In forceAmended2020 Revised Edition

Contents

Human Biomedical Research Act 2015 · 2020 Revised Edition · Part 6 · Regulation of Human Tissue Activities and Tissue Banks

35. Duties of tissue bank

Feedback & support

Amended

Last amended by an amending law of 2023.

(1)

Every tissue bank must, in respect of any tissue banking activity to be conducted under its supervision and control —

(a)

submit a notification in such form and manner, and within such time as may be prescribed, before the commencement of any tissue banking activity conducted under that tissue bank’s supervision and control; and

(b)

submit, in accordance with section 36, a declaration of compliance in respect of all tissue banking activities conducted under its supervision and control in the preceding 12 months, or such other period of time as the Director‑General may require.

(2)

Every tissue bank must, in respect of any tissue banking activity which is carried out under its supervision and control —

(a)

supervise, review and proactively monitor the conduct of the tissue banking activity;

(b)

designate a principal person in charge to be responsible for ensuring that the tissue bank complies with this Act;

(c)

formulate and implement appropriate standards, policies and procedures to supervise, review and monitor the conduct of the tissue banking activity;

(d)

investigate any areas of concern and take such remedial measures as appropriate;

(e)

ensure that the tissue banking activity —

(i)

is in compliance with the requirements of this Act; and

(ii)

is conducted in accordance with its standards, policies and procedures referred to in paragraph (c);

(f)

ensure that if any human tissue under its supervision and control is to be exported or otherwise removed from Singapore to a place outside Singapore, the export or removal is carried out in accordance with prescribed requirements, including but not limited to requirements in relation to consent from the donor;

(g)

ensure that if any human tissue is to be removed from its supervision and control in circumstances other than in paragraph (f), the removal is carried out in accordance with prescribed requirements, including but not limited to requirements in relation to approval for the removal of individually‑identifiable tissue from an institutional review board and scientific endorsement by experts on the merits of the research for which the tissue rendered non‑identifiable within the meaning of section 27(3) are removed; and

(h)

perform such other functions and duties as may be prescribed by the Minister.

(3)

Every tissue bank must notify the Director‑General, in such form and manner as may be prescribed, of —

(a)

the commission of any suspected offence or contravention under this Act or the regulations;

(b)

the occurrence of any serious adverse event; and

(c)

such other matters as may be prescribed.

(4)

The designation of a principal person in charge by a tissue bank under subsection (2)(b) does not absolve or relieve the tissue bank of any of its obligations or duties under this Act.

(5)

To avoid doubt, the delegation of any obligation or duty under this Act to another person or service provider under a contract or other arrangement does not absolve or relieve the tissue bank of any of its obligations or duties under this Act.

(6)

Any person who contravenes subsection (1) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $10,000 or to imprisonment for a term not exceeding 12 months or to both.

(7)

Any person who contravenes subsection (3) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 2 years or to both.

Terms defined in s 2

declaration of compliance
Defined · s 2
“declaration of compliance” means a declaration by a research institution or a tissue bank of its compliance with the requirements of this Act;
Open s 2
Director
Defined · s 2
“Director” means the Director of Medical Services;
Open s 2
donor
Defined · s 2
“donor”, in relation to human tissue, means a natural person, whether living or dead, from whose body the human tissue is obtained;
Open s 2
human tissue
Defined · s 2
“human tissue” or “tissue” means any human biological material but excludes human biological material specified in the First Schedule;
Open s 2
individually‑identifiable
Defined · s 2
“individually‑identifiable”, in relation to human biological material or health information pertaining to an individual, means that the individual can be identified —(a)from the human biological material or health information; or(b)from that human biological material or health information and other information to which the person, research institution, tissue bank or other organisation has or is likely to have access;
Open s 2
institutional review board
Defined · s 2
“institutional review board” means a board or committee appointed by a research institution under section 15 or 16 to conduct an ethics review of proposed human biomedical research;
Open s 2
research
Defined · s 2
“research” means any systematic investigation with the intention of developing or contributing to generalisable knowledge;
Open s 2
tissue
Defined · s 2
“human tissue” or “tissue” means any human biological material but excludes human biological material specified in the First Schedule;
Open s 2
tissue bank
Defined · s 2
“tissue bank” means an individual or a body of persons, whether corporate or unincorporate, or other organisation, that carries on or conducts any tissue banking activity but excludes an individual, a body of persons or an organisation that conducts any tissue banking activity solely for the purpose of the person’s or organisation’s own human biomedical research approved or exempted from review by an institutional review board;
Open s 2
tissue banking activity
Defined · s 2
“tissue banking activity” means a structured and an organised activity involving human tissue for the purposes of facilitating current or future research or for public health or epidemiological purposes or any combination of such purposes including any of the following activities:(a)the collection, storage, procurement or importation of human tissue;(b)the supply, provision or export of human tissue.
Open s 2