Informed consent form

Informed consent form

The elements of an informed consent form are outlined in the Health Products (Clinical Trials) Regulations and the Medicines (Clinical Trials) Regulations, and ICH E6 (R2) GCP guidelines.

The English informed consent form must be approved by the relevant Institutional Review Board (IRB) and us prior to use. Translated informed consent forms need not be submitted to us.

The language of the informed consent form should be non-exculpatory, non-technical, practical and understandable by the trial participant or legal representative (if applicable). The trial participant or legal representative (if applicable) should also be given ample time and opportunity to ask questions to consider participation.

Substantial amendments to informed consent form

All amendments to the informed consent forms must be submitted to the relevant IRB prior to use. Additionally, substantial amendments to the informed consent forms must be submitted to us for review and approval prior to use.

Refer to the Clinical Trials Guidance on Determining Whether an Amendment to a Clinical Trial is a Substantial Amendment348 KB for more details.

Obtaining informed consent

Informed consent must be obtained by an investigator delegated by the Principal Investigator to obtain informed consent.

It is not acceptable for other study staff (Clinical Research Coordinators, Research Assistants, Study Pharmacists etc.) to obtain informed consent.

Informed consent must be obtained from the trial participant or legal representative prior to any study procedures, and in a conducive environment without any coercion, duress or undue influence.

The informed consent form should also be personally signed and dated by the investigator obtaining informed consent, the trial participant or legal representative, and the impartial witness (if the trial participant is unable to read or personally sign or date the informed consent form).

If there are checkboxes to be completed in the informed consent form, it would be recommended that the checkboxes are personally completed by the trial participant or legal representative.

No signature and date stamps are allowed as a means of signing and dating.

The signature of the investigator obtaining informed consent should be consistent with the Signature Sheet.

There is no regulatory provision regarding the number of copies of informed consent forms that should be signed. The signed and dated informed consent form should also be provided to the trial participant or legal representative and also filed in the Investigator Site File.

Use of impartial witness

An impartial witness is required to be present during the informed consent process in any of the following scenarios:

• Trial participant or legal representative is unable to read the informed consent form.
• Trial participant or legal representative is unable to sign or date the informed consent form.

The role of an impartial witness is to attest that the informed consent has been accurately explained to the trial participant or legal representative, the informed consent has been apparently understood by the trial participant or legal representative, and the trial participant or legal representative has voluntarily agreed to participate in the clinical trial.

There is no regulatory provision regarding who can act as the impartial witness. One should consider whether the person who acts as an impartial witness is independent of the clinical trial and is not influenced by people involved in the clinical trial.

The possible choices would be either a family member, friend, clinic staff (who is not a part of the study team), or a layperson. The choice of an impartial witness should be made in the best interest of the trial participant.

Use of translator

A translator is required to be present during the informed consent process if the trial participant or legal representative is unable to converse with the investigator.

An individual who is adequately qualified or certified in the local language may act as a translator. The translator’s role is to translate one language to another and the translator may be part of the study team, unlike an impartial witness. Information on the translator should be completed in the informed consent form or trial participant medical records.

It is acceptable for an impartial witness to act as a translator if the impartial witness is able to fulfil that role as well.

The following table summarises when an impartial witness or translator is required during an informed consent process.

Trial participant or their legal representative (LAR)	Investigator	Language of written informed consent form	Translator required?	Impartial witness required?	Comments
Literate in English	Literate in English	English	No	No	N.A.
Literate in a local language	Literate in a local language	Local Language	No	No	N.A.
Literate in a local language	Literate in English and unable to communicate with trial participant or their LAR	Local Language	Yes	No	N.A.
Literate in a local language	Literate in English and unable to communicate with trial participant or their LAR	English	Yes	Yes	It is strongly recommended that the ICF in local language be made available. The impartial witness may act as a translator if he/she is able to fulfill this role. Alternatively, the English ICF and a Short Form Consent (in a local language that the trial participant or their LAR is literate in) could be signed by all parties involved in the informed consent process.
Illiterate or unable to read due to visual impairment	Literate in English only and unable to communicate with trial participant or their LAR	English	Yes	Yes	The impartial witness may act as a translator if he/she is able to fulfill this role.
Illiterate or unable to read due to visual impairment	Literate in English and a local language and able to communicate with trial participant or their LAR	English or Local Language	No	Yes	The choice of language of the written ICF depends on whether the impartial witness is literate in that language

