Informed consent (clinical trials) procedure

1 Aim

The aim of this SOP 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 SOP has been produced in accordance with Medicines for Human Use (clinical trials) Regulations 2004 and subsequent amendments, ICH good clinical practice (GCP), research governance framework, The Declaration of Helsinki and Human Tissue Act (2004).

This SOP applies to

research studies sponsored or co-sponsored by the trust
studies hosted by the trust that are not covered by the sponsor’s standard operating procedure on informed consent

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

Research governance policy

4 Procedure

It is the responsibility of the chief investigator (CI) or sponsor to create consent forms. 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 CI or delegated person is responsible for providing written information in the form of a participant information sheet approved by the reviewing 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 as approved by both the HRA and NRES (National Research Ethics Service). Where the project does not require review by an REC, review by a university research ethics committee may alternatively be required. It is the responsibility of the PI and sponsor to ensure the correct version of the participant information sheet and informed consent form are used.

The PI is responsible for the conduct of the informed consent process. The PI can delegate this duty to another suitably qualified member of the Research team. For CTIMPS and device trials, the suitably qualified member of the Research team must have valid GCP certification. This training must be clearly recorded within the investigator site file (ISF). This can be evidenced through the staff members CV, GCP certificate, or can be documented on the training log.

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

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

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

The PI 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 PI 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 PI or delegate. Under circumstances where the approved process for receiving informed consent consists of postal consent the presence of the PI or delegate is not required. Under circumstances where the approved process for receiving consent consists of phone consent the PI 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 PI 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 PI or delegate must ensure all signatures have the name of the person signing printed clearly. The PI or delegate must also ensure the correct date has been recorded.

The PI or delegate must ensure two copies of the consent form are taken from the original.

The original consent form is filed in the ISF and the details of the participant are recorded on the enrolment log.

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

The final copy of the consent form is filed along with a copy of the participant information sheet in the participant’s medical records or scanned into medical records if electronic. This however is not necessarily required when the research is purely observational and human tissue is not stored.

The PI 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. This however is not necessarily required when the research is purely observational and human tissue is not stored.

The PI 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.

The PI or delegate is responsible for ensuring that all original consent forms are filed in the ISF.

The PI or delegate is responsible for monitoring the presence of consent forms by cross-checking against the enrolment log.

The PI or delegate will ensure all consent forms are available on request for inspection and audit by the grounded research department, sponsor and regulatory authority 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 REC application and, or protocol content specifying that informed consent can be obtained by non-medical professionals.

The PI 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.

The task of receiving informed consent for a CTIMP 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.

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 (CTIMP studies)

An adult lacking 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 capacity an assessment must be made. The PI or another suitably qualified clinician (delegate) must undertake the assessment. The assessment and its results must be recorded in the patients’ medical notes. Adults lacking capacity must only be included where the research ethics committee (REC) approvals cover their involvement.

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

When involving a legal representative, the PI or delegate must follow the consent process that has received a favourable opinion from an appropriate REC. 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 PI 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 PI or delegate should judge the format and level of information that is appropriate for the adult lacking capacity.

During the study the PI or delegate must ensure that the legal representative who provided consent should be 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 PI or delegate must provide the participant with verbal and written information. If the participant refuses consent following regaining capacity or withdraws consent the PI must immediately withdraw them from the study unless this would pose a significant risk to their health.

Where the treatment to be given to an incapacitated adult as part of the trial needs to be given urgently, 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
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 REC

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-CTIMP studies)

Where it is suspected that a person may lack capacity an assessment must be made. The PI 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 PI 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 PI or delegate must take reasonable steps to identify a personal consultee before approaching a nominated consultee.

The PI 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
free to decide whether they wish to provide this opinion or not

The PI or delegate must ensure that the involvement of the consultee must follow the consent processes that have received a favourable opinion from an appropriate REC.

The PI 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 REC.

During the study the PI 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 PI or delegate must provide the participant with verbal and written information. If the participant refuses consent following regaining capacity or withdraws consent the PI must immediately withdraw them from the study unless this would pose a significant risk to their health.

