Informed Consent

Candy Wong
GH156
sau-ching-candy.wong@polyu.edu.hk

Touching lives, making an impact

觸動生命 啓廸新知
After this session, you will be able to……..

• Learn the definitions and concepts of informed consent.

• Understand the importance of informed consent in Clinical
practice and Clinical Research.
• Learn different types of informed consent.
• Know how can informed consent be implemented.
• What
• Why
• How
 What is Informed Consent……….
Inform Consent is……
• The patient has given proper explanation of the nature,
effect and risks of the proposed treatment and other
treatment options (including the option of no treatment);
• The patient properly understands the nature and
implications of the proposed treatment;
• Reasonable time is given to patient for making decision.
(Medical Council of HK, Code of Professional Conduct Jan 2016 p.16)
 What is Informed Consent……….
• voluntary agreement given by a person to allow something to happen to them and /or to
allow their participation in something.
• It is a fundamental right that every adult with capacity has the absolute right to determine
what happens to their own body and this right is protected in law.
• Physiotherapists should ensure that service users have the capacity to consent, give consent
voluntarily without coercion, and have sufficient information on which to make this decision.
• Consent should be reaffirmed throughout therapeutic interaction where there are significant
changes to the service user’s treatment plan or condition or the service user reports new
information
(Chatered Society of physiotherapy –Quality Assurance Standards for physiotherapy Service
Delivery, 2012 Section 5. p17 )
What is Informed Consent……….
• Primary paradigm for protecting
the legal right of patients and
guiding the ethical practice of
medicine.

(Hall et al 2012)
 Material Risk
A ‘Material risk’ is defined as
one that ‘in the circumstances of the
particular case, a reasonable person in
the patient’s position would be likely to
attach significance to the risk, or the
doctor is or should reasonably be aware
that the particular patient would likely
attach significance to it’

( Thomas 2020 )
 Material Risk
• In Roger vs. Whittaker in 1922 in Australia,
• a woman lost sight in her good eye after being
operated on her diseased eye.
• Despite the procedure being performed technically
perfectly, the patient became blind in the other
(previously normal) eye through an inflammatory
process called ‘sympathetic ophthalmia’.
• The risk of this happening was only 1:14,000
 Mrs Whitaker successfully sued her clinician for
negligence,
 claiming that if she had been aware of this risk
she would never have agreed to undergo the
procedure.
( Thomas 2020 )
 Why is it important……….
• Respect for the patients’ autonomy is expressed in common law;
to impose care or treatment on competent people without
respecting their wishes and right to self determination is not only
unethical, but may be illegal.
Failure to obtain informed consent can result in
Civil action being brought Regulatory proceedings

Criminal charges Disciplinary action

( Sokol, 2015 )
 Informed Consent

Professional

Ethical Legal
Ethical & Professional Issue
Informed consent as an ethical and professional
issue - a moral principle of respect for
autonomy
…..every adult with capacity has the absolute right
to determine what happens to their own body.
(Chartered Society of Physiotherapy, 2016, p.6)

Code of Practice of PT Board of HK (2014)

Part I: Basic Ethical Principles
1.Respect the rights and dignity of all individuals
 Ethical & Professional Issue
• “ From the ethical viewpoint of autonomy,
informed consent becomes a process of giving
the power of choice to patients by respecting
their decisions and providing them with the
information they need to make decisions about
their own health care.” (Aiken, 2004, p.247)
 Ethical & Professional Issue
• “If a patient refuses to agree to your planned treatment,
and they have capacity, you should accept that refusal
of treatment even if you think their decision is wrong,
irrational or made without reason at all.”
• If a patient makes an informed decision to refuse
treatment, it should be recorded and documented
carefully.
Respect for patient’s decisions
( Chartered Society of Physiotherapy, 2016, p.19)
 Ethical & Professional Issue
• Failure to obtain consent from patients for examination
and treatment is a violation of the fundamental moral
principle of respect for autonomy and individual’s right of
self-determination.
 Legal Issue
• In law, a doctor cannot perform
diagnostic procedures and medical
treatment on a patient who does not
consent to the treatment.
• A doctor who does so is liable to be sued
for the tort of battery or prosecuted for
criminal offences such as wounding and
assault occasioning actual bodily harm.
(Code of Professional Conduct , Medical Council of HK 2016,
p15)

