9.—(1) For the purposes of the donation of the cord blood of an infant donor, a licensee must obtain prior express written consent from the mother of the infant donor for all of the following before the mother is in active labour:
(a)
the donation of cord blood of the infant donor;
(b)
the collection and storage of any cord blood of the infant donor.
(2) A licensee must, before obtaining the mother’s consent under paragraph (1), provide adequate and appropriate counselling to the mother.
(3) A licensee must ensure that—
(a)
the counselling mentioned in paragraph (2) is conducted by one or more competent personnel who has appropriate qualifications or training; and
(b)
adequate records of the counselling provided are maintained.
(4) A licensee must, at the time the mother’s consent under paragraph (1) is sought —
(a)
inform the mother of all of the following:
(i)
the purposes for which the cord blood collected is to be used;
(ii)
any tests necessary to assess the suitability of the cord blood for use;
(iii)
where the cord blood is found to be of low potency or contaminated — the manner in which the licensee will deal with the cord blood;
(iv)
where the cord blood is distributed for the purpose of transplant — that the licensee will disclose to the acute hospital service licensee to which the cord blood is distributed (including the transplanting clinician who transplants or will transplant the cord blood) the following information:
(A)
the medical history of the infant donor of the cord blood and the mother;
(B)
information relating to the licensee’s testing and processing of the cord blood; and
[S 389/2023 wef 26/06/2023]
(b)
ascertain whether the mother, in the event of any abnormal finding or incidental finding relating to the infant donor or mother, consents to either or both of the following:
(i)
the infant donor or mother being re‑identified by the licensee and informed of the abnormal finding or incidental finding;
(ii)
the medical practitioner caring for the infant donor or mother (as the case may be) being informed of the abnormal finding or incidental finding.
(5) A licensee must ensure that —
(a)
the mother is given sufficient time, after receiving the counselling mentioned in paragraph (2), to decide whether or not to give her consent under paragraph (1); and
(b)
the mother’s consent under paragraph (1) is not obtained by means of coercion, intimidation, deception or misrepresentation by any officer, employee or agent of the licensee.
(6) This regulation applies in addition to and does not affect any requirement, restriction or prohibition under any other written law or rule of law.