Singapore legislation
Section 35
Section 35
Duties of tissue bank
(1)
Every tissue bank must, in respect of any tissue banking activity to be conducted under its supervision and control —
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
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 may require.
(2)
Every tissue bank must, in respect of any tissue banking activity which is carried out under its supervision and control —
supervise, review and proactively monitor the conduct of the tissue banking activity;
designate a principal person in charge to be responsible for ensuring that the tissue bank complies with this Act;
formulate and implement appropriate standards, policies and procedures to supervise, review and monitor the conduct of the tissue banking activity;
investigate any areas of concern and take such remedial measures as appropriate;
ensure that the tissue banking activity —
is in compliance with the requirements of this Act; and
is conducted in accordance with its standards, policies and procedures referred to in paragraph (c);
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;
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
perform such other functions and duties as may be prescribed by the Minister.
(3)
Every tissue bank must notify the Director, in such form and manner as may be prescribed, of —
the commission of any suspected offence or contravention under this Act or the regulations;
the occurrence of any serious adverse event; and
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.