Informed Consent is
a legal issue
 Legal Issue
Informed consent as a legal issue
 Trespass to the person
• A trespass to the person occurs when an individual either apprehends a touching of his /her
person (an assault) or the individual is actually touched (a battery) and has not given
consent. The person who has suffered the trespass can sue for compensation in the civil
courts (and a prosecution could also be brought in criminal cases).
(Dimond, 2009, p.77)
• In civil cases, the victim has to prove for the touching or the apprehension of the touching
• The victim does not have to show that harm has occurred. This is in contrast to an action for
negligence in which the victim must show that harm has resulted from the breach of duty of
care.
(Dimond, 2009, p.77)
 Legal Issue
Informed consent as a legal issue
 Duty to inform
• As part of the duty of care owed in the law of negligence the
professional has a duty to inform the patient about the significant
risks of substantial harm which could occur if treatment were to
proceed.
• If the harm has not been explained to the patient and the harm
then occurs, the patient can claim that, had he/she known of this
possibility, he/she would not have agreed to undergo the
treatment. The patient could then bring an action in negligence.

(Dimond, 2009, p.88-89)

 Legal Issue
Informed consent as a legal issue
 Duty to inform
• that there was a duty of care to give specific information;
• The defendant failed to give this information and in so doing was
therefore in breach of the reasonable standard of care which
should have been provided;
• As a result of this failure to inform, the patient agreed to the
treatment; and subsequently suffered the harm

(Dimond, 2009, p.89)

 Legal Issue
• In Mohr vs. Williams in 1905 in Minnesota, a woman agreed to an
operation on her right ear.
• During operation, Surgeon found her left ear in need of operation.
• The surgeon was subsequently sued and convicted because he
had not proceeded according to the preoperative agreement.
The judge  agreedment is a contract that authorizes the physician
to operate only to the extent of the consent given

(Leclercq et al,2010)
 Legal Issue
• In Schoendorff vs. Society of New York in 1914 in New York, a
woman had consented to an abdominal examination under
anaesthesia but not to an operation.
• However, the surgeon removed a tumour that eventually led the
patient to file a lawsuit against him.
• The judge
Every human being of adult years and sound mind has a right to
determine what shall be done with his own body.
Surgeon who performs an operation without patient’s consent
commits an assault.

(Leclercq et al,2010)
 Informed Consent Elements

II. Information III. Consent

I.Preconditions
Elements Elements
Disclosure of
Information & Decision by the
Competence
Recommendation of patient
a care plan

Understanding of
Authorization by the
Voluntariness this information by
patient to proceed
patient

(Leclercq et al,2010)
 Inform Consent Elements
I. Preconditions
a. Competence
• Adults ( aged 18+) are presumed to Can the patient …..
be competent unless demonstrated 1.understand the information given to
otherwise. him/her?
• In many case the issue of 2.Retain the information
competence will not arise, but if 3.Weigh up the information tn order to
there is doubt the patient’s capacity make a decision?
can be determined according to the
following test
(Chartered Society of Physiotherapy, 2016, p24) (Chartered Society of Physiotherapy, 2016, p.23)
Inform Consent Elements
4 steps in assessing patient’s
competence in giving informed consent
( Hospital Authority, 2018, p.4)

1.Is he capable of understanding and retaining in broad

terms information relevant to the decision including the
likely consequences of having or not having the proposed
treatment?
2.Is he capable of using the information and weighing it in
balance? AND
3.Does he have these abilities to a degree commensurate
with the gravity of the decision in question? AND
4.Is he capable of communicating a decision?
 Inform Consent Elements
Patient with Mental Health Disorder or Learning Difficulty

