Work Instruction Title: Informed Consent of Adults with Communication
Difficulties
Work Instruction Number: 22
Version Number: V.1
Effective Date: 11 November 2013
Author
Name: Ingrid Watmough
Title: Advanced Specialist Physiotherapist in Stroke
Rehabilitation
Date: 15 January 2010
Approved by
Name: Helen Macdonald
Title: Network Manager, PCRN – East of England
Date: 11 November 2013
Review date: 11 November 2014
Review History
Version No.
date
amendments
WI 22 Informed Consent of Adults with
Communication Difficulties
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1. Introduction, Background and Purpose
Patients with communication difficulties may need additional assistance with the
informed consent process. Standard Operating Procedures (SOPs) for taking
informed consent do not explore the difficulties present where patients have
communication problems. However a strategy should be in place to address these
issues.
The introduction of the Mental Capacity Act (2005) gives guidance on involving
people with communication disorders in research. It states that the “method of
presentation of information can affect your ability to make an informed decision.”
It also states that “central to a person’s ability to make decisions is the ability “to
communicate his decision (whether by talking, using sign language or any other
means)”. This Work Instruction (WI) sets out to provide guidance on taking Informed
Consent from adults with communication difficulties and documents some strategies
that may be used to achieve this. It is essential that this document is read in parallel
with the NIHR CRN Primary Care SOP 01‘Informed Consent’ and that the principles
of obtaining Informed Consent are understood and applied. GCP states ‘Freely given
informed consent should be obtained from every subject prior to clinical trial
participation.’
2. Abbreviations
See Reference Document: CRN Primary Care Glossary of Terms and Abbreviations.
3. Scope
This work instruction provides guidance to all staff in primary care seeking to recruit
patients to NIHR portfolio studies. This work instruction may be used for a research
study when the majority of the participants are expected to have communication
problems or in a research study where an individual participant is identified as having
communication problems
4. Responsibilities
All study staff are responsible to undertake recruitment procedures in line with ICH
GCP, the study protocol and using ethically approved documents and methods. It is
the responsibility of the study staff to ensure they are familiar with the SOP 01
‘Informed Consent’ and the processes and principles associated with it.
5. Procedures
5.1 Assess Mental Capacity
A person will need to understand information, retain it, weigh it up and
communicate a decision (whether by talking, using sign language or any other
means). If there is uncertainty about whether a person has capacity to make and
communicate a decision see WI 02
5.2 Assess Communication Skills and Language Skills (see Appendix 1)
 Communication – understanding, expression, reading and writing abilities.
 Language – level of verbal comprehension, level of verbal expression and
the ability to read and write in relation to the understanding and production
or formulation of words and sentences.
 Identify usual communication methods, e.g. speech, writing, gesture, sign
language, communication aid.
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 Ensure communication strategies used match the level of verbal or written
comprehension of the patient.
5.3 Strategies for talking to Patients with Communication Difficulties (see
Appendix 2)
 Effective conveying of information to the patient.
 Effective understanding of the patient.
 Environmental modification.
5.4 Provide accessible information (see Appendix 3 from Connect 2006)
 Use diagrams and pictures.
 Ensure trial Logo is on all documentation so that the institution can be clearly
identified.
 Initially speak to a relative or carer who is more experienced in communicating
with the patient in order to find out how a person is used to communicating e.g.
picture boards or computer.
 Accessible information guidelines (Appendix 3) assist people to understand if
they have a verbal or written comprehension level of about 3 key words.
 If the potential participant’s understanding is more severely affected (2 key word),
presenting one concept at a time using key words, pictures and animations on
powerpoint together with spoken explanation and gesture can help
understanding.
 Where a person has severely impaired understanding of verbal or written
information (less than 2 key words) it may be difficult for them to be fully
informed. In these circumstances, the general idea should be conveyed to the
person to see if they are interested and guidance in WI 02 followed.
5.5 Facilitate decision-making so that the patient can give consent for
themselves
 Ensure the potential participant has all the appropriate aids to enable her/him to
give fully informed consent for themselves, for example glasses, hearing aids
etc.
 Decide whether information has been presented in a way that s/he can
understand and retain it.
 If verbal communication skills are not used allow more time for effective
communication. Ideally when recruiting a participant, allow twice as long for
those with communication difficulties.
 Consider the use of professional help for specific communication disorders such
as a Sign Language interpreter or a Speech and Language therapist.
 Make the patient feel at ease e.g. right location, time of day or allow more time
to make a decision.
 Before taking consent, check the person has understood the key concepts e.g:
o Give forced alternatives – ‘am I going to give you a tablet or a
questionnaire’, ‘can you stop doing the project if you don’t want to take part
anymore – yes or no?’
o If comprehension is poor, get the patient to sort pictures into piles of
‘something to do with the project’ and ‘nothing to do with the project’
5.6 When the person taking informed consent is satisfied that the potential
participant has been fully informed and understands what study participation
entails the consent form should be signed and personally dated by the
potential participant and by the authorised person who conducted the
informed consent discussion. However, if the potential participant is unable to
sign or mark the consent form to indicate his/her consent, then consent may
be given orally in the presence of a relative or patient advocate. Consent can
also be recorded to provide a complete record with a copy of the tape for the
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participant. The tape must be stored securely by study staff as with all study
documentation. NB If an accessible format of information has been given, the
consent form should also be provided in this style.
5.7 The process of obtaining informed consent should be documented in the
participant’s clinical records, detailing the study title and/or acronym and the
date that consent was obtained. The role of the relative/advocate in the
consent process, e.g. acting as a witness or explaining the trial to the subject,
must be documented in the participant’s clinical records. The entry should be
dated and signed by the person authorised and responsible for conducting
and obtaining the participant’s informed consent. A copy of this process
should be attached to the consent form in the study site file.
5.8 If a participant is unable to sign the consent form and can just mark it then it is
important that a note be added to the consent form, ideally by a patient advocate to
say that the mark on the consent form was made by the participant. The person
taking the informed consent should document the process in a file note which
should be stored in the study site file and in the patient’s medical records.
6. Related SOPs, Work Instructions and Reference Documents
6.1 SOPs
SOP 01 Informed Consent
6.2 Work Instructions
WI 02 Informed consent with adults lacking capacity
6.3 Reference Documents
ICH Good Clinical Practice (GCP)
CRN Primary Care Glossary of terms and Abbreviations
7. Appendices
Appendix 1: Assessment of Communication and Language Skills.
Appendix 2: Strategies for Talking to Patients with Communication Difficulties
Appendix 3: Producing Accessible Information – from Connect 2006
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Appendix 1: Assessment of Communication and Language Skills(Palmer 2009)
Assessment of communication skills:
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What does the patient understand?
How does the patient express him/herself?
How much can the patient read?
How much can the patient write?
Assessment of language skills:

