Informed consent (clinical trials) procedure

1 Aim

The aim of this procedure is to describe who should receive consent, the procedure for receiving informed consent and how consent should be documented. It distinguishes between consent procedures for a clinical trial of an investigational medicinal product (CTIMP) and non-CTIMP studies, where applicable, especially regarding the process for adults lacking capacity and children.

2 Scope

This procedure has been produced in accordance with Medicines for Human Use (clinical trials) Regulations 2004 and subsequent amendments, International Council for Harmonisation Good Clinical Practice (GCP), research governance framework, The Declaration of Helsinki and Human Tissue Act (2004).

This procedure applies to:

• research studies sponsored or co-sponsored by the trust
• studies hosted by the trust where there is a sponsor procedure provided, the trust procedure supersedes the sponsor procedure, and the governance team will review to identify any inconsistencies

Informed consent is the process by which a person voluntarily confirms his or her willingness to participate in a research study, having been informed of all aspects of the study that are relevant to his or her decision to take part.

Informed consent is an ongoing process. It involves giving information to the potential participant, discussing, and clarifying the information, seeking his or her written consent and subsequently providing any new information that might affect his or her willingness to continue to participate in the study.

In obtaining and documenting informed consent, the research team must comply with Good Clinical Practice (GCP) and with the ethical principles that have their origin in the Declaration of Helsinki.

3 Link to overarching policy

This procedure is overarched by the research governance policy.

4 Procedure

It is the responsibility of the chief investigator (CI) or sponsor to create informed consent forms (ICF). Consent forms should conform to the example templates provided by the Health Research Authority (HRA). Best practice would be to ensure the consent form explicitly states that each statement should be initialled rather than ticked by the participant.

The chief investigator or delegated person is responsible for providing written information in the form of a participant information sheet approved by the reviewing Research Ethics Committee (REC) and the study sponsor. The information should be written in lay terms which are easy to understand. The format should be that of question and answer as approved by both the Health Research Authority (HRA) and National Research Ethics Service (NRES). Where the project does not require review by a Research Ethics Committee, review by a university Research Ethics Committee is required. It is the responsibility of the principal investigator (PI) and sponsor to ensure the correct version of the participant information sheet and informed consent form are used.

The principal investigator is responsible for the conduct of the informed consent process. The principal investigator can delegate this duty to another suitably qualified member of the Research team. For clinical trials of an investigational medicinal product (CTIMPs) and device trials, the suitably qualified member of the Research team must have valid Good Clinical Practice certification. This training must be clearly recorded within the investigator site file (ISF). This can be evidenced through the staff members curriculum vitae (CV), Good Clinical Practice certificate, or can be documented on the training log if provided.

The principal investigator records which individuals are appropriately qualified and have been delegated the conduct of the informed consent procedure. This is recorded in the investigator site file using a delegation log. Only those individuals named on the delegation log may obtain informed consent from participants.

The principal investigator or delegate is responsible for ensuring the participant receives a comprehensive explanation of the research.

The principal investigator or delegate ensures that the informed consent form refers to the current sponsor-approved patient information sheet, ensuring the correct version and date of this document is recorded.

The principal investigator or delegate allows the participant adequate time to decide whether to take part in the study. Ideally the participant should be able to take the information away to consider it and to take the opportunity to discuss it with others, family, friends, or general practitioner. The specific timelines will vary according to the nature of the research and are confirmed within the ethics application and the respective approval.

The principal investigator or delegate gives the participant every opportunity to ask questions before deciding to consent into the study.

The principal investigator or delegate makes it clear to the participant that declining to take part in the research will not affect their future care or treatment.

The principal investigator or delegate ensures that participants understand that they are free to withdraw from the study at any stage without providing a reason.

On the informed consent form the participant must initial in the box next to each corresponding statement. The participant then signs and dates the consent form in the presence of the principal investigator or delegate.

Where the approved process for receiving informed consent consists of postal consent the presence of the principal investigator or delegate is not required. Under circumstances where the approved process for receiving consent consists of phone consent the principal investigator or delegate must be party to this conversation.