•Incompetency should not be assumed for patients with mental

health disorder or learning difficulty
•Assessment and treatment must not be given without consent
(Chartered Society of Physiotherapy, 2016)
 Inform Consent Elements
Mentally Incapacitated Person
Mental Health Ordinance Cap. 136
Part I: Preliminary, Section 2 Interpretation:
Mental incapacity means (精神上無行為能力)
(a) mental disorder
(b) mental handicap.
Part IVC: Medical and Dental Treatment,
Section 59ZB Application and Principles:
A mentally incapacitated person
• is incapable of giving such consent if that person is incapable of
understanding the general nature and effect of the treatment or special
treatment.
•can consent to or refuse medical treatment if he can understand its nature
and effect.
 Inform Consent Elements
Mentally Incapacitated Person
Emergency situation,
a doctor can
- provide medical treatment to
mentally incapacitated adult
without consent
- such treatment is necessary
and for patient’s best interest
- obtained a second doctor’s
opinion in support.
(Hospital Authority, 2018, p.10)
Non-urgent situation,
a doctor has
- obtained a second doctor’s
opinion in support can provide
non-urgent treatment
- such treatment is necessary and
for patient’s best interest without
consent
- if the doctor to ascertain whether
or not a guardian appointed has
not been given the power to
consent to such treatment.
A guardian may have already been
appointed by the Guardian Board
- with power to consent to medical
treatment to the extent that the
mentally incapacitated person is
incapable of understanding the
general nature and effect of the
treatment in question. In such a
situation,
- the doctor has to obtain the
requisite consent from the
guardian.
 Inform Consent Elements
Patient with Communication Difficulty
•….involving relatives, caregivers,
using interpreters, and
communication aids where
possible.
Inform Consent Elements
Minors under 18 years of Age
•….no legal age limit for consent to
medical treatment
•…capable of consenting to medical
treatment
•….sufficient understanding and
intelligence to understand fully
•…good practice to involve parents
(Hospital Authority, 2018, p.8)
 Inform Consent Elements
I. Preconditions
b. Voluntariness
• Consent must be voluntary and adequate time should be given for the
patient to consider the options
• Attention should be paid to those patients who may be particularly
vulnerable for involuntary consent due to
- Communication barrier
- State of anxiety
- Low educational level
 Inform Consent Elements
II. Information Elements
a. Disclosure of Information &
Recommendation of A Care Plan
Physiotherapist must provide patients information they ask for or need
about
•“what they wants to know”, regardless of professional opinion and
judgement on whether this information would usually be provided or not
( Chatered Society of Physiotherapy, 2016, p4.)

•information about the assessment that they will undergo and what this
might involve.
•diagnosis and / or prognosis, where you are able to provide this
information.
•Any uncertainty over diagnosis and/or prognosis including the option or
needs for further diagnostic tests, where you are able to provide this
information.
(Chartered Society of Physiotherapy, 2016, p13)
 Inform Consent Elements
II. Information Elements

a. Disclosure of Information &

Recommendation of A Care Plan
Physiotherapist must provide patients information they ask for or need
about
•Options for treating or managing the condition
•Options that no treatment is necessary
• Choose not to have treatment.
• Purpose of any intervention, treatment, potential risk, benefits, side
effects and likelihood of success for each treatment option to be
considered.
(Chartered Society of Physiotherapy, 2016, p13)
Relationship of requirement to disclose to risk of occurrence and severity of harm
(Carlise, 2002, p.220)
 Disclosure of Information &
Recommendation of A Care Plan
Legal Issue
• In
Montgomery vs. Lanarkshire Health The Court held that Dr. McLellan should
Board in 2015 UK have
 Montgomery’s baby was born with  informed Montgomery of the risk and
serious disabilities because of discussed with her the option of a
shoulder dystocia during vaginal caesarian section.
delivery.  Doctor cannot withhold the information
 Dr. McLellan did not inform that should have been provides to that
Montgomery of the 9-10% risk of particular patient.
shoulder dystocia as she was diabetic (Sokol, 2015)
 Dr. McLellan defended that she did not
routinely discuss this risk with women
with diabetes for fear that , if told, such
women would opt for caesarean
section.
 Disclosure of Information &
Recommendation of A Care Plan
You must give patients information they ask for or
need about
• Any alternative or comparative Rx that may be
available for the condition, even if these treatments
cannot be offered by yourself and/or your hospital.
•The person, or wider team members, who may be
responsible for and involved in the patient’s care, and
whether pre-registration students may be involved.

