Singapore legislation
Regulation 16
Regulation 16
Consent of subjects, etc., in clinical trials
Subregulation 1
A principal investigator must ensure that no person is used as a subject in the clinical trial except in accordance with this regulation and regulations 17 to 20, as may be applicable.
Subregulation 2
Subject to paragraph (3), before an adult can be a subject —
a full and reasonable explanation of all of the matters referred to in regulation 19(1)(a) to (u), in accordance with regulation 19(3), must be given to the adult; and
the adult must consent to being a subject.
Subregulation 3
Despite paragraph (2), where an investigator of the trial who is a qualified practitioner, and another qualified practitioner who is a registered medical practitioner who is not conducting the clinical trial, certify in writing that —
the adult lacks capacity to consent to being a subject; and
it is not likely that the adult will regain capacity within the window period,then, the consent of the adult need not be obtained if the conditions in paragraph (4) are met.
Subregulation 4
For the purposes of paragraph (3), the conditions are all of the following:
a full and reasonable explanation of all of the matters referred to in regulation 19(1)(a) to (u), in accordance with regulation 19(3), is given to the adult’s legal representative, and the adult’s legal representative —
consents to the adult being a subject; and
if the legal representative is below 21 years of age, has sufficient understanding and intelligence to give the consent;
it is established that there is a reasonable prospect that participation in the clinical trial will directly benefit the adult, unless —
the objectives of the trial cannot be met by means of a trial in subjects who can give consent personally;
the trial is conducted in subjects having a disease or condition for which the medicinal product being tested in the trial is intended;
there is some direct benefit for the group of subjects involved in the trial;
the foreseeable risks to the subjects involved in the trial are low; and
the negative impact on the wellbeing of subjects involved in the trial is minimised and low.
Subregulation 5
Subject to paragraph (6), before a minor can be a subject, a full and reasonable explanation of all of the matters referred to in regulation 19(1)(a) to (u), in accordance with regulation 19(3), must be given to the minor and the minor’s legal representative, and —
the minor and the minor’s legal representative must consent to the minor being a subject; and
if the legal representative is below 21 years of age, the legal representative must have sufficient understanding and intelligence to give the consent.
Subregulation 6
Despite paragraph (5), where the minor lacks capacity to give consent to being a subject, or the minor lacks sufficient understanding and intelligence to give such consent, then, the consent of the minor need not be obtained if the conditions in paragraph (7) are met.
Subregulation 7
For the purposes of paragraph (6), the conditions are all of the following:
a full and reasonable explanation of all of the matters referred to in regulation 19(1)(a) to (u), in accordance with regulation 19(3), is given to the minor’s legal representative, and the minor’s legal representative —
consents to the minor being a subject; and
if the legal representative is below 21 years of age, has sufficient understanding and intelligence to give the consent;
it is established that there is a reasonable prospect that participation in the clinical trial will directly benefit the minor, unless —
the objectives of the trial cannot be met by means of a trial in subjects who can give consent personally;
the trial is conducted in subjects having a disease or condition for which the medicinal product being tested in the trial is intended;
there is some direct benefit for the group of subjects involved in the trial;
the foreseeable risks to the subjects involved in the trial are low; and
the negative impact on the wellbeing of subjects involved in the trial is minimised and low.
Subregulation 8
For the purposes of paragraphs (4)(b) and (7)(b), participation in a clinical trial does not have any reasonable prospect of direct benefit to a person unless —
appropriate non-clinical and clinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the proposed use of the medicinal product to provide a direct benefit to the person; and
the risks associated with the trial are reasonable in relation to what is known about —
the medical condition of the person;
the risks and benefits of standard therapy, if any; and
the risks and benefits of the proposed use of the medicinal product.
Subregulation 9
If a subject is an adult referred to in paragraph (3) or a minor referred to in paragraph (6), and the adult or minor subsequently regains capacity to consent to being a subject, the principal investigator must ensure that, at the earliest feasible opportunity —
the adult or minor is given a full and reasonable explanation of all of the matters referred to in regulation 19(1)(a) to (u), in accordance with regulation 19(3); and
the adult’s or minor’s consent to continue being a subject is obtained.
Subregulation 10
If the adult or minor referred to in paragraph (9) refuses to consent, the principal investigator must ensure that the adult or minor ceases to be a subject in the clinical trial.