HUMAN REPRODUCTIVE TECHNOLOGY ACT 1991 - SECT 44
HUMAN REPRODUCTIVE TECHNOLOGY ACT 1991 - SECT 44
44 . Records of procedures
(1) A licensee shall
make, maintain, keep and retain a proper record —
(a)
showing in relation to human gametes, human eggs undergoing fertilisation or
human embryos kept or used by that licensee —
(i)
if human gametes, the identity and consent of the donor
from whom, and the date when, received; and
(ii)
if human eggs undergoing fertilisation or human embryos,
their biological parentage and the date fertilisation commenced; and
(iii)
the place, period and method of collection and of
keeping; and
(iv)
the identity of any person to whom human gametes, human
eggs undergoing fertilisation or human embryos were supplied, of every person
for whom the gametes, eggs undergoing fertilisation or embryos were used in an
artificial fertilisation procedure, and, if known, the ultimate recipient;
and
(b) in
relation to all artificial fertilisation procedures carried out by or on
behalf of the licensee showing —
(i)
the identity of, and full particulars as to the consent
given by, each participant; and
(ii)
the reasons why each participant was assessed as being an
eligible person in respect of that procedure; and
(iii)
the nature of the procedure; and
(iv)
the identity of the individual who carried out that
procedure; and
(v)
where known —
(A) the outcome of the procedure; and
(B) whether any children were born that
appear to the licence supervisor to have been born as a result of the
procedure; and
(C) sufficient particulars to identify each
such child;
and
(c) of
all research relating to reproductive technology conducted, authorised or
facilitated by or on behalf of that licensee; and
(d) any
other information, procedure or matter of which a record is required under
this Act or any other written law,
in such a manner as to
comply with the terms of, and any condition imposed on, the licence or any
approval or direction relating to that licence and any requirement under this
Act, unless the CEO, in writing, otherwise directs.
(2) Subsection (1)
does not apply to the holder of an exemption conferred under section 28 or
28A, except in so far as the CEO —
(a) by a
condition imposed on that exemption, requires; or
(b) in
writing, otherwise directs.
(3) A person required
by subsection (1) to make a record of a matter shall —
(a) make
up the record as soon as is practicable after the occurrence to which it
relates; and
(b) keep
and retain a proper record, in such a manner as to keep secure the
confidential nature of the information contained in that record, in a place in
the State approved by the CEO for the purpose, for the prescribed number of
years after the date on which it was compiled; and
(c) make
the record available for inspection by an authorised officer,
and no information
shall be removed from any such record before the expiry of such period as may
be specified in the Rules or by directions for information of that kind.
(4) A licensee shall,
if so required by the CEO, furnish in a form acceptable to the CEO any record
to which subsection (1) applies and reports containing such further or other
information as the CEO may reasonably require —
(a) in
respect of any research; or
(b)
concerning —
(i)
any artificial fertilisation procedure using; or
(ii)
the keeping, or any facility or procedure relating to the
keeping, of,
any human gametes, a
human egg undergoing fertilisation or a human embryo; or
(c)
relating to any other matter, specified by the CEO as being relevant to the
administration of this Act, whether in relation to that licence or exemption
or otherwise,
in respect of such
period, or in relation to such circumstances, at and within such times, and
verified in such manner and by such a person, as the CEO may direct.
(5) Where a person
ceases to be a licensee, any record required to have been kept under this
section by that person shall be retained, in a manner and at a place approved
by the CEO for that purpose, by or on behalf of that person or may be lodged
with the CEO.
(6) A person who,
being a person to whom the relevant licence applies or applied, fails —
(a) to
make, maintain, keep or retain a record or report, as required by this
section; or
(b) to
keep secure the confidential information contained in such a record; or
(c) to
make such a record available for inspection by an authorised officer,
commits an offence.
Penalty: $5 000.
[Section 44 amended: No. 17 of 2004 s. 30; No. 28
of 2006 s. 270.]