Informed Consent

V2
Kai Shen
yoongkaishen@gmail.com
Overview
• What is informed consent
• The informed consent process
• Informed consent documentation
Definition
• Informed Consent:

A process by which a subject voluntarily confirms

his or her willingness to participate in a particular
trial, after having been informed of all aspects of
the trial that are relevant to the subject's decision
to participate.

Informed consent is documented by means of a

written, signed and dated informed consent form

(Malaysia GCP, 4th Edition)

This Photo by Unknown Author is licensed under CC BY-NC

What happened if consent is not taken?
 Subject’s Rights

❑Right to make decision for him/herself

❑Right to obtain information in a
language they can understand before
making their decision
❑Right to have ample time to make
decision
The process?

Information Information Decision Signing of

provided Understood made ICF
Informed Consent Documents
What information should be provided?
Informed Consent Documents
What information should be provided?
Informed Consent Documents
What information should NOT be in the ICF?
Who is Involved?

1. Consent Taker
Who is Involved?

1. Consent Taker
• Who can take consent?
• Principal Investigators (PI)
• Delegated personnel e.g Sub- Investigators
Who is Involved?

2. Potential Subject
Can be:
• Diseased patients
• Healthy subject
Who is Involved?

2. Potential Subject
For an effective consent, Investigators should access a potential subject’s competence:
❑Psychologically stable
❑Emotionally stable
❑Of a proper age
❑Adequately aware of reality

Other things to access:

❑Subject’s Illiteracy
❑Subject’s preferred language
❑Potential coercion
Who is Involved?

2. Potential Subject
What if subject is not competent to provide consent:
❑Children (minors)
❑Cognitively-impaired person
❑Patients with certain psychiatric disorders
❑Unconscious patient (e.g coma)

You will need to involved…

Who is Involved?

3. Legally Acceptable Representative (LAR)

An individual or juridical or other body authorized under applicable law to consent, on behalf
of a prospective subject, to the subject's participation in the clinical trial.
(Malaysia GCP, 4th Edition)

Example of LAR:
❑Parents
❑Spouse
❑Adult Children
❑Court appointed personnel
Who is Involved?
Scenario 1:
Who is Involved?

What’s happening:

❑Potential subject cannot read the consent form

❑Relies on the Investigator to read out the content to him (Blind-
trust in the investigator?)
❑Subject consented on the study without understanding the
study

What is the potential problem?

➢ Subject/ Subject’s LAR might enroll (subject) in a study without
being fully informed on all aspect of the trials

In such scenario, where subject or subject’s LAR is cannot read

the consent form, the Investigator should involve…
Who is Involved?
4. Impartial Witness

A person, who is independent of the trial, who cannot be unfairly influenced by people
involved with the trial, who attends the informed consent process if the subject or the subject's
legally acceptable representative cannot read, and who reads the informed consent form
and any other written information supplied to the subject.
(Malaysia GCP, 4th Edition)

∆Role of Impartial witness is to attest that:

The informed consent has been accurately explained to the
subject/ subject’s LAR
The informed consent has been apparently understood by the
subject/ subject’s LAR
The subject / subject’s LAR has voluntarily agreed to participate
in the trial
Who is Involved?
4. Impartial Witness

Someone who is
1. Independent of the trial
2. Cannot be unfairly influenced by people involved with the trial
3. Attend the consent process
4. Have the mental capacity to read the consent form to the subject/ subject’s LAR

Based on the above criteria, can the following persons be an impartial witness?
❑ Study Coordinator
❑ Research Assistant who works under the Investigator but is not delegated in the study
❑ Other subjects in the trial
❑ Subject’s relatives
❑ Subject’s friend
❑ Layperson
 Who is Involved?
Scenario 2
Who is Involved?

What’s happening:

❑There’s a language barrier between the investigator and the potential subject

In such scenario, where subject and the investigator could not understand each other, the
Investigator should involve…
 Who is Involved?

5. Interpreter/ Translator

The role of an interpreter in this process is to faithfully

interpret the communication exchanged between the
Investigator and the patient. The role of the interpreter is
not to administer or oversee informed consent; nor is it
to ensure the patient fully comprehends the treatment
or risk. The interpreter’s role is simply to facilitate the
message using appropriate linguistic equivalencies in
both language.

∆ Role of Interpreter/ Translator:

Attest that the interpreting was delivered faithfully and that the use of
vocabulary, language structure, syntax, etc. when going from source to
target language was appropriate
Who is Involved?

5. Interpreter/ Translator

Who can be an interpreter/ Translator:

• An individual who is adequately qualified or

certified in the language being translated
may act as a translator.

Can the impartial witness be the interpreter?

Who is Involved?

Scenario 1:

Madam Siti is an elderly Malay lady that couldn’t understand English, but she is able to read
Malay. Despite her old age, she can make sound decision. Dr White, would like to enroll her in
a diabetic trial. There is Malay consent form available. Dr. White is only fluent in English. In this
case, who should Dr. White involved in the informed consent process?

Madam Siti’s LAR

Impartial Witness
Translator
Who is Involved?

Scenario 1:

Madam Siti is an elderly Malay lady that couldn’t understand English, but she is able to read
Malay. Despite her old age, she can make sound decision. Dr White, would like to enroll her in
a diabetic trial. There is Malay consent form available. Dr. White is only fluent in English. In this
case, who should Dr. White involved in the informed consent process?

Madam Siti’s LAR

Impartial Witness
Translator
Who is Involved?

