sec.74CApproval of clinical research

### sec.74C Approval of clinical research The tribunal may approve clinical research only if the tribunal is satisfied— the clinical research is approved by an ethics committee; and any drugs, devices, biologicals or techniques to be trialled in the clinical research are intended to diagnose, maintain or treat a condition affecting the participants in the research; and the clinical research will not involve any known substantial risk to participants or, if there is existing health care for the particular condition, the research will not involve known material risk to the participants greater than the risk associated with the existing health care; and the development of any drugs, devices, biologicals or techniques to be trialled in the clinical research has reached a stage at which safety and ethical considerations make it appropriate for the drugs, devices, biologicals or techniques to be made available to participants in the research despite the participants being unable to consent to participation; and having regard to the potential benefits and risks of participation in the clinical research, on balance it is not adverse to the interests of participants in the research to participate. The fact the drugs, devices, biologicals or techniques to be trialled in the clinical research will or may involve giving placebos to some of the participants in the research does not prevent the tribunal being satisfied it is, on balance, not adverse to the interests of the participants to participate. The tribunal’s approval of clinical research does not operate as a consent to the participation in the clinical research of any particular person. s 74C ins 2019 No. 9 s 29 (sec.74C-ssec.1) The tribunal may approve clinical research only if the tribunal is satisfied— the clinical research is approved by an ethics committee; and any drugs, devices, biologicals or techniques to be trialled in the clinical research are intended to diagnose, maintain or treat a condition affecting the participants in the research; and the clinical research will not involve any known substantial risk to participants or, if there is existing health care for the particular condition, the research will not involve known material risk to the participants greater than the risk associated with the existing health care; and the development of any drugs, devices, biologicals or techniques to be trialled in the clinical research has reached a stage at which safety and ethical considerations make it appropriate for the drugs, devices, biologicals or techniques to be made available to participants in the research despite the participants being unable to consent to participation; and having regard to the potential benefits and risks of participation in the clinical research, on balance it is not adverse to the interests of participants in the research to participate. (sec.74C-ssec.2) The fact the drugs, devices, biologicals or techniques to be trialled in the clinical research will or may involve giving placebos to some of the participants in the research does not prevent the tribunal being satisfied it is, on balance, not adverse to the interests of the participants to participate. (sec.74C-ssec.3) The tribunal’s approval of clinical research does not operate as a consent to the participation in the clinical research of any particular person. - (a) the clinical research is approved by an ethics committee; and - (b) any drugs, devices, biologicals or techniques to be trialled in the clinical research are intended to diagnose, maintain or treat a condition affecting the participants in the research; and - (c) the clinical research will not involve any known substantial risk to participants or, if there is existing health care for the particular condition, the research will not involve known material risk to the participants greater than the risk associated with the existing health care; and - (d) the development of any drugs, devices, biologicals or techniques to be trialled in the clinical research has reached a stage at which safety and ethical considerations make it appropriate for the drugs, devices, biologicals or techniques to be made available to participants in the research despite the participants being unable to consent to participation; and - (e) having regard to the potential benefits and risks of participation in the clinical research, on balance it is not adverse to the interests of participants in the research to participate.