Simplified arrangements for seeking and evidencing consent in clinical trials survey results

Contents page

Executive summary

Survey results

Background

Methodological approach

Seeking and evidencing consent

Clinical trial criteria

Key findings

Mitigations

Conclusion

Next steps

Appendix 1: Thematic analysis of survey responses

Appendix 2: Online survey

Executive summary

The United Kingdom (UK) law governing clinical trials of investigational medicinal products (CTIMPs) has recently been updated and is due to come into force on 28 April 2026.

As part of these changes, a new provision will allow sponsors of certain clinical trials to use simplified arrangements for obtaining and evidencing consent, provided specific criteria are met.

Earlier this year, we ran an online survey to test one such approach: whether it would be acceptable for a doctor to record a participant’s consent directly in their medical records for eligible trials. We invited feedback from the public, researchers, research participants, and Research Ethics Committee (REC) members.

This report presents a summary of the responses received.

Survey results indicated that 55% of all respondents were unsupportive of the proposal. The primary concern from the public was the perceived absence of information about the clinical trial and physical proof for the participant that informed consent had been given.

It is important to acknowledge that following a verbal discussion the participant would be provided with a Participant Information Sheet to take away. The Participant Information Sheet offers physical indication of the clinical trial, although it is not evidence of consent.

Our current guidance clearly states a Participant Information Sheet should support the consent process by helping to ensure that all those who are invited to take part in a research study have been adequately informed.

While 53% of researchers responded positively to the proposal, the risk that, without a consent form, verbal consent could become overly brief and less informed was identified. Researchers did appreciate the potential for simplified arrangements to make seeking and evidencing consent simpler and a less intimidating way for participants to provide their consent, with the potential to widen participation.

It should be noted that the survey response rate for research participants was very low; of 33 research participants who responded to the survey, over half (57%) agreed to the proposal. Nevertheless, the same themes of concern were evident, including the lack of evidence of consent.

REC members were relatively evenly split between yes (46%) and no (42%) with don’t know (9%) and blank answers (3%) in their responses. REC members discussed the relationship between the potential participant and recruiter, expressing concern regarding the risk of abuse and coercion.

For the third survey question, respondents provided mitigating factors to consider should the proposal be implemented. Thematic analysis of the survey responses identified several considerations:

• the key principles of informed consent in common law remained important cornerstones for respondents and they wanted to see these reflected if the proposal was implemented
• review alternative ways to gather evidence of verbal consent, either using video or audio of the conversation, with the participant able to access this afterwards if necessary
• thought given to how participants might obtain a copy of their medical record, so they have proof of the consent conversation - the NHS app was mentioned by respondents as a way of achieving this
• explore how records could be monitored and audited, with a need for the process to be standardised, with potentially a standard set of questions and ways of documenting consent in medical records - there were suggestions the HRA produce a template and/or checklist
• examine ways to reduce the burden of long and complex patient information sheets and consent forms with more consideration given to accessibility

Our mission is to make it easier to do research that people can trust. Hearing from our stakeholders has deepened our understanding of their concerns. It has also highlighted where there might be opportunities to reduce burden and widen access.

In light of the survey findings, we are committed to seeking further input from stakeholders. Over the coming months, we will establish an advisory group with membership that has the appropriate expertise, skills, and experience to inform the development of new guidance.

Survey results

Background

The UK law governing clinical trials of investigational medicinal products (CTIMPs) has recently been updated and is due to come into force on 28 April 2026.

In 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health in Northern Ireland, working closely with the HRA, held a public consultation on a set of proposals to update the UK legislation that underpins the regulation of clinical trials.

One of the proposals set out to simplify the way that informed consent can be sought and evidenced for clinical trials involving authorised medicines. The majority of respondents to the public consultation agreed to this proposal but wanted future guidance to be informed by patient and public involvement. A government response to the public consultation confirmed the UK government’s commitment to the proposal.

To inform the development of future guidance in line with the UK government's commitment, the HRA conducted a survey to explore one possible approach to simplify the way that informed consent is sought: whether stakeholders would be comfortable with a doctor recording a participant's consent in their medical records for a clinical trial that meets certain conditions rather than requiring a signed consent form.

Methodological approach

Findings in this report are based on qualitative analysis from an online survey. Thematic analysis was employed to investigate survey responses. This included coding major and minor themes from the data we received in the survey free text box responses.

Survey respondents were asked to identify themselves with one of four roles, defined from a participatory perspective. These roles included researcher, member of the public, research participant and Research Ethics Committee member.

Using an online survey offered the benefits of collecting systematic data from many of our stakeholders, quickly. This survey offered an opportunity to hear directly from a range of people to explore one possible approach to make informed consent more proportionate and streamlined.