If the participant is unable to write, they must mark the consent form with an “X” and this must be signed by a witness other than the principal investigator or delegate taking the consent. If required, information on consent must be available in suitable formats such as large print. Interpreters can be used if required dependent on the information on the integrated research application system (IRAS) form and funding availability.

The principal investigator or delegate must ensure all signatures have the name of the person signing printed clearly. The principal investigator or delegate must also ensure the correct date has been recorded.

The principal investigator or delegate must ensure two copies of the consent form are taken from the original. This can be photocopies or a scanned copy.

The original consent form is filed in the investigator site file, if in another location a file note should be made stating where the investigator site file are stored, and the consent and the details of the participant are recorded on the enrolment log.

One copy of the consent form along with a copy of the participant information sheet, is given to the research participant to take away with them.

For clinical interventional research only a copy of the investigator site file is uploaded, along with a copy of the participant information sheet, in the participant’s electronic medical record in SystmOne.

For clinical interventional research only the principal investigator or delegate must ensure the consent process is recorded in the medical records of each participant. Specifically, the time and date of the initial approach, confirmation that the discussion took place, and that the participant had an opportunity to ask questions, needs recording in the medical records. This provides a clear audit trail to ensure no study specific activities occurred prior to consent being obtained.

The principal investigator or delegate is responsible for ensuring the information process continues throughout the participation in the study; this may involve re-consenting patients if any amendments to the study have a potential effect on the participants.

At each study contact the principal investigator or delegate should confirm verbally that the participant is happy to continue.

The principal investigator or delegate is responsible for ensuring that all original consent forms are filed in the investigator site file or a file note is provided confirming where they are stored.

The principal investigator or delegate is responsible for monitoring the presence of consent forms by cross-checking against the enrolment log in the investigator site file, if provided.

The principal investigator or delegate will ensure all consent forms are available on request for monitoring by the grounded research department, or sponsor as appropriate.

4.1 Non-medical professionals’ consent in clinical trials

If the consent process in a clinical trial is to be delegated to a non-medical professional, then the following requirements must be adhered to:

• Research Ethics Committee and sponsor agreement must be in place through the Research Ethics Committee application and, or protocol content specifying that informed consent can be obtained by non-medical professionals

The principal investigator must be willing to delegate the task of receiving informed consent and the non-medical professional must agree to this task.

The responsibility for receiving informed consent can only be delegated on a study-by-study basis. The task can only be delegated to an individual that has had appropriate training, for example Good Clinical Practice and any study specific training required by the sponsor.

The task of receiving informed consent for a clinical trial of an investigational medicinal product can only be delegated to a non-medical professional if a medically qualified doctor who is part of the trial team is readily available during or following the consent process. If the participant requires or requests further discussion relating to the medical care to be provided as part of the trial, then this must be documented as part of the consent process.

In a clinical trial of an investigational medicinal product, a medically qualified doctor must confirm in writing prior to dosing that the participant is eligible for the trial. As this is considered to be a medical decision it is therefore integral that the confirmation is made by a medically qualified doctor.

4.2 The consent procedure, adults lacking capacity (clinical trial of an investigational medicinal product studies)

An adult lacking mental capacity can be defined as an adult unable by virtue of physical or mental incapacity to give informed consent. Where it is suspected that a person may lack mental capacity an assessment must be made to establish capacity or lack of. The principal investigator or delegate (a suitably qualified clinician) must undertake the assessment. The assessment and its results must be recorded in the patients’ medical notes. Adults lacking mental capacity must only be included where the Research Ethics Committee (REC) approvals cover their involvement.

If the patient is deemed to lack capacity the principal investigator or delegate must receive written informed consent from either a personal representative or professional legal representative.

When involving a legal representative, the principal investigator or delegate must follow the consent process that has received a favourable opinion from an appropriate Research Ethics Committee. The legal representative must be given sufficient verbal and written information about the study to enable them to make an informed decision and they should be told that they are:

• being asked to give consent on behalf of the incapacitated adult
• free to decide whether they wish to make this decision or not
• being asked to consider what the incapacitated adult would want

The principal investigator or delegate must ensure that adults lacking capacity who are conscious should receive information about the study even if a legal representative is providing consent. The principal investigator or delegate should judge the format and level of information that is appropriate for the adult lacking capacity.

