Title: Informed Consent for Research and issue of Standard Operating
Procedures
SOP Number and Version: 4, V1
Effective Date: 26 September 2014
Review Date:
26 September 2017
Please check this is the latest version of the SOP on the Joint Research Office website:
www.ucl.ac.uk/jro.
Author:
Name: Todd Gumbleton
Position: Clinical Research Facility Lead Research Nurse
___________________________________
Signature
Date
Approved by:
Name: Suzanne Binks
Position: Quality Assurance Coordinator (Research Governance)
____________________________________
Signature
Date
Authorised by:
Name: Rajinder Sidhu
Position: Deputy Director of Research Support
____________________________________
Signature
Date
Informed Consent for Research, SOP 4, V1, 05/09/14
Page 1 of 10
Revision Chronology
Version
Number:
1
Effective
date:
26 September
2014
Reason for change:
Author:
Initial standardised SOP for use within UCLH.
Todd
Gumbleton
ACRONYMS
CI
Co-I
CTIMP
CTP
CRF
CV
EMA
DM
GCP
IC
ICF
ISF
PI
PIS
R&D
REC
RN
RM&G
SI
SOP
QA
Chief Investigator
Co-Investigator
Clinical Trial of an Investigational Medicinal Product
Clinical Trial Practitioner
Clinical Research Facility
Curriculum Vitae
European Medicines Agency
Data Manager
Good Clinical Practice
Informed Consent
Informed Consent Form
Investigator Site File
Principal Investigator
Patient/Participant Information Sheet
Research and Development Department
Research Ethics Committee
Research Nurse
Research Management & Governance
Statutory Instruments
Standard Operating Procedure
Quality Assurance
BACKGROUND
Informed consent (IC) is the process by which a subject voluntarily confirms their willingness to
participate in a particular study having been informed of all aspects of the study that are relevant to
the subject’s decision to participate. IC is documented by means of a written, signed and dated
informed consent form (ICF).
As per Statutory Instrument (SI) 2004/1031 Schedule 1 Part 3 conditions which apply in relation to
an adult being able to provide consent are:
1. The subject has had an interview with the investigator, or another member of the investigating
team, in which he/she has been given the opportunity to understand the objectives, risks and
inconveniences of the trial and the conditions under which it is to be conducted.
2. The subject has been informed of his/her right to withdraw from the trial at any time.
3. The subject has given his/her informed consent to taking part in the trial.
Informed Consent for Research, SOP 4, V1, 05/09/14
Page 2 of 10
4. The subject may, without being subject to any resulting detriment, withdraw from the clinical
trial at any time by revoking his/her informed consent.
5. The subject has been provided with a contact point whether he/she may obtain further
information about the trial.
Schedule 1 Part 1 clause 3b
Informed consent shall be written, dated and signed by the person performing the interview and
the subject or his or her legally designated representative after having been duly informed. Where
the subject is unable to write, consent may be given and recorded through appropriate alternative
means in the presence of at least one impartial witness.
The Principal Investigator (PI) shall follow Sponsor templates and Sponsor SOPs in relation to
informed consent and abide by the Trust’s Consent Policy for Research Participants. Templates for
different types of Patient/Participant Information Sheets (PIS) and ICFs are available on the Health
Research Authority website: http://www.hra-decisiontools.org.uk/consent/
PURPOSE
This standard operating procedure (SOP) describes the process for obtaining informed consent
from a subject (or their legally designated representative in the case of subjects under the age of
16, vulnerable subjects or incapacitated adults).
PROCEDURE
Actions (When? How?)
1
The Principal Investigator (PI) has signed the Study Delegation Log confirming that
they are willing to delegate the responsibility of taking informed consent to the
appropriate individuals. The PI is the person ultimately responsible for the subject’s
care.
2
If non-medical research staff (e.g. RN, CTP) are to accept responsibility for
supporting the IC process, it is important the following criteria are met:
Responsible
Persons
(Who?)
PI
CoInvestigator
(Co-I)