Despite its many advantages as a research tool, using an online survey to collect views on this specific proposal did have drawbacks. It is hard to know for certain whether certain groups were over or underrepresented. Only those with internet access could participate. The case study used was, on reflection, limited and this may have influenced responses.

Using a case study approach, we focused on a potential research participant named John to illustrate key aspects of the recruitment and informed consent process. We explained that John was aged 72 and had recently been advised by his GP to start a regime of statins to treat his high cholesterol. We elaborated that statins are a commonly prescribed medicine in the UK, used by millions of patients, but medical professionals are still unsure which treatment regime is the best. We then devised a hypothetical clinical trial so respondents could get a better understanding of the context in which simplified arrangements for informed consent could be applied for John.

Following the first question which asked if survey respondents would be okay with a doctor recording their consent in their medical records, a subsequent open-ended question invited respondents to share their thoughts on the proposal itself. This question provided an opportunity to explore the reasoning behind their responses to the initial closed question. The final question in the survey asked respondents to identify considerations the HRA should reflect on if the proposal were to be implemented. Similarly, this allowed for a deeper insight into the views expressed about the proposal

Data analysis shows the public were concerned that the proposal meant there was no physical evidence of consent. On reflection the case study in the survey should have outlined with more clarity that when a participant is recruited into a clinical trial they should be informed of the nature, significance, implications and risks of the trial.

Researchers are required to follow specific HRA guidance and participant information quality standards alongside our design review principles.

While the Participant Information Sheet does not constitute evidence of consent, and public concerns about the absence of physical proof of consent should not be overlooked. Nonetheless, the inclusion of additional information may have provided respondents with greater reassurance regarding the proposal. In the absence of this context within the case study, it is uncertain whether all respondents shared a consistent understanding of the scenario presented.

Seeking and evidencing consent

Informed consent remains a legal and ethical requirement, and for it to be considered both it must be:

• given by a person with capacity
• voluntarily given, with no undue influence
• given by someone who has been adequately informed
• a fair choice

We considered which elements supporting the seeking and documenting of informed consent could be streamlined without impacting the quality of informed consent. A pragmatic proposal was developed, taking away the need to record consent on a consent form and instead recording consent in the participant's medical record.

We asked respondents if they would be okay with a doctor recording their consent to participate in a clinical trial in their medical records rather than signing a consent form (see Appendix 2).

Clinical trial criteria

For a sponsor to use simplified arrangements for seeking and evidencing consent, the clinical trial will need to meet specific conditions, outlined in the updated legislation.

• the investigational medicinal product or, if there is more than one, each of the investigational medicinal products, is authorised for use in the UK and is used in accordance with that authorisation
• the investigational medicinal product or, if there is more than one, 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

The survey described the conditions above, explaining that the medicines involved in the clinical trial would pose little or no additional risk to participants. This is because the clinical trial would involve the use of standard medicines already routinely prescribed.

These medicines will have undergone all necessary safety evaluations required for use in the UK. The clinical trial would not involve any additional medical interventions or diagnostic procedures. However, participants may be asked to complete a questionnaire, keep a patient diary, or, in some cases, have their vital signs, such as blood pressure monitored.

Responses rate

We ran the online survey from Thursday, 28 November 2024, until Friday, 10 January 2025. The survey did not ask for any identifiable data but did ask for respondents to self-select a stakeholder group that they felt best reflected their role.

We received 924 responses across four stakeholder groups: members of the public, research participants, researchers, and Research Ethics Committee members.

Breakdown of responses by stakeholder groups:

• 445 members of the public
• 370 researchers
• 33 research participants
• 76 REC members

Key findings

The majority of respondents from the public did not support the proposal, and among those who indicated support, many subsequently raised concerns in the open response sections.

Respondents across all stakeholder groups expressed concern that trial participants would lack physical evidence of the specific trial into which they had been recruited. It is important to note that, following a verbal discussion and the documentation of informed consent in the participant’s medical record, a Participant Information Sheet would be provided for the participant to take away. While the Participant Information Sheet serves as a tangible reference to the clinical trial, it does not constitute formal evidence of consent

The HRA guidance clearly states that the Participant Information Sheet should facilitate the consent process by ensuring that all individuals invited to participate in a research study are adequately informed.

Although there was an even split between Research Ethics Committee members agreeing and disagreeing with the proposal, they still voiced their concern. Members believed the consent form offers an opportunity to prompt discussions and provides a formal process which signals to the participants their recruitment into the trial.

