Simplified arrangements for seeking and evidencing consent in low intervention CTIMPs guidance

Background

In 2022 a public consultation considered a set of proposals to update the UK legislation that underpins the regulation of clinical trials. The public consultation included a proposal to simplify arrangements when seeking and evidencing informed consent in low intervention CTIMPs. The majority of respondents agreed with the proposal. The UK government then confirmed its commitment as part of its response to the public consultation.

From November 2024 to January 2025 the HRA ran a survey to get a better understanding of people’s views on simplifying the arrangements for seeking and evidencing consent. The results of the survey highlighted the need for further consideration and to facilitate more substantive engagement with stakeholders.

In October 2025, we set up an advisory group to inform the development of a set of guiding principles for simplified arrangements for seeking and evidencing informed consent. The group was made up of 12 members including HRA staff, members of RECs, legal experts, researchers and sponsors, and members of the public. Collectively, the group had expertise in informed consent, ethics, and UK legislation, as well as experience of managing and taking part in clinical trials. Read more about the members and their experience.

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 draft principles.

Advisory group members met on 4 occasions, undertaking a peer review approach to the development of the principles. All 8 principles draw on best-practice methods and are grounded in the understanding that informed consent is a continuous process.

Simplified arrangements to seeking and evidencing consent in low intervention CTIMPs

From 28 April 2026, sponsors of clinical trials of investigational medicinal products (CTIMPs) can apply to use simplified arrangements for seeking and evidencing consent in low intervention CTIMPs.

In the context of the amended clinical trials legislation sponsors who wish to adopt simplified arrangements for seeking and evidencing informed consent must meet the following criteria:

• the investigational medicinal product or, if there is more than 1, each of the investigational medicinal products, is authorised for use in the United Kingdom and is used in accordance with that authorisation
• the investigational medicinal product or, if there is more than 1, each of the investigational medicinal products, is given to the participant in the course of that participant’s routine health care
• the participant receives no additional medication and undergoes no additional intervention or diagnostic procedure, solely for the purposes of the clinical trial

If a sponsor is planning to use simplified arrangements, these will need to be detailed in the protocol. The sponsor will need to include:

• the reason for obtaining consent using simplified arrangements
• the information to be provided to the participant, and the means of providing that information
• the means by which consent shall be evidenced

The amended regulations do not permit consent to be waived or presumed. However, they do allow sponsors of eligible low intervention CTIMPs to use simplified arrangements for seeking and evidencing informed consent. These arrangements may include proportionate approaches to the information provided, the way consent discussions are undertaken, and the means by which consent is evidenced, provided that consent remains informed, freely given, explicit and prospectively obtained. Any such arrangements must be clearly described in the protocol and approved by a Research Ethics Committee.

Seeking informed consent is 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.

Under The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. sponsors can apply to use simplified arrangements for seeking and evidencing consent in low intervention CTIMPs, but consent must remain informed and evidenced.

As a result, simplified arrangements that do not involve seeking prior explicit consent in advance of participant recruitment may not be used. This includes ‘opt-out’ recruitment methods, where consent is presumed rather than actively provided and evidenced.

8 principles to support the use of simplified arrangements for seeking and evidencing informed consent in low intervention CTIMPs

The 8 principles outlined in this guidance originate from the proportionate approaches to seeking and evidencing informed consent guidance but have been tailored for sponsors looking to use simplified arrangements for seeking and evidencing informed consent in low intervention CTIMPs.

1. Respect for autonomy
2. Rights, safety and dignity
3. Expectations, requirements and risks
4. Clarity in the conversation
5. Accessibility
6. Public involvement
7. Evidencing consent
8. When someone cannot consent for themselves

When planning to use simplified arrangements for seeking and evidencing consent, sponsors and research teams should reflect on the principles in this guidance early in the design process, working with public contributors to inform simplified arrangements for seeking and evidencing informed consent. Please refer to the HRA’s public involvement in research guidance for more information.

The scenarios outlined in this guidance highlight the principles rather than provide detail regarding the types of simplified arrangements that might be used.

1. Respect for autonomy

Simplified arrangements uphold respect for autonomy by removing unnecessary complexity and emphasising information that is material to a participant’s decision, particularly where a clinical trial follows standard clinical care and involves minimal additional risk or inconvenience.

This is achieved by:

Facilitating choice

Consider how to create conditions that facilitate voluntary and informed decisions about whether to take part in a low intervention CTIMPs. If someone chooses not to participate, they should be informed that their choice will not impact their access to standard care or treatment.

Tailoring information

Providing information that is relevant and meaningful to the potential participant results in better accessibility and understanding, without diminishing the substance of the information that needs to be provided to support informed consent.

Sponsors and members of the research team should consider:

• the order in which concepts are introduced to potential participants. They should prioritise information that is most relevant to the potential participant’s decision and refer to these concepts clearly and consistently
• whether the study materials are accessible to the target population. Pay particular attention to the length of words, sentences and structure of information. The suitability of reading materials should be checked through public involvement in study design
• if information delivery methods such as video recordings, digital, audio-visual are appropriate for use with the intended participants
• test materials with people representative of the study population to gain essential feedback, especially when working with underserved people and groups. Ensure that people from underserved groups are empowered to provide this feedback. Gaining this type of feedback can improve access and understanding. It can also strengthen participant recruitment and retention

2. Rights, safety and dignity

Respect for the rights, safety and dignity of potential participants remain core ethical requirements. Adopting simplified arrangements for seeking and evidencing informed consent should not reduce these obligations.