(Chartered Society of Physiotherapy, 2016, p13)

 Disclosure of Information &
Recommendation of A Care Plan
Physiotherapist must provide patients information they ask for or
need about
• It is particularly important that a person is
aware of the situation when students or
trainees carry our procedures to further
their own education.
• Where the procedure will further the
person’s care then, assuming the student
is appropriately trained in the procedure,
the fact that it is carried out by a student
does not alter the nature and purpose of
the procedure.
(Department of Health, 2009, p12)
• It is not a legal requirement to tell the
person that the clinician is a student (it
would be good practice to do so.)
• When a student proposes to conduct a
physical examination that is not part of
the person’s care then it is essential to
explain that the purpose of the
examination is to further the student’s
training, and to seek consent for that to
take place.
 Disclosure of Information &
Recommendation of A Care Plan
Physiotherapist must provide patients information they ask for or
need about
• Patient’s right to refuse to take part in
teaching or research or to allow students
to treat them
• Their options to seek a further opinion
from a colleague and/or to be reviewed by
a doctor if indicated
• Any bills and/or costs that the patient will
have to pay
(Chartered Society of Physiotherapy, 2016, p13)
 Inform Consent Elements
II. Information Elements
b. Understanding of Information by
Patient
Ask the patient to confirm in his/her own
words what they understand by the
proposed intervention.

•“usually do not feel the need for more

information
•their actual knowledge of the benefits and risks
involved remains poor. (Leclercq, 2010, p.1410).
• had difficulty in understanding of verbal
percentage probability correctly (Fuller et al, 2002).
 Inform Consent Elements
III. Consent Elements

Decision & Authorization by Patient

• Patients makes the decision to give/refuse
consent
• Consent  proceed with proposed intervention
• Consent is a PROCESS, not a ONE-OFF event
(Hospital Authority, 2018)
 Inform Consent Elements
III. Consent Elements

Decision & Authorization by Patient

Consent should be reconfirmed if

 A significant time has passed…..
 New information becomes available about the
proposed intervention
 Patient’s circumstances change or new
information
(Chartered Society of Physiotherapy, 2016, p.20)
 Type / Form of Consent

• Consent may be valid in law if it is either explicit

(written or oral) or implied
(Chartered Society of Physiotherapy, 2016, p.8)
• Written consent serves as a record of the consent
given, if the elements of voluntariness, appropriate
information and capacity have not been satisfied, a
signature on a form will not make the consent valid.
(Department of Health, 2009,p16)
 Documentation of Consent

• PT records should contain consent which is obtained by

written, verbal or implied.
• In majority cases, implied consent is probably sufficient,
because most therapeutic activities require some degree
of active cooperation from the patient; the act of
participating can be taken as consent
( Sim, 1996, p.106)
 Documentation of Consent
• PT records should contain consent which is obtained by written,
verbal or implied.
• In majority cases, implied consent is probably sufficient, because
most therapeutic activities require some degree of active
cooperation from the patient; the act of participating can be taken
as consent ( Sim, 1996, p.106)
• Some of the manoeuvres performed by manual therapists are
ones in which the patient is not required to participate in an active
manner, and, moreover, some of these techniques are by
definition ones that the patient is not capable of preventing from
occurring. ( Sim, 1996, p.106)
 Documentation of Consent
• The Charted Society of Physiotherapy recommends that
it is a good practice to obtain written consent for
Invasive Interventions:
Injection therapy in neurological and/or musculoskeletal
practice
Acupuncture
Dry needling
Performing nerve conduction studies
(Chartered Society of Physiotherapy, 2016, p9)
 Documentation of Consent
• In HK, there is no consensus on any particular
intervention that written consent must be obtained.
• Good practice to obtained written consent for the
following interventions:
Grade V Manipulation
Intimate examinations such as vaginal (PV) and rectal
(PR) examinations (also issues of privacy and
chaperoning)
 Cervical Manipulation/Mobilisation –
Adverse Events