The public were concerned misunderstandings are more likely where only verbal consent is required. Researchers were also worried that misunderstandings may occur in patient and clinician consultations, especially for vulnerable patients. They thought some people may not realise they have been recruited into a clinical trial as their standard of care would not change.

The public advocated for patient centric approaches, stating each participant is unique and has a differing level of understanding. The HRA emphasises the importance of effective informing, with the need for recruiters to tailor the consent conversation. Through our proportionate approach to seeking consent guidance we advise interactive questioning of participants within the consent process to aid understanding and highlight areas that could be misunderstood without appearing condescending.

Researchers were mindful that verbal consent remained informed but did appreciate that verbal consent has the potential to be a simpler and less scary way for participants to provide their consent. Researchers commented that the approach could widen participation in research, suggesting simplified approaches could be more acceptable to a potential participant if they have limited literacy or English language skills. Research participants emphasised the importance of widening participation in trials in a simple and unpressurised manner.

Researchers stated the importance of making it easier to conduct trials which look to understand the effectiveness of licensed treatments within the NHS. They emphasised how important these studies are to patients and welcomed any steps that are more streamlined.

The public and researchers highlighted concerns over the relationship between the potential participant and recruiter. Clinicians are often best placed to identify eligible trial participants, and it is common practice for clinicians involved in a patient’s care to also act as a recruiter for a clinical trial. The public however was concerned there is a conflict of interest and felt the use of verbal consent had the potential to facilitate abuse of trust between the clinician and the patient.

Researchers also highlighted concerns that the proposal could be at odds with elements of Good Clinical Practice training (GCP) as set out in The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for researchers conducting clinical trials.

Researchers felt the current process of seeking and evidencing consent is long and complex and therefore is a barrier for participants. For some the proposal was seen as pragmatic, with the potential to ease burden without undermining the core principles of informed consent.

Mitigations

The third survey question asked respondents, is there anything which you think should be considered if this proposal is implemented?

Main findings:

• the key principles as set out in common law remained important cornerstones for respondents and they wanted to see these reflected in a verbal consent process
• aligning with the main concern we heard from respondents, there were suggestions for alternative ways to gather evidence of the informed consent conversation, either using video or audio, with the participant able to access this afterwards if necessary
• researchers want us to consider how participants might obtain a copy of their medical record, so they have proof of the conversation and agreement to informed consent - the NHS app was mentioned by respondents as a possible way of achieving this
• consideration given on how records would be monitored and audited
• emphasis on a need for the process to be standardised, with a standard set of questions for recruiters to use when speaking to participants and documenting consent in medical records - there were suggestions the HRA produce a template and/or checklist
• researchers want patient information sheets and materials on the study to be more accessible and informative
• the need for updated training for recruiters was expressed, and a desire for new guidance

Conclusion

Our stakeholders have clearly expressed their reservations for this proposal, with 76% of the public unsupportive of the idea. The public had concerns about the lack of physical evidence of the clinical trial and consent process. On reflection the case study presented in the survey should have articulated more clearly and explicitly that all individuals recruited into a clinical trial are provided with a Participant Information Sheet to take away. The Participant Information Sheet offers physical indication of the clinical trial, although it is not evidence of consent.

Trust emerged as a central issue for both the public and researchers, expressing apprehension about the relationship between potential participants and recruiters who are also involved in clinical care. Members of the public indicated that a lack of trust could raise fears that recruiters might abuse their authority by enrolling patients without obtaining informed consent. Additionally, some researchers believed that the proposal offered limited benefits relative to the potential increased risks.

Researchers stated the importance of making it easier to conduct trials which look to understand the effectiveness of licensed treatments within the NHS and maintained the current process of seeking and evidencing informed consent is lengthy and complex, presenting a barrier to participant involvement. The proposal was viewed by some as a pragmatic approach, with the potential to reduce burden, widen participation, while preserving the fundamental principles of informed consent.

Next steps

We remain committed to identifying effective ways to support these important trials, which assess the effectiveness of licensed treatments within the NHS, while maintaining public trust.

Over the coming months, we will establish an advisory group with membership that has the appropriate expertise, skills, and experience to inform the development of new guidance.

Appendix 1: Thematic analysis of survey responses

Members of the public

A total of 445 members of the public responded to the survey.

Question 1 analysis

As a member of the public, would you be okay with a doctor recording your consent to participate in a low-risk clinical trial in your medical record rather than signing a consent form?

The majority of respondents, 76% who identified as the public did not agree with the proposal, and even those who did tick yes subsequently highlighted concerns in the free text boxes.

Question 2 analysis of free text boxes

The public was particularly concerned that the proposal would mean a lack of information about the clinical trial and evidence of verbal consent for the participant.

