In order to be enrolled in a clinical trial, subjects must give fully voluntary and informed consent. In some studies, consent may need to be renegotiated from time to time, especially if the trial is long-running or complex (i.e. genomics research). Match the following types of consent to their definitions:

According to the National Statement, which of the following clinical drug trials would not be allowed?

What is the primary guiding document for the current standards of ethical clinical research in Australia?

What is Australia’s primary national funding body for health and medical research?

Which one of the following responses is false?

Learning activities

iv. Clinical trials involving medicines

Activity

Say Mr Jones has full capacity to understand the implications and nature of the proposed trial. If you were the researcher, what general benefits and risks would you convey to Mr Jones in the patient recruitment stage?

Learning activities

iv. Clinical trials involving medicines

Match the following:

Match the following descriptions to match their corresponding clinical drug trial phase:

• Statement A - To assess pharmacokinetics and preliminary data on drug bioavailability
• Statement B - To assess drug safety; to assess tolerance; drug pharmacokinetics / pharmacodynamics and identify preferred routes of administration
• Statement C - To assess drug efficacy and further assess safety through pilot studies; to explore the therapeutic dose range
• Statement D - To assess drug efficacy and determine optimum therapeutic dose and regimen to inform conduct of subsequent trials
• Statement E - To test medicine efficacy in large groups of participants for whom the drug is eventually intended; to test efficacy by comparing new drug to other standard or experimental drugs; to monitor for rare side effects
• Statement F - Post marketing surveillance or resolution of treatment uncertainties; Monitor safety in real world populations; Trial combinations with existing products

Learning activities

iv. Clinical trials involving medicines

Match the following:

Match the following descriptions to match their corresponding clinical drug trial phase

Learning activities

i. Principles of research ethics and research publication

Mini Quiz

Select the 8 hallmarks for responsible clinical research, as outlined by the NHMRC ‘Research Code’ (8 correct, 2 incorrect answers):

Which of the following is important in fighting racism?