Singapore legislation
Section 37
Section 37
Restrictions on activities relating to human tissue
(1)
No person may remove any human tissue from a donor unless —
where the tissue is to be removed for a therapeutic or diagnostic purpose but will also be or is likely to be used for research purposes, appropriate consent has been obtained for these research purposes in addition to the consent obtained for the therapeutic or diagnostic purpose; or
where the tissue is to be removed for a research purpose, appropriate consent has been obtained for the tissue to be removed from the donor.
(2)
No person may remove any human tissue from any of the following persons unless the removal of the tissue was primarily for a therapeutic or diagnostic purpose:
an adult who lacks mental capacity;
a minor who lacks mental capacity;
a minor who lacks sufficient understanding and intelligence to give consent.
(3)
Despite subsection (2), an institutional review board may waive the requirement that the tissue be removed, from any person referred to in that subsection, primarily for a therapeutic or diagnostic purpose if the board is satisfied that —
the removal of the tissue involves no more than minimal risk to that person; and
there are reasonable grounds for believing that the proposed areas of research cannot be carried out without the use of the tissue from the class of persons to which that person belongs.
(4)
No person may store any human tissue for subsequent use in research unless that person is reasonably satisfied that —
appropriate consent has been obtained for the tissue to be stored for subsequent use; and
the storage is in accordance with any conditions or restrictions specified as part of the appropriate consent.
(5)
No person may supply any human tissue to another person for use in research unless that person is reasonably satisfied that —
appropriate consent has been obtained for the tissue to be used in research;
the intended use is in accordance with any conditions or restrictions specified as part of the appropriate consent; and
the recipient is informed of the requirements referred to in paragraphs (a) and (b).
(6)
No person may use any human tissue in research unless that person is reasonably satisfied that —
appropriate consent has been obtained for the tissue to be used in research; and
the intended use is in accordance with any conditions or restrictions specified as part of the appropriate consent.
(7)
No person may use any human tissue that has been —
removed from the donor where the sole purpose or one of the purposes of the removal is research;
stored for use in research; or
supplied for use in research,for any purpose other than research unless that person is reasonably satisfied that the use is in accordance with the conditions or restrictions (if any) specified as part of the appropriate consent for its use in research.
(8)
In the case of any human tissue which has been imported from a place outside Singapore, whether on its own or as part of a human body or body part, it is sufficient compliance with subsection (4), (5), (6) or (7) for a person to prove that there is documentary evidence that consent has been given in accordance with the legal or ethical requirements of that place.
(9)
Where the human tissue was removed from a donor for a therapeutic or diagnostic purpose, no person may store, supply or use the tissue for research or for any other purpose unless the medical practitioner or healthcare institution responsible for the medical treatment of the donor had completed all necessary therapeutic or diagnostic procedures and no longer requires the tissue or part of the tissue for the treatment.
(10)
This section does not apply to —
the removal, storage or supply of any human tissue in the course of a post-mortem examination conducted in accordance with the Coroners Act 2010 or carried out pursuant to the order of a Coroner made under that Act;
the removal, storage or supply of any organ as defined in the Human Organ Transplant Act 1987 and carried out in accordance with that Act; and
the removal, storage or supply of all or any part of a human body or a post-mortem examination carried out in accordance with the Medical (Therapy, Education and Research) Act 1972.
(11)
Any person who contravenes this section shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $50,000 or to imprisonment for a term not exceeding 5 years or to both.