Level of verbal comprehension (number of key words):
0 1 2 3 4 every day conversation.

Level of verbal expression:
- No difficulty
- Word finding difficulties
- Poor sentence formulation
- Limited meaningful speech
- Reduced speech intelligibility

Ability to read:
- None
- Single words
- 2-3 key words in sentence
- Paragraphs

Ability to write
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Appendix 2: Strategies for Talking to Patients with Communication
Difficulties(Palmer 2009)
1. Talking to the Patient
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Slow down
Use short sentences with one key word
Use gesture
Write key words
Draw
Use pictures/objects to point to
Ask question with yes/no answers
2. Understanding the Patient

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Give TIME
Ask patient to slow down and over-articulate (lip reading is often effective in
this instance)
Encourage patient to point to letters of the word
If you know what the patient is saying give a sound cue
Encourage a patient to describe if they can’t think of a word
Gesture
Point to pictures
Point to key words
3. Environmental Modification

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Face the speaker, make eye contact and do not do any other task whilst
speaking
Reduce background noise
Ensure the room is well-lit, particularly for non-verbal communication
Speak one at a time
Ensure any communication requirements are to hand, e.g. pen and paper,
communication aid or picture chart
Appendix 3
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Producing Accessible Information – from Connect 2006

Short sentences, one point per sentence

Lower case

Present, active tenses
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Question and answer format
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Keep instructions affirmative and specific
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Use familiar works, not jargon or acronyms
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Bulleted or numbered points
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Small blocks of text

Lots of white space

Large bold rather than upper case for emphasis

Large font size – at least pt 14

Diagrams and pictures – use one per concept/sentence, not for individual
words

Logo on all documentation related to same institution or therapy department so
easily identifiable
These strategies need to be used together as one approach. They are not as effective
when used independently.
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