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 the REC where it is not reasonably practicable to obtain agreement from a doctor who has no connection with the project.

Any doctor identified to agree to the inclusion of a person in an approved project must 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 REC 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 ISF 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 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 consent form 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 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 consent form in the patient notes. The original signed consent form should be kept in the study ISF.

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.

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 PI or delegate must ensure that prior to discussing a research study with a child the parent or guardian (non-CTIMP) or legal representative (CTIMP) of the child has had the opportunity to review the REC approved information sheets. There would usually be a patient information sheet or informed consent form (PIS or ICF) for parents or guardians, and an age appropriate PIS or assent form for children (for example, less than 6, 6 to 10, 11 to 15).

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

If the PI 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 CI 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 CI and sponsor are responsible for specifying the consent process to be used in the REC 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 REC.

In emergency research where the patient does not lack capacity the PI or delegate will follow the abbreviated consent procedure specified in the protocol using the study documents approved by the REC or HRA and sponsor.

The PI 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 REC as specified in the protocol and IRAS form.

Following the patient receiving the brief information sheet the PI or delegate will ensure the patient provides the relevant form of consent as approved by the REC 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 PI 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 REC as specified in the protocol and IRAS application verbal consent may be taken instead following the patient receiving the brief information sheet. Verbal consent should be recorded in the patient notes or study case report form as specified by the CI and sponsor

Once the emergency is over it is the responsibility of the PI or delegate to follow the consent procedure as specified in the protocol and IRAS application and as outlined in this SOP.

If the participant decides they do not wish to continue in the research after the emergency has passed the process outlined in this SOP 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 phone consent from participants. Any plan to obtain verbal consent or phone consent should be clearly described within the application submitted to the research ethics committee and subsequently approved by the committee. It is advisable to undertake the procedure of verbal consent or phone 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 PI or delegate to ensure an information sheet has been given or sent to a potential participant.

It is the responsibility of the CI 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 REC and the sponsor.

The PI 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 PI or delegate should answer any additional questions the participant may have. The PI or delegate may then obtain phone consent to participate in the research.

When documenting the consent process the PI 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 PI 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 PI 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 CI or sponsor to create a script for verbal consent. This script will include the same elements of consent as would be in a consent form. This script will be approved by the reviewing ethics committee.

When documenting the consent process the PI 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 PI 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 PI or delegate must ensure that the process documented in the study protocol for early termination is followed.

The PI 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 RDaSH has set out the following

For research characterised as CTIMPs or device trials either an accredited by the National Institute of Health Research (NIHR) good clinical practice (GCP) training or a GCP training course approved by a study sponsor is required; in line with the possible duration of RDaSH granted research honorary contracts, current GCP status is defined as three years since the date of last substantiated GCP 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 CTIMP or device trials or the NIHR informed consent training.

Full protocol training and study specific SOP 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 NIHR 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 PI.

5 References

6 Appendices

6.1 Appendix A Definitions and explanations of terms used

Acronym	Long form
CI	Chief investigator
CRN	Clinical research network
CTIMP	Clinical trial of an investigational medicinal product
DHSC	Department of health and social care
GCP	Good clinical practice
HRA	Health Research Authority
IRAS	Integrated research application system
ISF	Investigator site file
MHRA	Medicines and Healthcare products Regulatory Agency
NIHR	National Institute for Health Research
NMC	Nursing and Midwifery Council
PI	Principal investigator
NRES	National research ethics service
R and D	Research and development
REC	Research ethics committee
UK CRF	UK clinical research facility network

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

Document control

Version: 1.2.
Unique reference number: 599.
Date ratified: 29 January 2024.
Ratified by: Clinical policy approvals group.
Name of originator: Research governance manager.
Name of responsible individual: Executive medical director.
Date issued: 30 September 2024.
Review date: 30 November 2024.
Target audience: All staff involved in research.

Page last reviewed: October 11, 2024
Next review due: October 11, 2025

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