During the study the principal investigator or delegate must ensure that the representative, is informed of all material changes to the study and the participant’s condition. The legal representative has the right to withdraw the participant at any point in the study without it affecting the participant’s care.

If a participant regains capacity during a study, the consent provided by the legal representative remains valid, however at this point the principal investigator or delegate must provide the participant with verbal and written information. If the participant withdraws consent the principal investigator or delegate must immediately withdraw them from the study unless this would pose a significant risk to their health, in which case the participant should be asked to continue with safety elements only.

Where the treatment to be given to an incapacitated adult as part of the trial needs to be given urgently, for example in an emergency setting, time may not allow for the written consent of a legal representative to be obtained first. The incapacitated adult can be entered into a trial prior to consent being obtained from a legal representative provided that:

• having regard to the nature of the trial and the circumstances of the case, it is necessary to act for the purposes of the trial as a matter of urgency but:
  • it is not reasonably practicable to obtain informed consent prior to entering the participant
  • the action to be taken is carried out in accordance with a procedure approved by the Research Ethics Committee

Where an incapacitated adult is recruited in an emergency without prior informed consent, steps must be taken to seek informed consent from either the participant (if capacity has been recovered) or from the legal representative as soon as practicable after the initial emergency has passed. Where consent is withheld, the participant must be withdrawn from the trial.

4.3 The consent procedure, adults lacking capacity (non-clinical trial of an investigational medicinal product studies)

Where it is suspected that a person may lack capacity an assessment must be made. The principal investigator or another suitably qualified clinician (delegate) must undertake the assessment. The assessment and its results must be recorded in the patients’ medical notes.

If the patient is deemed to lack capacity the principal investigator or delegate must seek an opinion from a consultee. A consultee is someone either someone who know the patient such as a family member, or carer. The consultee may be a personal consultee or a nominated consultee. The principal investigator or delegate must take reasonable steps to identify a personal consultee before approaching a nominated consultee.

The principal investigator or delegate must ensure that the consultee is told that they are:

• being asked to provide an opinion for the adult lacking capacity to enter a study
• being asked whether the adult lacking capacity might wish to participate in the study
• are free to decide whether they wish to provide this opinion or not

The principal investigator or delegate must ensure that the involvement of the consultee follows the consent processes that have received a favourable opinion from the Research Ethics Committee.

The principal investigator or delegate must ensure that the opinion provided by a consultee is recorded on a consultee declaration form that has received favourable opinion from an appropriate Research Ethics Committee.

During the study the principal investigator or delegate must ensure that the consultee is informed of all material changes to the study and the participant’s condition. The consultee has the right to withdraw the participant from the study at any point without it affecting the participants care. If a participant regains capacity during a study, the opinion provided by the consultee remains valid, however at this point the principal investigator or delegate must provide the participant with verbal and written information. If the participant withdraws consent, the principal investigator must immediately withdraw them from the study.

Where the research is being delivered in an emergency setting and it is not possible to consult in the usual way, then the person who lacks capacity can be entered into an ethically approved study with either the agreement of a doctor who is not connected to the research or in accordance with a procedure previously agreed by a Research Ethics Committee where it is not reasonably practicable to obtain agreement from a doctor who has no connection with the project.

Any doctor identified to act as a consultee have no connection to the research. They must be provided with appropriate information about the nature of the study, the inclusion or exclusion criteria, and their duties. In the absence of any contrary information, it is justifiable for the doctor to assume that a potential participant would wish to receive an intervention that has the greatest chance of saving their lives or improving their health. Where there is genuine uncertainty about the relative benefits or harms of the standard treatment and the research treatment, it may be reasonable to assume that a potential subject would wish to enter the approved research project.

As soon as the emergency is over, arrangements must be made to seek consent in the usual manner or to seek advice from a consultee on the continued participation of the person who lacks capacity in the study in accordance with the processes described and approved in the Research Ethics Committee application. This should not compromise the provision of important clinical information, which must take priority over the consultation regarding any research.