As discussed above, the case study in the survey should have outlined in more detail and with clarity that when a participant is recruited into a clinical trial they would receive a Participant Information Sheet. The HRA requires researchers to follow specific guidance and our participant information quality standards alongside our design review principles. Without this additional information in the case study, we cannot be confident that all respondents had the same understanding of the case study provided.

The public believed that removing the need for a signed consent form equated to removing an established safeguard.

In the recruitment process, there needs to be a trusting relationship between the recruiter and potential participant. Some respondents felt that there is currently a lack of trust in GPs, across health professionals, and the health system itself.

This lack of trust could facilitate concerns that recruiters will abuse their power and sign up patients without informed consent.

It was clear the public wanted to see patient-centred approaches with more thought given to widening accessibility for potential participants.

From the public, there were fewer positive themes. Nevertheless, proportionality, practicality and lessening bureaucracy were highlighted.

Researchers

A total of 370 researchers responded to the survey.

Question 1 analysis

As a researcher would you be okay with a doctor recording your consent to participate in a low-risk clinical trial in your medical record rather than signing a consent form?

Question 2 analysis of free text boxes

Although most researchers agreed with the proposal the majority was slim. In many cases when researchers answered ‘don’t know’ they highlighted the same concerns as the public.

Researchers highlighted concerns that the proposal could be at odds with elements of Good Clinical Practice training (GCP) also known as The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for researchers conducting clinical trials.

The ICH E6 (R3) Guideline on good clinical practice (GCP)_Step 2b does detail that prior to trial participation, a consent form should be signed and dated by the participant or legal representative, with a physical or electronic signature (the ethical principles within the GCP have their origin in the Declaration of Helsinki).

The ICH E6(R3) Annex 2 draft Guideline on Good Clinical Practice reached Step 2b entered a public consultation period last year. The HRA has recently responded to this consultation, and we look forward to hearing more on the results and new guidance in due course.

Some researchers thought the proposal offered little benefit for increased risks. There was a focus on Participant Information Sheets and the need to simplify and shorten these.

In contrast, some researchers felt the proposal could offer an opportunity to be more pragmatic while reducing the burden and increasing access for potential participants.

Researcher participants

The survey response rate for this stakeholder group was extremely low, with a total of 33 research participants responding to the survey.

Question 1 analysis

As a research participant would you be okay with a doctor recording your consent to participate in a low-risk clinical trial in your medical record rather than signing a consent form?

Question 2 analysis of free text boxes

There was a split response between yes and no in this small group. Again, the same themes were evident in the free text box responses, including a lack of evidence, lack of trust and risk of abuse.

The need for evidence of informed consent remained strong in responses from research participants.

Research participants who responded positively to the proposal highlighted the opportunity to widen access and simplify the process.

REC members

A total of 76 REC members responded to the survey.

Question 1 analysis

As a REC member would you be okay with a doctor recording your consent to participate in a low-risk clinical trial in your medical record rather than signing a consent form?

Question 2 analysis of free text boxes

REC members were split in their views of the proposal. Members were concerned the proposal takes safeguards away, including conversational prompts provided when using the consent form.

Trust remained a crucial element for consideration for REC members and the process of reflection the consent form was seen to offer potential participants.

Members spoke of a desire to be more proportionate to the risks of the study involved, and to use layering of information provision where possible.

Some REC members felt signing the consent form was not the difficult part of the recruitment process, and in taking it away, would offer little benefit for more risk. REC members stressed the need for participants to have all the information provided to them in an accessible manner so that informed consent is sought.

Mitigations to consider

Analysis of free-text responses to question 3 reinforced the previously discussed themes and provided mitigations for consideration if the proposal was to be implemented.

Aligning with the main concern we heard from respondents, there were suggestions for alternative ways to gather evidence of consent, either using video or audio of verbal consent, with the participant able to access this afterwards if necessary.

The key principles as set out in common law remained important cornerstones for respondents.

Researchers want the HRA to consider how participants might obtain a copy of their medical records, so they have proof of the consent conversation. The NHS app was mentioned as a way of achieving this.

However, access to medical records across the UK would need to be considered. Currently, the NHS app is for patients registered with a GP surgery in England only.

In addition, there were suggestions to have patients sign documentation of consent in patient records.

Sponsors and researchers wanted consideration to be given to how records would be monitored and audited. They emphasised a need for the process to be standardised, with a standard set of questions for recruiters to use when speaking to participants and documenting consent in medical records. There were suggestions that the HRA should produce a checklist and/or template.

