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.]