achieved through the dialogue between members of the research team and potential participants. We recommend that the following aspects of the consent conversation be considered.
Conditions
Consider where the conversation is taking place, this includes online settings. If the conversation is in person the environment must be accessible and safe, and ideally somewhere the potential participant feels comfortable. Be mindful of the context of their care, as such the environment should have appropriate levels of sound, lighting and other sensory stimuli and accessibility features if required.
Framing
Plan how you will introduce the research. Reflect on what might matter most to the potential participant at this stage. Consider personal benefits and risks not just generic benefits and risks.
Timing
A potential participant is always more than just a potential participant. The person’s welfare always remains paramount. This remains true when considering the appropriate time to have the conversation. It is important to remember research can be an opportunity for participants. Having the confidence to offer the opportunity to a potential participant in a balanced way respects their autonomy to make an informed choice for themselves.
Delivery
When presenting information to the potential participant it should be provided in a layered way, offering study materials with summary information alongside more detailed versions. Potential participants should not feel rushed, particularly during discussions when they may need time to take in the information, consider and ask questions.
Assess understanding
It is important to consider whether what is being discussed has actually been understood by the potential participant. You could consider asking them to explain in their own words the main elements of the study they are considering joining.
Time to review
The time available for potential participants to consider taking part in a study should be tailored to the needs of the participants and reflect the nature, complexity, and level of risk of the study
Reachable
Potential participants must be able to contact the research team for any follow up questions or to notify members of the research team if they decide to withdraw from the study
Clarity in the conversation scenario
You are a clinician for a diabetes outpatient clinic and part of the research team for the Glu-NoW study. This study is evaluating a reduced dose regime of a licensed treatment, used in routine care for adults with stable type 2 diabetes. Participation in the study will include weekly blood tests and health check assessments with optional checks via video calls with participants to report new symptoms.
Amina is 65 and has been living with type 2 diabetes for 10 years. Amina has recently moved to the UK and speaks limited English but will be attending with an NHS approved interpreter. Amina has an outpatient appointment with you today to discuss their ongoing treatment of diabetes.
It was anticipated, when designing this study that potential participants might need a combination of different communication delivery methods. Participant information was developed in audio, pictorial, easy read and video formats. This will allow you to tailor your conversation with Amina, using the appropriate delivery method to aid the consent conversation, providing proportionate information in a layered and accessible way. You will ask Amina to explain in their own words what is being asked of their participation, using open questions to achieve this.
The Glu-NoW study involves a licensed treatment in routine care, and although it involves additional research interventions it is of low complexity and risk. Unless Amina asks for additional time to review this research opportunity, an informed decision can be made by Amina at today’s appointment.
5. Accessibility
The UK population is made up of a wide range of communities, groups, and individuals. To ensure that the whole population can benefit from research, there needs to be an understanding of how interventions work on and for different groups of people.
HRA and the Medicines and Healthcare products Regulatory Agency (MHRA) have been jointly developing a set of questions and supporting guidance for researchers to consider when they design clinical trials and clinical investigations. This will help ensure clinical research is designed to include people who could benefit from the findings, and that people underserved by research are not overlooked. Read more about this work.
When you design and develop your approaches and materials for potential participants, we would encourage you to read our Participant Information Design and Review Principles which outline the important ethical considerations for participant information. They also make clear what the Research Ethics Committees (RECs) will consider as part of the review of participant information and will support you to create information that meets the Participant Information Quality Standards.
Improving accessibility starts with understanding the individual participant and the nature of the research they will be involved in. Consider how vital information will be proportionately communicated and understood, when it will be communicated and who will be giving the information. Remember small achievable adjustments in one area could meaningfully improve accessibility.
Proportionate
Potential participants should receive a proportionate level of information in a way they can understand so they can feel confident in their decisions. Encourage participants to ask questions if they require more information than has already been provided.
Representation
Where there are inclusion concerns, work with public contributors from underserved groups that represent the study’s target population to review the planned approaches and empower them to offer recommendations. Please refer to the public involvement principle for more guidance.
Language
Ensure the literacy level and tone of the information match the intended population. Plan for translation and interpretation needs and how these will be met throughout the study. Attention should be paid to how key concepts (for example, randomisation, data protection) are introduced and explained, and the order in which they are presented, to ensure the information is understandable.
Design
Accessible design principles should be used in the design of information materials. Pay particular attention to the length of words, sentences and structure of information. The suitability of the materials should be checked by using appropriate public involvement. The use of images can be a good way of providing supporting information, but care must be taken to choose images that help support understanding and are appropriate and accessible.
Delivery
A combination of different communication options, including, written, audio, pictorial, easy read or video formats might be beneficial. Digital poverty affects some groups more than others; it is important to offer non-digital alternatives. Anticipate whether some participants might need Braille, large print or use British Sign Language as their first language. Some people might need a digital copy that is compatible with screen readers. If options are provided from the outset, it can reduce inequity and promote inclusion. In certain circumstances, it might be best to deliver the information in person, while for others digitally might be preferable. In some instances, it might be useful to use real life scenarios or case studies to help convey information.