They are prepared to take on this additional responsibility and feel confident to
take informed consent in line with their professional code of conduct (e.g. Nursing
and Midwifery Council Code of Professional Conduct, ICH GCP, etc.).
Research
Nurse (RN)

They have a comprehensive understanding of the study, potential
pharmacological interactions/treatment toxicities (where applicable) and the
associated disease area, which is documented in their training folder.
Clinical Trial
Practitioner
(CTP)

They should be qualified by experience and/or should have received
appropriate training for this study (e.g. have attended the site initiation visit where
applicable).
Data
Manager
(DM)

They are also required to provide an updated version of their CV and valid
GCP training certificate (where applicable) to be filed in the investigator site file
(ISF) and in the local central training file if available.
Informed Consent for Research, SOP 4, V1, 05/09/14
Page 3 of 10
If the IC process relates to a CTIMP the IC must be taken by a medical
professional.
An effective line of communication is maintained with the PI.
3
Identifying Research Participants
Healthcare
Professional
Subjects should be identified as potentially eligible for a particular study by a
healthcare professional who has clinical responsibility for the subject. This is to
ensure medical confidentiality is adhered to. Healthy volunteer studies will identify
subjects through a variety of study specific means (including advertising) for
consideration of study inclusion and referral.
All staff
delegated to
taking
informed
consent
Research participants will be assessed for their potential eligibility for a particular
study by a healthcare professional who is authorised to recruit to the particular
study or research project.
The person considering recruiting a subject onto a study should initially consider
whether the subject potentially fulfils the eligibility criteria by checking the subject’s
medical history.
Once a subject has been assessed and identified as potentially eligible for a
particular study, they should be approached and introduced to the study. This
process can include sending the PIS prior to a verbal interview or by conducting a
verbal interview and providing the PIS concurrently to the subject. The process
used needs to be documented in the patient’s medical notes.
The person approaching the subject about a particular study must ensure they are
familiar with all aspects of the study as described in the latest REC approved
version of the protocol.
The person taking IC must have the subject’s medical notes, the current REC
approved versions of the PIS and ICF available during interview. Other study
documents may also be used during the interview (e.g. subject diaries, study
schedule sheets).
All potential subjects should be provided with the PIS and allowed ‘adequate time’
to consider inclusion in the trial prior to providing written IC. It is commonly accepted
that subject should have a minimum of 24 hours between the date the PIS is
provided to the subject and the actual interview where the subject (and/or the
subject’s legally designated representative) signs the IC. ‘Adequate time’ may be
less if this is approved by the REC.
A verbal explanation of the study must be given to the subject (and friends and
family if appropriate), and if necessary diagrams may be used to explain the study.
Time for questions throughout the discussion must be given and questions
adequately addressed.
4
When describing the study, the person taking consent should explain the
following:

What the purpose of the study is and any background information that may
be relevant.

Why the subject has been approached.

That confidentiality will be maintained throughout the study should they
decide to participate.

Details of the study design

Details of the drugs (or interventions) used including any known safety
Informed Consent for Research, SOP 4, V1, 05/09/14
Page 4 of 10
Person
taking
consent
profiles. If there is a placebo arm then this should be explained (applicable to
clinical trials of investigational medicinal products, CTIMPs).

The number of people taking part in the study and how many have been
recruited to date, if information available.

The duration of the study and the number of study visits involved. It should
be explained where the subject will be seen and by whom.

All procedures that are required as part of the study, such as blood tests,
electrocardiograms (ECGs), etc.

The potential benefits and risks of participation in the study and any
alternative treatments available to the subject should be discussed.

The availability of compensation should something go wrong

That the subject enters the study voluntarily and can withdraw at any time
without any prejudice to them or their future care. Similarly if the PI feels that the
subject is not tolerating the IMP, the PI has the right to withdraw them from the
study in the interest of the subject’s safety (applicable in CTIMP trials only).