Respondents were concerned that sponsors of the research would not have access to clinical records to be able to ensure informed consent was sought and appropriately recorded.

The need for updated training for recruiters was also expressed, with a desire for new HRA guidance.

Researchers were concerned that this proposal does not reduce the burden of long and often complex information sharing. They want Participant Information Sheets and materials on the study to be more accessible and informative.

Appendix 2: Online survey

Medicines For Human Use (Clinical Trial) Regulations – simplified arrangements for obtaining and evidencing consent in low-risk clinical trials

What is the issue?

When a medicine is prescribed in the UK, we know it has already reached a certain standard of safety, quality and efficacy to be authorised for use.

What a prescriber, such as a GP, might not always know, is which medicine is best when compared with a range of treatment options. Low risk clinical trials can provide answers.

Low risk clinical trials present little or no additional risk to the participant. The participant is given a medical product as part of routine care. They receive no additional medication or additional interventions such as the collection of tissue samples. However, they might as part of the trial be asked to complete a questionnaire or have their blood pressure monitored. The participant’s data is extracted from their medical notes and compared for analysis.

Currently, prescribers and participants read, review and sign a consent form.

We are proposing a more proportionate approach, allowing prescribers, to document consent in a participant's medical records.

It is important to note, sponsors in their regulatory and ethics applications for low-risk clinical trials will be required to provide the reason for using simplified consent arrangements. They will need to document the information provided to participants, how it is provided and how consent will be documented.

What are we proposing?

Informed consent will still be a legal requirement, but we are proposing a more proportionate approach to the recording of consent for low-risk clinical trials.

In this survey we are asking for your views on a new way of recording consent for low-risk clinical trials, using an approach that people can trust.

Why are we asking now?

In the UK, the law which regulates the clinical trials of medicines is being updated.

In 2022 the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health in Northern Ireland consulted on a set of proposals to update the UK legislation that underpins the regulation of clinical trials.

The consultation outlined proposals to simplify the way that informed consent can be obtained and recorded for low-risk clinical trials, to encourage greater flexibility whilst ensuring consent is sought to the correct standards.

The majority of respondents to the consultation agreed to these proposals, however, there were calls for clear guidance and definitions to ensure clarity, and for guidance to be informed by patient and public involvement.

Seeking informed consent

A prescriber, who is also part of the research team, will have a verbal conversation with the potential participant to inform them of the benefits, risks and burden of participating in the trial. This will include the reason why the trial is taking place and the treatment being prescribed.

The participant will be provided with access to written information about the use of their data, in line with existing data protection legislation relevant to research.

The participant will be offered the opportunity for their data not to be used for the trial or may choose to request alternative treatment in line with standard clinical practice.

All information provided should be clear and concise to be understandable for potential participants or legally acceptable representatives.

What do we mean by low-risk?

Low risk trials present little or no additional risk to the participant as participants would receive a standard treatment routinely prescribed for their condition.

Such medicines have already gone through the steps needed to be deemed as safe to be used in the UK.

Low-risk trials involve no additional interventions or diagnostic procedures, they might however involve the completion of a questionnaire or patient diary for example. In some instances, a patient's vital signs such as blood pressure might be monitored.

What happens next?

This survey is an opportunity for you to tell us what you think of the proposal to record informed consent in medical records rather than signing a consent form when taking part in low-risk clinical trials.

We want to hear from a broad range of people including patients, research participants, the public, researchers, sponsors, and Research Ethics Committee members.

Your feedback will be used to inform future HRA guidance.

We will not be asking for any identifiable information in this survey.

Survey Questions

In what capacity are you responding to this survey?

You can complete this survey more than once in a different capacity.

• I am a member of the public
• I am a research participant
• I am a member of a Research Ethics Committee
• I am a researcher

Question 1.

As a member of the public, would you be okay with a doctor recording your consent to participate in a low-risk clinical trial in your medical record rather than signing a consent form?

• Yes
• No
• Don’t know

As a research participant, would you be okay with a doctor recording your consent to participate in a low-risk clinical trial in your medical record rather than signing a consent form?

• Yes
• No
• Don’t know

As a member of a research ethics committee, do you think it is okay for a doctor to record consent to participate in a low-risk clinical trial in a participant's medical record rather than signing a consent form?

• Yes
• No
• Don’t know

As a researcher, do you think it is okay for a doctor to record consent to participate in a low-risk clinical trial in a participant's medical record rather than signing a consent form?

• Yes
• No
• Don’t know

Question 2.

Do you have any views you would like to share on this proposal?

If so, please detail in the text box below.

Question 3.

Is there anything which you think should be considered if this proposal is implemented?

Please detail in the text box below.