Timing
Reflect on the order in which concepts relevant to the study are introduced and then referenced in order to align with the potential participants clinical pathway. Provide stage-wise, staggered information, particularly for complex, long-term or multi-stage studies. This avoids overwhelming participants with excessive detail at once, ensuring they understand the immediate implications of participation before committing to future, potentially more intense phases.
Accessibility scenario
You are the sponsor for the Monitor+ study which is testing a new remote-monitoring app for managing heart failure among adults aged 70 plus. GPs across 4 NHS Trusts will recruit potential participants via GP practices. To overcome digital exclusion participants will be given mobile phones with the remote monitoring app and provided training on how to use the app for the purposes of the study.
Accessibility was considered from the early stages of study design, reflecting the potential needs of the patient population who might face barriers without appropriate adjustments.
A workshop was held with public contributors to inform different delivery methods that the research team could adopt. These delivery methods were then piloted and informed the final approaches taken in the study.
Participant information was kept proportionate. A balance was found between not over burdening the potential participant with unnecessary information or omitting key information needed to make an informed decision.
Participant information used plain language, short sentences with key concepts being introduced and then fully explained. Information delivery was in a digital format that was compatible with screen readers and through a video with closed captions. Demonstrations of the remote-monitoring app were provided with step-by-step instructions.
eConsent was sought and evidenced via touchscreen tablet computers by research team members.
* eConsent refers to the use of any electronic media (such as text, graphics, audio, video, podcasts or websites) to convey information related to the study and to seek and/or document informed consent via an electronic device such as a smartphone, tablet or computer. Please read the HRA and MHRA’s joint statement on seeking consent by electronic methods for more information.
6. Public involvement
We know public involvement is an essential part of health and social care research, which has been shown to improve the quality, trust and research impact. Consider ways to work with public contributors to advise on proportionate approaches to seeking and evidencing informed consent in the design and dissemination of study materials.
Representation
Where concerns regarding inclusion remain, work with public contributors, including underserved people and groups with the characteristics of the study target population, to review approaches and offer advice. Ensure that people from underserved groups are empowered to provide this feedback. Collecting this type of feedback can improve access, and understanding, it can also strengthen participant recruitment and retention.
Testing materials
Involve public contributors to pilot approaches to seeking and evidencing consent and participant facing materials. Use their feedback to adapt your approaches.
Sharing experience
Consider if members of the research team need additional support, asking public contributors to help develop and deliver insights to share experiences with team members.
Verbal consent
In settings where verbal consent is legally permissible and acceptable from an ethics perspective, the research team should consider how public involvement can help decide whether this is the right approach and, if so, advise on how it should be used, ensuring that verbal consent is evidenced appropriately.
Public involvement scenario
You are a sponsor of a new device study called the Maker-44 study which will involve testing a new CE/CA marked pacemaker at community hospitals across South London.
Participation in this study for participants will involve several additional monitoring visits to hospital in between routine appointments as well as the need to record experiences in a weekly diary. The pacemaker will be fitted through an outpatient hospital appointment which will include the procedure being recorded and photographed.
During the design phase of this study, it became clear that a substantial proportion of potential participants would include people of Asian (including Indian, Pakistani, Bangladeshi) Chinese, Black African and Black Caribbean ethnicities. In response public contributors from these communities were asked to codesign a comprehensive e-Consent process.
This included short, accessible videos explaining the study’s nature, significance, risks, benefits and impact. This information was presented in plain language and featured people of Asian (including Indian, Pakistani, Bangladeshi) Chinese, Black African and Black Caribbean ethnicities. The videos were complimented by written information on tablet computers that provided proportionate, layered information in different languages. Information could be printed out upon request or emailed directly.
e-Consent was sought via tablet computers to enable participants to move through the information at their own pace, returning to sections of information to reread if necessary. Inbuilt prompts were used to highlight key points for consideration. Public contributors worked with the design team to tailor and test out the information and visual design.
Working with public contributors to design the seeking and evidencing of consent in this manner resulted in greater accessibility and trust for potential participants.
7. Evidencing consent
For CTIMPs, informed consent must be documented by a dated signature, by the participant (the exception to this is when sponsors look to use simplified arrangements to seek and evidence consent in low intervention CTIMPs as defined in The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025).
Non-CTIMPs sponsors and research teams have a range of options for evidencing informed consent. This flexibility supports proportionate and where appropriate innovative approaches while ensuring consent remains informed. Possible approaches to evidencing informed consent could include:
e-Consent
The use of a digital signature or a clickwrap agreement (a clickwrap agreement refers to a digital consent in which a participant actively offers agreement by clicking an “I agree” button or checking a box) in documentation could help accessibility. The use of e-Consent can allow potential participants time to review information at their own pace and in private.
Evidencing in medical records
In situations where verbal consent is legally permitted and ethically acceptable, members of the research team can document informed consent in the participant's medical records. However, consideration should be given to how participants access proof of consent in the future.
