Singapore legislation
Regulation 16
of Healthcare Services (Human Tissue Banking Service) Regulations 2023
Regulation 16
Written consent required for collection and use
Subregulation 1
A licensee must, before collecting any human tissue or arranging for the collection of any human tissue by another person on behalf of the licensee, obtain prior written consent for the collection from —
where the human tissue is to be collected from the body of a living donor — the living donor; or
subject to paragraph (2), where the human tissue is to be collected from the body of a deceased individual — the authorised person.
Subregulation 2
Paragraph (1)(b) does not apply where the human tissue is to be collected pursuant to —
section 4(1) of the Human Organ Transplant Act 1987;
a gift made by a deceased individual under section 3 of the Medical (Therapy, Education and Research) Act 1972; or
a donation under section 4 of the Medical (Therapy, Education and Research) Act 1972.
Subregulation 3
A licensee must, before obtaining the consent mentioned in paragraph (1) —
provide the following information to the living donor or the authorised person, as the case may be:
the purposes for which the human tissue collected is to be used;
every test that will be conducted on the human tissue for assessing the suitability of the human tissue for use;
where the human tissue is found to be of low potency or contaminated — the manner in which the licensee will deal with the human tissue;
the disposal of unused donated human tissue at the end of their viability period;
where the human tissue is distributed for the purpose of transplant — that the licensee will disclose to the transplanting licensee to which the human tissue is distributed the following information:
the medical history of the individual from whom the human tissue is collected;
information relating to the licensee’s testing and processing of the human tissue;
whether there is evidence of therapeutic use of the human tissue;
the options for how excess human tissue collected and other surgical residues are to be dealt with; and
where the donor is a living donor, ascertain whether the donor, in the event of any abnormal finding or incidental finding relating to the donor, consents to either or both of the following:
the licensee informing the donor of the abnormal finding or incidental finding;
the licensee informing the medical practitioner overseeing or performing the collection of the human tissue, or any medical practitioner nominated by the donor, of the abnormal finding or incidental finding.
Subregulation 4
A licensee must ensure that —
the information mentioned in paragraph (3)(a) is explained to the donor or authorised person by a transplanting clinician or a transplant coordinator;
the donor or authorised person is given sufficient time, after the information mentioned in paragraph (3)(a) is explained to the donor or authorised person, to decide whether or not to give consent under paragraph (1);
the consent under paragraph (1) is not obtained by means of harassment, coercion, intimidation, deception, misrepresentation, reward or remuneration by any officer, employee or agent of the licensee; and
records are kept in relation to the explanation of the information mentioned in paragraph (3)(a) that has been explained to the donor or authorised person.
Subregulation 5
A licensee must not collect any human tissue if the licensee knows or has any reason to suspect that the consent given for the collection of the human tissue under paragraph (1) was obtained by reason of any harassment, coercion, intimidation, deception, misrepresentation, reward or remuneration by any person.
Subregulation 6
Where a licensee handles, processes, tests, stores or distributes any human tissue from a living donor that is not collected by the licensee, the licensee must —
obtain from the person who collected the human tissue a copy of the consent given by the living donor for the collection; and
keep records of that consent.
Subregulation 7
A licensee mentioned in paragraph (6) must not handle, process, test, store or distribute any human tissue from a living donor if the licensee knows or has any reason to suspect that the consent given by the living donor for the collection was obtained by reason of any harassment, coercion, intimidation, deception, misrepresentation, reward or remuneration by any person.
Subregulation 8
In paragraph (4), “transplant coordinator”, in relation to a licensee, means a person who is the licensee’s personnel and —
has at least a diploma in nursing, science, social work or psychology;
has at least 6 months on-the-job training under the supervision of a Clinical Governance Officer, transplanting clinician or another of the licensee’s personnel with at least 2 years of experience providing donor counselling in relation to the provision of a human tissue banking service; and
has been assessed by a Clinical Governance Officer or any suitably qualified personnel designated by a Clinical Governance Officer to have the appropriate competency in providing donor counselling in relation to the provision of the human tissue banking service.