Adverse Events in Manual Physiotherapy:

the patient, practitioner and research
experience (Carlesso 2013)
Cervical Manipulation/Mobilisation –
Adverse Events

(Carlesso , et al 2010)
 Cervical Manipulation/Mobilisation –
Adverse Events
• A study from Canada reported that for every 100,000
persons younger than 45 years receiving chiropractic
treatment, approximately 1.3 cases of vertebrobasilar
accidents attributable to that treatment……
• The incidence of life-threatening complications of cervical
manipulation is still largely unknown.
(Stevinson & Ernst, 2002, p.567)
Cervical Manipulation/Mobilisation –Adverse Events

( Canadian Academy of Manipulative Physiotherapy, 2008 )

 Acupunture-Adverse Event
Nonserious Adverse Events of Acupuncture Reported in 97 733 Patients
( Melchart et al, 2004)
 Acupunture-Adverse Event
Potentially Serious Adverse Events of Acupuncture in 6 of the 97 733
Patients ( Melchart et al, 2004)
Acupunture Check list
Electrotherapy-Adverse Event
Unexpected effects of Electrotherapy ( Kitchen 2000)
IFT IFT check list
Laser Laser check list
 How can informed consent be
implemented…….
A systematic approach is important.
 relevant details about the treatment ,benefits, and risks
 possible alternative,
 what to anticipate before and after procedure,
 ensure patient has the capacity to make decisions,
 the choice is being made voluntarily,
 routinely check the patient’s understanding of the informed consent process
( Hall et al 2012)
Informed Consent in Clinical Research

Informed consent is a process by which a

subject is informed of the known and
potential risk and benefits as well as all other
relevant aspects of a clinical study and
voluntarily confirms his/her willingness to
participate in the study
(Hospital Authority, 2015, p63)
Essential elements that must be incorporated into the
Informed Consent for Clinical Study
• The nature and purposes of study
• The study treatment and arrangement
• Potential risks and benefits of the study
• Subject’s right of voluntary participation in and free withdrawal
from the study.
• Personal data protection………

(Hospital Authority, 2015, p65)

 Informed Consent In Clinical Reaearch
The requirement of informed consent in clinical research was
incorporated into the Declaration of Helsinki in 1964, amended in
2013 ( World Medical Association, 2013):
 the aims, methods, sources of funding, any possible conflicts of interest, institutional
affiliations of the researcher, the anticipated benefits and potential risks of the study and the
discomfort it may entail, post-study provisions and any other relevant aspects of the study.
Personal data protection………
 the right to refuse to participate or withdraw consent at any time
 Informed consent is preferably in writing
 Non-written consent must be documented and witnessed
 Case sharing
Back pain with operation done 2 Dec 2020

Consent case reports (medicalprotection.org)

 Back pain with operation done
2 Dec 2020
• Mrs. P , age of 40, Nurse
• C/O back pain GP with analgesia.
• 1/12 consult NS Mr. S for conservative Rx.
• 1/12 Mrs. P phoned NS Mr. S, ↑BK pain + L Sciatica confirmed by GP with MRI Disc Bulge. Off Work. Mr S
suggested Microdisectomy and discussed the options with her through phone, and explained the operation
and its pros and cons. He recorded the phone call in medical records but did not state exactly what was
discussed. Mrs. P was happy to proceed and operation was arranged. Mr. S wrote a letter to the GP informing
him of the plan.
• Mr. S saw Mrs. P on the day of operation as she brought in to be anaesthetized. He had a brief conversation
with her, confirming that she was happy to go ahead and that she had no questions.
• She signed the consent form which listed none of the pros and cons of the operation
• The operation was straightforward and there were no observed complications.
• 2/12 after the operation Mrs P felt that her pain was worse, and she had genital numbness and urinary
symptoms. Her urodynamic investigations were normal but she was numb in the S3 dermatome………..
 Upper GI with perforation