4.4 The consent procedure, Human Tissue Act

Investigators intending to use human tissue taken specifically for research must always obtain informed consent from the donor for this use. The signed informed consent forms must be kept in both the investigator site file (or a file note s provided to confirm where stored) and in the medical notes of the patient.

The only exceptions to obtaining consent are if:

• the tissue was collected before 1 September 2006
• the tissue has been taken from a living person and the researcher is not able to identify the donor and the research is ethically approved by a research ethics committee
• it is imported tissue

Appropriate consent is always required under the Human Tissue Act to remove tissue from the deceased for research purposes.

Where investigators are required to obtain a donor’s consent, investigators must ensure that participant information sheets (PIS) state clearly the intention to use tissue samples taken at clinic or surgery in research. The participant information sheet should contain sufficient information so that it is clear to the participant, within the description of study procedures, the nature of the tissue sample to be donated and state:

• whether new tissue samples will be taken as part of the research (for example, blood, tissue, specifically for this study)
• whether tissue samples excess to a clinical procedure will be asked for
• access to existing stored samples will be asked for
• the security procedures in place for collecting, using, and storing samples whether there will be any possible intended use in the future for research that cannot yet be specified (a separated or two-part informed consent form (ICF) is recommended if future use is intended, and it should be clear if further ethical approval will be sought)
• whether tissue samples will be used for genetic testing
• who will have access to use the tissue sample
• the level of confidentiality (for this study and for storage for future studies)
• provision for disposal of the tissue sample after use in research
• procedures for possible feedback of individually significant information from their use
• whether tissue samples will be transferred outside the UK

There must be a section on the informed consent form which allows for the recording of a donor’s explicit consent for the use of their tissue. Investigators taking consent should record the process in the patient’s notes and file a copy of the participant information sheet and signed informed consent form in the patient notes. The original signed informed consent form should be kept in the study investigator site file.

Where an investigator wants to obtain tissue samples from children, the consent process must include assent from the child (if applicable age) and consent from the parent or legal guardian if under 16 years of age.

Where an investigator cannot obtain written consent from a donor due to the disability of that individual, the consent process must be witnessed by another party independent of the research team. The Human Tissue Act details those individuals with ‘qualifying relationships’ allowing those individuals to give consent on behalf of the incapacitated donor.

Where an investigator wishes to use tissue samples from the deceased, consent is always required unless the tissue samples were obtained before 1 September 2006. A person may consent for their tissue to be used for research after their death. If there is no record of the deceased wishes, consent can be obtained from relatives or a person acting on the deceased’s behalf.

Informed consent forms must be accessible to those using or releasing tissue for research and for those needing to conduct an audit.

4.5 The consent procedure, paediatric setting

For research involving those under the age of 16 years the initial approach for informed assent or consent of a child must be done through the parent. If a parent is unavailable a guardian or legal representative may be approached.

The principal investigator or delegate must ensure that prior to discussing a research study with a child the parent or guardian (non-clinical trial of an investigational medicinal product) or legal representative (CTIMP) of the child has had the opportunity to review the Research Ethics Committee approved information sheets. There would usually be a patient information sheet or informed consent form participant information sheets or informed consent form for parents or guardians, and an age-appropriate participant information sheets and assent form for children (for example, less than 6, 6 to 10 and 11 to 15).

The principal investigator or delegate must also allow sufficient time for the parent or guardian or legal representative to consider participation. This process will ensure the parent or guardian or legal representative is given the opportunity to understand the objectives and risks of the study and the environment and conditions which it is to be conducted.

The principal investigator or delegate must ensure that the parent or guardian or legal representative has been provided with a contact point where further information about the trial can be sourced.

The principal investigator or delegate must receive informed consent from the parent or guardian or legal representative for the child to take part in the research project.

The parent or guardian or legal representative of the child may, without the child being subject to any resulting detriment, withdraw the child from the research project at any time by revoking the informed consent.

The principal investigator or delegate must ensure that the child has full age-appropriate information about the research in order receive their full assent to take part. Assent must be freely volunteered by the child. The Research Ethics Committee application will set out what age groups of children are expected to provide assent in addition to parent or guardian or legal representative consent.

