Singapore legislation
Regulation 18
Regulation 18
General requirements as to consent
Subregulation 1
Any consent required under these Regulations for a person to be a subject must be obtained by a principal investigator or an investigator authorised by a principal investigator, in accordance with this regulation.
Subregulation 2
The consent must be —
in writing and in the form approved by both the Authority and the relevant institutional review board of the clinical trial; and
signed and dated by the person giving the consent.
Subregulation 3
If the person giving the consent is unable to sign or date the written form referred to in paragraph (2)(a), the consent must —
be signed and dated in the form and manner approved by the relevant institutional review board; and
be obtained in the presence of an impartial witness.
Subregulation 4
If the person giving the consent is unable to read, the written form referred to in paragraph (2)(a) must be read and explained to the person in the presence of an impartial witness.
Subregulation 5
The impartial witness referred to in paragraph (3) or (4), as the case may be, must sign and date the written form mentioned in paragraph (2)(a) to attest that —
in the case of paragraph (4), the written form was accurately explained to the person giving the consent; and
in any case, the person’s consent was freely given.
Subregulation 6
Any legal representative making a decision for the purposes of regulation 16 or 17, or a family member making a decision in connection with regulation 17(5), must act in the best interests of the person to be used as a subject in the clinical trial.
Subregulation 7
Section 6 of the Mental Capacity Act 2008 applies for the purpose of determining what is in the best interests of a subject in a clinical trial.
Subregulation 8
Where consent for a person to be or to continue to be a subject is obtained in accordance with these Regulations, or is not required under these Regulations, then the consent is validly obtained or waived, as the case may be, despite any other requirement in any other written law or rule of law.