14Interim regulatory recommendations and guidelines

#### 14 Interim regulatory recommendations and guidelines CEO may make interim regulatory recommendations and issue interim guidelines without Council in urgent circumstances (1) If a matter: (a) would ordinarily be the subject of a regulatory recommendation made, or guidelines issued, as provided to the CEO under subsection 9(1); and (b) must, in the opinion of the CEO, for any reason, be dealt with urgently; the CEO may, despite subsection 9(1), make a regulatory recommendation, or issue guidelines, without receiving them from the Council. (2) Within 30 days after the CEO makes an interim regulatory recommendation or issues interim guidelines in accordance with subsection (1), the CEO must publish a notice on the NHMRC’s website: (a) setting out his or her reasons for making the recommendation or issuing the guidelines; and (b) setting out: (i) a summary of the recommendation; or (ii) the guidelines; and (c) inviting persons or bodies to make submissions to: (i) in the case of human research guidelines—the Australian Health Ethics Committee; or (ii) otherwise—the Council; relating to the recommendation or guidelines in accordance with the procedures, and within the period, specified in the notice; and (d) including the information prescribed by the regulations. Council may provide recommendations and guidelines to CEO without consultation in urgent circumstances (3) If a matter: (a) would ordinarily be the subject of a regulatory recommendation, or guidelines (other than human research guidelines), provided to the CEO under subsection 9(1); and (b) must, in the opinion of the Council, for any reason, be dealt with urgently; the Council may provide a regulatory recommendation or guidelines to the CEO without first undertaking one or more of the steps set out in section 12 or 13. (4) Within 30 days after the CEO makes an interim regulatory recommendation, or issues interim guidelines, provided to him or her in accordance with subsection (3), the Council must publish a notice on the NHMRC’s website: (a) setting out its reasons for providing the recommendation or guidelines to the CEO; and (b) setting out: (i) a summary of the recommendation; or (ii) the guidelines; and (c) inviting persons or bodies to make submissions to the Council relating to the recommendation or guidelines in accordance with the procedures, and within the period, specified in the notice; and (d) including the information prescribed by the regulations. Australian Health Ethics Committee may provide human research guidelines to Council without consultation in urgent circumstances (5) If a matter: (a) would ordinarily be the subject of human research guidelines provided to the Council under subsection 10(2); and (b) must, in the opinion of the Australian Health Ethics Committee, for any reason, be dealt with urgently; the Committee may provide guidelines to the Council without first undertaking one or more of the steps set out in section 13. (6) Within 30 days after the CEO issues interim guidelines provided to the Council in accordance with subsection (5), the Australian Health Ethics Committee must publish a notice on the NHMRC’s website: (a) setting out its reasons for providing the guidelines to the Council; and (b) setting out the guidelines; and (c) inviting persons or bodies to make submissions to the Committee relating to the guidelines in accordance with the procedures, and within the period, specified in the notice; and (d) including the information prescribed by the regulations. Council must advise CEO to confirm, vary or revoke interim regulatory recommendations or guidelines (7) If the CEO makes an interim regulatory recommendation or issues interim guidelines: (a) in the case of human research guidelines—the Australian Health Ethics Committee must: (i) as soon as practicable after, but not later than 30 days after, the end of the period specified in the relevant notice under subsection (2) or (6); and (ii) having regard to any submissions received; advise the Council to advise the CEO to confirm, vary or revoke the guidelines; or (b) otherwise—the Council must: (i) as soon as practicable after, but not later than 30 days after, the end of the period specified in the relevant notice under subsection (2) or (4); and (ii) having regard to any submissions received; advise the CEO to confirm, vary or revoke the recommendation or guidelines. (8) The Council may only advise the CEO to confirm, vary or revoke interim human research guidelines in accordance with the Committee’s advice under paragraph (7)(a). However, the Council is not obliged to provide particular advice to the CEO merely because it has been advised to do so by the Committee in accordance with this section. Interim regulatory recommendations and guidelines automatically revoked after 45 days (9) If the CEO fails, within 45 days after the end of the period specified in the relevant notice under subsection (2), (4) or (6), to confirm, vary or revoke an interim regulatory recommendation or interim guidelines in accordance with the Council’s advice (if any) under paragraph (7)(b) or subsection (8), the CEO is to be treated as having revoked the recommendation or guidelines.