If there are any payments made for participation in the study or for out of
pocket expenses.

The responsibilities of the subject if they chose to take part, particularly if the
study duration is lengthy.

A subject giving informed consent does not necessarily mean that they will be
enrolled onto the study if it is discovered that they have not met the
inclusion/exclusion criteria for that study (e.g. study specific diagnostic test(s)).

That the subject will have 24 hour contact number should they need to
contact the clinical team for medical emergencies whilst on the study, and why this
is important. (This may not be necessary for all studies; e.g. non-interventional
research.)

The contact details where the subject may obtain further information about
the study. This could be the PI’s number and/or the contact number for other
members of the study team.
5
Evidence of Informed Consent
The date and time the trial was discussed and the date the PIS was given to
the subject must be documented in the medical notes.
To ensure adequate time for the subject to consider the study a subsequent
interview may be necessary where the IC form can be signed. Once the subject has
had ample time to read the PIS and has had any questions regarding their
participation answered satisfactorily, the person taking IC will ask the subject to
clearly print their name, sign and date the ICF and initial any statements
required by the study ICF.
The person taking consent must also clearly print their name, sign and date
the ICF together with the participant (on the same day). If a protocol states any
additional signatures are required then this process must be followed accordingly.
The person who took signed IC must add to the subject’s medical notes the
following:

The date the subject received the PIS and which version they were provided.

The date the subject signed the ICF and which version they were given.

The name of the study they have consented to.

Confirmation that the subject has given IC and can proceed to trial screening
(as required).
The consent form must be signed prior to any study related pre-screening or
screening procedures being performed.
Informed Consent for Research, SOP 4, V1, 05/09/14
Page 5 of 10
Person
taking
consent
The person taking consent should also inform relevant team members of the
treatment decision for the subject.
Any research staff involved in giving information during the informed consent
procedure should document in the patient’s medical notes the fact they have
informed the subject about a particular aspect of the study and when the information
was given.
The IC process should be documented in the subject’s medical notes in a detailed
and chronological order. The PIS will be placed in the subject’s notes with the ICF
to provide study specific information.
6
Participant Documentation
Research
Team
PIS and ICFs provided by the sponsor are to be submitted to R&D for approval prior
to use.
They must be on local headed paper using authorised templates and contain local
contact names and telephone numbers prior to being used in the IC process.
The ‘footers’ of the PIS and ICF should contain the following information:




REC reference
Short study title
Document version and date
Page number of total number of pages
The ‘header’ should have the Trust logo on the front page, and contact details of the
research team.
Once all parties have signed and dated the ICF:

One copy should be given to the participant

One copy should be placed in the patient’s medical notes

The signed original should be placed in the Investigator Site File (ISF),
unless stated otherwise in the protocol (some trial centres or Sponsors request
copies of signed ICFs as explained in the PIS).
7
For Participants Who Do Not Speak English
The Trust independent Interpreting Service ‘Language Line’ should be used for
participants who do not speak English. To access this service, call via the UCLH
Switch Board. Ideally face-to-face interpreting is preferable to using the telephone
interpreting service. Both of these services can be booked by calling Language
Line. Face-to-face interpreting requires a minimum of 48 hours’ notice but telephone
interpreting is immediate. Appropriately translated PIS and ICF with REC approval
should be used where available.
Person
taking
consent
As with all IC processes, check the requirements of the trial’s REC application
regarding interpreting services for patients who do not speak English or require
interpreting assistance.
8
Re-Consent of Participants
The IC process should not stop once the ICF has been signed. The practice of
giving information about the study to subjects should be an ongoing process. This is
particularly significant with the introduction of protocol amendments and the
availability of important new information that may be relevant to the subject’s
Informed Consent for Research, SOP 4, V1, 05/09/14
Page 6 of 10
Person
taking
consent
willingness to continue participating in the study. For any substantial amendments
affecting the PIS and ICF, the Sponsor may request recruited subjects to be reconsented with the approved updated version in addition to their original consent
form in order to continue involvement in the study. The details of when a subject
gives additional consent should also be documented in the subject’s medical notes.
9
Withdrawal of Participants
Where a subject volunteers to withdraw from a study or the PI/treating clinician
responsible for the subject’s care decides it is in the best interest of the subject to
withdraw them from a study, please ensure the following:
Person
taking
consent

