Conducting clinical trials

  1. ​Informed consent

​Informed consent

Understand the informed consent process for clinical trials.

What is informed consent

Informed consent is a fundamental ethical and legal requirement in clinical trials. Freely given informed consent should be obtained from every subject or legal representative (if applicable) prior to clinical trial participation.

Informed consent must be obtained from the subject or legal representative (if applicable) prior to any study procedures. It should be done in a conducive environment without any coercion, duress or undue influence.

Informed consent is documented by means of a written, signed and dated informed consent form, and the process relies on three principles, in accordance with the Belmont Report:

  1. Information
  2. Comprehension
  3. Voluntariness     

Informed consent form

Informed consent form

The elements of an informed consent form are outlined in Regulations 19(1) of the Health Products (Clinical Trials) Regulations and the Medicines (Clinical Trials) Regulations, and Section 4.8.10 of 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, but should be submitted to the relevant IRBs prior to use, in accordance with IRB guidelines.

The language of the informed consent form should be non-exculpatory, non-technical, practical and understandable by the subject or legal representative (if applicable). The subject 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 Amendment572 KB for more details.

Obtaining informed consent

Informed consent must be obtained by an investigator who is a qualified practitioner and delegated by the Principal Investigator to obtain informed consent. A qualified practitioner is a registered medical practitioner under the Medical Registration Act or a registered dentist under the Dental Registration Act. Please refer to Regulations 18(1) of the Health Products (Clinical Trials) Regulations and the Medicines (Clinical Trials) Regulations, and Section 4.8.8 of ICH E6 (R2) GCP guidelines.

It is not acceptable for an investigator who is not a qualified practitioner and other non-investigators (Clinical Research Coordinators, Research Assistants, Study Pharmacists etc.) to obtain informed consent.

Informed consent must be obtained from the subject or legal representative prior to any study procedures, and in a conducive environment without any coercion, duress or undue influence. Please refer to Regulations 16(1), 16(2) and 20 of the Health Products (Clinical Trials) Regulations and the Medicines (Clinical Trials) Regulations, and Section 4.8.3 of the ICH E6 (R2) GCP guidelines.

The informed consent form should also be personally signed and dated by the investigator obtaining informed consent, the subject or legal representative, and the impartial witness (if the subject 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 subject 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 subject 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:

  • Subject or legal representative is unable to read the informed consent form.
  • Subject 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 subject or legal representative, the informed consent has been apparently understood by the subject or legal representative, and the subject 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 subject.

Use of translator

A translator is required to be present during the informed consent process if the subject 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 subject 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.

Subject or subject's legal representative 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 subject or subject's LAR Local Language Yes No N.A.
Literate in a local language Literate in English and unable to communicate with subject or subject's 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 subject or the subject’s 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 subject or subject's 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 subject or subject's 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
  • 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
  • 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 Subjects617 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 subject
  • 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 Subjects617 KB for more details. 

Re-consent of subject

Re-consent of subject

A subject must be re-consented as soon as possible if:

  • New information that may affect the subject'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 subject'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 subject 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.

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