Evidencing consent scenario
You are a qualified midwife and research nurse based in a maternity unit, and part of a research team examining foetal development. The GRoW 100 study is a single research activity (non-CTIMP) which involves taking 1 additional measurement during growth scans of pregnancies between 30-36 weeks.
Today you will meet Phoebe who is aged 32 and is currently 30 weeks pregnant with her second child. She is attending hospital for a routine growth scan.
During this routine appointment, if Phoebe agrees to take part in this study, the extra measurement will take approximately 2 minutes and Phoebe’s age and due-date would be collected and recorded for the purposes of the study.
The GRoW 100 study, is a data only, low intervention study and therefore a proportionate approach for seeking and evidencing consent has been adopted. Verbal consent will be sought and consent recorded in Phoebe’s medical records.
A tailored participant information sheet has been designed to cover the nature, significance, risks and impact of participation. As a member of the research team, you should allow extra time during the scan in case Phoebe has any questions about the study.
8. When someone cannot consent for themselves
This principle is to encourage sponsors and members of the research team not to exclude individuals who cannot consent for themselves:
- for CTIMPs, the principles set out in this guidance should be taken into account when applying a proportionate approach to seeking informed consent from a legal representative of the individual who is unable to give consent
- for CTIMPs, the participant must receive information, according to their capacity of understanding, about the trial and its risks and benefit
- for non-CTIMPs, the principles set out in this guidance should be taken into account when seeking advice from a consultee under the Mental Capacity Act 2005 (MCA). In the case of Adults with Incapacity (Scotland) Act 2000 informed consent can be sought from a legal representative
- for non-CTIMPs, the participant themselves should receive information, according to their capacity of understanding, about the study and its risks and benefits
Please refer to the HRA decision tool for more information.
When someone cannot consent for themselves scenario
You are a sponsor of the COG-DET: Cognitive Digital Evaluation Tool study. This UK multi centred study will be evaluating a new digital screening tool for diagnosis of mild cognitive decline for older adults.
The process of seeking and evidencing consent has been co-designed with public contributors, including individuals with early-stage dementia, their carers, and loved ones. A workshop was held with public contributors and members of the research team to consider communication behaviour and strategies.
For participants who lack mental capacity to consent, consultees will be provided with proportionate information and will be involved in exploring the potential participants wishes.
The first stage in seeking and evidencing consent for the COG-DET study will include a brief introductory conversation between the potential participant and consultee with a member of the research team, including a short video. The video will explain the study’s purpose and procedures ensuring key concepts are introduced and explained in the order in which they are presented to ensure information is cognitively accessible. Information will be proportionate and delivered through communication strategies, such as using memory aids.
The second stage will be a follow-up meeting, revisiting consent, after the potential participant and consultee has had time to consider all the information. During this second stage meeting written or e-Consent can be sought.
Further resources
We hope you found this guidance helpful. The development of this document was informed by the following resources and literature.
Davies, H., Kolstoe, S. E., & Lockett, A. (2024). Reshaping consent so we might improve participant choice (III) – How is the research participant’s understanding currently checked and how might we improve this process? Research Ethics, 20(3), 604-612 doi: 10.1177/17470161241235910
HRA Consent and participant information guide
HRA Participant Information Quality Standards
HRA Participant Information Design and Review Principles
ICH Harmonised Guideline for Good Clinical Practice E8 (R3) Final Version Adopted on 06 January 2025
Infected Blood Inquiry Report: recommendations for recognition, healthcare and patient safety
Imperial College Healthcare NHS – The Research Governance and Integrity Team: SOP for informed consent RGIT_SOP_016_Informed_Consent_v20.0_May_2024-(1).pdf
Kadam, Rashmi Ashish (2017) Informed consent process: A step further towards making it meaningful! Perspectives in Clinical Research 8(30) p107-112 https://doi.org/10.4103/picr.picr_147_16
Memon, R., Asif, M., Shah, B.A. et al., (2024) Clinicians’ experiences of obtaining informed consent for research and treatment: a nested qualitative study from Pakistan, BMC Med Ethics 25, 131 https://doi.org/10.1186/s12910-024-01119-8
MHRA (2025) Explanatory Memorandum to the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 No. 538
NHS England » Accessible information standard
NICE Guideline: shared decision making, 2017 Recommendations | Shared decision making | Guidance | NICE
Shepherd, V., Russell, AM., Jayes, M., Wade, J., Volkmer, A., Treweek, S. (2025) OPTIMISE Recommendations for designing inclusive consent processes in trials [online] Cardiff University. available at: https://www.capacityconsentresearch.com/optimise (01/10/2025)
The NHS Constitution for England - GOV.UK
UK Policy Framework for Health and Social Care Research
Wiertz S, Boldt J, (2024) Ethical, Legal, and Practical Concerns Surrounding the Implementation of New Forms of Consent for Health Data Research: Qualitative Interview Study, J Med Internet Res;26:e52180, https://doi.org/10.2196/52180