The withdrawal process and reasons for withdrawal are fully documented in
the medical notes.

The withdrawal process in the study protocol is referred to and acted upon

Document if the subject withdraws consent for all study follow-up or confirm if
they are willing to continue to have future details sent to the sponsor.

The sponsor is informed of the process and the reasons through study specific
withdrawal forms or SAE forms as required.
10
Informed Consent of Incapacitated Adults / Those Who Lack Capacity to
Consent for Themselves
For a person to have capacity, the following conditions must be satisfied:

The person must be able to absorb, comprehend and retain relevant
information

The person must be able to use that information to arrive at a decision

The person must be able to communicate that decision in some way
Research involving adults unable to consent for themselves requires specific REC
notice of favourable opinion from a recognised Mental Capacity Act Flagged REC.
The research provisions of the Mental Capacity Act 2005, sections 30-34 apply to
the conduct of research.
There is a hierarchy for determining which type of legally designated representative
should be approached to give informed consent on behalf of an adult who lacks
capacity for inclusion in research as described below:
1. Personal legal representative: a person not connected with the conduct of the
trial that is suitable to act as a legally designated representative by virtue of their
relationship with the adult, and available and willing to do so.
2. Professional legal representative: a person not connected with the conduct of
the trial that is the doctor primarily responsible for the adult’s medical treatment, or a
person nominated by the relevant healthcare provider (e.g. NHS Trust); a
professional legally designated representative may be approached if no suitable
personal legally designated representative is available.
Once a subject has been assessed and identified as potentially eligible for a
particular study and is agreeable, the PI, Co-I or delegated RN should discuss the
process for determining which legally designated representative should be
approached to introduce the study.
The process of IC includes in addition the following conditions:

The legally designated representative has had an interview with the PI, or
another member of the research team, in which opportunity has been given to
Informed Consent for Research, SOP 4, V1, 05/09/14
Page 7 of 10
Person
taking
consent
understand the objectives, risks and inconveniences of the trial and the conditions
under which it is to be conducted.

The legally designated representative has been provided with a contact point
where further information about the trial may be obtained.

The legally designated representative has been informed of the right to
withdraw the subject from the trial at any time.

The legally designated representative has given IC to the subject taking part in
the trial.

The legally designated representative may, without the subject being subjected
to any resulting detriment, withdraw the subject from the trial at any time by
revoking the IC.

The subject has received information, according to his or her capacity of
understanding, about the trial and its risks and benefits.

The investigator must consider the explicit wish of a subject capable of forming
an opinion and assessing the information provided. This applies both to the wish of
a subject to refuse to take part, or to withdraw from the trial at any time.

No incentives or financial inducements are given either to the subject or to the
legal representative, except the provision of compensation for injury or loss.

There are grounds for expecting that administering the medicinal product to be
tested in the trial will produce a benefit to the subject outweighing the risks or
produce no risk at all.

The trial is essential to validate data obtained (a) in other clinical trials involving
persons able to give informed consent, or (b) by other research methods.

The clinical trial relates directly to a life-threatening or debilitating clinical
condition(s) from which the subject suffers.
Principles

IC given by a legally designated representative shall represent the presumed
will of an incapacitated adult.

The trial has been designed to minimise pain, discomfort, fear and any other
foreseeable risk in relation to the disease and the cognitive abilities of the subject.

The risk threshold and the degree of distress have to be specially defined and
constantly monitored.