The principal investigator or delegate must ensure that the information presented to the child and parent explains fully what will happen in the research, what is being asked of the child and it must be conveyed that the child or parent can refuse to take part without adverse consequences.

The principal investigator or delegate must ensure that the information given is in a clear, understandable language which the child and parent can comprehend.

If the principal investigator or delegate deems the child incapable of understanding the implications of taking part in a research project or where the child is regarded as incompetent to assent, parental consent alone is acceptable.

4.6 Consent in emergency research

In some cases, research will involve a need to act upon recruitment during a short period of time due to the nature of the project or investigation. In an emergency it is not always possible to get consent to involve a person in research using the standard consent procedures.

In designing such emergency research projects the chief investigator and sponsor must carefully consider what level of consent it may be possible to obtain prior to the intervention taking place. Except in cases where the patient is incapacitated it is usually possible to provide limited information about the research and gain at least verbal consent before including the participant in the study. The chief investigator and sponsor are responsible for specifying the consent process to be used in the Research Ethics Committee application and for designing suitable brief information sheets which will provide shortened guidance on what will happen to the patient if they participate.

The Mental Capacity Act (2005) permits urgent research in emergencies to start when it is not practical to consult someone about involving a person who lacks capacity in research. In this situation you must either get agreement from a doctor not involved in the research, or follow the procedure approved by a Research Ethics Committee.

In emergency research where the patient does not lack capacity the principal investigator or delegate will follow the abbreviated consent procedure specified in the protocol using the study documents approved by the Research Ethics Committee or Health Research Authority and sponsor.

The principal investigator or delegate will provide the patient with an abbreviated information sheet as approved by the sponsor or, where a brief information sheet is not provided otherwise follow the process for gaining emergency consent that has been approved by the Research Ethics Committee as specified in the protocol and integrated research application system form.

Following the patient receiving the brief information sheet the principal investigator or delegate will ensure the patient provides the relevant form of consent as approved by the Research Ethics Committee prior to receiving any study related intervention. Where written consent is required the participant will sign and date the form to indicate they are willing to receive the treatment. The principal investigator or delegate will then countersign the document to indicate they bore witness to the patient agreeing to take part in the research. Alternatively, depending on what has been approved by Research Ethics Committee as specified in the protocol and integrated research application system verbal consent may be taken instead following the patient receiving the brief information sheet. Verbal consent should be recorded in the patient notes and or study case report form as specified by the chief investigator and sponsor.

Once the emergency is over it is the responsibility of the principal investigator or delegate to follow the consent procedure as specified in the protocol and integrated research application system and as outlined in this procedure.

If the participant decides they do not wish to continue in the research after the emergency has passed the process outlined in this procedure should be followed.

4.7 Alternative processes

Not all research will require written informed consent. In some situations, it will be more appropriate to obtain verbal consent or telephone consent from participants. Any plan to obtain verbal consent or telephone consent should be clearly described within the application submitted to the Research Ethics Committee (REC) and subsequently approved by the committee. It is advisable to undertake the procedure of verbal consent or telephone consent with a colleague who can verify the process.

4.7.1 Phone consent

When phone consent is planned for the research it is the responsibility of the principal investigator or delegate to ensure an information sheet has been given or sent to a potential participant.

It is the responsibility of the chief investigator or sponsor to create a script for the consent process. A consent script should include the same elements as would be in a consent form, but in a more conversational manner. This script will be approved by the reviewing Research Ethics Committee and the sponsor.

The principal investigator or delegate will ensure the potential participant is granted sufficient time to consider whether to participate in the research. After allowing the potential participant sufficient time, the principal investigator or delegate should answer any additional questions the participant may have. The principal investigator or delegate may then obtain phone consent to participate in the research.

When documenting the consent process the principal investigator or delegate should record the reading of a consent statement, and the answers of the participants indicating willingness to participate. The documented record of events verifies the phone consent process.

4.7.2 Verbal consent

The principal investigator or delegate is responsible for providing written information in the form of a participant information sheet approved by the reviewing research ethics committee and the study sponsor. The information should be written in lay terms which are easy to understand. The format should be that of question and answer. The principal investigator or delegate must also explain the study to the potential participant verbally, providing all pertinent information (purpose, procedures, risks, benefits, alternatives to participation), and must allow the potential participant suitable time and opportunity to ask questions.