(video)
Consent case reports (medicalprotection.org)
Upper GI with perforation
• The effective way to convey the risk to the patient.
• To check that patient understands the risks.
• The documentation is accurate and clear.
• A complication during a procedure isn’t always evidence of negligence as long as the
patient has been warned of the risks.
• The procedure has been carried out to an acceptable standard and
• All reasonable steps have been taken to minimise the effects of the complication.
• It is to be open and honest with patients, particularly about possible complications.
 Reference
• Aiken TD (2004) Legal, Ethical. And Political Issues in Nursing, 2nd ed, Philadelphia: F.A. Davis
• Aveyard H (2002) Implied consent prior to nursing care procedures. Journal of Advanced Nursing
39:201-207
• Canadian Academy of Manipulative Physiotherapy (2008) Cervical Manipulation Information Sheet.
• Carlesso LC, Gross AR, Santaguida PL, Burnie S, Voth S, Sadi J. ( 2010) Adverse events associated with the use
of cervical manipulation and mobilization for the treatment of neck pain in adults: A systematic review. Manual
Therapy 15:434-444
• Carlisle JR (2002) Informed consent in physical medicine and rehabilitation: The Physician/patient relationship-the
doctor as a fiduciary. Physical Medicine and Rehabilitation Clinics of North America 13:213-224
• Chartered Society of physiotherapy (2012) –Quality Assurance Standards for physiotherapy Service Delivery,
(Section 5. p17 )
• Chartered Society of Physiotherapy (2016) Consent and Physiotherapy Practice, 2nd. London: Chartered Society of
Physiotherapy.
• Department of Health (2009) Reference Guide to Consent for Examination or Treatment, 2nd ed,UK: Department of
Health.
• Dimond B (2009) Legal Aspects of Physiotherapy, 2nd, Oxford: Wiley-Blackwell.
• Fuller R, Dudley N, Blacktop J (2002) How informed is consent? Understanding of pictorial and verbal probability
information by medical inpatients. Postgraduate Medical Journal 78: 534-544.
 Reference
• Hall DE, Prochazka AV, Fink AS (2012) Informed consent for clinical treatment Canadian Medical Associate Journal
2012 184(5): 533-540
• Hong Kong Physiotherapy Association (2003) Standards of Physiotherapy Association.
• Hospital Authority (2015) Clinical Research Management and Compliance at Study Sites. A practical handbook for
Investigators, Clinical Research Personnel and Administrator of Hospital Authority of Hong Kong
• Hospital Authority (2018) Legal Principles on Informed Consent. Version2. HK: Legal Services Department, Hospital
Authority.
• Kitchen S (2000) Audit of the unexpected effects of electrophysical agents. Interim report: responses January to
June 2000. Physiotherapy 86: 509-911
• Leclercq WKG, Keulers BJ, Scheltinga MRM, Spauwen PHM, van der Wilt GJ (2010) Review of Surgical Informed
Consent: Past, Present, and Future. A quest to help patients make better decisions. World Journal of Surgery
34:1406-1415.
• Mediros JM (2001) Cervical spine manipulation-is it safe? Journal of Manual & Manipultive Therapy 9: 187-189
• Melchart D, Weidenhammer W, Streng A, Hoppe A, Ernst E, Linde K (2004) Prospective investigation of adverse
effects of acupuncture in97733 patients. Archives of internal Medicine 164: 104-105.
• National Center for Biotechnology Information (1973) Informed Consent.
• Physiotherapists Board Hong Kong (2014) Code of Practice. HK: Government of the Hong Kong Special
Administrative Region.
• Sim J (1986) Informed Consent: ethical implications for physiotherapy. Physiotherapy 72 : 584-587.
 Reference
• Sim J (1996) Informed Consent and manual therapy. Manual Therapy 2:104-106.
• Sokol DK (2015) Update on the UK law on consent. British Medical Journal 350:h1481.
• Stevinson C, Ernst E (2002) Risks associated with spinal manipulation. American Journal of Medicine 112: 566-570.
• Walton T (2020) Material risk: a review of informed consent in the UK Orthopaedics and Trauma 34:3 131- 134
• World Medical Association (2013) World Medical Association Declaration Helsinki: Ethical Principles for Medical
Research Involving Human Subjects.