The interests of the subject always prevail over those of science and society.
11
Informed Consent for Subjects under the age of 16
For subjects under 16, the legally designated representative (often one of the
parents) would sign the consent form on behalf of the minor. The assent form
corresponding to their age range will be signed by the minor. If during a clinical trial
the minor reaches the age of majority, their express informed consent shall be
obtained before the trial may continue.
There is a hierarchy for determining who should be approached to give IC on behalf
of a minor prior to their inclusion in the study, see Table 1 below. The provisions for
IC by a legal representative only apply in the case of emergency treatment where
no person with parental responsibility can be contacted prior to the proposed
inclusion of the minor.
Informed Consent for Research, SOP 4, V1, 05/09/14
Page 8 of 10
Person
taking
consent
Table 1 - Hierarchy of Informed Consent for a Minor
1
12
Person Who
May Give
Consent
Parent
2
Personal Legal
Representative
3
Professional
Legal
Representative
Definition
Comments
A parent or person with
parental responsibility
A person not connected with
the conduct of the trial who is
suitable to act as the legal
representative by virtue of
their relationship with the
minor, and available and
willing to do so.
A person nominated by the
relevant healthcare provider
(e.g. an acute NHS Trust or
Health Board) who is not
connected with the conduct of
the trial.
Should always be approached
when available
May be approached if no person
with parental responsibility can be
contacted prior to the proposed
inclusion of the minor, by reason of
the emergency nature of the
treatment provided as part of the
trial.
May be approached if no person
suitable to act as a personal legal
representative is available.
Informed consent must be given
before the minor is entered into the
trial.
The process of taking consent includes in addition the following conditions and
principles which apply to the inclusion of a minor in a clinical trial.
Conditions

The parent or legal representative has had an interview with the investigator,
or another member of the research team, in which opportunity has been given to
understand the objectives, risks and inconveniences of the trial and the conditions
under which it is to be conducted.

The parent or legal representative has been provided with a contact point
where further information about the trial may be obtained.

The parent or legal representative has been informed of the right to withdraw
the minor from the trial at any time.

The parent or legal representative has given IC to the minor taking part in the
trial.

The parent or legal representative may, without the minor being subject to
any resulting detriment, withdraw the minor from the trial at any time by revoking
the IC.

The minor has received information, according to their capacity of
understanding, about the trial and its risks and benefits. The information must be
given by staff with experience of working with minors.

The investigator must consider the ability of a minor in forming an opinion
and assessing the information provided. This applies both to the wish of a minor to
refuse to take part, or to withdraw from the trial at any time.

No incentives or financial inducements are given either to the minor or to the
parent or legal representative, except the provision of compensation for injury or
loss.

The clinical trial relates directly to a condition from which the minor suffers or
is of such a nature that it can only be carried out on minors.

Some direct benefit for the group of patients involved in the trial is to be
obtained from the trial.

The trial is necessary to validate data obtained (a) in other clinical trials
involving persons able to give IC, or (b) by other research methods.

The corresponding scientific guidelines of the European Medicines Agency
(EMA) are followed.
Informed Consent for Research, SOP 4, V1, 05/09/14
Page 9 of 10
Person
taking
consent
Principles

IC by a parent or legal representative shall represent the minor’s presumed
will.

The trial has been designed to minimise pain, discomfort, fear and any other
foreseeable risk in relation to the disease and the minor’s stage of development.

The risk threshold and the degree of distress have to be constantly
monitored.

The interests of the patient always prevail over those of science and society.
As soon as the subject is 16 he/she should sign the consent form to continue on
the trial.
REFERENCES
Trust Consent Policy for Research Participants
Health Research Authority: http://www.hra-decisiontools.org.uk/consent/examples.html
Mental Capacity Act 2005
Statutory Instrument 2004/1031
Informed Consent for Research, SOP 4, V1, 05/09/14
Page 10 of 10