It is the responsibility of the chief investigator or sponsor to create a script for verbal consent. This script will include the same elements of consent as would be in an informed consent form. This script will be approved by the reviewing Ethics Committee.

The principal investigator or delegate will ensure the potential participant is granted sufficient time to consider whether to participate in the research. After allowing the potential participant sufficient time, the principal investigator or delegate should answer any additional questions the participant may have. The principal investigator or delegate may then obtain verbal consent to participate in the research.

When documenting the consent process the principal investigator or delegate should record the reading of a consent statement, and the answers of the participants indicating willingness to participate.

4.7.3 Withdrawal of consent

Where a research participant, the legal representative, or parent or guardian wishes to withdraw consent from a study or the principal investigator responsible for the participants care decides it is in the best interest of the participant to withdraw them from a study, the withdrawal process and reasons for withdrawal must be fully documented in the participant’s medical notes.

The principal investigator or delegate must ensure that the process documented in the study protocol for early termination is followed.

The principal investigator or delegate must document in the medical notes whether the participant has withdrawn consent for all study follow up or confirm if the participant is willing to continue follow up until the study naturally ends.

4.8 Training and experience

While there are no national guidelines in place for what constitutes appropriate training and experience for the receiving of consent, the trust has set out the following.

For research characterised as clinical trials of an investigational medicinal product or device trials either an accredited by the National Institute of Health Research (NIHR) Good Clinical Practice (GCP) training or a Good Clinical Practice training course approved by a study sponsor is required; in line with the possible duration of trust granted research honorary contracts, current Good Clinical Practice status is defined as three years since the date of last substantiated Good Clinical Practice education and experience. Sponsors may advise two yearly renewals.

Where applicable, completion of the UK clinical research facility network (UKCR) informed consent competency training for research characterised as clinical trial of an investigational medicinal product or device trials or the National Institute of Health Research informed consent training.

Full protocol training and study specific procedure training which is then to be documented via the signing of the signature log in the investigator site file (ISF).

Ideally an individual who will receive consent will also endeavour to attend either the National Institute of Health Research informed consent training day which can be booked via the local management system (LMS) or another appropriate training approved by the sponsor. It would also be encouraged for the individual to undergo shadowing with the principal investigator.

5 References

• The Medicines for Human Use (clinical trials) Regulations 2004 Statutory Instrument 2006/1031, implemented on the 1 May 2004 as amended
• International Council for Harmonisation harmonised tripartite guideline for good clinical practice (1996) and E6 (R2) (2017)
• Mental Capacity Act (2005) code of practice
• Declaration of Helsinki (2013 version)
• UK Framework for health and social care research (HRA and Department of Health published October 2017)
• Mental Capacity Act, Health Research Authority
• UK clinical research facility network
• National Institute of Health Research

6 Appendices

6.1 Appendix A definitions and explanations of terms used

6.2 Appendix B parental responsibilities

• The law does not define parental responsibility in detail, but key roles include:
  • protecting and maintaining the child
  • agreeing to the child’s medical treatment
  • allowing confidential information about the child to be disclosed
• Mothers have automatic parental responsibility for their child from birth.
• If parents are married at the time of birth or have jointly adopted a child, they have joint parental responsibility.
• Parental responsibility remains in place even after divorce.
• A father does not have automatic parental responsibility for a child if he was not married to the mother at the time of the child’s birth unless the child was born after 1 December 2003 and the father is named on the birth certificate.
• If a father does not have automatic parental responsibility, he can acquire parental responsibility for his child via:
  • formal agreement with the mother
  • subsequent marriage to the mother
  • an order of the court
  • a residence order in relation to the child

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Document control

• Version: 2.
• Unique reference number: 599.
• Date ratified: 9 September 2025.
• Ratified by: research and innovation group.
• Name of originator: research governance manager.
• Name of responsible individual: chief medical officer.
• Date issued: 12 September 2025.
• Review date: 31 September 2028.

Page last reviewed: September 12, 2025
Next review due: September 12, 2026

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