41ADefinitions—pt 4.3A

41A Definitions—pt 4.3A (1) In this part: approved, for medical research or low-risk research, means medical research or low-risk research approved by a human research ethics committee constituted in accordance with, and acting in compliance with, the National Statement on Ethical Conduct in Human Research (2007), published by the NHMRC, as in force from time to time. Note The National Statement on Ethical Conduct in Human Research (2007) is accessible at www.nhmrc.gov.au. low-risk research, in relation to a person— (a) means research carried out for medical or health purposes that— (i) poses no foreseeable risk of harm to the person, other than any harm usually associated with the person’s condition; and (ii) does not change the treatment appropriate for the person’s condition; but (b) does not include research that is part of a clinical trial, unless the trial is evaluating only the following: (i) a therapeutic good that is included in the Australian Register of Therapeutic Goods (other than the part of the Register for goods known as provisionally registered goods); (ii) a health care procedure, process or technique supported by a substantial number of practitioners in the relevant field of health care. 1 a comparative assessment of the effects of different methods of drug administration proven to be beneficial in the treatment of a condition (such as a continuous infusion as opposed to a once-a-day administration) 2 a comparative assessment of the angle at which to set a tilt bed to best assist a person’s breathing 3 research comparing the effectiveness of paracetamol and ibuprofen during routine health care medical research, in relation to a person— (a) means research in relation to the diagnosis, maintenance or treatment of a medical condition that the person has or has had or to which the person has a significant risk of being exposed; and (b) includes— (i) experimental health care; and (ii) the administration of medication or the use of equipment or a device as part of a clinical trial; and (iii) research prescribed by regulation as medical research; but (c) does not include— (i) low-risk research; or (ii) research prescribed by regulation not to be medical research. Example—par (b) (ii) a clinical trial involving a drug usually used for a particular medical condition but trialled as a treatment for a different medical condition medical research power of attorney, for a principal, means— (a) an enduring power of attorney under which the principal authorises an attorney to exercise power in relation to a medical research matter; or (b) an enduring power of attorney— (i) under which the principal authorises an attorney to exercise power in relation to a health care matter; and (ii) that was made before the commencement of the Powers of Attorney Amendment Act 2016. Australian Register of Therapeutic Goods means the register maintained under the Therapeutic Goods Act 1989 (Cwlth), section 9A. Note The Australian Register of Therapeutic Goods can be accessed at www.tga.gov.au/resources/artg. experimental health care means research— (a) into health care that— (i) has not yet gained the support of a substantial number of practitioners in that field of health care; and (ii) may, but need not, be medical in nature; and (b) delivered as part of a test or trial. 1 trialling increased physical therapy for patients on ventilation apparatus 2 trialling a new absorbent material after bathing to treat dermatological conditions NHMRC means the National Health and Medical Research Council established under the National Health and Medical Research Council Act 1992 (Cwlth), section 5B. personal health information—see the Health Records (Privacy and Access) Act 1997, dictionary. personal information—see the Information Privacy Act 2014, section 8. therapeutic goods—see the Therapeutic Goods Act 1989 (Cwlth), section 3.