Scenario 2:

Encik Meng is visually-impaired. Dr Brown would like to enroll him to an ophthalmology study.
Dr Brown and Encik Meng are both fluent in English. In this case, who should be involved in
the informed consent process?

Encik Meng’s LAR

Impartial Witness
Translator
Who is Involved?

Scenario 2:

Encik Meng is visually-impaired. Dr Brown would like to enroll him to an ophthalmology study.
Dr Brown and Encik Meng are both fluent in English. In this case, who should be involved in
the informed consent process?

Encik Meng’s LAR

Impartial Witness
Translator
Who is Involved?

Scenario 4:

If a research subject has metacarpal syndrome and could not sign the ICF due to the pain,
can subject use thumb print?

Will the subject’s LAR need to sign the consent form?

Who is Involved?

Scenario 4:

If a research subject has metacarpal syndrome and could not sign the ICF due to the pain,
can subject use thumb print?

Yes. Thumbprint is allowed as per Malaysia GCP Guidelines

Will the subject’s LAR need to sign the consent form?

Who is Involved?

Scenario 4:

If a research subject has metacarpal syndrome and could not sign the ICF due to the pain,
can subject use thumb print?

Yes. Thumbprint is allowed as per Malaysia GCP Guidelines

Will the subject’s LAR need to sign the consent form?

Metacarpal syndrome does not affect patient’s mental capacity; therefore LAR is not
necessary. However, if research team foresee patient might encounter difficulties in future re-
consent process, LAR can be added.
Things to Note about Signing Informed Consent
Vulnerable Group

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the
expectation, whether justified or not, of benefits associated with participation, or of a
retaliatory response from senior members of a hierarchy in case of refusal to participate.
(1.70, Malaysian GCP)

Children Pregnant Prisoners Cognitively

Woman Impaired Person
How about in Emergency Situation when prior consent is not possible?
When Consenting Vulnerable Group..

❑Be aware of regulations and guidelines regarding vulnerable groups

E.g. MREC has a guideline on conducing research study on minor

❑Involved LAR if applicable

❑Follow protocol’s requirement if applicable

When does it happen?

• Any study procedures are

Before performed

• IRB/IEC had approved the consent

form
• Discuss the consent form with subject
After • Subject’s questions, concerns are
answered
• Ample time given for subject to
consider his/her participation

This applies to Re-consenting as well!

Reconsenting… When does it happen?
Reconsenting… When does it happen?
Breakout Room: for small group discussion
You will be separated into smaller groups (break out rooms) for group discussion.

What you will see:

Your Group Number

Don’t have to do anything when your screen is showing this

Breakout Room: for small group discussion

You will then see yourself

with your groupmates!
Say HI!
Breakout Room: for small group discussion

What you will see this once the group discussion is almost over:
Breakout Room: for small group discussion

Once time is up, you will see this:

Don’t have to do anything when your screen is showing this

Breakout Room: for small group discussion

And you will be back in the main room where everyone is!
What should be documented?
Document the consent process:

Information Information Decision Signing of

provided Understood made ICF

• What is the study protocol?

• Who conducted the consent process?
• Version and language of ICF used?
• What language was used to communicate?
• Who is present during the consent process?
(LAR, Impartial witness, translator etc)
• Where was the information given?
• What time did the consent process started?
• Any other documents used? (e.g Brochure)

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What should be documented?
Document the consent process:

Information Information Decision Signing of

provided Understood made ICF

• Are all questions/concerns answered/

addressed?
• Any special circumstances or
clarification?
• Did subject / LAR understand the
information given during the discussion?

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What should be documented?
Document the consent process:

Information Information Decision Signing of

provided Understood made ICF

• Ample time given to make decision?

• Did subject/ LAR agree to participate
voluntarily?

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What should be documented?
Document the consent process:

Information Information Decision Signing of

provided Understood made ICF

• Who signed the ICF?

• How many copies were signed?
• Is 1 copy of the signed ICF
provided to subject?
• What time is the consent form
signed?

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Preparing for informed consent process
✓Confirm that you are delegated, approved by IRB/EC, trained on study
protocol and qualified to take consent
✓Prepare the documents to be used:
▪ Updated IRB approved Informed Consent documents (2 copies of ICFs, flipcharts/ study
brochure etc)
▪ Language of documents
✓Be familiar with the content of the informed consent form
✓Identify fields in the ICF to be filled, signed and date
✓Determine
• If there is a need for LAR/Impartial Witness/ Translator
• When and where to conduct the informed consent process

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 Common Consent Issues
• Person consenting is not listed as per the study’s delegation log
• PI or consent personnel or subject did not personally sign/thumbprint &
date the form
• Failure to re-consent when new information becomes available
• Use of expired forms or non-validated/unapproved forms
• Failure to provide copies of the forms to subjects
• Keeping only the last page of the consent document in study files
• Check boxes within the consent form incomplete

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More Examples
• Missing consent documents
• No documentation that consent process took place
• Use of wrong form (e.g., child signing parental permission form, patient
signing “healthy control” form, or subject signing the wrong version)
• Changes made to the consent documents by hand AND without IRB
approval (e.g., crossed out information about procedures, increased
amount of payment)

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• ForSummary
an ethically valid and real informed
consent, these critical elements are
required:
❑Information Disclosure
❑Decision-making capacity by Subject
❑Voluntary Participation

• Informed Consent is an on-going process

• Documentation of the informed consent

process is as important as the signed
consent form

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