When designing and implementing simplified arrangements, sponsors and research team members should ensure that respect for rights, safety and dignity is upheld while avoiding unnecessary complexity or information overload that could undermine participant understanding or decision-making.

Rights

Using simplified arrangements to seek and evidence informed consent must never adversely affect ethical standards or the participant’s legal 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 and how to raise any concerns.

Safety

Echoing the first principle of the UK Policy Framework for Health and Social Care Research, the safety and well-being of the potential research participant must prevail over the interests of science and society.

Dignity

Potential participants should be respected as autonomous individuals and you should seek to understand their needs, abilities and limits in the potential research setting.

GDPR (General Data Protection Regulation) requirements

Sponsors and members of the research team must follow our GDPR guidance. Steps include how the participant’s data will be managed, stored, used for future research and/or where appropriate, destroyed. All of which should be clearly explained to the potential participant.

3. Expectations, requirements and risks

Consideration should be given to the specific expectations of the potential participant. The potential participant in a low intervention clinical trial must (as a legal requirement) be informed of the nature, significance, implications and risks of participation.

Adopting simplified arrangements does not diminish the responsibility to inform the potential participant, instead, simplified arrangements should enable information on risks and expectations to be presented in a way that is both proportionate and easy to understand for the potential participant.

Setting expectations

Detail study risks, requirements and mitigations; potential participants might need time to consider and ask questions.

Risks and inconveniences

Continuously assess risks and inconveniences throughout the research lifecycle. Members of the research 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 impact of participation, aligns with participants values and promotes trust in research. Simplified arrangements should facilitate information that is genuinely important to inform a potential participant’s decision, rather than a long, exhaustive lists of theoretical risks that can make key points harder to identify.

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.

4. Clarity in the conversation

Seeking and evidencing informed consent encompasses a series of steps within the consent conversation between members of the research team and potential participant.

Simplified arrangements support clarity in the conversation by focusing attention on what is most relevant to the individual, reducing unnecessary procedural or informational overload, enabling genuine engagement.

Consider the following:

Conditions

Consider where the conversation is taking place, this includes online settings

Framing

Plan how you will introduce the research. Reflect on what might matter most to the potential participant at this stage.

Timing

A potential participant is always more than just a potential participant. The person’s welfare always remains paramount. This remains the case when assessing when to have the conversation for low intervention CTIMPs.

Delivery

When presenting information to the potential participant it should be provided in a layered way, allowing essential information to be communicated clearly while enabling further detail to be explored if the participant wishes. Simplified arrangements support this approach by avoiding unnecessary repetition. 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

To determine whether the potential participant has understood your discussion you could ask 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 low intervention CTIMP.

5. Accessibility

Improving accessibility derives from a person-centred approach. Improving accessibility starts with understanding the individual participant and the nature of the research they will be involved in.

The potential participant must be informed of the nature, significance, risks and implications of participation. Consider how this information will be communicated and understood, when and by whom the information is being given.

Information

Simplified arrangements should provide potential participants with the information they need, in a way they can understand to feel confident in their decisions. Consider how to adjust the information content for the potential participant. They might not speak English as a first language, they might have a learning difficulty, they might be short of time.

Format

Think about the best ways of constructing and delivering information. This might include a combination of different options, written, audio, pictorial, easy read or video formats. Anticipate that some of your participants might need Braille or large print, some might use BSL (British Sign Language) as their first language, and some might need a digital copy that is compatible with screen readers. If these are provided as options from the outset, it can reduce inequity and improve representation in the study population. In certain circumstances, it might be best to deliver the information in person, while in others electronically might be preferable. Consider using real life scenarios to help convey information. Ask public contributors to help design and test different ways of communicating the information needed for informed consent.

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 and impact of studies. It promotes trust in research.

Develop materials

Before the study begins, work with public contributors to advise on or develop participant information and other study materials which will be used to communicate with potential participants.

Representation

Where inclusion concerns remain, consider involving public contributors who can represent the study population to review the approach and confirm what works for them.

Testing materials

Involve public contributors to trial study materials that have been developed to inform participants of the research.

Research staff experience

Where members of the research team need additional support consider asking public contributors to help develop and deliver insights to share experiences can be valuable.

7. Evidencing consent

The amended clinical trials regulations make clear that where simplified arrangements are applied, consent must remain informed and appropriately evidenced.

Sponsors and members of the research team now have a range of options available for evidencing informed consent. This flexibility is intended to support proportionate and, where appropriate, innovative approaches that align with the way care is delivered, while ensuring that consent remains informed, explicit and prospectively sought.

Sponsors may propose alternative approaches to evidencing consent, such as electronic or digital records, or other audio‑visual records of an explicit consent discussion and agreement. Any proposed approach must be clearly justified in the context of the specific study, grounded in appropriate public or patient involvement, and subject to approval by a Research Ethics Committee.

Clinician-recorded consent in medical records is permitted under the amended Regulations. However, public feedback has indicated concerns about this approach when considered in general terms. Where researchers wish to propose clinician recorded consent or similar approaches, they should provide evidence of study‑specific patient or public involvement demonstrating why the approach is appropriate, acceptable, and supported by the relevant participant community.

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.

• the principles set out in this guidance should be taken into account when applying simplified arrangements to seeking informed consent from a legal representative of the individual who is unable to give consent (for example, paediatric populations, those lacking mental capacity)
• the participant themselves must also receive information, according to their capacity of understanding, about the trial and its risks and benefit