Clinical trials in minors

Clinical trials in minors

A minor is a legal person who is below 21 years of age, and is not and was never married. For clinical trials in minors, the legal representative must either be the:

• Deputy of the minor
• Adult parent of the minor
• Legal guardian of the minor

The investigator should determine if the minor has sufficient capacity or understanding and intelligence to give consent.

• If the minor has sufficient capacity or understanding and intelligence to give consent, the minor’s legal representative and the minor must give consent for the minor to participate in the clinical trial.
• If the minor does not have sufficient capacity or understanding and intelligence to give consent, the minor's legal representative must give consent for the minor to participate in the clinical trial.
• If the minor is subsequently deemed to have the capacity or understanding and intelligence to give consent during the clinical trial, the minor must be re-consented accordingly.

Refer to the Guidance on Safeguards and Consent Requirements in Vulnerable Participants441 KB for further details. 

Clinical trials in adults lacking capacity

Clinical trials in adults lacking capacity

A person who lacks mental capacity in relation to a matter is someone who, at the material time, is unable to make a decision for himself or herself in relation to the matter due to an impairment of, or a disturbance in the functioning of, the mind or brain.

An individual is unable to make a decision for himself if he is unable to perform any one or more of the following functions:

• Understand the information relevant to the decision
• Retain that information
• Use or weigh that information as part of the decision-making process
• Communicate his decision, whether by talking, using sign language, or any other means

For clinical trials in adults lacking capacity (ALC), the legal representative must be either one of the following:

• The donee or deputy appointed pursuant to, or under the Mental Capacity Act in relation to the giving or refusing of consent on behalf of the adult to be a trial participant
• Where there is no appointed donee or deputy, any one of the following persons can be the legal representative, in descending order of priority:
  
  • A spouse of the adult
  • An adult child of the adult
  • A parent or guardian of the adult
  • An adult sibling of the adult
  • Any other adult named by the adult (i.e. when the adult did not lack capacity) as someone to consult on the issue of the adult being a subject

Refer to our Guidance on Safeguards and Consent Requirements in Vulnerable Trial Participants441 KB for more details. 

Clinical trials in emergency situations

Clinical trials in emergency situations

A clinical trial in emergency situation is a clinical trial to determine the safety or efficacy of an investigational product where:

• The trial participant is facing a life-threatening situation where intervention is necessary.
• The trial participant is unable to give consent for the clinical trial as a result of their medical condition.
• It is not feasible to request consent from their legal representative during the window period. 

Refer to our Guidance on Safeguards and Consent Requirements in Vulnerable Participants441 KB for more details.

Re-consent of trial participant

Re-consent of trial participant 

A trial participant must be re-consented as soon as possible if new information that may affect the trial participant's decision to continue participating in the clinical trial becomes available

It is recommended that the sponsor provides details of the re-consent process in writing to the relevant IRB and us prior to implementation.

Documenting informed consent

Documenting informed consent

It is recommended that the person obtaining informed consent document the following in the trial participant's medical records:

• Protocol reference
• Date of informed consent
• Informed consent process (e.g. use of legal representative/impartial witness/translator)
• Signed copy provided to subject

Use of assent forms

Use of assent forms

Assent forms for clinical trials in minors do not need to be submitted to us. Please check with your IRB about the requirements for assent forms. 

Use of short form consent forms

Use of short form consent forms

There is no regulatory provision for the use of short form consent forms. The trial participant or legal representative (if applicable) must sign the full informed consent form that has been approved by the IRB and us (except for changes of administrative nature). Please refer to the relevant IRB for further information on the use of short form consent forms.